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The ASCO eLearning Podcast is an educational series focused on helping learners identify knowledge gaps and stay up-to-date with the latest in new drug developments, cancer treatments and patient care approaches.The purpose of this podcast is to educate and to inform. This podcast is provided on the understanding that it does not constitute medical or other professional advice or services. It is no substitute for professional care by a doctor or other qualified medical professional and is not intended for use in the diagnosis or treatment of individual conditions. Guests who speak in this podcast express their own opinions, experience and conclusions. Neither American Society of Clinical Oncology nor any of its affiliates endorses, supports or opposes any particular treatment option or other matter discussed in this podcast. The mention of any product, service, organization, activity or therapy on the Podcast should not be construed as an ASCO endorsement.

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The ASCO eLearning Podcast is an educational series focused on helping learners identify knowledge gaps and stay up-to-date with the latest in new drug developments, cancer treatments and patient care approaches.The purpose of this podcast is to educate and to inform. This podcast is provided on the understanding that it does not constitute medical or other professional advice or services. It is no substitute for professional care by a doctor or other qualified medical professional and is not intended for use in the diagnosis or treatment of individual conditions. Guests who speak in this podcast express their own opinions, experience and conclusions. Neither American Society of Clinical Oncology nor any of its affiliates endorses, supports or opposes any particular treatment option or other matter discussed in this podcast. The mention of any product, service, organization, activity or therapy on the Podcast should not be construed as an ASCO endorsement.

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ASCO eLearning Podcasts

Latest release on Jan 10, 2020

The Best Episodes Ranked Using User Listens

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Rank #1: ASCO Guidelines: Management of the Neck in Squamous Cell Carcinoma of the Oral Cavity and Oropharynx Guideline

