ASCO Guidelines
195 episodes — Page 4 of 4
Ep 45Optimum Imaging Strategies for Advanced Prostate Cancer Guideline
An interview with Dr. Edouard Trabulsi from the Sidney Kimmel Medical College at Thomas Jefferson University on "Optimum Imaging Strategies for Advanced Prostate Cancer: ASCO Guideline." This guideline outlines techniques available and provides recommendations on appropriate use of imaging for specified patient subgroups. Read the full guideline at www.asco.org/genitourinary-cancer-guidelines. TRANSCRIPT The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. [MUSIC PLAYING] Hello, and welcome to the ASCO Guidelines Podcast Series, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. My name is Shannon McKernin, and today I'm interviewing Dr. Ed Trabulsi from the Medical College at Thomas Jefferson University in Philadelphia, Pennsylvania, lead author on "Optimum Imaging Strategies for Advanced Prostate Cancer: ASCO Guideline." Thank you for being here today, Dr. Trabulsi. Thanks, Shannon. Thanks for inviting me. So first, can you give us a general overview of what this guideline covers? Sure. So the purpose of this guideline, and it's fairly broad, is to try to come up with some recommendations and strategies for appropriate imaging for patients with advanced prostate cancer. Also, that includes patients that are newly diagnosed that are high or very high risk for having micrometastatic disease. Also, patients that have been treated and are suffering recurrence of disease as indicated by rising PSA. And then also, patients with metastatic disease, either on initial diagnosis, or on treatment and who are contemplating changing treatments. Also, it has a wide range of different patient populations that all fit in the category of advanced prostate cancer. And the idea is to try to figure out or make some recommendations on strategies for what imaging is appropriate for each of those groups of men. So what are the key recommendations for this guideline? Well, the big impetus for this guideline is the awareness of what we would consider next-generation imaging, meaning that there's a large group of new or novel imaging studies available and on the horizon. And we're trying to figure out the best way to fit them in in the context of traditional imaging in what we would call conventional imaging. So that would be-- conventional imaging would be imaging tests like CAT scan, radionuclide bone scan, prostate MRI, that sort of thing. Next-generation imaging would include some of the newer PET imaging scans, using different tracers and isotopes, and some of the new SPECT imaging scans, as well as full body MRI. And so how to interweave those different imaging tests is really what's proving to be not as straightforward as we'd like. And so we realized that we need to really approach this based on a clinical disease state model. So not just one monolithic category of advanced prostate cancer, but looking at specific scenarios. And we developed this guideline as a scenario-based algorithm. So the initial diagnosis of prostate cancer of men that are at high risk, what images we think about there; for men that have been treated and their PSA is rising, and so forth. And so we shouldn't jump to next-generation imaging across the board. We really should look very specifically at circumstances where these new, novel, and unfortunately, expensive imaging tests could have real clinical impact. So patients that are newly diagnosed that are high risk who have suspicious or equivocal conventional imaging, so they have a CAT scan or a bone scan or something that we're really not sure if something that we're seeing there might be an indication of disease, that's a good spot where next-generation imaging might be very helpful. For patients that have been treated and their PSA is rising, say, after surgery or, say, after radiation, and they get traditional, what we would call conventional imaging, and we don't see a source for the PSA, well, that is another scenario where a patient-- or a category where next-generation imaging should be considered. In that specific space, there actually are two PET imaging studies that have been approved by FDA in the US with C-11 choline, as well as the fluorine-18 fluciclovine scans. And then also overseas, or not yet approved in the US, there are other PET-based agents that are being used in that specific space. Another important aspect of this is that it should have real clinical impact. So if you have a man who unfortunately may be suffering, or evidence
Ep 44Estrogen and Progesterone Receptor Testing in Breast Cancer Guideline Update
An interview with Dr. Kimberly Allison from Stanford University School of Medicine and Dr. Antonio Wolff from Johns Hopkins University on "Estrogen and Progesterone Receptor Testing in Breast Cancer Guideline: ASCO/CAP Guideline Update." This guideline updates key recommendations of the American Society of Clinical Oncology/College of American Pathologists estrogen and progesterone receptor testing in breast cancer guideline, and focuses on low estrogen receptor expression cases. Read the full guideline at www.asco.org/breast-cancer-guidelines.
Ep 43Molecular Biomarkers in Localized Prostate Cancer Guideline
An interview with Dr. Scott Eggener of University of Chicago Medicine on "Molecular Biomarkers in Localized Prostate Cancer: ASCO Guideline." This guideline provides recommendations for available tissue-based prostate cancer biomarkers geared toward patient selection for active surveillance, identification of clinically significant disease, choice of postprostatectomy adjuvant versus salvage radiotherapy, and to address emerging questions such as the relative value of tissue biomarkers compared with MRI. Read the full guideline at www.asco.org/genitourinary-cancer-guidelines TRANSCRIPT If you like what you hear from the ASCO podcast, please let us know. Take our listener survey and help shape the future of the ASCO Podcast Network. Visit podcast.asco.org, and click on the survey link. Once again, that's podcast.asco.org. The survey will just take a few minutes to complete and will help us get to know you better. Thank you so much for listening. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello and welcome to the ASCO Guidelines Podcast Series brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content and offering enriching insight into the world of cancer care. You can find all the shows including this one at podcast.asco.org. My name is Shannon McKernin. And today I'm interviewing Dr. Scott Eggener from the University of Chicago Medicine, lead author on molecular biomarkers in localized prostate cancer ASCO Guideline. Thank you for being here today, Dr. Eggener. Thanks for having me, Shannon, and covering the guideline. So first, can you give us a general overview of what this guideline covers? Yeah, this guideline has been two years in the making and is an overview of the available molecular biomarkers to help clinicians and patients make smart decisions for men with localized prostate cancer. And that's in the newly diagnosed setting, as well as for certain patients that have undergone surgery and are considering adjuvant radiation therapy. And so what are the key recommendations for this guideline? So there was a lot of data that the team looked through with the help of the ASCO home office, and a Herculean amount of work went into it. There's a lot of commercially available tests out there. Most of them are quite expensive. And we are trying to make sense of the available literature and provide a guide to clinicians on what these tests are, which patients they might be relevant for, and how to interpret them. The key takeaways that the data that's been published for most of these biomarkers are purely prognostic. And there is good science and good data supporting them. But they have not been embedded in a rigorous fashion or within trials or validated to have the highest level of evidence. However, they can be used in certain situations to add additional info for the patient and clinician to try to make smart decisions based on prognostic information. Another key recommendation is that there are select patients that these can be helpful for. And we dive into a lot of the details on who these patients may be. Number one is a patient newly diagnosed with prostate cancer who is trying to determine whether to do treatment of the prostate cancer or embark on active surveillance. And some of those decisions are relatively easy and straightforward. But when the clinician and the patient are looking for all pieces of information to influence one way or the other, genomic or molecular biomarkers can be useful at that critical fork in the road. However, we made it very clear multiple times throughout the guideline that our group's recommendation is that the biomarkers should not be reflexively ordered for every individual newly diagnosed with prostate cancer. It seems wasteful and not an appropriate use of resources. The other situation clinically where these can be used are for men that have had previous surgery and are considering secondary radiation therapy, which can be given in an adjuvant or salvage manner. And there are some data suggesting that a specific test by Decipher, a genomic classifier, can be used to help inform whether adjuvant radiation would be appropriate or not. So that was a good overview. And this guideline also includes some special commentary sections with additional research questions that the expert panel wanted to address. So can you tell the listeners a little more about these important considerations? Yeah, it's critically important to know that these tests are not black and white. And they don't always clarify a data-based path forward. But we tried to emphasize in m
Ep 42Patient-Centered Standards for Medically Integrated Dispensing: ASCO/NCODA Standards
An interview with Dr. Melissa Dillmon on the Patient-Centered Standards for Medically Integrated Dispensing: ASCO/NCODA Standards. The interview covers the findings of the systematic review, which were consistent with the NCODA patient-centered standards for patient relationships and education, adherence, safety, collection of data, documentation and other areas. NCODA standards were adopted and used as basis for these ASCO/NCODA standards. Additional information is available at www.asco.org/mid-standards.
Ep 41Management of Osteoporosis in Survivors of Adult Cancers with Nonmetastatic Disease Guideline
An interview with Dr. Charles Shapiro from Mount Sinai Hospital in New York and Dr. Joan Neuner from Medical College of Wisconsin, co-chairs of "Management of Osteoporosis in Survivors of Adult Cancers with Nonmetastatic Disease: ASCO Clinical Practice Guideline." This guideline includes recommendations on assessing risk factors and interventions, including pharmacologic and nonpharmacologic options. Read the full guideline at www.asco.org/survivorship-guidelines TRANSCRIPT Hi. My name is Clifford Hudis, and I am the CEO of the American Society of Clinical Oncology as well as the host of the ASCO in Action podcast. About twice a month, I interview thought leaders in healthcare care and experts in oncology, and we provide analysis and commentary on a wide range of cancer policy and practice issues. You can find the ASCO in Action podcast on Apple podcasts or wherever you are listening to this show, and you can find all nine of ASCO's podcasts, which cover a wide range of educational and scientific content, and offer enriching insight into the world of cancer care at podcast.asco.org. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello and welcome to the ASCO Guidelines Podcast series, brought to you by the ASCO Podcast Network, a collection of nine programs covering a range of educational and scientific content, and offering enriching insight into the world of cancer care. You can find all of the shows, including this one, at podcast.asco.org. My name is Shannon McKernin and today on the ASCO Guidelines Podcast, I'm interviewing Dr. Charles Shapiro from Mount Sinai Hospital in New York, and Dr. Joan Neuner from the Medical College of Wisconsin, Milwaukee, co-chairs of management of osteoporosis in survivors of adult cancers with non-metastatic disease ASCO clinical practice guideline. Thank you for being here, Dr. Shapiro and Dr. Neuner. Thanks a lot. Pleasure to be here. So first, can you give us a general overview of what this guideline does cover? This guideline covers very important topics, that of osteoporosis and that of cancer survivorship. It's the coalescence of these two common problems that is the impetus for this guideline. It covers risk factors and what you can do as a cancer survivor to mitigate your risk. It covers screening and identification of the best test to use to measure your bone density, and it covers how to treat or pull the trigger for anti-osteoporosis drugs based on the guidelines that are contained within the document. And what are the key recommendations for this guideline? So we developed this guideline with three key guideline questions in mind. And they really required a fairly extensive search of the literature to address them. And we did that by looking to some of the literature outside of cancer in osteoporosis screening in other patients as well. So I'll sort of talk about it in terms of the three key questions. So the first question we had was, which patients with non-metastatic cancer are at increased risk for developing osteoporotic fractures? So that first question was, which patients are we really addressing in this guideline? And how do we assess whether they're at potentially increased risk? So in response to that, we strongly recommend that oncologists teaming with other physicians, including primary care doctors like myself, evaluate their patients to determine whether they're high risk. And so we provide a lot of details in an extensive document. But in our bottom line, we have a summary of the most common and the most severe risk factors. And those include things like advanced age, current smoking, excessive alcohol consumption, and a history of prior fractures, so already showing that they're at high risk for fractures. So we recommend you look to that list. And then add in your own clinical judgment, particularly about patients who have added risks from their cancer treatments. And so we do also talk about those patients. And in particular, we call out patients with specific anticancer therapies, for example, aromatase inhibitors given to breast cancer patients, antiandrogens or GnRH agonists given to breast cancer and prostate cancer patients and call out how they're at particular risk. And finally, in response to this question, we also recommend that you consider using a risk assessment tool. And here, I mention that we had to look to the non-cancer literature. So here, the WHO actually developed something called the Fracture Risk Assessment Tool, or FRAX. And we do recommend that you use this tool or something like it to help you to assess whether your patient is at high risk. And those are readily available on
Ep 40Use of Endocrine Therapy for Breast Cancer Risk Reduction Guideline
