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Welcome to the ASCO Guidelines episode of the ASCO University Weekly Podcast. My name is Alexander Drilon, and I'm the Clinical Director of the Early Drug Development Service at Memorial Sloan Kettering Cancer Center and editorial board member for ASCO University.

Today, we feature an ASCO guideline published in the Journal of Clinical Oncology. The episode you are about to hear was originally aired on the ASCO Guidelines Podcast Series. The ASCO Guidelines Podcast Series features interviews with panelists of recently-published ASCO clinical practice guidelines products, highlighting recommendations and noteworthy qualifying statements made by the expert panel.

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Hello, and welcome to the ASCO Guidelines Podcast Series. My name is Shannon McKernin and today, I'm interviewing Dr. Supriya Mohile from University of Rochester Medical Center, lead author on "Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Chemotherapy-- American Society of Clinical Oncology Guideline for Geriatric Oncology." Thank you for being here today, Dr. Mohile.

Thank you very much.

First, what is the purpose of this guideline, and can you tell us about the research that was reviewed to inform the recommendations?

Sure. So we know that our population is aging. So currently, there are an incredible number of patients who are age 65 and over with cancer. The statistics are showing that more and more older adults are developing cancer.

And this was really informed by our movement in geriatric oncology that ASCO has supported over the last 10 to 15 years. When I started my fellowship, which was now close to 15 years ago, there was very little knowledge about how to treat older patients with cancer. We know that clinical trials include fewer older adults and that the older adults that are enrolled tend to be more fit than those older adults seen in community practices and being cared for by, really, community oncologists.

Therefore, there is a large gap in knowledge in terms of what might be safe and effective in a phase III clinical trial that provides our evidence for cancer treatment and what might be safe and effective for an older patient-- say 75-plus-- who's being seen in community who has medical conditions such as cognitive impairment or significant comorbidities that may limit their life expectancy.

So the guideline really strives to address how older patients should be evaluated and managed in oncology clinics specifically. And this guideline is geared towards older patients with cancer who are undergoing a decision or who are receiving chemotherapy because that's really where the data and the evidence for geriatric oncology practices supports at this point. There's less data for evaluating patients who are going to undergo targeted agents or immunotherapy.

But we have, now, a robust level of evidence for older patients who are undergoing chemotherapy. And so this guideline could help clinicians with how to best manage and evaluate and make decisions for older patients with cancer who they're seeing in their clinic. And it can also help support other guidelines that ASCO and others put forth.

For example, I sat on the ASCO Guidelines Committee, and we were looking at a guideline for bladder cancer. And some of the guidelines were related to life expectancy. So a intervention is appropriate, for example, for patients who have a 10- or more-year life expectancy.

However, there's very limited information for how physicians should estimate life expectancy in our guidelines. And so this guideline includes that kind of information that could help really support other guidelines when we're talking about things like life expectancy, underlying health status, comorbidities, that might influence outcomes for older patients with cancer.

In terms of what research was reviewed to inform the recommendations, well, we in the geriatric oncology field-- and many of the co-authors are geriatric oncologies-- worked with others in specific fields, such as cognition, physical health, and community oncologists and primary care doctors, to develop a very comprehensive yet practical way for oncologists to really assess older patients. As I mentioned, our field is small, and it started about 10 to 15 years ago, really focusing on this toolkit called geriatric assessment.

Geriatric assessment is a compilation of, really, patient-reported outcomes that can assess health status for older patients. And we sort those pieces in the geriatric assessment into domains. And each domain is known to predict morbidity and mortality in older adults.

So those domains include things like cognition, function, psychological status, comorbidities, polypharmacy, social support. And we know from the evidence in community-dwelling older adults without cancer that each of those domains are predictive of outcome. So it made sense to us, having been trained in both geriatrics and oncology, to think about this tool as a way to evaluate underlying health status in older patients with cancer.

And the field started by looking at feasibility of geriatric assessment in oncology clinics. These efforts were led by Arti Hurria and the Cancer and Aging Research Group and others. And over time, there has been a lot of data showing that geriatric assessment is feasible in oncology clinics. They can be incorporated in both academic settings and community oncology clinics.