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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. So the next recommendation that's really helpful is who can be observed after surgery? And specifically low-volume N1 you can consider observing in oral cavity cancer, whereas N2 or N3 patients all need radiation or chemoradiation in the setting of extranodal extension and positive margins. We did come out pretty firmly advocating for bolus cisplatin 100 milligrams per meter squared every three weeks as recent studies suggest that weekly cisplatin or other regimens are not as effective, and we were pretty clear about that. We were pretty synchronized with recent ASCO-endorsed guidelines in oropharynx cancer that say similar things. In addition, one of the very important questions that comes up is a surgeon will say, well, I'm cutting out the neck tumor, and I know it comes to midline and he's got a bunch of nodes on the right side, but do I really need to do a left neck dissection? Aren't you going to radiate it anyway? And that comes up all the time. Is radiation adequate to manage a clinically negative neck in oral cavity cancer and oropharynx cancer? I think in oropharynx cancer everybody feels pretty comfortably yes. I think in oral cavity cancer it's been somewhat controversial. We favor neck dissections when possible, but if radiation is known to be happening, especially to an elective contralateral neck, that that is adequate therapy. However, we're pretty strong in the fact that neck dissections are the tried and true way to treat oral cavity cancer and that in a T2 or above tumor where a neck dissection is indicated, just resecting the primary and leaving the neck to elective radiation is not something that we thought there was enough evidence for to advocate, and we still advocate classic neck dissection first followed by adjuvant radiotherapy as indicated. One area of controversy that we did touch on is the issue of early stage tongue cancers and whether they need a neck dissection at all. And we came down pretty consistently with all of the co-authors on the guideline that we advocated for a neck dissection for all patients with oral cavity cancer unless it is a very small tumor that we define with very compliant patient who is amenable to very rigorous follow-up that has been done in Europe and in some other places with, specifically, people trained in careful neck ultrasound techniques. So all of those really help guide, both in early stage and more advanced stage, how to manage the neck and oral cavity cancer. And in oropharynx cancer, again, many of the same quality metrics apply. We have some guidance about when doing transoral robotic surgery how to reduce bleeding risk by ligating feeding blood vessels, which is an important addition. We also discuss the fact that, as opposed to lateralized oral cavity patients where a unilateral either neck dissection of radiation is often indicated, in oropharynx cancer the group felt very strongly that bilateral neck should be treated. And typically if tumors extend to midline or involve the posterior oropharyngeal wall, which has bilateral drainage, that either bilateral neck dissection should be performed in those cases or a unilateral neck dissection can be done as long as adjuvant radiation is planned to both necks. Finally, a couple of very important questions of who should not be treated surgically and who should be treated with a nonoperative chemoradiation based approach. In oral cavity cancer, as long as they were not metastatic, we felt people should be resected as long as they were surgically resectable and medically operable. In oropharynx cancer, however, anybody who had unequivocal extranodal extension of nodes into soft tissues or involvement to the carotid artery or extensive cranial-nerve involvement or skull-based involvement by extensive nodal disease are not good candidates for surgery and should be preferentially treated with chemoradiation. That was pretty strong. And finally, the other thing we gave clarity on is when we treat oropharynx cancer with chemoradiation, how do we follow them and when do we decide to do a neck dissection or not? And essentially we recommended a PET CT scan at 12 weeks. And as long as that was negative, a neck dissection should not be done. If you don't have a PET scan and you just have high quality CT or MRI but all of the neck disease has resolved, similarly there should be no neck dissection. And then most importantly, the situation we all face which is very complex is what happens when you have a PET CT done three to four months after treatment and you have small nodes that are still there? You have a little bit of uptake. The FDG avidity is much less than it was. There still is a lesion there, but it's much better and the patient is feeling well. And we felt pretty comfortable not doing a standard neck dissection on those patients but rather following them closely with a follow-up CT scan two to three months later and continual assessment and reserving surgery for obvious progressive disease. So why is this guideline so important, and how will it change practice? So this guideline is really important because head and neck cancer being not the most common cancer, and especially because head and neck cancer is not really one disease-- there's so many different diseases. Even oral cavity and oropharynx, there's quite a bit of variability in how we think about it. There's not a one size fits all recipe for how to manage people properly, and that leads to a lot of confusion and sometimes doubt as to what the best thing to do is in these patients. And that is a very common thing. So I think the most important reason why these guidelines are helpful is they're really clear. They give really clear guidelines of if you're going to do surgery, here's the expectations of what nodal levels to take out and how many nodes to take out. Here's when you should do adjuvant radiation. Here's when you should do adjuvant chemoradiation. Here's when you should treat one side of the neck. Here's when you should treat both sides of the neck. If you're not going to do surgery, here's when you do radiation. And for oropharynx cancer, here's when you can consider surgery. Here's where surgery is not the best idea. And when you treat them and if you do surgically, here's how you do it. If you do with radiation, here are the nodes that should be treated, the nodal levels. And finally, after you do that, how do you watch and act to make sure that people don't fail? So I feel like all of those things lend a lot of clarity to some complicated decision-making processes for these patients, and this really lends clarity to that, which should help kind of lend consistency of practice. That's really our goal. Our goal was there a lot of great docs taking care of these patients out there, but patients are treated in very different ways depending on who they're seeing and where you go. Our goal was to try to increase the consistency of how people are treated no matter where they are. And if practitioners, surgeons, radiation oncologists, medical oncologists see this guideline and kind of follow it and, of course, reach out with any questions at any time, then what we'll be able to do is kind of harmonize the way patients are treated in this country, which should help, I think, the quality of care. And finally, how will these guideline recommendations affect patients? They're going to affect patients because right now a lot of patients get great care, but there are some patients that are not getting ideal care either because maybe they're in parts of the country that don't have the same access to resources or they're in places where the volume of these kind of very complicated and yet not so common diseases aren't seen as high and there's confusion about how to manage them or what the quality metrics are. I think patients are going to be affected knowing, hey, if I'm going to have a neck dissection, here's what I should be asking to make sure my surgeon knows to do and does consistently to make sure it's of high quality. Here's where I think I should be treated with surgery, maybe I shouldn't be treated with surgery, and here's how to follow me. Because there is a lot of variability in how patients are treated, and sometimes there's too many surgeries being done, not enough surgeries being done. If they're being done, maybe they're not the best quality. Even if we don't treat with surgery and we do chemoradiation, we're watching them and we may not be following them as closely, and then people may be recurring and we're not picking it up closely enough. So I think it's going to harmonize, for patients, the way they're ultimately treated. If everybody in the country is treated relatively compatible with this guideline, I think the standard of care will go up across the board. Great. Thank you so much for your work on this important guideline, and thank you for your time today, Dr. Koyfman. Thank you so much. And thank you to all of our listeners for tuning into the ASCO Guidelines podcast series. If you've enjoyed what you've heard today, please rate and review the podcast and refer the show to a colleague.

Nov 13 2019

13mins

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Rank #2: Contrasting Cases: Cancer Prevention

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Dr. Noelle LoConte, associate professor of medicine at the University of Wisconsin, presents two patient cases regarding cancer prevention.

TRANSCRIPT

Hello. My name is Noelle LoConte. I am a physician and associate professor at the University of Wisconsin Carbone Cancer Center in Madison. I am a GI medical oncologist in my clinical practice, and also the principal investigator of my state's Comprehensive Cancer Control program, and an implementation science researcher in cancer prevention and screening. 