An interview with Dr. Kala Visvanathan from Sidney Kimmel Comprehensive Cancer Center, and Johns Hopkins Bloomberg School of Public Health on the guideline update. This update adds anastrozole to the options of pharmacologic interventions for breast cancer risk reduction based on recent practice changing data. Read the full guideline at www.asco.org/breast-cancer-guidelines. TRANSCRIPT Hi. My name is Clifford Hudis, and I am the CEO of the American Society of Clinical Oncology as well as the host of the ASCO in Action podcast. About twice a month, I interview thought leaders in health care and experts in oncology. And we provide analysis and commentary on a wide range of cancer policy and practice issues. You can find the ASCO in Action podcast on Apple Podcasts or wherever you are listening to this show. And you can find all nine of ASCO's podcasts, which cover a wide range of educational and scientific content and offer enriching insight into the world of cancer care at podcast.asco.org. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello, and welcome to the ASCO Guidelines Podcast series. My name is Shannon McKernin, and today I'm interviewing Kala Visvanathan from the Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, and Johns Hopkins Bloomberg School of Public Health, co-first author on "Use of Endocrine Therapy For Breast Cancer Risk Reduction: ASCO Clinical Practice Guidelines Update." Thank you for being here, Dr. Visvanathan. Thank you as well for having me. So can you tell us about the phase III randomized trial, which provided the signal for this update? Yes. This was the IBIS-II trial that was reported out by Cuzick, et al in 2014. It was a double-blind, randomized placebo-controlled trial that assessed the safety and efficacy of Anastrozole, the aromatase inhibitor Anastrozole, at 1 milligram per day for five years. And the primary endpoint was the reduction of the incidence of breast cancer in postmenopausal women at increased risk of developing breast cancer. The trial itself was reported out with a median follow up of five years and the intention-to-treat analysis actually revealed that 85 women in the placebo group and 40 women in the Anastrozole group had developed both invasive and noninvasive breast cancer. What it showed was that there was a reduction in the incidence of breast cancer of 53% overall. It included both invasive and non-invasive breast cancer after a seven-year followup. And importantly, in subgroup analysis, similar to the other hormone endocrine therapy prevention trials, it also showed that the reduction in breast cancer risk among invasive cancers was limited to those individuals with ER-positive and PR-positive tumors. And the reduction in breast cancer incidence was among hormone-positive breast cancers. Another interesting point to mention here was that the five-year adherence was only slightly less in the Anastrozole arm compared to placebo. So it was well tolerated. And that was 68% in the Anastrozole group compared to 72% in the placebo group. And in all the subgroup analysis, there was no significant difference, except when they stratified by hormone replacement, women who had no prior hormone replacement, they saw a clear risk reduction. And this was not seen in women with prior hormone replacement therapy. And so what are the key recommendations for the update of this guideline? So based on these results, the update really adds Anastrozole as another option for endocrine prevention in women at increased risk. So specifically, we say that Anastrozole 1 milligram per day orally for five years should be discussed as an alternate to tamoxifen, raloxifene or exemestane in postmenopausal women for the reduction of breast cancer in women at increased risk. We also clarify further who are the women most likely to benefit from Anastrozole or the other endocrine prevention drugs. And these are women diagnosed with atypical hyperplasia, either ductal or lobular, or lobular carcinoma in situ or women with an estimated five-year risk of at least 3% based on the NCI Breast Cancer Risk Assessment tool or a 10-year risk of at least 5% based on the IBIS Tyrer-Cusick Risk Calculator. But we also give parameters for other risk models, and that is a relative risk of at least four times the population risk for women in the age group 40 to 45 and two times that of the population age group from 45 to 69. I think this is an important part of the recommendations, because up till now, the recommendations for women at increased risk have really followed the eligibility criteria for these trials, which were often a fi
Ep 39Venous Thromboembolism Prophylaxis and Treatment in Patients with Cancer Guideline Update
An interview with Dr. Anna Falanga on "Venous Thromboembolism Prophylaxis and Treatment in Patients with Cancer: ASCO Clinical Practice Guideline Update." The guideline revises several previous recommendations. Most notably, direct oral anticoagulants (DOACs) have been added as options for VTE prophylaxis and treatment. Read the full guideline at www.asco.org/supportive-care-guidelines Find all of ASCO's podcasts at podcast.asco.org TRANSCRIPT Hi, my name is Clifford Hudis and I am the CEO of ASCO and the host of the ASCO in Action Podcast. About twice a month, I interview thought leaders in health care and experts in oncology, and we provide analysis and commentary on a wide range of cancer policy and practice issues. You can find the ASCO in Action Podcast on Apple Podcasts or wherever you are listening to this show, and you can find all 9 of ASCO's podcasts which cover a wide range of educational and scientific content and offer enriching insight into the world of cancer care at podcast.asco.org Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello and welcome to the ASCO Guidelines Podcast series. My name is Shannon McKernin. And today I'm interviewing Dr. Anna Falanga from the hospital Papa Giovanni XXIII in Bergamo, Italy. Senior author on "Venous Thromboembolism Prophylaxis and Treatment in Patients with Cancer: ASCO Clinical Practice Guidelines Update." Thank you for being here today, Dr. Falanga. Yes, thank you. I am very happy to talk on the update of the ASCO VTE guidelines. So this guideline was first published in 2007 with an update in 2013 and a reaffirmation in 2015. So what prompted this 2019 update? Thanks for this first question. I think that an update was urgently needed at this time. You know, before, the ASCO guidelines were published in 2007. And then an update was made in 2013, and the second one in 2015. But in 2015 was basically a confirmation of the previous 2013 update. Now the update was urgently needed, because in the very recent years there has been even more evidence of the relevance and impact of a venous thromboembolism in the cancer patients. But in addition, and very importantly, new data from prospective randomized clinical trials with the new drugs for the management of VT in the oncological patients have become available. In particular, as you know, low molecular weight heparins were largely used in the setting of the treatment and trauma prophylaxis in the cancer patients. And actually, the low molecular weight tapering have been the standard of treatment for many years. However, recently the results of prospective randomized clinical trials of direct oral anticoagulant, particularly, the anti-Xa inhibitors, Edoxaban and Rivaroxaban, for cancer associated with [INAUDIBLE] treatment support the role of this new oral agent in the VT management in this setting. And this is related to new politics in the VT management in these patients. So what are the key recommendations for this guideline update? The main changes to the previous recommendations are first that Rivaroxaban and Edoxiban, the two anti-Xa inhibitors oral anticoagulants have been added as an option for routine treatment in cancer patients in this update. Also, now we may offer thrombo prophylaxis with Apixaban, Rivaroxaban, or low molecular weight tapering to selected high-risk outpatients with cancer. And about other changes of these new guidelines compared to the last one include that patients with brain metastases have been addressed in the VT type treatment sections, whereas before, only patients with the primary tumors were mentioned in the previous edition. And finally, the recommendation regarding long-term postoperative thromboprophylaxis with low molecular weight heparin expanded to patients undergoing a major open or laparoscopic abdominal or pelvic surgery. These are the main changes that all I think are very, very important. Why is this guideline so important? And how does it affect practice? Well, I think that the question how these changes affect our practice is a very important question, because I believe that these guidelines reflect the new evidence that we have from the new data. And this data clearly expand our possibility to choose now between the different treatment options in the single patient in the cancer population. For instance, the new data show that treatment with [INAUDIBLE] anticoagulants compared to low molecular weight heparin lower the risk of a recurrent thrombosis. But in some instances there's a higher risk of bleeding, particularly in the gastrointestinal and urinary tract cancer patients. So therefore it is evident th
Ep 38Medication-Related Osteonecrosis of the Jaw Guideline
An interview with Dr. Noam Yarom, Dr. Charles Shapiro, Dr. Deborah Saunders and Dr. Doug Peterson on "Medication-Related Osteonecrosis of the Jaw: MASCC/ISOO/ASCO Clinical Practice Guideline." This guideline addresses the prevention and management of MRONJ in patients with cancer. This guideline is intended for oncologists and other physicians, dentists, dental specialists, oncology nurses, clinical researchers, oncology pharmacists, advanced practitioners, and patients with cancer. Read the full guideline at www.asco.org/supportive-care-guidelines Find all of the ASCO podcasts at podcast.asco.org TRANSCRIPT Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello, and welcome to the ASCO Guidelines podcast series. My name is Shannon McKernin. And today, I'm interviewing a panel of authors from "Medication-Related Osteonecrosis of the Jaw: MASCC/ISOO/ASCO Clinical Practice Guideline." So could I have you each introduce yourselves for the listeners today? Thank you, Shannon. I'm Dr. Deborah Saunders. I'm the president of the International Society of Oral Oncology and was the section head for the Systematic Review on "Medication-Related Osteonecrosis of the Jaw," with MASCC and ISOO. I was a proud part of the steering committee and one of the authors. Thank you, Debbie. My name is Dr. Douglas Peterson. I am professor of oral medicine in the School of Dental Medicine at the University of Connecticut Health Center in Farmington, Connecticut. I am also a faculty member in the Head and Neck Cancer Oral Oncology Program at the university's Neag Comprehensive Cancer Center. I'm a member of the steering committee for this clinical practice guideline and one of the co-authors as well. In addition, and as of June 2019, I have been serving as chair elect during this next year for ASCO's Clinical Practice Guidelines committee. Thank you, Doug. My name is Noam Yarom. I'm an all medicine specialist from the Sheba Medical Center in Tel Aviv University in Israel. I'm serving as a culture of this guideline, and it is a pleasure to be with you today. Thanks, Noam. I am Dr. Charles Shapiro, professor of medicine at the Mt. Sinai Hospital in New York. And I'm co-chair of the guideline "Medical-Related Osteonecrosis of the Jaw." And I'm happy to be here. Thank you all for being here today to discuss this guideline on the podcast. So first, can you give us a general overview of what this guideline covers. Sure. So you know, ASCO and MASCC, as well as ISOO decided that it would be great to provide a practical evidence-based approach in a multidisciplinary type setting to address this important topic that impacts all of our professions, that being medication-related osteonecrosis of the jaw. It's terminology and its definition and the path that's varied and even part of this publication identifies the need for us to move forward with a concise definition and similar terminology, that being medication-related osteonecrosis of the jaw. Medication-related osteonecrosis of the jaw is defined as the presence of an exposed or bone that is probable by a probe in a patient that has a history or is undergoing present use of a bone-modifying agent. This being in the absence of any patients having received any radiation to the head and neck and the absence of metastatic lesions to the jaw. The importance of us identifying this definition and agreeing on the terminology allows us to move forward in future publication to better compare outcome and provide better prevention and treatment for our patients moving forward. And what are the key recommendations of this guideline? There are six clinical questions associated with this clinical practice guideline as well as a series of recommendations built within each of the clinical questions. Clinical question one is directed to the preferred terminology and definition for osteonecrosis of the jaw, both of the maxilla and the mandible, as associated with pharmacologic therapies in oncology patients. The panel recommends that the term medication-related osteonecrosis of the jaw, MROJ, be used when referring to bone necrosis associated with pharmacologic therapies. As Dr. Saunders has described, the definition contains three key elements-- current or previous treatment with a bone-modifying agent or angiogenic inhibitor, exposed bone, or bone that can be probed through an intra or extra-oral fistula in the maxillofacial region and that has persisted for longer than eight weeks. And third, no history of radiation therapy to the jaws and no history of metastatic disease to the jaws. Clinical question two is directed to specific steps that should be taken
Ep 37Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision-Making for Early-Stage, Operable Breast Cancer Update
An interview with Dr. Lynn Henry from University of Utah Huntsman Cancer Institute on "Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision-Making for Early-Stage, Operable Breast Cancer: Update of the ASCO Endorsement of CCO Guideline." This guideline update includes data from the MINDACT and TAILORx trials to clarify the recommendations for patients with hormone receptor-positive, HER2 not overexpressed, axillary node-negative early breast cancer. Read the full guideline at www.asco.org/breast-cancer-guidelines TRANSCRIPT The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello and welcome to the ASCO Guidelines Podcast Series. My name is Shannon McKernin. And today, I'm interviewing Dr. Lynn Henry from the University of Utah Huntsman Cancer Institute, lead author on "Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision-Making for Early-Stage, Operable Breast Cancer: Update of the ASCO Endorsement of CCO Guideline." Thank you for being here today, Dr. Henry. Thank you very much for the invitation. So this guideline was updated to incorporate new data from the TAILORx and the MINDACT trials. So can you give us an overview of these trials and their results? Sure. So patients with hormone receptor-positive, HER2 negative breast cancer, are generally treated with anti-estrogen treatment and are sometimes also recommended to have chemotherapy. Since these tumors don't always respond well to chemotherapy, tests have been developed that provide more information about how much benefit, in terms of reduction of the likelihood of cancer coming back, an individual patient is likely to get from treatment with chemotherapy. It is important that the benefit of a treatment outweighs the risk of toxicity from the treatment. Two of those tests are called Oncotype DX and MammaPrint. And they have recently been tested in large clinical trials. So TAILORx is a large prospective trial that tested the Oncotype DX assay. In the Oncotype DX assay, a tumor is tested to get more information about how likely a cancer is to return and how much benefit the patient is likely to get from chemotherapy. Scores on this assay can range from 0 to 100. Previously, a study showed that patients whose tumors had scores of 10 or less, and who received five years of anti-estrogen treatment, were very unlikely to have their tumors return. So chemotherapy is not recommended for them. For patients with higher scores, above 30, we also already knew that chemotherapy is likely to decrease the chance of cancers in those patients, and, so, therefore, we generally recommend chemotherapy for women with higher scores. In the TAILORx trial, the recently reported trial, more than 6,700 women with hormone receptor-positive, HER2 negative, lymph node-negative breast cancer had their tumors tested and were found to have Oncotype DX recurrent scores between 11 and 25, which is in that intermediate range or at the higher end of the low range. Before this trial was conducted, many people with tumors like these, in the intermediate range, were treated with both chemotherapy and endocrine therapy because we weren't sure how much benefit they would obtain from chemotherapy, and we didn't want to leave out a potentially helpful treatment. In this trial, patients were randomized, or randomly assigned by a computer, to treatment with chemotherapy followed by endocrine therapy or to treatment with endocrine therapy alone. The trial was mainly looking at whether leaving out chemotherapy would increase the likelihood of invasive cancer returning. And, luckily, overall, the trial showed that the likelihood of cancer returning in those patients who got endocrine therapy alone, without chemotherapy, wasn't significantly different compared to those who were treated with chemotherapy followed by endocrine therapy. They also looked, specifically, at the group of women who were 50 years of age or younger. So mostly premenopausal women. Now, this was an exploratory question, meaning it provides information that may be correct, but it hasn't been as fully tested as the main question about what do we do for all women? In these younger women, there appeared to be some benefit from chemotherapy in those whose tumors had scores from 21 to 25, and, also possibly, in those whose tumors had scores from 16 to 20. Therefore, we still consider giving chemotherapy to younger women with Oncotype DX scores in the middle range, from 16 to 25, but not to women over age 50. So that was the TAILORx trial. The MINDACT trial was a bit different. It was testing the MammaPrint assay and the trial also included primarily wo