In addition, there's been data to support that geriatric assessment is feasible in clinical trials. And so, as we started to grow that data in the field, then there have been large studies looking at prediction of outcomes and looking to see if geriatric assessment and the domains within geriatric assessment can help clinicians identify older patients who are at most risk from adverse outcomes from chemotherapy.

And that data has grown significantly. So when that data grew, we paused as a community and really partnered with ASCO, who's been incredibly supportive, to think about a guideline to really summarize the literature-- and not only summarize the literature but to communicate it to clinicians as the audience to really communicate a way that geriatric assessment can be practically incorporated and integrated into routine clinical care for older adults with cancer.

And so those are the studies we looked to. We worked with ASCO. ASCO, as you know, has a very rigorous methodology for looking at research. And in our field, the research is less RCT-based-- although randomized controlled trials are forthcoming-- but more based on large, robust, very well-done prospective observational studies. And we reviewed the literature for that in a systematic way and summarized that in the guidelines.

And what are those key recommendations for this guideline?

So the guideline breaks down into four important components. So the first component really focuses on the value added by geriatric assessment to routine oncology clinical care. And so that recommendation was based on data that shows geriatric assessment identifies factors that can be routinely missed in routine oncology care and are not captured by our routine oncology assessments like ECOG Performance Status or Karnofsky Performance Status assessments.

So there is a very robust data that shows those domains that I spoke about earlier-- functional status, physical performance and falls, comorbid medical conditions, depression, social activity and support, nutritional status and cognition-- add value by identifying vulnerabilities or impairments that are not routinely captured in oncology assessments. And that's a very high level, or strong level, of evidence.

The second component of the guideline really focuses on how to practically incorporate, or integrate, geriatric assessment into routine oncology care. And so we took a step back and looked at the literature, at what was feasible-- not for academic, robust groups that have a ton of support but really for community oncologists who are seeing many patients in their clinic, really getting their feedback on what might be practical and the quickest way, and the most high-priority tools to assess these domains.

And so the tools that were identified were pulled out of the literature in that each of these tools captures an important domain that's predictive of outcomes. So we know that these tools can help identify older patients at high risk for adverse outcome. And they are practically able to be incorporated in the clinic and do not need to be done by a physician. They can be done by a technician, a staff member, a nurse. And so we thought about that in terms of selection of the tools.

And so the second recommendation is that the evidence supports, at a minimum, assessment of function, comorbidity, falls, depression, cognition, and nutrition. And we recommended, as a panel, the Instrumental Activities of Daily Living-- which is a short, very well-validated patient-reported outcome with a few questions to assess function; a thorough history or validated tool to assess comorbidity-- so this can happen as part of a routine history and physical exam that physicians are often already doing as part of their assessment; a single question for falls-- so have you fallen in the last six months, or have you fallen since the last visit?; the Geriatric Depression Scale as a screen for depression; the Mini-Cog or Blessed Orientation-Memory-Concentration test-- they're both very short, less than two minute type assessments of cognition-- they're administered to the patient by a staff member to screen cognitive issues; and an assessment of unintentional weight loss to evaluate nutrition.

And in addition to those tools, if these are being used to evaluate an older patient who's starting chemotherapy, using a validated tool that assesses the risk of chemotherapy toxicity can be informative in helping with the discussion about risk in the informed consent process. And there are two tools that do that-- the Cancer and Aging Research Group tool, and the CRASH tool out of Moffitt, which is called the Chemotherapy Risk Assessment Scale for High-Age Patients-- CRASH tool. Both of those help predict or estimate risk of chemotherapy toxicity.

There are, in addition, two additional tools that are short screening tools that can help identify patients at risk for early mortality. Those are called G8 or the Vulnerable Elders Survey-13. So this can form a sort of minimal data set to a basic geriatric assessment.

There are options for each of those domains in terms of the tools to be used. So these are our recommendations, but they're not set in stone. In fact, which recommendation to use doesn't have a super high level of evidence. It's a moderate level. Because we don't know, necessarily, which one tool is better than another.

We do know that these domains should be captured-- so function, cognition, depression, et cetera-- but which tool to use can be more flexible. So in the guideline, there is the main tool, sort of the recommended tool, but also options for other tools so that practices and physicians can pick what works best for them.