Today, we will compare two patient cases that relate to cancer prevention. These two cases have similarities yet the recommended treatments may be different. Let's look at our cases. 

Patient case number one is Harold. Harold is a 55-year-old man with a history of head and neck cancer treated with curative intent with chemotherapy and radiation, which was completed about six months ago. He is seeing you for a follow-up surveillance visit. He reports he is currently drinking three to four beers per day, most days of the week. He had quit smoking at diagnosis, but prior to diagnosis had a 45 pack-year history. He recently reports that he started vaping or using e-cigarettes. 

Our second patient case is Susan. Susan is a 44-year-old woman with node-negative, ER-positive, PR-positive, HER2 neu-negative breast cancer. She has also been treated with curative intent with surgery, chemotherapy, and radiation, and has completed her treatments about six months ago. She is seeing you for a routine follow-up visit and reports no new symptoms. She tells you she is drinking two glasses of wine per day, and she denies any history of smoking. 

As you can see, both cases are very similar, but there are some differences. How would you counsel each patient about their use of alcohol? And in the case of Harold, about his use of e-cigarettes? Do either of these affect the risk of recurrence for the patient? And what are the alcohol-associated cancers? 

For background, the cancer burden attributable to alcohol is significant. In 2012, an estimated 5.6 percent of worldwide cancer deaths were attributable to alcohol-associated cancers. In the United States, alcohol accounted for about 3.5 percent of cancer deaths in 2009. Both of these numbers are increasing over time as alcohol use is becoming more common both in the US and globally. 

Upper airway and squamous cell esophageal cancers accounted for the majority of alcohol-attributable deaths among men. Breast cancer accounted for the majority among women. Additional cancers causally linked to alcohol include hepatocellular carcinoma and colorectal cancer. Cancer risk correlates with increasing alcohol consumption for cancers in which alcohol is implicated. 

E-cigarettes are currently approved for adults as a way to decrease the harms from combustible tobacco products, but much about their risk remains unknown, particularly for cancer survivors. Although the risk appears to be lessened with e-cigarette use, they are not proven to be safe and can often serve as a gateway product for youth and nonsmokers to more traditional combustible smoking products. 

In both cases, each patient has an alcohol-associated cancer. However, it is unclear for all but head and neck cancers and esophageal squamous cell carcinoma if cutting down on alcohol intake after cancer diagnosis reduces the risk of recurrence. E-cigarette use among cancer survivors is an emerging issue for clinicians, who often do not know how to counsel their patients about these products. 

For Harold, with his head and neck cancer, there is clear data that supports that patients with that diagnosis who continue to drink do have higher rates of recurrence and also secondary head and neck cancers. Thus, the oncologists should counsel him to stop, or at least cut down on his alcohol drinking.  The current guidelines recommend no more than two servings of alcohol a day for men and no more than one per day for women. As a reminder, a serving of alcohol varies dependent on the product being consumed. It is roughly one 12 ounce bottle of regular beer, five ounces of wine, or 1 1/2 ounces of distilled spirits. 

For Susan, who has an estrogen and progesterone receptor-positive breast cancer, the data is less clear. There is a suggestion in some studies that ongoing alcohol use for hormone receptor-positive patients may increase the recurrence rates. However, the data is not definitive. It would be prudent for all health risks related to alcohol to counsel her to stick to the recommended amounts of alcohol use, however. So for her, this would be one drink per day for women. 

For e-cigarette use, a 2015 ASCO and AACR statement on ENDS, or electronic nicotine delivery systems, concludes that oncologists should not recommend e-cigarettes to their patients as first-line treatment for quitting smoking. Oncologists should also be aware that more and more cancer survivors are using e-cigarettes and similar products, and they should ask about use at each visit. The unclear health risks of e-cigarettes should be discussed with patients. 

Thank you for listening to this week's episode of the ASCO eLearning weekly podcast. For more information on cancer prevention, including additional patient cases and opportunities for self-evaluation, visit the comprehensive eLearning center at elearning.asco.org

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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. 

Apr 10 2019

6mins

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Rank #3: Recent Approvals: Larotrectinib for the Treatment of Advanced Solid Tumors Containing NTRK Gene Fusion

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Dr. Yosef Landman is a graduate of the Sackler School of Medicine, Tel Aviv University. He is currently a medical oncology resident at Davidoff Cancer Center, Rabin Medical Center in Petach Tiqva, Israel. In today's episode, he discusses the recent approval of larotrectinib for tumor-agnostic treatment of advanced solid tumors containing NTRK gene fusion. Dr. Landman, a co-author on the journal paper Rapid Response to Larotrectinib (LOXO-101) in an Adult Chemotherapy-Naive Patients With Advanced Triple-Negative Secretory Breast Cancer Expressing ETV6-NTRK3 Fusion (Clinical Breast Cancer, June 2018), provides background on the recent approval as well as a case-based example of larotrectinib treatment. If you enjoyed this podcast, make sure to subscribe for more weekly education content from ASCO University. We truly value your feedback and suggestions, so please take a minute to leave a review. If you are an oncology professional and interested in contributing to the ASCO University Weekly Podcast, email ascou@asco.org for more information.

