ASCO Guidelines

Latest Episodes:

Management of Hereditary Breast Cancer Guideline Apr 03, 2020

Show notes

An interview with Dr. Nadine Tung from Beth Israel Deaconess Medical Center in Boston, MA on "Management of Hereditary Breast Cancer: ASCO, ASTRO, and SSO Guideline." This guideline covers recommendations for the management of patients with breast cancer with germline mutations in breast cancer susceptibility genes. Read the full guideline at www.asco.org/breast-cancer-guidelines

Systemic Therapy for Melanoma Guideline Mar 31, 2020

Show notes

An interview with Dr. Pauline Funchain from Cleveland Clinic in Cleveland, OH on "Systemic Therapy for Melanoma: ASCO Guideline." This guideline provides recommendations on systemic therapy options for adult patients with cutaneous and noncutaneous melanoma. Read the full guideline at www.asco.org/melanoma-guidelines

Treatment of Patients with Late-Stage Colorectal Cancer Resource-Stratified Guideline Mar 09, 2020

Show notes

An interview with Dr. Gabriela Chiorean from the University of Washington, Fred Hutchinson Cancer Research Center, Dr. Mary Chamberlin from Dartmouth-Hitchcock Medical Center, and Dr. Pritesh Lohar from the HCG Cancer Center, on "Treatment of Patients With Late-Stage Colorectal Cancer: ASCO Resource-Stratified Guideline." This guideline provides guidance for resource-constrained settings on the management of late-stage CRC. Read the full guideline at www.asco.org/resource-stratified-guidelines.

Management of Male Breast Cancer Guideline Feb 14, 2020

Show notes

An interview with Dr. Sharon Giordano from MD Anderson Cancer Center and Dr. Michael Hassett from Dana-Farber Cancer Institute on "Management of Male Breast Cancer: ASCO Guideline". This guideline provides recommendations concerning the management of male breast cancer; addressing five main areas where treatment for men differs from the approach used for women with breast cancer: adjuvant endocrine therapy, endocrine therapy for advanced/metastatic cancer, adverse effects of endocrine therapy, germline genetic testing, and survivorship. Read the full guideline at www.asco.org/breast-cancer-guidelines.

Therapy for Stage IV Non–Small-Cell Lung Cancer Without Driver Alterations Guideline Jan 28, 2020

Show notes

An interview with Dr. Nasser Hanna from Indiana University Simon Cancer Center and Dr. Gregory Masters from Helen F. Graham Cancer Center and Research Institute on "Therapy for Stage IV Non-Small-Cell Lung Cancer Without Driver Alterations: ASCO and OH (CCO) Joint Guideline Update." This guideline provides recommendations on systemic therapy treatment options for patients with stage IV non-small-cell lung cancer (NSCLC) without driver alterations in epidermal growth factor receptor or ALK, based on histology, PD-L1 status, and/or the presence or absence of contraindications. Read the full guideline at www.asco.org/thoracic-cancer-guidelines.

Transcript

[MUSIC PLAYING] 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 the shows including this one at podcasts.asco.org.

My name is Brittany Harvey. And today, I'm interviewing Dr. Nasser Hanna from Indiana University's Simon Cancer Center and Dr. Gregory Masters from Helen F. Graham Cancer Center and Research Institute, co-chairs on therapy for stage IV, non-small cell lung cancer without driver alterations, ASCO and CCO Joint Guideline Update. Thank you for being here today Dr. Hanna and Dr. Masters.

Thank you. Glad to be with you.

My pleasure. Thanks.

First, Dr. Hanna, can you give us a general overview of what this guideline covers?

Sure. So the ASCO guidelines for the treatment of patients with stage IV, non-small cell lung cancer were last updated in 2017. And since that time, there has been a tremendous amount of change that has taken place. The 2017 guidelines included recommendations for basically three subgroups-- those patients with non-small cell lung cancer who have certain targetable DNA mutations and those who do not have those mutations but have a PD-L1 score of 50% or higher and then everyone else.