In terms of the third recommendation, the third recommendation is focused on estimation of life expectancy. As I mentioned earlier, estimating life expectancy is often part of our guidelines when we're thinking about high-risk interventions.

We want to be able to identify as best as we can, with the tools that we have available, patients who are likely to live long enough to benefit from high-risk interventions like chemotherapy, like adjuvant treatment, like high-risk surgeries-- for example, cystectomy for bladder cancer. You know, those kinds of approaches deserve a thoughtful approach to life expectancy estimation.

A lot of what we do in clinical practice is Gestalt, so it's sort of the eyeball test-- well, I think my patient might live five years. I think my patient might live 10 years. And we know from the literature that the eyeball test is very subjective, and every individual physician has their different perspective on how long someone might live. And we are, as a medical community, not very good at estimating prognosis.

They're all tools that could help this approach and they're all available on the web. And we recommended the Schonberg Lee Index, which is part of ePrognosis, where, as part of the assessment process, there are easy-to-capture variables that can be included. And it creates a very standardized, validated approach to life expectancy estimation that can be shared with a patient.

Of note, as part of that recommendation, they do ask about cancer because cancer influences life expectancy. And our recommendation is to say no to that question. Because we're looking at life expectancy from the perspective of outside of cancer-- so in other words, other medical problems that might influence life expectancy, not the cancer, in order to inform decisions for treatment of cancer.

The last recommendation really focuses on management. And here's where there are randomized controlled trials in progress. There are consensus studies that are from experts in geriatric oncology that have developed algorithms to incorporate management options for each domain impairment.

So for example, one finds that a patient may be falling. That's a domain impairment we assess with the question-- that's the tool-- so have you been falling? and perhaps another type of test-- an objective physical performance test, for an example. And then, we institute, or implement, geriatric-relevant management interventions such as physical therapy, an evaluation for assistive device, a safety evaluation at home, making sure that the patient is not alone at home, looking at medications to make sure their blood pressure medicines aren't too strong and they're going to become orthostatic.

So there are these algorithmic approaches to each domain. And these are outlined in several papers that have looked at these Delphi consensus approaches to these algorithms. And these algorithms are now being tested in randomized controlled trials both in the United States and in Europe. And so that's the summary for the recommendations for this guideline.

So you mentioned some of those assessment tools, like the CARG tool and the CRASH tool. So how do you implement those in practice?

So in the guideline, we have several examples of how a practitioner can use this toolkit to really help with clinical decision-making in a very practical way. So embedded in the guideline is an older patient being considered for adjuvant chemotherapy and the approach-- all the way from the patient is sitting in the clinical setting outside and is filling out the surveys to the plan where they come into the clinic office, someone administers the cognition tool, the nurse or the physician captures the correct information, they go online, and they plug in the information, and they print out the tools.

So all of the tools will be made available on relevant ASCO websites-- so the main ASCO website, the educational ASCO websites-- and also the tools themselves, plus the guideline recommendations, and also cases. So we have one case embedded in the actual guideline, but we also, in the supplement, have several additional cases that can be reviewed to really show how to incorporate this in clinical practice. So as part of ASCO, the panel members plus the ASCO geriatric oncology task force that works out of the Health Disparities Committee are going to do our best to make the translation of these guidelines into implementation as easy as possible and have everything available.

The three tools that I mentioned-- the CARG toxicity tool, the CRASH tool, and the ePrognosis tool-- are all already available online. And so those links are available in the guideline and can be used right away. The other tools will be available on the ASCO website. We will put that on so that people can download them and use them in the clinic setting.

Great. And what interventions can be informed by the results of geriatric assessment? I know you mentioned physical therapy. What else can you tell us about that?

So as part of those Delphi consensus process there, we developed sort of an algorithmic approach to the different interventions for each of the domains. So there is a table in the guideline that summarizes the high-priority interventions that the experts use in their clinic when they identify patients with impairments.

So as I mentioned, there are things like physical therapy for people with physical performance problems or people who have functional issues, strength and balance training, assistive device evaluation, exercise programs, fall prevention. For comorbidities, thinking about communication aspects of talking to patients and caregivers about how to use multiple medications, talking to other important members of the team like the primary care doctor or pharmacist to help decrease risk from medications.