Ep 36Potentially Curable Pancreatic Adenocarcinoma Guideline Update
An interview with Dr. AloK Khorana from Cleveland Clinic on "Potentially Curable Pancreatic Adenocarcinoma: ASCO Clinical Practice Guideline Update." This guideline update adds another treatment regimen to the options for patients with resected pancreatic adenocarcinoma who did not receive preoperative therapy. Read the full guideline at www.asco.org/gastrointestinal-cancer-guidelines See all of ASCO's podcasts at www.asco.org/podcasts The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello, and welcome to the ASCO Guidelines Podcast series. My name is Shannon McKernin, and today I'm interviewing Dr. Alok Khorana from The Cleveland Clinic, lead author on "Potentially Curable Pancreatic Adenocarcinoma: ASCO Clinical Practice Guideline Update." Thank you for being here today, Dr. Khorana. Thank you for having me. So this guideline was first published in 2016. And then we saw an update in 2017. And now we've just updated it again. So can you tell the listeners what has prompted these updates? In the world of pancreatic cancer, this has been an evolution in adjuvant treatment, which is sort of a surprise, because we've been treating pancreatic cancer in a very similar fashion over the past several decades. And between the 1990s and until just a few years ago, there hasn't really been much progress in terms of what to do with pancreatic cancer patients after they've had their cancer resected. It's pretty clear that these patients should not have just the surgery, that they should have additional treatment after the surgery. And for decades, the standard treatment after surgery was either 5-fluorouracil or gemcitabine, but most oncologists are opting for gemcitabine. The two recent updates of the ASCO Guidelines reflect two large randomized trials that have been published in this area. The first changed-- added a new standard of care, which was a doublet adjuvant therapy with gemcitabine and capecitabine. And the reason for this most recent update is the publication of a large randomized trial of adjuvant FOLFIRINOX for patients with pancreatic cancer that was published in December 2018 in "The New England." And we felt that the results were so compelling that we needed to update the guidelines so oncologists and practitioners would have the most current data to help them make decisions for patients. So for our listeners who may not now, can you tell us what changes have been made to the recommendations in this newest version of the guideline? So this is a guideline on a potentially curable pancreatic adenocarcinoma, which is we are saying these are resectable pancreatic cancer patients. And the guideline update changes primarily one recommendation, recommendation 4.1, which is a listing of additional adjuvant therapy options. As I mentioned earlier, the most common monotherapy option used to be the gemcitabine 5-fluorouracil. And that recently changed to doublet therapy. And we've kept those recommendations, but we've added the modified combination regimen of 5-fluorouracil, oxaliplatin, and irinotecan, which is known as the FOLFIRINOX regimen. And we are making this the preferred regimen for patients in the absence of concerns for toxicity or tolerance. We are still keeping the recommendations for the doublet therapy with gemcitabine capecitabine as well as monotherapy with gemcitabine alone or fluorouracil with cholanic acid. But those are not the preferred regimens, because the data for FOLFIRINOX is much better than prior regimens. Having said that, there are concerns about using such an aggressive regimen and in patients who have undergone a major surgery. So patients have not recovered from operation, then it's reasonable to consider one of the other regimens. But the update primarily focuses on adding adjuvant FOLFIRINOX as the preferred option in the adjuvant setting. And how has this guideline and its updates affected care for patients with pancreatic adenocarcinoma? I think since the results of this trial, the PRODIGY 24 trial came out of post-operative FOLFIRINOX. Almost every oncologist I know that focuses on treating patients with pancreatic cancer has suddenly added its use in patients that respected pancreatic cancer who are healthy enough to tolerate adjuvant FOLFIRINOX therapy. So it's definitely a practice-changing landmark paper. The results of the study were really quite impressive. The use of adjuvant therapy with FOLFIRINOX led to much longer survival than we've seen in any trial of adjuvant therapy of pancreatic cancer, almost 54 months-- or actually just over 54 months, almost 55 months-- in patients who are randomized to the modified FOLFIRINOX gro
Ep 35Use of Biomarkers to Guide Decisions on Adjuvant Therapy for Early-Stage Invasive Breast Cancer Guideline Update
An interview with Dr. Fabrice Andre from Institute Gustave Roussy, Paris Sud University, in Paris, France on "Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Early-Stage Invasive Breast Cancer: ASCO Clinical Practice Guideline Update: Integration of Results from TAILORx." This update provides updated recommendations on chemoendocrine therapy for patients who present with a hormone receptor positive, HER2 not overexpressed, axillary node negative early breast cancer. TRANSCRIPT The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello, and welcome to the ASCO Guidelines Podcast Series. My name is Shannon McKernin, and today I'm interviewing Dr. Fabrice André from the Institute Gustave Roussy in Paris, France, lead author on "Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Early Stage Invasive Breast Cancer. ASCO Clinical Practice Guideline Update: Integration of Results from TAILORx." Thank you for being here today, Dr. André. Thank you. So based on the title of this guideline, we know that this update was prompted by the results of the TAILORx trial. So can you tell us more about that trial and what its results were? Yes. So the TAILORx trial was a trial that randomized two treatment modalities, endocrine therapy versus chemotherapy endocrine therapy in patients who presented what we call an intermediate recurrence cohort. So before moving to the results, maybe we can discuss a little bit the background. What we knew from the past is the fact that patients who present a recurrence score below 11 should be treated with endocrine therapy alone, because they have the good outcomes. And patients who present recurrence score that is high, 31 but also can be more on 25, should receive chemotherapy. And we are talking about patients with hormone-receptor receptor positive, HER2-negative early breast cancer without lymph node involvement. And this is extremely important. So to summarize, it's a clinical trial that includes patients with hormone-receptor positive HER2-negative lymph node negative in early breast cancer, who present with recurrence score between 11 and 25. And the question is whether we can avoid adjuvant chemotherapy in these patients who present this intermediate score. So this is the general design and the question. In terms of research, what we have learned. We have learned that for patients above 50 years old, there is no difference between endocrine therapy and chemotherapy followed by endocrine therapy. So it means that this patient or these patients, we would consider endocrine therapy alone. Then, for patients below 50 years old, there was some difference. And I think we go further into the detail. There was some difference favoring the use of chemotherapy in the group of patients who presented with recurrence score from 16 to 25. And so what changes were made to the recommendations in this update of the guideline? So first, what were [INAUDIBLE] the previous guidelines. The previous guidelines were telling the clinician which genetic tests they could use in patients with hormone-receptor positive, HER2-negative early breast cancer. Now, the big change is that we are making guideline to explain how to use the test. And what is new is that we have made three important decisions. So first, for the patient is at the age above 50, now it is recommended clinician may recommend endocrine therapy alone for women older than 50 who present a recurrence score below 26. Before, the recommendation to use endocrine therapy alone was for patient's who present with low recurrence score. So it means now we have broadened-- we have increased the number of patients who could receive endocrine therapy alone and not receive chemotherapy. Then, for patients who present a recurrence score between 16 to 25 and who are below 50 years old, the clinician may offer chemotherapy followed by endocrine therapy, meaning that we are moving from [INAUDIBLE]. This intermediate score between 11 to 25 was what we call a [INAUDIBLE]. There was no recommendation on how to use the recurrence score. So right now, the update from the ASCO guideline is to provide recommendation on which treatment to administer in case a patient presents with intermediate recurrence score, and there are two different situations above 50 years old and below 50 years old. So why are these changes so important and how will they affect practice? So they will affect practice because for many reasons, I will say. In the US, they would affect practice because they increase the number of patients who will not receive adjuvant chemotherapy, because right now, we have an answer f
Ep 34Role of Treatment Deintensification in the Management of p16+ Oropharyngeal Cancer PCO
An interview with Dr. David Adelstein of the Cleveland Clinic on the ASCO PCO which provides statements on the role of treatment deintensification in the management of p16+ oropharyngeal cancer. Read the full PCO at www.asco.org/head-neck-cancer-guidelines The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello and welcome to the ASCO Guidelines Podcast series. My name is Shannon McKernin. And today I'm interviewing Dr. David Adelstein from the Cleveland Clinic Taussig Cancer Institute. Lead author on "Role of Treatment Deintensification in the Management of p16 Positive Oropharyngeal Cancer: ASCO Provisional Clinical Opinion." Thank you for being here today, Dr. Adelstein. Thank you, Shannon. Before we get started, I'd like to first note the contributions of my panel co-chair, Drew Ridge, and those of all of the other panel members. And I'd like to extend a special thank you to ASCO for their support in allowing us to put this together and specifically Nofisat Ismaila who did a tremendous amount of work in allowing us to complete this provisional clinical opinion. First, can you give us an overview of the clinical issue for this PCO? Sure. So this really came out of the implications of human papillomavirus mediated oropharynx cancer. I think as most of the listeners know, over the last several decades we've recognized the fact that oropharynx cancer has a second ideology, that not all of it is caused by tobacco use, but that the human papillomavirus is now the major ideologic factor in North American and northern Europe. The importance of this is that the human papillomavirus-induced oropharynx cancer is a different disease. It has a number of different characteristics from the kinds of head and neck cancer we've seen in the past. It's a disease that tends to occur in younger patients, patients who are otherwise generally more healthy. It is unassociated with smoking, although it can occur in smokers. But it's much more frequent in nonsmokers. And I think most importantly, it's a disease that has a dramatically better prognosis than the tobacco related disease. Now over the last several decades, our ability to treat advanced head and neck cancer has improved significantly, because we've begun to incorporate non-operative treatments-- chemotherapy and radiation-- and have been more aggressive in our utilization of chemotherapy and radiation with significantly greater success than we had in the past. The problem with this kind of treatment is that it is quite rigorous. And there's a good deal of acute and, more importantly, late toxicity that patients experience from these kinds of approaches. Now as we became more familiar with the importance of HPV associated oropharynx cancer, we realized that there are subgroups of these patients who have cure rates that are in excess of 90%. And the question arose whether the kinds of rigorous chemotherapy and radiation therapy treatments that we were utilizing were really necessary. Was it necessary to cause this much acute and late toxicity in patients who in vast majority of cases were going to be cured of the disease. And it's important, because these are younger patients. And the late toxicities are going to have a major impact on their quality of life for a number of years. What came about was the notion of treatment deintensification, the idea that perhaps it would be possible to deintensify the kinds of treatments we were giving in select patients. It's a very compelling hypothesis for medical oncologists and radiation oncologists. But there are a number of problems as we try to test this hypothesis. The first problem is how do we identify the good risk patients? There are patients with HPV-positive disease who do not do so well-- the heavy smokers and patients with very advanced tumors. And we need to be careful if we're going to be talking about giving less treatment that we don't give less treatment to the patients who have a worse prognosis. We pick the best prognosis patients. There have been a number of what we call risk stratification schemes that have been developed looking at trying to identify the very good prognosis patients-- those patients who are HPV positive who don't smoke and who have relatively limited disease extent. There's not universal agreement on how best to define these patients. All we know is that they do exist, that you can look at patients with these characteristics and see very good outcomes. One of the issues that has come up is how do we utilize the American Joint Committee staging system-- AJCC the 8th edition. One of the things that AJCC 8 did which is new is that it defined a separate st
Ep 33Duration of Oxaliplatin-Containing Adjuvant Therapy for Stage III Colon Cancer Guideline