But because of the rapid and vast changes that have taken place, we decided to make a separate guideline for those with targetable DNA mutations and to focus this current guideline on those without the targetable mutations. So within that context, this guideline categorizes patients by whether their tumors have a PD-L1 score of 0% to 49% or those who have a PD-L1 score or 50% or greater.

And within those categories, recommendations are characterized based upon whether the patient has squamous cell histology or non-squamous cell histology. And we also consider whether patients are candidates for chemotherapy or perhaps even those that decline chemotherapy and whether they have any contraindications for immunotherapy.

So what distinguishes these guidelines from other guidelines is our attempt to adhere to the strongest available evidence-based medicine. And while not every iteration of clinical management can be covered, these guidelines provide oncologists with a strong, evidence-based roadmap to treat the vast majority of patients with non-small cell lung cancer.

So as a result of this collective effort by ASCO staff and the guideline writing committee, this report offers a substantial amount of change to the recommendations from the clinical practices guidelines provided in 2017. In 2017, the only recommendations for the use of immunotherapy were in the first line setting for patients who had a PD-L1 score of greater than 50% and in the second line setting of patients progressing after first line chemo.

But these updated guidelines include the incorporation of immunotherapy in all subgroups of patients regardless of histology and PD-L1 score. So as a result, there are about three times the number of options to consider in the first line setting with these new guidelines compared to the 2017 guidelines. However, the 2020 guidelines provides a preferred treatment regimen for each situation to simplify the decision making process for most patients.

And what are those key recommendations of this guideline update for patients without driver alterations?

So the key changes for 2020 is the incorporation of immunotherapy into nearly all settings in the first line setting, regardless of tumor histology and regardless of PD-L1 score. For those patients who have a PD-L1 score of 50% or higher, single agent pembrolizumab remains the preferred treatment for most patients.

But new evidence does provide a rationale for giving select patients chemotherapy, either carbo and pemetrexed if they have non-squamous, or carbo plus paclitaxel or nab-paclitaxel for squamous plus the addition of pembrolizumab in this subgroup of patients. For those patients with PD-L1 scores of 0% to 49% who are eligible and willing to take chemotherapy, these new guidelines recommend chemotherapy plus pembrolizumab.

For those who have a PD-L1 score of 1% to 49% are not appropriate for chemo or decline chemotherapy, these guidelines suggest single agent pembrolizumab as a reasonable option. The guidelines also provide the option of alternative chemo immunotherapy regimens to be used in patients with non-squamous, non small-cell that were not included in the prior guidelines.

And while these are not necessarily preferred for most patients, select patients can be considered for these regimens, which include the immunotherapy drug, atezolizumab, and combination chemo with atezolizumab and bevacizumab. And the guidelines provide some commentary on potential scenarios in which these options should be considered.

Dr. Masters, why is this guideline important, and how will it change practice?

Well, the new ASCO CCO joint non-small cell lung cancer guideline update is important in that it clarifies recommendations for an international audience and is co-sponsored by the American Society for Clinical Oncology and Cancer Care Ontario. These guidelines were developed through a rigorous, evidence-based process with a broad range of experts, including a multidisciplinary team of clinicians, researchers, data specialists, and patient representatives.

The new guideline update provides a comprehensive review and analysis of the current literature on the treatment of advanced non-small cell lung cancer. The current update also includes a data supplement with evidence tables, slide sets, and links to patient information through cancer.net, ASCO's patient information website.

In an increasingly complicated environment for oncologists, managing patients with advanced cancer, we're learning how to incorporate molecular testing and other biomarkers. And this guideline will help change day-to-day practice for clinicians as they implement these recommendations. This guideline will help clarify the optimal treatment strategies for non-small cell lung cancer patients without driver gene mutations and allow individualization based on tumor histology and immunotherapy biomarkers, such as PD-L1 testing.

At the same time, the update allows clinicians to use their individual judgment and experience to incorporate unique, intangible characteristics of patients. It also emphasizes the importance of patient preferences in deciding the optimal care for an individual affected by advanced non-small cell lung cancer.