Feb 06 2019

6mins

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Rank #4: Self-Evaluation: NSCLC Treatment Metastatic

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Shadia Jalal, MD, Assistant Professor of Clinical Medicine Department of Medicine Division of Hematology/Oncology Indiana University School of Medicine, presents a self-evaluation question from an ASCO University course focusing on the treatment of non-small cell lung cancers.

May 16 2018

6mins

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Rank #5: ASCO Guidelines: Initial Diagnostic Workup of Acute Leukemia Guideline

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If you enjoyed this podcast, make sure to subscribe for more weekly education content from ASCO University. We truly value your feedback and suggestions, so please take a moment to leave a review. If you are an oncology professional and interested in contributing to the ASCO University Weekly Podcast, email ascou@asco.org for more information.

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. 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 those discussion points that were made and why the panel decided to include these?

The discussion points include mostly issues regarding diagnostics that involve flow cytometry and molecular techniques as addressed in part one and two of the guidelines. We think that the cytomorphologic assessment is essential for initial diagnosis of acute leukemia.

Multicolor flow cytometry using 8 to 10 colors has led to a better distinction between myeloids, lymphoid, and mixed lineage blast origin. Even when the number of cells are limited, for instance in CNS involvement, fine needle aspirate of extramedullary leukemic infiltration, or skin biopsy for leukemic cutis.

Also, it was suggested to better assess the central nervous system involved in leukemia. The expert panel recommends the immunophenotyping studies as an additional detection technique next to the cytomorphological examination of cytospins and particularly for those with a low level involvement of acute leukemia that cannot be well addressed by a morphologic examination only.

The TDT immunohistochemistry staining of cytospins has alternatively been used for detection of CNS disease in AML and evaluation of CSF by multicolor flow cytometry has been recently adopted in some centers. Flow cytometry, using at least six, but we now use in some laboratories, even 8 to 10 colors has led to a much more specific in tentative diagnosis. And this has improved the detection of CNS involvement.

The use of molecular tools, for instance, polymerase change reaction, PCR, NGS for low-level CSF involvement is still under study, and therefore, we did not recommend this in our discussion.

Regarding the molecular markers and MRD detection, the discussion here was mainly based upon the results of translational research supported by better molecular detection techniques. And those molecular diagnoses have been developing in the past few years with the inclusion of many more molecular markers. And they included one of the key diagnostic criteria in the revised WHO classification, which was revised in 2017. And we made substantial changes that have been made in the ASH-CAP guidelines concerning molecular diagnostics.

Those newly identified targets by advanced molecular techniques give possibilities for better risk stratification. Some examples of better molecular characterization of acute lymphoblastic leukemia are, for instance, additional testing for MLL translocations. Furthermore, we can look in patients with T-ALL for NOTCH1, and FBXW7 mutations.

The Ikaros family zinc finger gene, the IKZF1 gene is frequently deleted in adults as well in children with B-ALL. And it was shown to have an independent prognostic significance and was also associated with poor clinical outcome.

In the current text of the current risk that the protocols IKZF1 should be regularly included in the screening panels for all ALL patients.

If we look for examples for better characterization of AML, acute myeloid leukemia, we have found an increasing number of additional cytogenetic aberrations, like for instance FLT3 ITD which is associated with poor outcome.

Another example is appropriate mutational analysis for kids, which can be detected both in adult patient as pediatric patients with a confirmed core binding factor acute myeloid leukemia. So this is myeloid leukemia with a translocation A21, RUNX1, or inversion 16.

This recommendation is very strong in adults, whereas in children, this prognostic fact impact remains unclear. So there have been proven several publications which refer to a similar prognosis for children and others who refer to a poor prognosis in comparison to known mutated genes. So we suggest to test for this mutation in adults, especially, but also in children to learn from it.

Finally, emerging evidence supports molecular studies as principle test for monitoring minimal residual disease of acute leukemia. And there are several key molecular markers that are included in the initial workup, which will be carried on for monitoring MRD, for instance, PML- RAR-alpha, RUNX1-RUNXT1, CBFB-MYH11, and NPM1, CEBP-alpha and others.