An intervew with Dr. Nancy Baxter on "Duration of Oxaliplatin-Containing Adjuvant Therapy for Stage III Colon Cancer: ASCO Clinical Practice Guideline." The guideline makes recommendations based on the results of the IDEA collaboration. Read the full guideline at www.asco.org/gastrointestinal-cancer-guidelines The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello, and welcome to the ASCO Guidelines Podcast series. My name is Shannon McKernin. And today, I'm interviewing Dr. Nancy Baxter from St. Michael's Hospital in Toronto, senior author on "Duration of Oxaliplatin-Containing Adjuvant Therapy for Stage III Colon Cancer: ASCO Clinical Practice Guideline." Thank you for being here today, Dr. Baxter. Thanks very much, Shannon, for speaking with me. I'm happy to share our work developing this guideline. So first, can you give us a general overview of what this guideline covers and the studies which provide the evidence? Absolutely. So use of adjuvant therapy for patients with stage III colon cancer is common, and it's effective. We know that these patients are at substantial risk of recurrence of their disease and that adjuvant therapy can reduce that risk. But we also know that comes with a cost. The most effective adjuvant therapy is FOLFOX or oxaliplatin-containing chemotherapy regimens. And we know that a really substantial number of people will end up with neurotoxicity, with peripheral sensory neurotoxicity, that can be long lasting and certainly affects their quality of life. So the whole question was whether the duration of oxaliplatin-containing chemotherapeutic regimens could be shortened when they're used for adjuvant therapy, so if we could give three months instead of six months. Because we know that if we give three months of therapy, the risk of neurotoxicity is much lower. So if we had the same effectiveness with the shorter duration, then we could spare patients the negative consequences of the agent given for a longer period of time. So in developing these guidelines, we looked at the results of international group of trials, the six trials from the IDEA collaboration. So these were six randomized trials in various jurisdictions that tried to look at this question, so three months of an oxaliplatin-based chemotherapeutic regimen for adjuvant therapy for stage III cancer versus six months duration of therapy. And so there was a planned analysis to bring all of these data together to develop the evidence base to make this recommendation. So our guideline and our systematic review basically identified this is the key piece of literature to base our recommendations and guidelines on. That's essentially the main study, so the meta-analysis of these six randomized controlled trials that formed the basis of the IDEA collaboration. So the IDEA collaboration studies-- there were six individual randomized trials that formed part of the IDEA collaboration. And they were conducted in Italy, Greece, Japan, North America, through CALGB/SWOG, the UK, Denmark, Spain, Australia, Sweden, and New Zealand, as well as France. So data came from, really, around the world. The median age of people in the studies was 64 years of age. And these people had a really good performance status, so almost all of these patients had an ECOG performance status of 0 or 1. So they were healthy patients that were in the study. And so some patients received CAPOX, and some received FOLFOX. That wasn't part of the randomization scheme. Other than the CALGB/SWOG study, this was up to the discretion of the investigator or patient. In the SWOG/CALGB study, only FOLFOX was given. And the authors planned a prespecified subgroup analysis to look at differences between CAPOX and FOLFOX. There was also a prespecified analysis to look at differences based on stage. What they found when they looked at the results was that, overall, the difference between groups in terms of the three months versus six months was that the hazard ratio between these two was 1.07, meaning a small difference between the groups in terms of recurrence or death between three months and six months overall. But because the prespecified confidence interval, noninferiority interval, for the difference in outcome was 1.12, the 95% confidence interval for the hazard ratio was above this. So it was 1.15, indicating that this prespecified noninferiority margin was exceeded. And so the study did not prove noninferiority of the three-month regimen. So we're left with an inconclusive result. So that's why our guidelines don't have a strong recommendation for the three months, because we can't rule out a small but potentially important
Ep 32Management of Cancer-associated Anemia with Erythropoiesis-Stimulating Agents Guideline
An interview with Dr. Alejandro Lazo-Langner on Management of Cancer-associated Anemia with Erythropoiesis-Stimulating Agents: ASCO/ASH Clinical Practice Guideline Update which provides recommendations on ESAs (and biosimilars) for patients with chemotherapy-associated anemia in the noncurative setting. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello and welcome to the ASCO Guidelines Podcast Series. My name is Shannon McKernin, and today I'm interviewing Dr. Alejandro Lazo-Langner from Western University in London, Ontario, senior author on Management of Cancer-Associated Anemia with Erythropoeiesis-stimulating Agents, ASCO/ASH Clinical Practice Guidelines Update. Thank you for being here today, Dr. Lazo-Langner. Thank you very much for the invitation to present the new guidelines. So this guideline has been updated now three times since its original publication in 2002. So how has this guideline changed over time? Since initial publication in 2002, this guideline has undergone a number of different changes. If you look at the initial series of recommendations in the 2002 guideline, it was really limited and it was fairly upfront recommending the use of erythropoiesis-stimulating agents in this setting. But during the last two updates in 2007 and 2010, that has changed significantly. And in the current guidelines, we have added some additional evidence that has been published in the last eight years. And now, in general, what we can tell is that the use of erythropoiesis-stimulating agents is now more restrictive than in the original guideline and is basically recommended for only one or two situations. There has been some other updates in the last iteration of the guideline that I can certainly discuss in more detail later. But basically, in general, the guideline has now, in the last iterations, restricted the recommendations that were much more general during the first edition of this guideline, almost all of them based on available and emerging evidence regarding the onset of their side effects with these medications. And can you give us a general overview of what this new guideline update covers, especially that new evidence that's emerged? Yeah. So the new guideline has changed a few items. And indeed, we-- the committee did a little bit of an overhaul in the recommendations that are not in the same order as they were in the previous editions. We can say that there is a couple of important updates. The first one would be addressing the use of biosimilars, which were not available in the previous guidelines. And we have addressed that in the current edition. The biosimilars have not been extensively studied in cancer, but they have. And so far, the committee considered that they were equivalent in terms of effectiveness and safety to the originator agents, both epoetin and erythropoietin. And the second most important update on the guideline is the recommendation of the concurrent use of iron supplementation in patients who are receiving erythropoietin-stimulating agents. The previous versions of the guideline just recommended the use of iron supplementation in patients with documented iron deficiency. However, in the last eight years, there's been a number of studies that have suggested that the concurrent use of iron supplementation, irrespective of the baseline iron status, does increase the efficacy of the agents. Third point is that, although this is not new, there's been more emerging evidence supporting the notion that all of the erythropoietin-stimluating agents increase the risk of thromboembolism. And this has been very consistent across all studies, and in particular derive from Julia Bohlius's systematic review and meta-analysis that was published a few years ago. And she's the lead author on these guidelines now. This has been confirmed, and I think that at this point this is probably the main limiting factor on the use of these medications. And the final minor update was that regarding the use of erythropoietin in patients with myelodysplastic syndrome. This guideline now suggests baseline serum erythropoietin level cut-off that might actually increase the chances of the erythropoietin-stimluating agents of being effective. This has been updated from the previous guidelines based on recent research. And what are the key takeaways of this guideline update? Well, the key takeaways is that if a clinician is deciding to use erythropoietin-stimluating agents, in agreement with the previous guidelines, the first thing that you have to consider is that you should not use these agents in patients that are receiving chemotherapy with a curative inte
Ep 31Treatment of Multiple Myeloma Guideline
An interview with Dr. Joe Mikhael from the City of Hope Cancer Center and International Myeloma Foundation on the ASCO and CCO joint clinical practice guideline. The guideline makes recommendations for patients who are transplantation eligible and ineligible with relapsed or refractory disease. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello, and welcome to the ASCO Guidelines Podcast series. My name is Shannon McKernin, and I'm interviewing Dr. Joe Mikhael from the City of Hope Cancer Center and International Myeloma Foundation, lead author on "Treatment of Multiple Myeloma: ASCO and CCO Joint Clinical Practice Guideline." Thank you for being here today, Dr. Mikhael. It's a pleasure to be with you. So first, can you give us some context as to why this guideline was developed? Well, we had a lot of ideas when we put together this guideline, but most importantly, multiple myeloma continues to be a rare disease in the cancer world. It really only accounts for about 1% to 2% of cancers. So for the practicing oncologist, they spend perhaps 3-ish percent of their time doing multiple myeloma. And when you add to that there has been really a revolution in myeloma with new drugs approved, new treatments, new approaches, it really leaves the general oncologist with a complexity of how to treat this disease. And so we wanted to create a very practical guideline that would give very precise advice to walk through how one would care for a multiple myeloma patient, right from their diagnosis to indeed relapse disease. We felt this approach was so important now, more than ever, because of the fact that myeloma has really changed so much, and now, thankfully, we're seeing our patients live so much longer that the treatment options can become a little bit more complicated over time. Furthermore, we partnered with Cancer Care Ontario, because this was really felt to be not just an American phenomenon, but really a full North American phenomenon of how we could work together to really give practical advice as to how to treat this disease. So what are the key recommendations of this guideline? In this guideline, we focused really on the treatment of the disease itself. There have been other guidelines that have focused on supportive care and bone disease and multiple myeloma, but we really focused on the treatment of patients really from induction therapy through to relapse. So we spend time helping guide the decision around whether or not a patient is transplant eligible or ineligible, because that's really the first dividing marker in myeloma, because we know that transplant still has a role in myeloma, and eligible patients should have a transplant, or at least have access to a transplant. And historically, this was really done on the basis of age. But the guidelines helps the clinician see that it's really not just an age phenomena. It's really a decision based on comorbidities and really what's best for the patient. So we spend time helping making that decision, and then provide very practical advice as to how to treat a patient who's going to transplant versus a patient who's not going to transplant. We also, then, after the transplant, or in lieu of a transplant, we discuss the importance of continuous therapy, or sometimes called, maintenance therapy in myeloma. Again, we've seen maintenance therapy, now, have an impact on both progression free and overall survival. And so we felt it was really important to be very practical in giving advice as to what maintenance therapy agents to use and how to use them. And then lastly, the guideline provides a lot of practical advice as to a patient who has relapsed with multiple myeloma. We have so many choices now with three major classes of drugs of proteasome inhibitors, immuno-modulatory drugs, and now newer monoclonal antibodies, it can be difficult sometimes to know which combination to use. We know that triplet combinations tend to be preferred. So we walk through a number of those triplets and provide advice as how to explicitly use them. We do emphasize the importance of supportive care and of risk factor analysis throughout the guideline, so that we can understand the difference between high risk and low risk myeloma, so that we can understand how important a patient's comorbidities, especially in a disease that primarily affects older patients, can be managed. And so we try to do so in a comprehensive way, but one that really distills down to the critical pieces to allow the practicing clinician some real advice. So why is this guideline so important, and how will it change practice? There are several kinds of guidelines
Ep 30Anticonvulsant Prophylaxis and Steroid Use in Adults with Metastatic Brain Tumors Endorsement
An interview with Dr. Susan Chang from the University of California San Francisco on the ASCO and SNO Endorsement of the CNS Guidelines. Read the full guideline at www.asco.org/neurooncology-guidelines The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello and welcome to the ASCO Guidelines Podcast series. My name is Shannon McKernin, and today I'm interviewing Dr. Susan Chang from the University of California San Francisco, lead author on "Anticonvulsant Prophylaxis and Steroid Use in Adults with Metastatic Brain Tumors: ASCO and SNO Joint Endorsement of the CNS Guidelines." Thank you for being here today, Dr. Chang. Thank you so much for this opportunity. So first, can you give us the general overview of what this guideline covers and about the endorsement process? Absolutely. So one of the things we've noticed, of course, is that the incidence of newly diagnosed adult patients with brain metastases is now estimated to be in the range of about 20,000 to 40,000 per year. And this has really been increasing because of several factors. This includes improved imaging tools, the fact that there's an increase in the number of cancers that are prone to spread to the brain, and the improved survival of patients with cancer. And so the Congress of Neurological Surgeons have developed a series of guidelines on the treatment of adults with metastatic brain tumors. That includes systemic therapy, as well as supportive care. There are two guidelines that address the role of anti-convulsant abuse and steroids in the care of patients with brain tumors. Specifically, the guideline questions were do prophylactic anti-epileptic drugs decrease the risk of seizures in both non-surgical and post-surgical patients, who are otherwise seizure free? So these are patients who have never had a seizure, does it make any sense to use these drugs? The second is do steroids, which are commonly used in patients when there is increased mass effect and cerebral edema, could that help to improve neurological functioning or quality of life, compared to supportive care or other treatments? And if they are used, what sort of dose should be used? So the process of endorsing these guidelines included an initial assessment by content evaluators from ASCO and members of the Society of Neuro Oncology, or SNO guidelines committee. And subsequently, it was determined that a detailed review of the guidelines should be pursued. So in this joint effort of both ASCO and SNO, a multidisciplinary expert panel of medical and radiation oncologists and neurosurgeons, neurologists, and others providing care for adults with metastatic brain tumors reviewed the content to determine the appropriateness for endorsement by the two professional societies. So what are the key recommendations of this guideline? The key recommendations of this guidelines include the fact that routine use of prophylactic anti-epileptic drugs is not recommended for patients who are seizure free, either in the non-surgical and post-surgical settings, and that steroids could be used when patients had mild, moderate, or severe symptoms that were related to mass effect in the brain. This choice of steroids that was recommended was dexamethasone, and the doses was about 4 to 16 milligrams, depending on the severity of the symptoms. Now, what they found was that there was insufficient evidence to recommend steroid use in asymptomatic patients, when they didn't have any mass effect. And one of the additional aspects that the panel provided was that the minimal effective dose should be used, and that nighttime doses should be avoided. And this is because of the known side effect of insomnia that a lot of our patients experience when taking this medication right before they go to sleep. So why is this guideline so important, and how will it change practice? Well, these guidelines provide a basis for oncologists to avoid the over prescription of anti-epileptics and steroids in patients with brain metastases, particularly in those who are asymptomatic and those without signs of mass effect. It also highlights that if steroids are going to be administered, that clinicians should be very familiar with both the short and long term sequelae of steroid therapy, and they should have a plan to taper the steroids as fast as can be clinically tolerated. So finally, how will these guideline recommendations affect patients? Well, both anti-epileptics and steroids have a wide range of toxicities that can adversely affect a patient's quality of life. And so the routine use of these drugs in patients with incidentally discovered or asymptomatic brain metastases is not s