And finally, how will these guideline recommendations impact patients?

The broad range of experts who've contributed to these guidelines includes a multidisciplinary team, including clinicians, researchers, data specialists, and patient representatives. This assures patients of a consensus opinion based on the available clinical research on treating advanced non-small cell lung cancer. It provides clinicians with the best up-to-date distillation of the many complicated trials of chemotherapy and immune checkpoint inhibitor therapy in an area where patient-centered, precision medicine dictates the optimal treatment strategies.

We incorporate molecular testing in these guidelines, although this particular guideline is directed at patients without driver gene mutations. We include recommendations on implementation of chemotherapy and immunotherapy based on the best available data on biomarker testing for PD-L1.

We recognize, however, that new research continues into treatment strategies and molecular analysis to help guide incorporation of targeted therapy and immunotherapy. We recognize that new treatment options and combinations will become available, and new testing techniques will help guide the decision process in the future. We plan to continue to analyze the available research and update these guidelines as clinically indicated to provide the best options for our patients.

Most of our patients will still be treated with palliative intent. But a growing number of patients have sustained control of their cancer with recent studies and updates suggesting that up to 25% of patients may have control of their disease for five years or longer. Now that more patients can maintain their quality of life with prolonged survival, with the current therapy, it is also critical that we continue to look to patient reported outcomes as an important way of defining the best options for our patients.

Thank you both for your work on this ASCO CCO guideline update for therapy for stage IV, non-small cell lung cancer without driver alterations and for coming on the podcast today to provide an interview, Dr. Hanna and Dr. Masters.

Thanks for having us on the program. And we have enjoyed being part of the process.

Thank you.

And thank you to all our listeners for tuning into the ASCO Guidelines Podcast series. To read the full guideline, go to www.asco.org/thoracic-cancer-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines app available and iTunes or the Google Play Store. If you've enjoyed what you've heard today, please rate and review the podcast and be sure to subscribe so you never miss an episode.

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Bone Health and Bone-Targeted Therapies for Prostate Cancer Guideline Endorsement Jan 28, 2020