Beside those aforementioned markers, it's very important to screen for other molecular markers that have predictive or prognostic value in the individual. And it is possible to use them for MRD. We have found a recent consensus from the European Leukemia Net MRD Working Group, who was proposing that for detection of molecular MRD, and they refer the RT PCR platform to NGS and digital PCR platforms.

Although all those molecular techniques have been developed very quickly and it is very tempting to use them for initial diagnostics, currently, not all laboratories will have all those techniques available. So the expert panel strongly advises understanding to make distinction between diagnostic that are needed in the first phase to start treatment and subsequently, treatment stratification, in contrast to the usual dose findings in a broader research.

For instance, available karyotyping, FISH, PCR techniques, if possible, NGS can be used in the initial start of treatment, whereas techniques like whole exome sequencing, whole genome sequencing, RNA sequencing, and epigenomic studies are meant for a broader research.

And finally, how will these guideline recommendations affect patients?

Well, in the end, the patients will receive better and especially, more personalized treatment. If we have results available within two weeks from diagnosis, it will be possible to better identify which basis will better benefit from more intensified and more personalized treatment, whereas others may need less intensive treatment with less toxicity.

If you use traditional techniques to do this supported by molecular techniques like karyotyping, FISH, and PCR techniques, and in the end, following MRD to see which patients are responding to treatment, MRD detection will help to identify these patients and stratify them finally to the best treatment.

Great. Thank you for your work on this important guideline, and thank you for your time today, Dr. de Haas.

OK. Thanks a lot.

And thank you to all of our listeners for tuning in to the ASCO Guidelines podcast series. If you've enjoyed what you've heard today, please rate and review the podcast and refer this show to a colleague.

Dec 19 2018

12mins

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Rank #6: Annual Meeting 2019 - Clinical Conundrums in the Management of Rectal Cancer

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In this episode of ASCO eLearning Weekly Podcast Dr. Alessandro Fichera, Division Chief of Gastrointestinal Surgery at University of North Carolina at Chapel Hill, discusses clinical choices in managing rectal cancer. When is surgery the correct choice? When can we put down the knife?

Jun 03 2019

12mins

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Rank #7: Contrasting Cases: Frontline Immunotherapy in Metastatic Non-Small Cell Lung Cancer

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Apr 17 2019

8mins

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Rank #8: Self-Evaluation: Metastatic Breast Cancer

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Dr. Aditya Bardia, attending physician at the Massachusetts General Hospital Cancer Center, presents a self-evaluation question on the treatment of metastatic breast cancer.

Dec 13 2017

3mins

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Rank #9: Recently Approved Drugs: Nivolumab for Metastatic Colorectal Cancer

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Dr. Matthew Yurgelun, assistant professor of medicine at Harvard Medical School and gastrointestinal medical oncologist at the Dana Farber Gastrointestinal Cancer Center and Cancer Genetics and Prevention Program, presents information on the recently approved nivolumab for the treatment of patients 12 years and older with mismatch repair deficient and microsatellite instability high metastatic colorectal cancer.

Nov 22 2017

8mins

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Rank #10: Self-Evaluation: Breast Cancer

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Dr. Shaheenah Dawood, consultant medical oncologist and lead of the oncology research program at the Comprehensive Cancer Center Mediclinic City Hospital in the United Arab Emirates, presents a self-evaluation question on the predictive and prognostic rule of pathological complete response attained in the treatment of breast cancer.

Feb 07 2018

4mins

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Rank #11: ASCO Guidelines: Antimicrobial Prophylaxis for Adult Patients with Cancer-Related Immunosuppression Guideline

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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 one does is carefully assess, really, what the risk of febrile neutropenia is. And that includes assessment of patient, what the cancer is, and what the treatment-related factors are. And then after they're risk adjusted and risk assessed, then we take, in turn, different forms of prophylaxis that we consider.

And so the first one that we always consider is antibiotic prophylaxis against bacterial infections. And the recommendation is still with the fluoroquinolone. And that's recommended for most patients who are at high risk for febrile neutropenia or profound, really prolonged neutropenia, such as those getting therapy for AML, or myelodysplastic syndrome, or stem cell transplant recipients, particularly with myeloablative regimens. In the lower risk groups, such as those with most solid tumors, fluoroquinolone prophylaxis is not recommend.

In terms of antifungal prophylaxis, what is recommended is an oral triazole or Micafungin-- for patients, again, at risk for profound protracted neutropenia such as that AML, MDS, stem cell transplant group during that period of neutropenia.