Ep 29Adjuvant Therapy for Resected Biliary Tract Cancer Guideline
An interview with Dr. Rachna Shroff from the University of Arizona Cancer Center on the guideline which provides recommendations on the role of post-operative therapy in patients who undergo surgical resection for biliary tract cancers. Read the full guideline at www.asco.org/gastrointestinal-cancer-guidelines The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello and welcome to the ASCO Guidelines Podcast series. My name is Shannon McKernin, and today I'm interviewing Dr. Rachna Shroff from the University of Arizona Cancer Center, lead author on "Adjuvant Therapy for Resected Biliary Tract Cancer: ASCO Clinical Practice Guideline." Thank you for being here today, Dr. Shroff. Thank you so much for having me. So what does this guideline recommend? This is a guideline that is basically looking at the role of post-operative therapy in patients who undergo surgical resection for biliary tract cancers. Biliary tract cancers are a somewhat heterogeneous group of malignancies that include intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancer. And so the question always in most cancers are, if you are able to undergo surgical and curative treatment, is there a role for post-operative chemotherapy or radiation therapy to help improve the chance of cure and decrease the risk of recurrence? So that is exactly what we investigated as an expert panel. So our recommendations are actually twofold. The first one is that we are clearly recommending that patients with resected biliary tract cancer should be offered adjuvant chemotherapy with capecitabine for a total of six months. Within that recommendation, we do acknowledge that this is based on the BILCAP phase III randomized controlled trial and that there was a specific dosing and treatment schedule that was done in that study, but that we are allowing for institutional and regional variances that we've noted in terms of dosing of capecitabine. And so as a result, we're recommending adjuvant capecitabine, and we're allowing practitioners to determine what the best and safest dosing would be, based on their experience. The second recommendation is more specifically for patients with extrahepatic cholangiocarcinoma or gallbladder cancer who undergo resection and have a microscopically positive surgical margin, which is an R1 resection. And in those patients, we are recommending that we could consider offering these patients chemoradiation therapy. Now, again, this is not as strong of a recommendation, because we do not have prospective randomized phase III data to support it. This was based more on a prospective single-arm study out of the Southwest Oncology Group, as well as some other retrospective studies. And so we do go on to qualify that that recommendation should really be made in a shared decision-making approach, with a multidisciplinary conversation to decide the risks and benefits of radiation in these patients-- and that we acknowledge that a prospective study would really help clarify that question a little bit more. So can you tell us about the research that informed these recommendations? There have been a number of studies that have looked at the role of adjuvant therapy in biliary cancers. And up until very recently, a lot of these studies were small retrospective series, single-institution or multi-institution, but everything in retrospect-- no prospective or randomized data. And so I think a lot of the reasons that we decided to have these guidelines come out now is that in the last two to three years we do finally have prospective randomized data that helps guide the recommendations. And the majority of the recommendations that we made are based on one randomized phase III, which is BILCAP study. This was a study that was done in the UK and was presented at ASCO in 2018 and is currently in press. And it is basically a randomized controlled trial that compares adjuvant capecitabine by itself versus surveillance alone in patients who undergo surgery for biliary tract cancers. And so our recommendations, which include that study as well as a couple others, is primarily hinged on that, since that is the largest prospective data we have so far. And based on that study, we did in fact recommend that there was a role for adjuvant chemotherapy with capecitabine after complete resection for biliary tract cancers. And based on that research that was done in that trial that was completed, we do believe that the role for capecitabine for six months is pretty strong and that the data supports that now. So why is this guideline so important, and how will it change practice? Well, I think it
Ep 28Management of the Neck in Squamous Cell Carcinoma of the Oral Cavity and Oropharynx Guideline
An interview with Dr. Shlomo Koyfman of the Cleveland Clinic on "Management of the Neck in Squamous Cell Carcinoma of the Oral Cavity and Oropharynx: ASCO Clinical Practice Guideline" which provides recommendations on topics such as neck dissections and postoperative treatment. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello and welcome to the ASCO Guidelines podcast series. My name is Shannon McKernin, and today I'm interviewing Dr. Shlomo Koyfman from the Cleveland Clinic, lead author on "Management of the Neck in Squamous Cell Carcinoma of the Oral Cavity and Oropharynx: ASCO Clinical Practice Guideline." Thank you for being here today, Dr. Koyfman. It's a pleasure. So first, can you give us a general overview of what this guideline covers? Yeah, so this is an exciting guideline because it covers a topic that we don't usually think about in head and neck cancer in a formal way, and that is management of the neck in squamous cell cancer of the oral cavity and the oropharynx. So there's a lot of literature and guidelines out there on how to manage oropharynx cancer, which is becoming a more and more common cancer, especially in the HPV-positive era, less so on oral cavity. But a lot of times it's focused on people who don't get surgery, chemoradiation, or people who do get surgery and TORS, Transoral Robotic Surgery, and different approaches. But rarely do we have something focus on management of the neck per se, which is really, really important in these cancers and often overlooked in favor of the primary tumor itself. So these guidelines really take us through some salient questions in how to manage the neck in these two cancers. And what are the key recommendations of this guideline? The recommendations came off of six fundamental questions, three in oral cavity and three in oropharynx. There are some commonalities between the two and some differences. A lot of the fundamental questions revolve around surgical quality, and neck dissection is the standard surgical approach for management of the neck in these patients. And as we enter the quality era, how do we define benchmarks of surgical quality, which is one thing that it deals with. The other is when to do adjuvant therapy like adjuvant radiation or chemoradiation. We also deal with when to do surgery for the neck or to do nonoperative approaches like radiation or chemoradiation. And then lastly, how do you follow patients after you've treated them? So those are kind of the salient issues that we dealt with. And what we came out with was nothing earth shatteringly new, but I think the way it was organized and systematically put together, I think it's going to be really, really helpful for people. So some of the most important findings that this recommendation does, I think this is the first that incorporates surgical quality, as I mentioned before. So specifically neck dissection should have 18 or more nodes as multiple studies have shown that that's associated with better outcomes. And similarly we define for different diseases of oral cavity and oropharynx, and depending on what kind of tumor it is and where, what nodal levels should be dissected or treated, whether surgically or nonsurgically, and when to do just one side of the neck versus both sides of the neck. So I think there's a lot of good guidance there in terms of the surgical quality. From a standpoint of adjuvant therapy, we define pretty clearly indications for when after surgery for oral cavity cancer, for example, when radiation should be added and when chemoradiation should be added, and I think that's very helpful. And especially for the neck itself, there's been confusion about what happens if I have 30 nodes taken out and they're all negative but I have a big, large primary tumor. What do I do with the neck? Do I radiate it? Do I not radiate it at one side, both sides? And this guideline gives some pretty clear guidance in different scenarios about how to think about that, which is pretty novel and really important, I think. I get questions about this all the time. It comes up in tumor boards all the time, and it's pretty practical. And mostly what we say is if you have a primary tumor that's like a T3 or T4 oral cavity cancer or it approaches midline, either a contralateral neck dissection should be done or radiation should be done to the contralateral neck. And even if you have a lot of lymph nodes taken out and they're negative, if you have very high-risk primary tumor features like very large tumor or multifocal perineural invasion, those kinds of things, even with a negative neck dissection we still typically do treat the neck
Ep 26Early Detection for Colorectal Cancer Resource-Stratified Guideline
An interview with Dr. Marcia Cruz-Correa from the University of Puerto Rico and MD Anderson Cancer Center on the ASCO Resource Stratified Guideline on early detection for colorectal cancer. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello, and welcome to the ASCO Guidelines Podcast series. My name is Shannon McKernin. And today, I'm interviewing Dr. Marcia Cruz-Correa from the University of Puerto Rico and MD Anderson Cancer Center, senior author on "Early Detection for Colorectal Cance: ASCO Resource-Stratified Guideline." Thank you for being here today, Dr. Cruz-Correa. Well, thank you very much for the opportunity to speak with you today. So first, can you give us a general overview of what this guideline covers? Absolutely, Shannon. Well, we are very excited to review the content of the guideline. And we put together a summary of the current guidelines out there for patients that are undergoing colorectal cancer screening. With these particular resource, a certified guideline takes, for the first time, into account the place where the colorectal cancer screening is being delivered, which is different from when you read any other colorectal cancer screening guidelines, where normally we assume that all available methodologies are equally distributed regardless of the country or the setting. So in our particular guideline, we really emphasize the fact that, depending on where our clinicians are, they might have differing technologies available. And that's why it's called resource-stratified-guidelines, to help our clinicians and our practicing physicians to understand what would be the best method to be able to implement screening in their own settings. So what are the key recommendations of this guideline? I think that the most important recommendation is that colorectal cancer is a prevalent disease, not only affecting very highly developed countries, but a disease that we're seeing more and more in low-to-middle-income countries. As ASCO is an organization that has members from around the world, being cognizant of the fact that colorectal cancer affects many individuals across different settings, and countries, and continents, for that matter, allows us to provide the most important information which is to consider colorectal cancer screening across the different settings, so not only in the industrialized well-developed first-world country, but also in the low-to-middle-income, or those that are becoming more and more industrialized. So our main recommendation-- it's number one-- that we need consider colorectal cancer screening even in settings where, for many years, the burden of disease was really focused in infectious-driven diseases. Nowadays, we're seeing more and more low-to-middle-income countries where the number one cause of death, it's not an infectious-driven disease, but rather a cancer. And colorectal cancer, it's one of the top cancers that we're seeing in many of the settings. So our number one recommendation is to be cognizant about that so that different countries and different settings, the practitioners consider screening. And our second and most important recommendation is that, the important thing is to consider what you have available in your setting, in your clinical practice. And depending on what you have available, then you can offer the method that could be given to your patient. So it's almost like thinking differently. It's not a one size fits all, but rather it's more or less of a personalized recommendation based on your setting, based on your clinical practice methods available to you. So why is this guideline so important? And how will it change practice? We believe that it's very important, because when you look at guidelines in any published article out there, we read it. And it looks as if everyone had every resource available. And when you're practicing in a low-to-middle-income country, or a place-- it could be a rural area where you have more basic settings or more limited settings-- you might not have that new machine or that new equipment. So then, as a practitioner, you feel that you're not equipped to be able to provide the best care to your patients. So this guideline, it's mirrored after a previous guideline that was put together by the ASCO Clinical Practice Group, where we stratify the type of practice for our-- where our practitioners are providing care. There are four main practice settings. The first one is what we call the basic setting, which is where you have the minimal necessary facilities to be able to evaluate patients and provide first primary care services. The second tier, it's called the limite
Ep 27Treatment of Patients with Early-Stage Colorectal Cancer Resource-Stratified Guideline