Show notes

An interview with Dr. Philip Saylor from Massachusetts General Hospital on "Bone Health and Bone-Targeted Therapies for Prostate Cancer: ASCO Endorsement of a Cancer Care Ontario Guideline." This guideline includes recommendations for management of osteoporotic fracture risk in nonmetastatic disease and interventions for men with castration-resistant prostate cancer metastatic to bone. Read the full guideline at www.asco.org/genitourinary-cancer-guidelines. Transcript [MUSIC PLAYING] 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 the shows, including this one, at podcast.ASCO.org. My name is Brittany Harvey, and today I'm interviewing Dr. Philip Saylor from Massachusetts General Hospital, lead author on "Bone Health and Bone-Targeted Therapies for Prostate Cancer: ASCO Endorsement of a Cancer Care Ontario Guideline." Thank you for being here today, Dr. Saylor. Oh, it's my pleasure. First, can you give us a general overview of what this guideline covers and about the endorsement process? Yes. So the Cancer Care Ontario has a program in evidence-based medicine, and they periodically put out clinical practice guidelines for management of a whole variety of topics. And they relatively recently put out a publication on bone health and bone-targeted therapies in prostate cancer. And so that's a really big topic because bone health is such a big part of prostate cancer care across the entire range of scenarios that patients can face. And their guideline addresses topics all the way from osteoporosis and fragility fractures and that risk as it relates to GnRH agonist, androgen deprivation therapy that men can get for really any prostate cancer scenario, goes all the way from that to improving quality of life in patients who have bone metastases that have progressed despite systemic therapy. So it's really a very broad series of topics that they addressed. And so when they put out that guideline, ASCO identifies it as something that's very relevant to the ASCO community and goes through, then, a formal process of reviewing the methodology of those guidelines and then having an expert panel discuss the quality and evidence of the guidelines and really provide, if appropriate, an endorsement and some additional discussion of those topics. So what are the key recommendations of this guideline? They really have four sort of subtopics within this bone-themed guideline that are addressed and discussed in a fair amount of detail. And each one of those four topics deserves some of its own discussion. The first topic is osteoporosis and risk for just fragility fractures, like hip fracture and vertebral body compression fractures. That's one. The second is potential prevention of bone metastases in a patient that does not yet have bone metastases. The third one is management of castration-resistant prostate cancer metastatic to bone. And the fourth one is symptomatic management of men with CRPC metastatic to bone. So it is probably worth discussing each one of those, in some detail, one by one. So for the osteoporosis fracture risk question, Cancer Care Ontario, their recommendation really is that men with non-metastatic prostate cancer at high risk for fracture who are receiving ADT should be considered for the osteoporosis dosing of denosumab. And in situations or places where denosumab is not available, then patients can consider a bisphosphonate as an alternative. So we had a fair amount of discussion of that recommendation. We endorsed that recommendation. And I guess my personal emphasis would be that osteoporotic fracture risk is really the biggest challenge to that is not forgetting about it. So you can often have men who are in a good prostate cancer scenario, likely to be cured by their therapy. They're going to get some duration of ADT. And they look healthy as they sit there in clinic with you. They're likely to do well from a prostate cancer standpoint. And it just would be so easy not to adequately screen for osteoporotic fracture risk, and just not to remember that because so many of our discussions together in clinic are focused on the prostate cancer more than the broader health questions. And so, I mean, to me, I think not forgetting about this issue is really one of the most important things to emphasize in any discussion of osteoporosis. And so really, it's a fairly simple problem to screen for and manage. Most men should be, if they're going to be on any duration of ADT, should be tested with a bone density test, a DEXA scan. It's really a fairly inexpensive and easy test for getting a sense for where their bone health is as they begin. And I usually tell my patients in clinic that most men don't need any new prescription medicines to manage that risk, but we'll never figure out the ones who need it unless we go through the very disciplined systematic work of doing that screening. And then among those who really do deserve treatment, it's really denosumab at the osteoporosis dosing or a bisphosphonate. Really, any of those choices really works well for improving bone mineral density. One of the big ASCO discussion points is that denosumab is the only medicine that's been shown definitively to improve fracture risk in this setting. But that's really a product of denosumab being studied in a really large prospective randomized controlled trial. And so that's one where they required more than 1,000 patients in order to assess that fracture endpoint. So the reason, perhaps-- probably the most important reason that bisphosphonates have not been shown to improve fractures is that none of them have been studied in such a big study. The bone mineral density trials that have studied bisphosphonates are all on the order of maybe 30 to 100 patients rather than 1,000. So really, in many clinical settings, cost and convenience are important considerations. And when those are factored in, it's often very reasonable to use a bisphosphonate rather than denosumab, though either one really could be considered a gold standard. So that's point number one from the guidelines. Number two really discusses the issue of prevention of bone metastases. And so there are a couple of sub-recommendations from Cancer Care Ontario. But really, the most important point from that is that there is no bone-targeted drug that has been shown to prevent or delay the development of the first bone metastasis. So a number of different studies have tried to address this question in slightly different clinical scenarios. But the bottom line is, we don't use bone-targeted medicines to prevent the first bone metastasis. And so there's always been sort of an attractive potential effectiveness there because you think if your bone-targeted therapy changes the bone microenvironment, could the natural history of prostate cancer play out differently? But the answer is that we really don't have any convincing evidence of effectiveness on that front using any drug, in any situation. So that's a pretty easy one to summarize. For the third category of situation that's addressed in the guideline really relates to castration-resistant prostate cancer metastatic to bone. And so there are three sub-recommendations there. In that situation, either zoledronic acid or denosumab in monthly dosing at the skeletal event preventing dosing is a gold standard and reasonable to pursue. So that's one thing. In men with symptomatic disease, radium-223 can be considered, both to prevent skeletal events and to improve health-related quality of