When the risk of invasive aspergillus is high, such as in patients with AML or MDS during the neutropenia period while getting chemotherapy, then the consideration of a mold-active triazole is recommended and in addition should be considered in the context of stem cell transplant recipients with graft versus host disease.

In terms of PCP prophylaxis, PCP preventive therapies are recommended for those at high risk for PCP, which include those on greater than what we say 20 milligrams of prednisone equivalent a day for over a month, or based on purine analog use.

Viral prophylaxis for HSV is recommended for seropositive patients undergoing allogeneic stem cell transplant or leukemia induction.

And then as I mentioned before, patients at risk for hepatitis B reactivation are recommended treatment with a nucleoside reverse transcriptase inhibitor. And this is more carefully discussed in the ASCO Provisional Clinical Opinion on Hepatitis-B Virus Screening for Patients With Cancer Before Therapy.

It's also recommended that a yearly flu vaccine is given to patients as well as given to family, household contacts, and health care workers. Other vaccination recommendations are as per the Infectious Disease Society of America Guidelines for Vaccination of Immunocompromised Hosts.

And then the other things that are recommended are really review and repeat recommendation of adherence with hand hygiene, with respiratory etiquette, which is recommended and really required for all health care workers. And that out patients with neutropenia from cancer chemotherapy should avoid high risk activities, which include really contact with environments that have high concentration of fungal spores such as construction and demolition, high intensity gardening, et cetera.

So those are really a summary of the key recommendations of this guideline.

And finally, how will these guideline recommendations affect patients?

I think it's important to remember that to ensure best practices on infection prevention, the literature needs to be reviewed frequently and guidelines need to be updated. I don't think that these current guidelines will dramatically change the preventive strategies that are used for patients, with the exception of perhaps a few extra vaccines-- some newer indications for pneumocystis prevention, hepatitis B reactivation prevention, those kinds of things.

However, I think in reviewing the literature, it becomes clear what will we will need to be thinking about in the coming years, what we will need to be assessing. And a couple of those things are the dramatic increase in the use of immune-based therapies and how that will affect infection risk in patients with or without neutropenia. We need to be considering the effects of routine antibiotic prophylaxis on the microbiome and the risks that that might incur. And we need to really understand how new vaccines can be utilized.

So yeah, I think these areas are really ripe for research and need to be followed closely to ensure optimization of these preventive strategies for our patients in the future.

Thank you for your time today, Dr. Taplitz.

You're quite welcome.

And thank you to all of our listeners for tuning into the ASCO Guidelines podcast series. If you've enjoyed what you heard today, please rate and review the podcast and refer this show to a colleague.

Nov 06 2019

10mins

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Rank #12: ASCO Guidelines: Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer Update

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Dr. Gregory Riely, medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, presents the ASCO Guideline update on Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer, published in the Journal of Clinical Oncology in August 2017.

Dec 06 2017

5mins

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Rank #13: ASCO Guidelines: Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision-Making for Early-Stage, Operable Breast Cancer Update