An interview with Dr. Manish Shah from New York Presbyterian Weill Cornell Medical Center on the ASCO Resource Stratified Guideline which covers treatment of patients with early-stage colorectal cancer. To read the full guideline go to www.asco.org/resource-stratified-guidelines The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello, and welcome to the ASCO Guidelines Podcast series. My name is Shannon McKernin. And today, I'm interviewing Dr. Manish Shah from New York Presbyterian Weill Cornell Medical Center, senior author on "Treatment of Patients with Early-Stage Colorectal Cancer: ASCO Resource-Stratified Guideline." Thank you for being here today, Dr. Shah. Thank you, it's a pleasure and honor to be here. So first, can you give us a general overview of what this guideline covers? Yes, absolutely. So the "Treatment of Patients with Early-Stage Colorectal Cancer" is a resource-stratified guideline. And it focuses on the management of patients with early-stage colon cancer. It's different than the surveillance and screening guideline that was written simultaneously for ASCO as another resource-stratified guideline. We felt that this was a big enough topic that we should keep it separate. So it really talks about the management of pre-malignant lesions, as well as early-stage colon cancers, as well as rectal cancers. And the other aspect of this is that we really focused on how the guideline may apply in settings where there-- they don't have maximal resources, so basic or limited settings as well. So I would like to talk a little bit about how the guideline was created, because I think that's an important aspect. And it distinguishes it from typical other ASCO Guidelines. So the management of colon cancer or colorectal cancer, there's a lot of literature on this. And there are several guidelines that have been produced by colorectal cancer societies, or surgical societies, or from other countries like the EORTC, or Japan, or Korea, or even the UK. So in fact, there were, I think, 30 to 40 different guidelines that we reviewed. And we felt that, instead of doing a new literature search to kind of rehash much of the same information, we reviewed all the guidelines for certain quality measures to then select a handful of guidelines that we would use as the reference for each of our key questions or key points. And this was done in a formal process, the first by ASCO and Sarah, who was the ASCO staff who wrote the guideline, along with the members of the guideline panel. And in this process, I think that we have a pretty comprehensive guideline that covers the questions with the best evidence available. So what are the key recommendations of this guideline? Yeah, so we addressed some several questions with regard to key recommendations. The first question, for example, was, what's the optimal treatment for patients with colon cancer that would be clinical stage 1 through 3c? And we distinguish that from a non-obstructing cancer to obstructing cancers as well, because the management would be very different. And what we really sort of focused on is that these patients should have resection following oncologic principles. Then ideally, they should have an en bloc resection by a surgical oncologist to give the patients the best chance of care. But I think what's unique to resource-stratified guidelines, and what we have to do is sort of highlight the care that would be achieved in settings that have less resources. So a non-obstructing colon cancer in a basic setting should still have surgery and should still undergo an en bloc resection following standard oncologic principles. So that was, for example, one of the key points that was uniform across all the settings. Other things were how to manage [INAUDIBLE] colon cancer. So in more enhanced and maximal settings, sometimes there might be opportunity to place a colonic stent, for example, by either a colorectal surgeon or by someone who has specialized training in the placement of these stents. And that would be a preferred approach in both the enhanced and maximal guidelines, whereas in a more basic setting, the recommendation was to perform a resection and possibly, if required, if a resection was not possible, a diversion to overcome the obstruction in that localized setting. There were other recommendations that were also important. So for example, in early-stage rectal cancer, so clinical stage 1, T1 and 0 rectal cancer, in a maximal setting, these are sort of low-risk cancers without adverse features like high-grade or involvement of lymphovascular structures. The surgical oncologist and/or colorectal surgeon might
Ep 25Safe Handling of Hazardous Drugs: ASCO Standards
An interview with Dr. Paul Celano from the Greater Baltimore Medical Center on the recently published ASCO Standards on safe handling of hazardous drugs. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello and welcome to the ASCO Guidelines podcast series. My name is Shannon McKernin. And today I'm interviewing Dr. Paul Celano from the greater Baltimore Medical Center, lead author on "Safe Handling of Hazardous Drugs: ASCO Standards." Thank you for being here today, Dr. Celano. Thank you for having me. I'm certainly glad to talk about these standards. They're very important to our employees and our patients. So first I want to make the distinction that this publication is not a guideline like we usually cover on this podcast. So can you tell us what standards are and how they differ from guidelines? Well, guidelines really are intended to guide practitioners around recommended care options. They give obviously a lot of latitude to clinical judgment and circumstances. Standards, on the other hand, are really meant primarily for the organization of care and are intended to have a higher level of obligation to help drive either practice or policy or even legislative efforts. So that's really the distinction. And what are the standard statements that are made by ASCO in this publication? The publication really is about safe handling of hazardous drugs. This all came about is because recently there have been a number of national guidelines or standards that have been offered by other organizations, but not specifically oncology or certainly ASCO or the ASCO organization. We felt a need to address the standards that have been put out on the basis of the evidence, so that best practices can be offered. Initially, we did collaborate with other societies, such as the Oncology Nursing Society and the Hematology Oncology Pharmacy Association. That was really the impetus behind making sure that we are, in a sense, congruent with standards that are already being published and discussed, but also to also place in our interpretation of these standards so that they're based on the best evidence that's available. And what qualifying statements are there to note about these standards? Well, I think the best way to look at these standards is there has been recently published or offered what's been called the UST 800 standards, which really incorporate other previous standards by the Pharmacy Association as well as OSHA, the Occupational Safety and Health Association, as well as NIOSH, the American Society of Hospital Pharmacists, Oncology Nursing, etc. So there's a lot of standards that have been offered. And in fact, the ASCO review of this really in a sense agrees with many of the standards that have already been published and offered-- types of exposures, the responsibilities of personnel handling the drugs, the personal protective equipment, how we communicate the hazardous drugs, the training of compounding personnel, how the drugs are dispensed and even transported. So there's lots of things that we really do agree with. I think it's also important to understand that the objectives of this is really to protect personnel and the environment to make sure the standards apply to all personnel who compound hazardous drugs and preparations, all places where hazardous drugs are prepared and stored, transported and administered. So that's really a key part of this. These are a comprehensive program really to prevent worker environmental exposure and to provide the most practical safety environment for all involved. So finally, why are these standards so important? And how will they affect practice? Well, they effect practice in many ways. I mean, the key thing is making sure that our employees, meaning the nurses, pharmacy, the technicians, really everyone involved that they're not unduly exposed to these hazardous drugs. And so that's really the key thing that we're all trying to achieve by this. Now, what really makes the sort of ASCO standards somewhat different or the things that we came into a contention with has to do with the differences that ASCO has come up with in contrast to some of the other standards. And these have to do with really four main areas within these standards. They have to do with medical surveillance, external ventilation, closed system transfer devices, and also proper assignment of our personnel while they may have either trying to conceive or pregnant or nursing. So those areas that in our review, the ASCO review, have come under some question. As an example, medical surveillance, there in some of the standards offered-- not ASCO's-- that there's a number
Ep 24Initial Diagnostic Workup of Acute Leukemia Guideline
An interview with Dr. Valerie de Haas from Princess Máxima Center for Pediatric Oncology in the Netherlands on "Initial Diagnostic Workup of Acute Leukemia: ASCO Clinical Practice Guideline Endorsement of the CAP and ASH Guideline." ASCO fully endorses the CAP-ASH guideline on initial diagnostic work-up of AL and includes some discussion points according to clinical practice and updated literature. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. [MUSIC PLAYING] Hello and welcome to the ASCO Guidelines podcast series. My name is Shannon McKernin and today I'm interviewing Dr. Valerie de Haas from Princess Máxima Center for Pediatric Oncology in the Netherlands, lead author on "Initial Diagnostic Workup of Acute Leukemia: ASCO Clinical Practice Guideline Endorsement of the CAP and ASH Guideline." Thank you for being here today, Dr. de Haas. Thank you. So first, can you give us a general overview of what this guideline covers? Well, yes. The laboratory evaluation of patients who are suspected of having acute leukemia is very complex, and it has evolved significantly with the incorporation of advanced laboratory techniques. The traditional backbone of initial workup of AL, of acute leukemia, is composed of ctyomorphology, cytochemistry, immunophenotyping, and molecular cytogenetics. These techniques are the backbone of the initial diagnostic workup of acute leukemia. This is leading to risk stratification and fine tuning of the therapy by molecular signatures. The advanced molecular diagnostics, such as next-generation sequencing, has become more important in the diagnosis and in the risk stratification of acute leukemia. This guideline is meant for both pediatric and adult patients, and it was initially published in 2017. This year, we reviewed this guideline, and we have taken into account two important developments. First, since 2017, we've seen that there are major advances in molecular techniques and also that we can identify and validate new molecular markers. And those two events have contribute to a better risk stratification. And the second development is the effect that the WHO classification was revised in 2017 which also has led to new risk recoveries and refined subclassifications. So what are the key recommendations of this guideline? Well, in total, we have reviewed 27 guideline statements by the ASCO endorsement expert panelists. And discussion points are used to summarize issues that were identified from the updated literature. The ASCO expert panel determined that the recommendations from the guideline as published in 2016 are clear, thorough, and they are based upon the most relevant scientific evidences. We fully endorse the CAP-ASH guideline on initial diagnostic workup of acute leukemia. And we decided to include some discussion points according to clinical practice and according to the updated literature. In fact, we identified four categories of key recommendations. The first one is the initial diagnostics focusing on basic diagnostics and determination of risk parameters. This concerns, in total, about 11 guideline recommendations, and they give an overview of the initial workup varying from the collection of the clinical history of the patient to initial basic diagnostics by cytomorphology, flow cytometry and molecular cytogenetic analysis of peripheral blood, bone marrow, and cerebrospinal fluids. Secondly, the second category were molecular markers and MRD detection, and they were addressed by 10 of the recommendations. And these recommendations give a structural overview of the molecular and cytogenetic workup for acute lymphoblastic leukemia versus acute myeloid leukemia identifying different prognostic markers. Also, the detection of MRD is taken into account in this recommendation. There is a major difference between children and adults, and this part is given most attention in the discussion part as the developments have been major during the past few years. The third one is the context of referral to another institution with expertise in the management of acute leukemia. This is addressed by four recommendations, emphasizing the point that referral to an institution with specific expertise is of major importance for the central workup of acute leukemia. And finally, the final reporting and report keeping is reflected in three recommendations, mainly supporting conclusions from 2017 which were describing the fact that the complete report with basic diagnostics in one central report should be available within 48 to 72 hours. And this should be followed by complete, final, comprehensive report in one or two weeks. So can you tell us about
Ep 23Evaluating Susceptibility to Pancreatic Cancer PCO
An interview with Dr. Elena Stoffel from University of Michigan on Evaluating Susceptibility to Pancreatic Cancer: ASCO Provisional Clinical Opinion. This PCO addresses identification and management of patients and family members with possible predisposition to pancreatic adenocarcinoma. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello, and welcome to the ASCO Guidelines Podcast Series. Is my name Shannon McKernin and today, I'm interviewing Dr. Elena Stoffel from the University of Michigan, lead author of "Evaluating Susceptibility to Pancreatic Cancer: ASCO Provisional Clinical Opinion." Thank you for being here today, Dr. Stoffel. I'm delighted to join you. So first, can you tell us what a professional clinical opinion is and why this topic is so important to ASCO? Well, a provisional clinical opinion is a statement that ASCO puts out when we are seeing trends that are relevant to the care of our patients but that may not necessarily have the level of evidence needed to include in a true clinical guideline. This particular provisional clinical opinion that deals with the management of patients with pancreatic cancer and their families is based on some new data that has been published regarding the prevalence of inherited factors influencing pancreatic cancer risk. So what are the key statements of this Provisional Clinical Opinion or also known as a PCO? This particular provisional clinical opinion, which is about just the inherited susceptibility to pancreatic cancer, was prompted by several recent publications, which found that the prevalence of genetic predisposition among patients with pancreatic cancer was much higher than we had originally anticipated. And this is relevant because in talking about pancreatic cancer as one of the deadliest cancers in both in the United States and worldwide, we are very interested in finding ways to reduce the morbidity from this cancer to patients and their families. And this particular provisional clinical opinion addresses the role that genetic risk assessment should have in the care of pancreatic cancer patients and also the role for clinical genetic testing, as well as the risks and benefits of pancreatic cancer screening for at risk family members. What considerations are there for having these conversations with patients and their families? Well, many times when we see families affected with cancer, one of the questions they have is what is the likelihood that this will happen to other individuals in our family and what can we do to prevent cancers in other family members. And I think what's important here is that review of the data from multi-gene panel genetic testing in unselected individuals diagnosed with pancreatic cancer identified pathogenic germline variants in 1 out of every 10 individuals. And this is really important because when you think about it, if 1 out of every 10 patients with pancreatic cancer develop their cancer in the setting of a genetic predisposition syndrome, this has tremendous implications for management both for them as well as for their family members. One of the most common inherited cancer syndromes identified in families affected with pancreatic cancer is hereditary breast ovarian cancer associated with mutations of BRCA1 and BRCA2. As you know, there are definite screening recommendations we make for individuals who carry these genetic alterations. And certainly if a family member is diagnosed with a genetic alteration, then that has an impact for cancer screening and management. Furthermore, there are emerging data about the utility of pancreatic cancer screening in high risk individuals. And while there's still some controversy about how to screen individuals at risk for pancreatic cancer, certainly there are some emerging data suggesting that this may have a role for early detection. And finally, the panel included a discussion section on the limitations of the research and future directions. So what are the key points of this section? I think that what we're learning is with genetic testing, and particularly with multi-gene panel testing, we are we often find unexpected results. Certainly variants of uncertain significance are not uncommon when multi-gene panel tests are used. And being able to interpret the clinical significance of some of these genetic test results can pose some challenges, especially for clinicians who don't have specific expertise in genetics. Certainly being able to deal with the volumes of patients who need genetic testing who are also battling pancreatic cancer, we want to make sure that we have the resources to be able to offer genetic testing to ever