life. And then, finally, all radiopharmaceuticals can be considered in that situation for palliation of bone pain. And so we endorsed those recommendations as well. And we added a fair amount of discussion about how to optimally support men's health in those situations. For one thing, it's important to note that monthly zoledronic acid or monthly denosumab, whichever is pursued, is a fairly intensive osteoclast-targeted therapy. And so the studies that formally establish those as gold standards in that setting, they really only treated for about two years, plus or minus. So we don't know a lot about the safety of that intensity of therapy beyond two years. And so that's an important consideration, because there are many men who do well, thankfully, for a lot longer than two years in the castration-resistant setting with bone metastases. And so we really do, as clinicians, need to respect the possibility of toxicities, especially osteonecrosis of the jaw seems to be a much, much more common phenomenon with longer durations of treatment and with these more intensive regimens. So that's one thing that deserves a lot of attention by clinicians. The other thing is that dental evaluation and proactive dental care before and during any of these bone-targeted therapies is really an important issue not to miss. So the highest risk for having osteonecrosis of the jaw is in patients who are on one of these intensive regimens and then need to have invasive dental work when they're already been started on one of those regimens. Those are the jaws and mandibles that seem not to heal as well. And so ideally, every patient that is going to go on intensive osteoclast-targeted therapy really should be evaluated by a dentist with the question of whether there's any dental work that really needs to be done proactively before the start of one of those medicines. And so I always say I have to be humble as a medical oncologist to say I really know little to nothing about teeth. And so I have to reach out to my colleagues in the dental field to tell me which are the patients that need to do something ahead of time and heal before they start one of these medicines. So those are a couple of important points. And then the other thing that's really not a new piece of information but is important to emphasize is that it's really monthly therapy with denosumab or zoledronic acid should really be used only for patients with castration-resistant prostate cancer metastatic to bone. So the patients who are responding to their systemic therapy really seem not to benefit from the bone-targeted therapy. And that's likely because any systemic therapy that's controlling the prostate cancer, in general, that's active against the cancer, in general, is going to prevent skeletal complications. We just have a lot fewer of those events, thankfully, when the disease is under control. And then, finally, the fourth category of recommendation addresses symptomatic castration-resistant prostate cancer metastatic to bone. And that's a situation where the radium-223 given in the typical once per month times six series of treatments is a gold standard, improves health-related quality of life and overall survival. I think one of the important discussion points on that front relates to recent clinical trial data that examines the use of other secondary systemic therapies in addition to the radium. So we have a prospective randomized study that looked at abiraterone with or without radium. And what it really showed was that the combination of abiraterone and prednisone with radium resulted at a very high rate of fractures and worsened overall survival. So that's really a combination that should absolutely not be pursued outside of a clinical trial. And so that's an important thing to know, but it's also sort of a cautionary tale that if we're tempted to combine other secondary medicines with our radium treatment, we really don't have a lot of evidence for the safety or efficacy of doing that. So that's the sort of thing that really should be reserved for clinical trials. And those are probably the most important-- those are the four main topics addressed by the guidelines. As you can tell, it really includes situations that are relevant to just about every man who receives systemic therapy for prostate cancer. Absolutely. And thank you for that comprehensive overview and those considerations of the guideline endorsement panel. Why if this guideline important? And how will it impact practice? So I think there's really sort of two main ways that it's important to the reader in 2020. I'd say, first of all, as a reminder and sort of educational promotion of awareness of the things that we already know but are easy to overlook. And I think the things that are really there are that it is easy to focus on the cancer therapy and easy to overlook the bone-targeted therapy. So as we have an increasing number of systemic therapies that are active against the cancer itself, and as we have sort of, in the best possible way, more options and more molecular considerations for our prostate cancer patients, we really can't forget to do the fundamentals, like doing monthly zoledronic acid or monthly denosumab in men with castration-resistant disease that's metastatic to bone. So I think that's the kind of thing that would be easy to forget, but that we shouldn't. And the second subtopic there would be screening for osteoporosis in any man who receives ADT. And again, that's something that-- osteoporosis or someone at high risk for fragility fracture, that's an asymptomatic situation until the fracture occurs. And then at that moment, you're really thinking back and saying, man, I wish I'd done something three years ago, or five years ago, or 10 years ago to improve bone health so that this wouldn't have happened in the first place. So it really is up to us as the clinicians caring for these prostate cancer patients to advocate for their general health in a way that includes their bone health. We just have to really not forget to screen for osteoporotic fracture risk. So I think those reminders of things that we already know but are really easy to miss, I think that's one aspect of this. And I think the other is just discussion of the data. It really adds some richness to the topics. And we do have these updates in an emerging field, particularly when it relates to radium-223. It seems like a drug really on, like, a drug strategy that could easily be paired with other drug strategies because it's reasonably well-tolerated. But we learned, really especially from that clinical trial experience of radium with abiraterone, we really learned that freewheeling combinations are not necessarily safe and not necessarily effective. And so we have to just be mindful of recently emerging data and have an ear to the ground about ongoing clinical trials, sort of how to best combine and sequence all the different medicines that are sort of in our back pocket. And finally, how will these guideline recommendations affect patients? Yeah. I mean, I think bone health is really just so important to every patient with prostate cancer. And it's almost, for clinicians, it's almost an educational issue where we have to help our patients understand how important bone health is. When we talk in clinic about a DEXA scan to look at bone density, a lot of men really look at me a little bit blankly. They think of osteoporosis more as this sort of issue that women deal with more so than men. But…