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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 women with hormone receptor-positive, HER2 negative breast cancer. But in this case, most women's sorry lymph nodes were negative, although a few women had up to three lymph nodes involved. In that trial, patient's risk of disease recurrence was assessed in two ways. First, it was assessed based on clinical factors. So the size of the tumor, how many lymph nodes were involved, and the estrogen receptor, progesterone receptor, and HER2 receptors. Second, it was assessed based on genomic factors-- that was using the MammaPrint test. So if patients were low for both clinical factors and genomic factors, they only were treated with anti-estrogen therapy. If they were high for both clinical factors and genomic factors, then they were treated with chemotherapy followed by anti-estrogen therapy. However, if they were high for one and low for the other, then they were randomized to either endocrine therapy alone or chemotherapy followed by endocrine therapy. So it was a little bit of a confusing trial. In the MINDACT trial, those patients who were thought to be high risk based on their clinical risk, so the size of the tumor, the number of lymph nodes, but then found to be low risk on the MammaPrint assay. They found that there was no benefit to treatment with chemotherapy in terms of how likely a woman was to develop distant metastatic disease. And if they were low risk, based on the clinical assessment, then there didn't appear to be a benefit of actually doing the test, the assay, because chemotherapy wouldn't be recommended for the patient, regardless of the results. So that was the MINDACT trial. So what are the new and updated recommendations for the guideline? Yes, so in this guideline, we, based on the TAILORx trial, we made new recommendations for use of the Oncotype DX results. All of these results apply to women with hormone receptor-positive, HER2 negative, lymph node-negative breast cancer. So for women older than age 50, if they have an Oncotype score of 25 or lower, then clinicians may offer endocrine therapy and no chemotherapy. However, for women age 50 or under, if they have an Oncotype score of 15 or lower, 15, then, clinicians may offer endocrine therapy and no chemotherapy. But if the score is 16 to 25, then chemotherapy can be considered in addition to endocrine therapy. So it made a difference in that gray area in the middle. For all women with score 26 to 30, chemotherapy may be considered. And for scores above 30, chemotherapy should definitely be considered. The data from the MammaPrint trial actually aren't that new. Results from that trial were originally published in 2016. However, that was after the original guideline was published, so we wanted to add these results to these updated guidelines for completeness. For a patient with hormone receptor-positive, HER2 negative, node-negative breast cancer, who is thought to be at high clinical risk of breast cancer recurrence, if the MammaPrint assay shows low genomic risk, then treatment with chemotherapy can be avoided. If a patient is thought to be at low clinical risk, the MammaPrint should not be used as chemotherapy can be avoided regardless. And for a patient with hormone receptor-positive, HER2 negative breast cancer, but who has one to three positive lymph nodes, who is thought to be at high clinical risk of breast cancer recurrence, if the MammaPrint assay shows low genomic risk, then it is possible that chemotherapy could be avoided, especially if only one lymph node is involved. So I think the bottom line for this part is that both of these tests-- there are now women who previously would have been recommended to have chemotherapy that maybe now we can avoid chemotherapy based on using these assays on their tumors. So why are these changes so important and how will they affect practice? Yes, that's a good question. Before the publication of the TAILORx trial, we had good information about how to treat patients who had either very low or very high Oncotype scores. But we really weren't sure how best to treat those patients who scores fell in the middle. Now, we have important information to guide decisions about chemotherapy for patients with intermediate scores. For many patients with scores in this range, these new results mean they will be able to avoid chemotherapy and just get endocrine therapy. While these results don't give us answers for every patient, they do provide more information that oncologists can use when having discussions with patients about the benefits and risks of chemotherapy. And what does this mean for patients with early-stage invasive breast cancer? And what should they talk to their doctors about? So as a result of both of these trials, we now have additional tools that can help oncologists provide more individualized treatment recommendations for patients and really assess whether or not chemotherapy, in addition to endocrine therapy, is likely to provide benefits. Knowing which patients' tumors will respond to chemotherapy can help some patients avoid unwanted side effects from a treatment that's not likely to actually give them much benefit. Now, these tests aren't appropriate for everyone and don't provide all the answers, but they are an important step in the right direction for providing more personalized treatment for women newly-diagnosed with certain types of breast cancer. Patients should talk with their doctors about whether these tests are right for them when they're making important decisions about whether or not they should receive treatment with chemotherapy. Great. Thank you, Dr. Henry, for this informative overview of the guideline. Keeping these clinical practice guidelines updated is really crucial and it takes a lot of careful thought to ensure these recommendations represent the evidence. So thank you for coming on the podcast to discuss the "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 very much for the opportunity to talk with you today. And thank you to all of our listeners for tuning into the ASCO Guidelines Podcast Series. To read the full guideline, go to www.asco.org/breast-cancer-guidelines. And if you've enjoyed what you've heard today, please rate and review the podcast and refer the show to a colleague.

Oct 23 2019

10mins

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Rank #14: Recently Approved Drugs: Olaparib for germline BRCA-mutated metastatic breast cancer

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Dr. Linh Alejandro, a clinical oncology pharmacist at the University of California, San Diego Health Systems discusses the approval of olaparib for germline BRCA-mutated metastatic breast cancer.

May 30 2018

5mins

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Rank #15: ASCO Guidelines: Treatment of Multiple Myeloma

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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 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 for multiple myeloma, but I really think this is a critical guideline because it is so clinical and practical in its essence. It's really designed to not just give the utopian view or the clinical trial view of a disease, but practically in the trenches, how do we use the drugs that we know are going to benefit our patients. Myeloma is one of the few cancers where we have seen a doubling, if not a tripling of survival in the last decade, because of so many of these new agents. And so making sure that our patients are treated optimally really is important. And we want to be able to ensure that they receive the best therapy possible, so they can live a longer life, but also live it with a greater quality of life. And so finally, how will these guideline recommendations affect patients? Well, we really hope that this is going to help patients all across North America and the whole world, because it will give very concrete advice to the practicing clinician in how to approach the disease. And one of the things I think will directly impact patients, if you will, right away is one of the themes of these guidelines, which is that you don't treat a patient simply based on the biopsy or simply based on their age, but that it is really a complex network of comorbidities, risk factors from the disease itself, the potential side effects of certain drugs, and a patient's own very personal history. It really fits in with the ASCO modality that we have of ensuring that we bring personalized medicine to our patients. And so this will allow the person who's reading it and who's applying it to their patient to recognize the importance of general guidelines, but also of applying it to the specific patient they care for. Because as I like to say, we don't treat multiple myeloma, we treat people. And so hopefully, this will allow the clinician to have that precision to care for their patient in the best way possible. Great. Thank you for that overview of this guideline, and thank you for your time today Dr. Mikhael. It's been a real pleasure. Thank you very much. And thank you to all of our listeners for tuning into the ASCO Guidelines Podcast series. To read the full guideline, go to www.asco.org/hematologic-malignancies-guidelines. And if you've enjoyed what you've heard today, please rate and review the podcast, and refer the show to a colleague.