Ep 22Adjuvant Endocrine Therapy for Women with Hormone Receptor Positive Breast Cancer Guideline
An interview with Dr. Jennifer Griggs from University of MIchigan on Adjuvant Endocrine Therapy for Women with Hormone Receptor Positive Breast Cancer: ASCO Clinical Practice Guideline Focused Update. This guideline provides recommendations on extended adjuvant therapy. on particular, use of aromatase inhibitors in women who had completed five years of adjuvant endocrine therapy. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello, and welcome to the ASCO Guidelines podcast series. My name is Shannon McKernin and today I'm interviewing Dr. Jennifer Griggs from the University of Michigan, senior author on "Adjuvant Endocrine Therapy for Women with Hormone Receptor Positive Breast Cancer: ASCO Clinical Practice Guideline Focused Update." Thank you for being here, Dr. Griggs. And thank you for the opportunity to talk about this focused update to the guidelines on extended adjuvant therapy. I would, of course, like to thank all my co-authors in the ASCO guidelines team for their contribution to this effort. So first, can you give us a general overview of what this guideline covers and their research which informed this focus update? Yes. First of all, the goal of the guideline was to give an update to the previous guidelines on this topic. And we specifically focused on extended adjuvant therapy. In particular, the aromatase inhibitors in women who had completed five years of adjuvant endocrine therapy. And it goes without saying, but it's worth reminding our listeners that the guideline is restricted only to post-menopausal women with hormone receptor-positive breast cancer. And, of course, our guidelines are only as good as the data upon which we rely. So for this guideline, six phase III randomized controlled trials met the pre-specified eligibility criteria for the updated systematic review and provide the evidence base for the guideline recommendations on the duration of aromatase inhibitor therapy. Each of the trials used the standard doses of the drugs that we use in practice today. So I'm not going to say the doses of each of the medications. So I'm going to go briefly over those six trials and just describe them so everybody's up to date with how the studies were designed. So briefly, the first trial I'll describe is MA17R, which compares letrozole to placebo for five years in over 1,900 women who had already received 4.5 to six years of adjuvant therapy with an AI, proceeded in most women by treatment with tamoxifen. The second study is NSABP B-42. And this also compares letrozole to placebo in nearly 4,000 women who'd completed five years of endocrine therapy with either five years of an aromatase inhibitor or up to three years of tamoxifen followed by an aromatase inhibitor, for a total of five years. The third study that we looked at is the DATA trial, which stands for the Different Durations of Adjuvant Anastrozole Therapy. This trial compared six years of adjuvant anastrozole with three years of adjuvant anastrozole in over 1,600 women after two to three years of adjuvant tamoxifen. The fourth trial out of the six is the IDEAL trial, the Investigation on the Duration of Extended Adjuvant Letrozole. This study randomized over 1,800 women to either 2 and 1/2 or five years of letrazole after five years of tamoxifen, an AI, or a combination in sequence of tamoxifen and an AI. So very similar study designs. The fifth study is the ABCSG-16 trial, the Austrian Breast Cancer Study Group Trial 16, which randomized nearly 3,500 women following four to six years of adjuvant therapy with tamoxifen and AI or a sequence of tamoxifen and then an AI, to either two or five years of anastrozole as extended therapy. And finally, the study of letrozole extension, or the SOLE trial, randomized over 4,800 women with node-positive breast cancer who had completed five years of adjuvant endocrine therapy to receive either continuous letrozole for five years or five years of an intermittent schedule of letrozole given nine months on and three months off in years one to four and on continuously for a year or five. So I know that's a lot to take in, but I do think it was important for our audience to understand the six trials that were included. These were all large studies, randomized, and patients had completed five years of adjuvant endocrine therapy. And then, were randomized either to placebo or different durations of an aromatase inhibitor or a placebo. For all of these studies, it's important to know that the primary outcome was disease-free survival. Overall survival and adverse events where secondary outcome. Great. So given that research and those trials, what are the ke
Ep 21Hypofractionated Radiation Therapy for Localized Prostate Cancer Guideline
An interview with Dr. Scott Morgan from the Ottawa Hospital and University of Ottawa on "Hypofractionated Radiation Therapy for Localized Prostate Cancer: an ASTRO, ASCO, and AUA Evidence-Based Guideline." This guideline provides recommendations on hypofractionated external beam radiation therapy for localized prostate cancer. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello and welcome to the ASCO Guidelines Podcast series. My name is Shannon McKernin and today I'm interviewing Dr. Scott Morgan from the Ottawa Hospital and University of Ottawa, lead author on "Hypofractionated Radiation Therapy for Localized Prostate Cancer: an ASTRO, ASCO, and AUA Evidence-Based Guideline." Thank you so much for being here today, Dr. Morgan. It's my pleasure, Shannon. I'm happy to take part in the podcast and hopefully share the highlights of the guideline with your listeners. So first, can you give us a general overview of what this guideline covers? Yeah. So the guideline covers really hypofractionated external beam radiation therapy, which is a treatment for localized prostate cancer, and for the non-radiation oncology folks in your audience, I think it's important to begin by placing the guideline sort of in its context and going over some of the terminology that we use as radiation oncologists. So external beam radiotherapy, it's a standard treatment-- standard local treatment option for men with localized prostate cancer. It gives outcomes which are really equivalent to those of radical prostatectomy or brachytherapy, which are the other two standard local treatment options. And traditionally, it's given in small daily fractions over several weeks and the usual daily fraction size is 1.8 to 2 Gray per day. And this is called conventional fractionation. And that really translates into a course of about seven and a half to nine weeks of treatment. And so that total dose which is delivered in those daily treatments, five days a week, is about 76 to 80 Gray. And that's what we call conventional or standard fractionation. And there's a theoretical framework in radiation medicine and there's some evidence to accompany that that suggests that prostate cancer is quite sensitive to radiation fraction size. And just to give a brief primer, for any tissue, cancerous or non-cancerous, there's a sensitivity to fraction size and it's characterized by something called the alpha-beta ratio. And for prostate cancer, that's felt to be low compared to most other cancers, the alpha-beta ratio, and indeed, it's thought to be lower than the adjacent dose-limiting normal structure, which is the rectum. And so an implication of that is that hypofractionation, and by that we mean daily fraction size of more than 2 Gray, might improve the therapeutic ratio of radiation therapy in localized prostate cancer. Now the guideline-- and I think it's important to emphasize this-- it draws a distinction between what we call moderate hypofractionation and ultra-hypofractionation. Clearly, fraction size is a continuous variable, so any subdivision that we might make is necessarily a bit arbitrary, but it turns out that at least in clinical practice, there's been really two distinct approaches to hypofractionation that have arisen. And one of these is moderate hypofractionation and that's an approach where the fraction size is modestly higher than 2 Gray per fraction, and in the guideline, it's been defined as a fraction size between 2.4 and 3.4 Gray, whereas ultra-hypofractionation, this is defined in the guideline as a fraction size greater than 5 Gray. And it's also been referred to in the literature as extreme hypofractionation or Stereotactic Body Radiation Therapy, SBRT, or SABR, Stereotactic Ablative Radiation Therapy. But in any case, we are talking here about, with ultra-hypofractionation, with radical courses of treatment that are often delivered over as few as five fractions, often on an alternate day approach over two or two and a half weeks. And so the guideline really was largely motivated by the publication of a number of randomized trials, including four large-scale trials in the past two years that have compared conventionally fractioned radiation therapy and moderately hypofractionated radiation therapy. So that is really what stimulated the guideline, which was the evidence concerning moderately hypofractionated radiation therapy. But at the same time, there has been an increasing use in routine clinical practice that's been observed of ultra-hypofractionated radiotherapy, so the decision was made to make recommendations on it as well. So ASTRO, American Society for Radiation Oncology, in
Ep 20Human Papillomavirus Testing in Head and Neck Carcinomas Endorsement Guideline
An interview with Dr. Carole Fakhry from Johns Hopkins School of Medicine on the ASCO endorsement of the CAP guideline on human papillomavirus (HPV) testing in head and neck carcinomas. Read the full guideline at www.asco.org/head-neck-cancer-guidelines The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care, and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello, and welcome to the ASCO Guidelines podcast series. My name is Shannon McKernin, and today I'm interviewing Dr. Carole Fakhry from Johns Hopkins School of Medicine, lead author on Human Papillomavirus Testing in Head and Neck Carcinomas: ASCO Clinical Practice Guideline Endorsement of the CAP Guideline. Thank you for being here today, Dr. Fakhry. Thanks for having me. So first, can you give us a general overview of what this guideline covers? Sure. This guideline serves to guide multi-disciplinary clinicians in the evaluation of head and neck cancers. And it really starts to clarify which HPV tests to order and when. Also discusses some of the imitations of using surrogate HPV testing in specific situations. The College of American Pathology Guidelines were recently published and we are providing an endorsement with certain classifications and discussions of nuances that we as a committee felt were important and clinically significant, specifically, aspects that could alter clinical care. So what are the key recommendations of this guideline? So first and foremost, the key recommendation is that HPV tumor detection should be performed in oropharynx tumors and not for non-oropharynx tumors. An important aspect of that is that HPV tumor testing should not be altered based on sex, race, age, or smoking history. Another important recommendation is that the term "high-risk" only be used when HPV-specific testing is performed. That would establish the tumor is ideologically related to the infection human papillomavirus. In the absence of HPV-specific testing, we recommend that the term HPV-related tumors be used, and that p16 deserving for oropharynx tumors only. And can you tell us a little bit about the qualifying statements made on some of these recommendations, and why the expert panel decided to include these? Sure. So one of the qualifying statements that we did make was a generalized one, and the one that I kind of just touched upon, that the term "high-risk HPV" should only be used in situations when HPV-specific testing was performed. And that's because sometimes things are p16 positive but not necessarily HPV-related or etiologically related to the infections. So as a committee, we wanted to make sure that that was clear. In light of that, one of the recommendations from the CAP Guidelines was that for tissue specimens presenting with medistatic squamma cell carcinoma of unknown primary and cervical upper, or mid-jugular, chain lymph nodes, pathologists should perform p16 in situ hybridisation. They also had added a note saying that additional high-risk HPV testing on p16-positive cases should be performed for tumors located outside of level two or three in the neck, and/or for tumors with keratinizing morphology. So in the qualifying statement, our committee felt that p16 immunohistochemistry alone was not sufficient in the scenario of an unknown primary cancer. We can get false positives and tumors that are p16-positive but not related to HPV. Can arise in situations of metastasis from the skin cancers, salivary gland malignancies, or even lung primaries. Therefore, in the case of an unknown primary, we would recommend HPV-specific testing. What other important consideration that our committee felt was important to clarify was that in the unknown primary, whether or not a tumor is felt to have keratinizing or non-keratinizing morphology, that HPV-specific testing should be done. And the reason for that is that the pathologists acknowledge that considering a tumor keratinizing or non-keratinizing may be a difficult distinction for most pathologists, and that discerning HPV status may actually be easier and may help hone in on the diagnosis. And as part of this, what we did was we created an algorithm which simplified the College of American Pathologists algorithm for HPV detection. So there are fewer nodes in terms of HPV detection. And in general, for oropharynx tumors, we recommend starting a p16 immunohistochemistry. We endorse the 70% cutoff used on immunohistochemistry for p16. And if it's an oropharynx tumor with greater than 70% p16 staining, then that can be considered an HPV-related squama cell carcinoma. For non-oropharynx tumors, we don't ever recommend HPV tumor status evaluation. And then for unknown primary, whether or not it's a level 2 or 3,
Ep 19Clinically Localized Prostate Cancer Endorsement Guideline