Full show notes at the publisher

Germline and Somatic Tumor Testing in Epithelial Ovarian Cancer Guideline Jan 27, 2020

Show notes

An interview with Dr. Christina Annunziata from the National Cancer Institute on "Germline and Somatic Tumor Testing in Epithelial Ovarian Cancer: ASCO Guideline". This guideline provides recommendations for women diagnosed with epithelial ovarian cancer and their families on which individuals should receive risk evaluation, counseling, and genomic testing, and when they should be tested. Read the full guideline at www.asco.org/gynecologic-cancer-guidelines.

Transcript

[MUSIC PLAYING]

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 the shows including this one at podcast.asco.org.

My name is Brittany Harvey. And today, I am interviewing Dr. Christina Annunziata from the National Cancer Institute, co-chair on Germline and Somatic Tumor Testing and Epithelial Ovarian Cancer: ASCO Guideline. Thank you for being here Dr. Annunziata.

Oh, it's my pleasure. Thank you.

First, can you give us a general overview of what this guideline covers?

Sure. So this guideline is covering the use of molecular testing in women diagnosed with ovarian cancer. And that's specifically what tests should be done and when to do them.

And what are the key recommendations of this guideline?

The key recommendations really are that all women diagnosed with ovarian cancer should be tested for certain gene mutations that are responsible for predisposing people to ovarian cancer and also that a genetic counselor should be involved in discussing the results of these tests with the person involved and with her family. In the guidelines, we go into specifics of which genes should be tested at what point in the course of the disease. And the guidelines mainly focus on the BRCA genes and mismatch repair genes because these are the ones with approved treatments for cancers with these mutations.

What are the clinical questions that you addressed in this guideline?

So we have three main questions when we started out. We wanted to know, first, in which individuals should risk evaluation counseling genomic testing for germline and somatic tumor alterations be performed. We also wanted to know, number two, which genomic alterations had actually demonstrated clinical utility to direct therapy for women with ovarian cancer. And third, what is the most appropriate sequence and timing of testing, meaning specifically at what point in the course of the diagnosis and the treatment of the women should we be performing this testing?

So we came up with specific answers to each of these questions. And just to briefly summarize, for the first questions in which individuals should we test, we did find evidence that all women diagnosed with ovarian cancer should be offered germline testing for, specifically, BRCA1 and BRCA2 cancer susceptibility genes, irrespective of whether or not they had a family history of the disease.

Also within that question, we found evidence that women who have non-high grade serous ovarian cancer, specifically clear cell endometrioid or mucinous ovarian cancer, should have somatic tumor testing for mismatch repair deficiency. And both of these recommendations are because there are FDA approved therapies for women with cancers with these particular genetic makeups.