For cognition, for people who have impaired cognitive status, we have very limited data about the safety of chemotherapy in this population. It's under-recognized. Even me, who have many years of working with older patients, cannot tell just by looking or talking to an older adult that they have cognitive impairment. And so screening tools are absolutely necessary.

If someone has impairment on a validated cognitive screen like the Mini-Cog or Blessed that I mentioned earlier, thinking about a formal assessment of decision-making capacity and ability to consent for treatment is important. And as we start implementing practices in the clinics to really capture consent processes, even for routine chemotherapy-- off-clinical trials-- this is an important aspect to consider. Delirium risk counseling, medication review, again, are all important things to consider for somebody who has cognitive impairment.

For depression, with screening for depression, there is already an ASCO guideline in place for management of patients in general who have depression. And we incorporated some of those management recommendations-- so considering cognitive behavioral therapy, if that's available, social work involvement, counseling.

We do consider medications but try the other mechanisms first before medication use in an older adult because medications may have more side effects. And for nutrition, thinking about nutritional interventions, a need for extra support and availability of caregiver to provide extra support for meal preparation.

So there is a table, and there's also references to other papers that have Delphi guidelines in place of how to utilize management recommendations. There is also a table that summarizes the ongoing clinical trials. And as we learn more about incorporating this as an evaluation of management plan in terms of improving outcomes for older adults with cancer, we'll be able to expand the guideline to incorporate that information, in addition.

So finally, what difference does it make to patients, performing these assessments? How are they impacted by these recommendations?

So we truly believe that the evidence shows that assessing older patients with a standardized validated geriatric assessment measure can improve the identification process and discussion surrounding chemotherapy risk. And that is important for this population.

Because this population is less included in clinical trials and, therefore, the safety and efficacy of treatments are often uncertain for older adults who are 75-plus because just that population itself is underrepresented in clinical trials-- but also those who are older who have other medical issues. And so that discussion itself, as part of communication for informed consent, is very important. And that's outlined in the communications section of the guideline.

In addition, the guideline stresses that factors that identify patients as vulnerable are captured by geriatric assessment. We have standardized tools to assess risk through toxicity tools and mortality. We have standardized tools to help assess life expectancy when one is considering an older adult for adjuvant treatment, which may be six months, a year long. If the older adult you're seeing has a life expectancy of one year based on their comorbid conditions, does it make sense to put them through a one-year program of adjuvant treatment or a big surgery?

In addition, it also helps identify those older patients who are fit-- so not just identifying patients who may be at risk, but the other side of the coin is you're 80, but you're healthy. You're fit. You don't have a high risk of toxicity or higher risk than maybe those patients that were included in the clinical trial because your health status is good. And you should get treatment, right? So that conversation is also very important.

And again, as I mentioned, there is an example in the guideline where we take an older adult who has some medical issues, and we take them through the process by which these tools can be used to help with the decision-making process. And also, we compare that to a patient that's 10 years older that doesn't have those same health conditions and show the comparison and the contrast between the recommendations.

So the older adult, in our example, who is actually, chronologically, 10 years older is actually probably less likely to have harm from treatment than the person that was in their 70s who has other medical problems. And that just goes to show how important underlying health status is when we're making our clinical decisions for treatment.

We still need to know more about direct decision-making. We know that geriatric assessment influences oncology decision-making. That data has been shown. In other words, when our oncologists get this information from geriatricians at a tumor board, or it's provided to them through a summary, they utilize that, and they change what they're going to do on average 30% to 50% of the time. Because they value that information, and that information adds value to what their plan is.

But what we're still waiting for with these randomized trials is, does geriatric assessment and management approach decrease harm overall, improve survival, decrease toxicity, et cetera? There has been some data in geriatric assessment incorporated into therapeutic trials that shows that when a geriatric assessment plan is used that that might lower toxicity.

But we still need more data in that area. And that was recommendation four. And so that recommendation will be more robust as the data matures from these randomized controlled trials. But just to summarize, the panel feels, and ASCO feels, based on this guideline, that there is enough data to support using the tools that we recommend to help assess and manage older adults receiving chemotherapy.

Great. Thank you so much for your work on this important and very comprehensive guideline. And thank you for your time today, Dr. Mohile.

Thank you very much for inviting me.

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 the show to a colleague.

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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.