An interview with Dr. Justin Bekelman from University of Pennsylvania Perelman School of Medicine on the ASCO endorsement of the AUA/ASTRO/SUO Guideline on the management of localized prostate cancer. Read the full guideline at www.asco.org/genitourinary-cancer-guidelines The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello and welcome to the ASCO Guidelines Podcast Series. My name is Shannon McKernin, and today I'm interviewing Dr. Justin Bekelman from University of Pennsylvania Perelman School of Medicine, lead author on "Clinically Localized Prostate Cancer: ASCO Clinical Practice Guideline Endorsement of an AUA/ASTRO/SUO Guideline." Thank you for being here today, Dr. Bekelman. Thanks for having me. First, can you give us a general overview of what this guideline covers? Sure. So this guideline addresses the key question about what is the current best practice available for the management of localized prostate cancer. It's an endorsement guideline, which means it reinforces the recommendations offered by the American Urologic Association, ASTRO, SUO, which is the Society of Urologic Oncology. In April of 2017, these three groups got together to release a joint evidence-based practice guideline on clinically localized prostate cancer. And then, now more recently, in 2018 ASCO assembled a panel to review those policies, update them, and endorse them as appropriate. So this guideline has over 60 recommendations. So I'm not going to ask you to read through all of them. But can you talk about some of the key topics and discussion points that was added by the ASCO expert panel? Yeah, absolutely. I'd like to highlight four areas. The first area-- panel endorsed guideline recommendations on active surveillance for men with low risk Gleason 6 prostate cancer, what's called grade 1 prostate cancer now. The panel also felt it reasonable to add that ASCO has also produced a guideline on active surveillance which provides more context and counsel for clinicians and patients. It also includes a discussion of how surveillance might be considered for men with low volume Gleason 3+4, or what's called grade 2 cancers. And so I would reference that ASCO guideline on active surveillance for folks who are interested in that. Second, panel updated the recommendation regarding the length of androgen deprivation therapy or hormone therapy for men with higher risk clinically localized prostate cancer. Prior recommendations considered 24 to 36 months to be appropriate. And that's what's captured in the 2017 guidelines from the AUA, ASTRO, and SUO. But new evidence released after those guidelines were published from two trials-- one called RADAR and one called PCS IV trial-- shows that 18 months may be equivalent and permissible, and thus these trials should be followed really closely. But that's really interesting, provocative information for patients as they consider adjuvant hormone therapy for high risk cancers when they're receiving radiation. Third, the panel describes two really high impact quality of life studies comparing surgery, external beam radiation, and brachytherapy that were published in JAMA in 2017, again, after the AUA guideline was published. These two studies are actually summarized in the discussion of the panel findings. And they are an excellent reference for both clinicians and patients as they consider the potential benefits and harms of the various treatments for prostate cancer. The last one I'd want to highlight to the audience is the panel's recommendations regarding cryosurgery. And even though the original guidelines stated that selected patients are candidates for cryosurgery, the panel found that there was insufficient evidence to support the use of cryosurgery for clinically localized prostate cancer. So those are four highlights from the evidence based review. And why is this guideline so important? And how will it change practice? This guideline represents the most up to date consensus recommendations from the major professional societies that represent clinicians-- the surgeons, the radiation oncologists, the medical oncologists-- who counsel and treat men with prostate cancer. So it's a really important initial original guideline and then a really important endorsement. I think it will change practice by highlighting what the current best practice standards of care are for clinically localized prostate cancer. And finally, how will these guideline recommendations affect patients? I think this guideline will have an immediate impact on important questions that patients and their clinicians want answered. I think that's how the panel actually took it
Ep 18Antimicrobial Prophylaxis for Adult Patients with Cancer-Related Immunosuppression Guideline
An interview with Dr. Randy Taplitz from UC San Diego Health on the guideline update which addresses antimicrobial prophylaxis for adult patients with immunosuppression associated with cancer and its treatment. Read the full guideline at www.asco.org/supportive-care-guidelines The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. Hello and welcome to the ASCO Guidelines podcast series. My name is Shannon McKernin, and today I'm interviewing Dr. Randy Taplitz from UC San Diego Health, lead author on Antimicrobial Prophylaxis for Adult Patients With Cancer-Related Immunosuppression: ASCO and IDSA Clinical Practice Guideline Update. Thank you for being here, Dr. Taplitz. Thank you. So first, can you give us a general overview of what this guideline covers? Yes. I mean, I think we're all aware that infection in the setting of neutropenia associated with cancer chemotherapy is really a major cause of morbidity in these patients. And it's also important to be aware that prevention and appropriate management of febrile neutropenia and infection should thus be a critical focus in cancer care. So the focus of this particular guideline was to evaluate the risk and benefits of antimicrobial prophylaxis in these patients and really to determine evidence-based best practices for prevention of infection and how to go about doing that. So In this guideline, what we do is we identify the groups at risk for febrile neutropenia and really recommend settings for which prophylaxis with antibacterial, antifungal, antiviral medications are indicated. And then as well make recommendations for consideration of vaccination and other measures such as respiratory etiquette, and hand hygiene, and the like that will help reduce the risk of infection in these vulnerable patients. So since this is an update of a 2013 guideline, what are the major changes? And can you tell us a little bit about the research that informed this update? Yes. Really, when you update a guideline, one is informed by review of articles that encompass, in this setting, randomized clinical trials as well as meta analysis of interventions to prevent microbial infections in patients with neutropenia or other types of immunosuppression. And one example of this-- I think one of the better examples-- is we reviewed a large meta analysis of antibiotic prophylaxis in neutropenic patients after chemotherapy that showed that for fluoroquinolone prophylaxis resulted in really significant reductions in all cause mortality and febrile episodes, particularly in patients who were high risk, meaning the hematologic malignancy population and stem cell transplant population. And in that particular population, in fact, the number needed to treat to prevent one death was 29. So therefore, in that high risk population, really as with prior guidelines, the fluoroquinolone prophylaxis is recommended. However, we also reviewed other articles that include emerging data on some of the risks of fluoroquinolone prophylaxis. So for instance, the effect of fluoroquinolone on the intestinal microbiome and its association with selection of fluoroquinolone-resistant bacteria such as Gram-negative rods, as well as selection of organisms such as Clostridium difficile and enterococcus. And then we also reviewed fluoroquinolone toxicities. So what is added to this guideline are some qualifying statements alerting clinicians to really be aware for these concerns and to consider what the clinical spectrum of things like Clostridium difficile infection, et cetera, look like. In terms of antifungal prevention, including pneumocystis prevention, we really haven't made any major changes to this guideline with the exception that in this new guideline, the panel has also started looking at complications associated with immunotherapy and actually makes a suggestion that people consider pneumocystis prophylaxis in the setting of prolonged steroid use when it's used to treat immune-related adverse events that we've begun to see in increasing numbers associated with agents like checkpoint inhibitors and other immunotherapies. In terms of viral infections, the updated guidelines recommend risk assessment for hepatitis B reactivation and then treatment in accordance with other ASCO guidelines and yearly influenza vaccine, as well as really endorsing other vaccines as described in the Infectious Disease Society of America Guideline for Vaccination in Immunocompromised Hosts. So really, those are the main new events since 2013. And what are the key recommendations of this guideline? So the key recommendations-- the first thing is what we call a risk assessment. So after-- what on
Ep 17Disease Management for Patients With Advanced HER2 Positive Breast Cancer and Brain Metastases Guideline
An interview with Dr. Naren Ramakrishna from University of Florida Health Cancer Center at Orlando Health on the guideline update which addresses management of brain metastases for patients with human epidermal growth factor receptor 2–positive advanced breast cancer. Read the full guideline at www.asco.org/breast-cancer-guidelines
Ep 16Systemic Therapy for Patients with Advanced HER2 Positive Breast Cancer Guideline
An interview with Dr. Nancy E. Davidson from Fred Hutchinson Cancer Research Center and University of Washington on the guideline update which provides recommendations on systemic therapy for patients with human epidermal growth factor receptor 2 (HER2)–positive advanced breast cancer. Read the full guideline at www.asco.org/breast-cancer-guidelines
Ep 15Integrative Therapies During and After Breast Cancer Treatment Guideline
An interview with Dr. Gary Lyman from Fred Hutchinson Cancer Research Center and University of Washington and Dr. Lorenzo Cohen from the University of Texas MD Anderson Cancer Center on the ASCO endorsement of the SIO guideline on use of integrative therapies during and after breast cancer treatment. The guideline addresses the use of integrative therapies for the management of symptoms and adverse effects. Read the full guideline at www.asco.org/supportive-care-guidelines.
Ep 14Treatment of Malignant Pleural Mesothelioma Guideline
An interview with Dr. Hedy Kindler of the University of Chicago on the guideline which includes recommendations on diagnosis, staging, chemotherapy, surgical cytoreduction, radiation therapy, and multimodality therapy in patients with malignant pleural mesothelioma. Read the full guideline at www.asco.org/thoracic-cancer-guidelines
Ep 13HER2 Testing in Breast Cancer Guideline
An interview with Dr. Antonio Wolff from Johns Hopkins Sidney Kimmel Comprehensive Cancer Center on the ASCO/CAP guideline update which addresses IHC and ISH testing for HER2 in breast cancer. Read the full guideline at www.asco.org/breast-cancer-guidelines
Ep 12Metastatic Pancreatic Cancer Guideline
An interview with Dr. Davendra Sohal from the Cleveland Clinic on the guideline update regarding second-line therapy for patients with metastatic pancreatic cancer. Read the full guideline at www.asco.org/gastrointestinal-cancer-guidelines
Ep 11Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer Guideline
An interview with Dr. Neelima Denduluri from US Oncology, Virginia Cancer Specialists, on the key recommendations of the ASCO guideline adaptation of the Cancer Care Ontario guideline on the selection of optimal adjuvant chemotherapy regimens for early breast cancer and adjuvant targeted therapy for breast cancer. Read the full guideline on www.asco.org/breast-cancer-guidelines
Ep 10Practical Assessment and Management of Vulnerabilities in Older Patients Guideline
An interview with Dr. Supriya Mohile from University of Rochester on the guideline published in JCO which provides guidance regarding the practical assessment and management of vulnerabilities in older patients undergoing chemotherapy. To read the full guideline go to www.asco.org/supportive-care-guidelines.
Ep 9ASCO Clinical Practice Guidelines Committee Leadership
An interview with Dr. Neelima Denduluri, Dr. Manish Shah, Dr. Mariana Chavez Mac Gregor, and Tom Oliver discussing the ASCO Clinical Practice Guidelines program, methodology, panel representation, and vision for the future. Read more at www.asco.org/guidelines
Ep 8Palliative Care in the Global Setting Guideline
An interview with Dr. Nahla Gafer from Radiation & Isotope Center in Sudan on the Palliative Care in the Global Setting: ASCO Resource-Stratified Guideline. The purpose of this new resource-stratified guideline is to provide expert guidance to clinicians and policymakers on implementing palliative care in resource-constrained settings and is intended to complement the Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology (ASCO) Clinical Practice Guideline Update of 2016. It is the view of the ASCO that health care providers and health care system decision makers should be guided by the recommendations for the highest stratum of resources available. The guideline is intended to complement but not replace local guidelines. Read the full guideline at www.asco.org/resource-stratified-guidelines
Ep 7Antiemetics Guideline
An interview with Dr. Paul Hesketh from Lahey Hospital and Medical Center on the antiemetics guideline update published in 2017. The guideline update expands the recommendations to include olanzapine and neurokinin 1 receptor antagonists. Read the full guideline at www.asco.org/supportive-care-guidelines
Ep 6Patient-Clinician Communication Consensus Guideline
An interview with Dr. Timothy Gilligan from Taussig Cancer Institute and Institute and the Center for Excellence in Healthcare Communication, Cleveland Clinic, Cleveland, OH on the guideline providing guidance to oncology clinicians on how to use effective communication to optimize the patient-clinician relationship, patient and clinician well-being, and family well-being. Read the full guideline at www.asco.org/supportive-care-guidelines
Ep 5Integration of Palliative Care into Oncology Guideline
An interview with Dr. Betty R. Ferrell of City of Hope Medical Center on the guideline "Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update" which provides evidence-based recommendations to oncology clinicians, patients, family and friend caregivers, and palliative care specialists on the integration of palliative care into standard oncology care for all patients diagnosed with cancer. A guideline on palliative care in the global setting is currently in press with the Journal of Global Oncology and there will be an episode on this topic when it publishes. Read the full guideline at www.asco.org/supportive-care-guidelines
Ep 4Fertility Preservation in Patients with Cancer Guideline
An interview with Dr. Alison W. Loren of Perelman School of Medicine of the University of Pennsylvania on the ASCO guideline update which provides current recommendations about fertility preservation for adults and children with cancer. Read the full guideline at www.asco.org/survivorship-guidelines
Ep 3Optimizing Anticancer Therapy in Prostate Cancer Guideline
An interview with Dr. Michael J. Morris from Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine on the ASCO clinical practice guideline which addresses abiraterone or docetaxel with androgen-deprivation therapy (ADT) for metastatic prostate cancer that has not been treated (or has been minimally treated) with testosterone-lowering agents. Read the full guideline at www.asco.org/genitourinary-cancer-guidelines
Ep 2Outpatient Management of Fever and Neutropenia Guideline
An interview with Dr. Christopher Flowers of Emory University School of Medicine on the ASCO/IDSA clinical practice guideline which provides updated recommendations on outpatient management of fever and neutropenia in patients with cancer. Read the full guideline at www.asco.org/supportive-care-guidelines
Ep 1Management of Immune-Related Adverse Events Guideline
An interview with Dr. Bryan Schneider of the University of Michigan on the ASCO clinical practice guideline to increase awareness, outline strategies, and offer guidance on the recommended management of immune-related adverse events in patients treated with immune checkpoint inhibitor (ICPi) therapy. Read the full guideline at www.asco.org/supportive-care-guidelines