In the second question, we asked, which genomic alterations have demonstrated clinical utility? This goes specifically into, which specific genes should be tested in the germline and the somatic setting? And in that recommendation, specifically, we focused on, again, the BRCA1 and 2 genes and the mismatch repair deficiency genes.

We did not make specific recommendations for the homologous recombination deficiency assays at this time. Those are still undergoing evaluation. And it's likely in the near future that we will amend this recommendation to specifically discuss those.

In the third question, what is the most appropriate sequence and timing of the testing? That goes into, when should we be doing this in the course of the disease? And we did want to emphasize that women with ovarian cancer should be tested at the time of diagnosis because of the specific implications for therapies. If they have not had testing at the time of initial diagnosis-- let's say they were diagnosed several years ago-- then they should be tested at the time of their first recurrence or subsequent recurrences if those have already happened. And again, these have implications for treatment.

Why is this guideline important, and how will it impact practice?

So one of the most important recommendations is that all women should be tested at the time of the initial diagnosis. In practice today, we estimate that only about 1/3 of women are actually being tested at the time of diagnosis. This testing is important, especially for the BRCA genes, because this has implications for the choice of treatment because of recent FDA approvals for PARP inhibitors in this setting.

And how will these guideline recommendations affect patients?

Our goal is to ensure that all women have access to the best treatments for their ovarian cancer. In order to achieve this goal, doctors need to be aware of best practices, and patients need to understand the results in the context of their disease.

This is why we recommend that the results of the gene testing be delivered to the patient in conjunction with a genetic counselor because this has been shown to increase understanding of the tests and follow through on the recommended treatments. In some settings, we know it may be difficult to arrange these discussions with a genetic counselor, so we hope that these guidelines will emphasize the importance of this step.

Well, thank you for your overview of these and for your work on these guidelines. And thank you for taking the time today to come on the show, Dr. Annunziata.

Oh, you're very welcome. And thank you for the opportunity to highlight these guidelines.

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/gynecologic-cancer-guidelines. You can also find many of our guidelines and interactive resources in the free ASCO Guidelines app available and iTunes or the Google Play Store. If you have enjoyed what you've heard today, please rate and review the podcast and be sure to subscribe so you never miss an episode.

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Optimum Imaging Strategies for Advanced Prostate Cancer Guideline Jan 15, 2020

Show notes

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 of recurrence of disease after surgery or radiation, but because of their comorbidities or age or patient preference, they're not necessarily going to be aggressive with additional therapy, then we probably don't need to chase some of these next-generation imaging studies in that man.

In the confirmed metastatic patient population, that is a little more unclear in terms of what the benefit of next-generation imaging would be outside of the setting of a clinical trial. And in those patients, if it is thought that there would be a change in clinical treatment based on the results of the scan and of next-generation imaging, then that would be a scenario where those might be considered. But we wouldn't necessarily recommend them across the board.

And so why is this guideline so important? And how will it change practice?

Well, it's important and timely because of the tidal wave that we are expecting of novel, next-generation imaging that is going to become closer and closer to clinical practice. Patients are aware of these studies, and they're asking for them, even if they're not currently available or approved by an FDA or covered by a third-party insurance.

There's been a plethora of research studies and new imaging tracers in Europe, Southeast Asia, and Australia. And so trying to get ahead of where they might fit in, and which patients might benefit now and in the future, was really one of the main drivers to come out with a strong position statement on the appropriate use of imaging.

There's a lot of controversy about some of the implications of the next-generation imaging, such as the potential for false positives and the attendant prognostic tests, that that might trigger false negatives, and potentially offering clinicians or patients a more optimistic outlook than may be really present.

And so figuring out specific scenarios and specific patient populations that would benefit from next-generation imaging is the real goal of this guideline.

And so finally, how will these guideline recommendations affect patients?