Apr 03 2019

7mins

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Rank #16: Recently Approved Drugs: Durvalumab for patients with stage III Non-Small Cell Lung Cancers (NSCLC)

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Rami Manochakian, M.D., a thoracic clinical oncologist at the Mayo Clinic in Florida, presents information on the recently approved drug in oncology, durvalumab for patients with stage III Non-Small Cell Lung Cancers (NSCLC) after the completion of radiation therapy.

Jun 27 2018

11mins

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Rank #17: Annual Meeting 2019 - Managing Burnout in Oncology

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Dr. Amy Comander, a hematologist-oncologist specializing in breast cancer at Mass General Hospital, and Dr. Rachel Jimenez, Associate Program Director of Harvard Radiation Oncology Residency Program, have a personal discussion about burnout and practical ways to combat it. 

Jun 19 2019

6mins

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Rank #18: ASCO Guidelines: Safe Handling of Hazardous Drugs

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An interview with Dr. Paul Celano from the greater Baltimore Medical Center, lead author on "Safe Handling of Hazardous Drugs: ASCO Standards."

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. 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 of medical surveillance procedures that have been elucidated, that really we find, number one, have really not any proven value for our employees and generate a lot of confusion in terms of how this process is supposed to be done. Obviously, if one of our employees has some undue exposure, such as a spill of chemotherapy or even just have flat out a concern, then obviously those things will be clearly investigated. But to have general medical surveillance of all employees, really we did not feel was of great value.

But also further, we really feel that this is an area where more research needs to be done to better elucidate really what should this process look like and what value are we providing to our employees.

Another aspect of this is the use of what are called closed system transfer devices. Currently, there are a number of these devices available that there is interestingly no standard way that these devices have been evaluated. And so it's hard to recommend one device over another, because there is no standards for which they're really being compared. And there certainly have been no studies looking at really any form of health outcome that really help us to direct this to how best to use these devices. And so really, a lot of these objections are more around let's do things in an evidence-based way so we can better know how to best direct our practices.

Another area of concern in terms of ASCO standards have been the implementation of external ventilation in either containment secondary engineering controls or other situations. And the challenges is that HEPA filters are probably appropriate for collecting solid or aerosolized particles, but don't capture vaporized drugs. But there's little data available on the ability of hazardous drugs to vaporize within the workplace environment and what those hazards really are. And so again, it's is a call for more research to have an optimal environment for preparing these drugs and without having to place undue burdens in terms of external ventilation.

Another area is options for alternative duties for workers who are actively trying to conceive or are pregnant or breastfeeding. And these we recognize can be special burdens to small practices looking to implement alternative duty programs. There is a lot of controversy regarding the potential level of risk that really these workers really have. And basically our stance has been that we should have a policy that identifies alternative work options for workers who are trying to conceive, are pregnant or are breastfeeding, and that this information needs to be conveyed to these employees at the time of their hire so they understand what their risks are and what their options are within the workplace.

Again, trying to make sure everyone is well informed and aware of what the work environment they're in and as their life circumstances change what they can do to change with this. I think the key is that we all feel that this is an area that we should have continued research on. And our standard, certainly ASCO's standards will continue to evolve as more and more research and evidence becomes available.

Thank you so much for taking the time to explain these standards to us today, Dr. Celano.

You're welcome.

And thank you to all of our listeners for tuning into the ASCO Guidelines podcast series. If you've enjoyed what you've heard today, please rate and review the podcast and refer the show to a colleague

Apr 24 2019

10mins

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Rank #19: Annual Meeting 2019 - PD1 Inhibitor Resistance in PDL1 Overexpressed Tumor

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Jun 26 2019

8mins

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Rank #20: ASCO Guidelines: Outpatient Management of Fever and Neutropenia

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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

May 23 2018

11mins

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