Well, the ultimate goal is to improve patient care and improve patient outcomes. And so by coming up with some reasonable templates and framework of where some of the next-generation imaging will fit in on a patient's disease spectrum and disease course will help them both to potentially indicate when treatment changes may be necessary, or to isolate areas of disease, and to importantly and accurately give their correct stage. And then that will translate, or we hope and expect, with more information and more accuracy in diagnosis, in better treatment plans and better patient outcomes.

Great. Thank you for your work on this important guideline on Optimum Imaging Strategies for Advanced Prostate Cancer. And thank you so much for your time today, Dr. Trabulsi.

Thank you so much. Thanks for having me.

And thank you to all of our listeners for tuning into the ASCO Guidelines Podcast Series. To read the full guideline and find additional resources, such as the guideline pocket card, go to www.asco.org/genitourinary-cancer-guidelines.

And you can find many of our guidelines and interactive resources in the free ASCO guidelines app available on iTunes or the Google Play Store. And if you've enjoyed what you've heard today, please rate and review the podcast, and be sure to subscribe so you never miss an episode.

Estrogen and Progesterone Receptor Testing in Breast Cancer Guideline Update Jan 13, 2020

Show notes

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.

Molecular Biomarkers in Localized Prostate Cancer Guideline Dec 12, 2019

Show notes

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.

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 many different areas that integrating genomic or molecular information can be integrated into optimizing decisions.

And the special commentary really dives into a lot of those details on working with the pathologists on selecting the appropriate biopsy sample to send to one of these laboratories. It gets into some of the specifics on interpreting the data, as well as the role of CLIA-approved labs and non-CLIA-approved labs for certain staining that's done internally within organizations or with biomarker panels.

And so would you be able to expand a little more about which patients may benefit from having molecular biomarkers?

Yeah, the sweet spot for some of these biomarkers include a couple different patient groups. The first one is what I alluded to earlier-- the man newly diagnosed with prostate cancer deciding whether to do active surveillance, which is a monitoring program, or to have treatment of the prostate typically by either surgery or radiation therapy.

Again, worth emphasizing-- these tests are not appropriate for every newly diagnosed patient. And I would argue even for the man deciding between surveillance and treatment, there are specific men, perhaps those with higher volume low risk prostate cancer or lower volume favorable intermediate risk prostate cancer, that provides the ideal patient that may benefit from some of these tests.

The second clinical scenario that was discussed amongst the group were patients where treatment intensification might be valuable. Again, these biomarkers are purely prognostic, and there's no high level evidence suggesting that treatment intensification leads to better outcomes. Although intuitively, the higher risk profile a patient has, either by clinical factors or biomarkers, there is a conceptual rationale that treatment intensification might prove beneficial.

And the third category of patients that may benefit are those who have had prostatectomy where the pathology shows some adverse features, and there's a high likelihood of recurrence, and the clinician's decision is to guide the man on whether pure adjuvant radiation in the setting of an undetectable PSA or early salvage therapy at the time of biochemical recurrence would be more valuable. And there is one test that is commercially available that can help inform that decision.

Great, so finally, what do you envision as the future of molecular biomarkers for localized disease?

As we took an overview of the landscape in 2018 and 2019 of these molecular biomarkers, much of the group thought this was version 1.0 or 2.0 in this space.

And it is our hope and likely scenario that not only will we have better data on some of the currently available biomarkers with higher levels of evidence from either correlative science from randomized trials or formally embedded into randomized trials, but also that there's a large amount of work being done to improve the quality of biomarkers and that, in the future, we'll see improvements on the currently available ones or newer biomarkers coming around that will be valuable for these men as they make decisions along their prostate cancer course.

Great. Thank you for your work on this important guideline. And thank you for your time today, Dr. Eggener.

Thank you, Shannon.

And thank you to all of our listeners for tuning into the ASCO Guidelines Podcast Series. To read the full guideline and find additional resources such as the guideline's pocket card, go to www.asco.org/genitourinary-cancer-guidelines. And you can find many of our guidelines and interactive resources in the free ASCO guidelines app available on iTunes or in the Google Play Store. And if you've enjoyed what you've heard today, please rate and review the podcast and be sure to subscribe so you never miss an episode.

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