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Evidence-Based Oncology January 2019
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AJMCtv® Interviews, January 2019
Produced by Samantha DiGrande and Jaime Rosenberg

AJMCtv® Interviews, January 2019

Produced by Samantha DiGrande and Jaime Rosenberg
AJMC®TV interviews let you catch up on what’s new and important about changes in healthcare, with insights from key decision makers—from the clinician, to the health plan leader, to the regulator. When every minute in your day matters, AJMC®TV interviews keep you informed. Access the video clips at ajmc.com/interviews.
 
Right now, a fit patient would still likely be offered a conventional induction strategy or Vyxeos, the CPX-351 liposomal cytarabine– daunorubicin combination. But perhaps in the future, we might be able to change our approach.

I think the molecular profiling has also unveiled a variety of targets that we can use in combination with traditional chemotherapeutics. So, as highlighted by Keith W. Pratz, MD, associate professor of oncology, John Hopkins University, and Eytan Stein, MD, hematologic oncologist, Memorial Sloan Kettering Cancer Center, up-front combinations of both novel Flt-3 inhibitors and IDH [isocitrate dehydrogenase] inhibitors with conventional chemotherapy like 7+3 can provide really substantial rates of remission induction success and potentially deep molecular emissions, which may translate into better long- term survival for patients.

Kavita Patel, MD, MS, Nonresident Senior Fellow, Brookings Institution

How has the Oncology Care Model (OCM) evolved? What do you think it does well, and what are some of the pain points that participating practices continue to face?

The OCM has evolved in a couple of interesting ways. Data are now a very regular kind of term with the OCM practices. Almost all of them have done something with the access to claims data that they have, so that’s actually progress.

The second thing that they’ve all noticed is that these transformation activities—care transformation and quality improvement—are all actually working. Not necessarily in the way they might have thought, but they’re making patients feel like they’re getting better care and, in some cases, they’re delivering on improvements in quality measures.

The thing that’s still not working as well is this kind of clunkiness with things like attribution. It takes a long time—there’s a lag in how CMS processes the data about attribution and what we call reconciliation. It might take doctors up to about 18 months to ultimately know if the patient they thought they were taking care of is actually acknowledged by Medicare as their patient, and then vice versa. People that they thought were their patients are not neces- sarily theirs, and they don’t find out until about a year later. So, there are still some clunky things that have to do with how Medicare just processes claims under the model.

Can you discuss some of the key trends from the OCM’s second performance period results?

Practices overall are doing better, but it’s not like it’s a massive shift. There were improvements from the first to second performance period, but we ultimately haven’t seen a large majority of practices with improvements. Now, what I don’t know about is the financial; CMS doesn’t publish the financial improvements, so you’re hearing kind of fits and spurts about practices saving money that did not save it before.

So overall, I would say if I were sitting in CMS’s shoes, I’d be like, “Yes, this program is still working and it’s working well.” I don’t know if it’s necessarily “meeting the expectations” of what people thought they would be when they started the OCM, but I spend a lot of time looking at all of CMS’ models and this is a model that’s doing pretty well compared to [accountable care organizations and some others. So even I would step back from performance period 2 and say that this is a model that’s working.

Theresa H.M. Keegan, PhD, MS, Associate Professor, Hematology and Oncology, University of California, Davis, Comprehensive Cancer Center

How represented are adolescents and young adults in clinical trials?

Overall, AYAs, which are adolescents and young adults—and we typically define that as 15 to 39 years of age—are less represented in clinical trials than children. So, back in 2006, we reported that 14% of AYAs participated in clinical trials. This was using population-based data in the Surveillance, Epidemiology, and End Results Program. This is in contrast

to children, where approximately 90% are treated at institutions with NCI [National Cancer Institute]–sponsored clinical trials and as many as two-thirds [are] participating in clinical trials. So, there’s pretty dramatic differences by age, in terms of clinical trial participation.

Has representation changed over recent years?

So, not really, actually. Part of our goal was to look at changes over time. There’s been substantial efforts to increase both access to and participation for AYAs in clinical trials, and this is really because we’ve noticed less improvement in AYAs in survival over the past 30 years, and this has been attributed to lower participation in clinical trials as well as a number of other factors.

So, our goal was to look to see if we have seen an increase in participation over time. We were able to do some work ourselves in population-based data and found that in 2012 and 2013, we saw a modest increase from 15% to 18%, and these were in patients with acute lymphoblastic leukemia [ALL], Hodgkin, non-Hodgkin lymphoma patients, and sarcoma. But really, no significant increases over time.

There was a suggestion that there is an increased participation in ALL trials, and this has been noted by others. So, that may be the one exception; that for those patients that there is some increase in trial accrual. And there has been a lot of attention given to adolescent and young adult patients with ALL. But again, overall and in general, we don’t see increased clinical trial participation.

Jeff Sharman, MD, Medical Oncologist, Willamette Valley Cancer Institute and Research Center; Medical Director, The US Oncology Network

How does the standard of care for CLL differ based on treatment setting?

Chronic lymphocytic leukemia [CLL] is a slow-growing disease. It takes a long time for many patients to have their disease grow to a point where it needs treatment, and when patients need their first-line therapy, there are a lot of choices out there, and they’re broadly divided into a chemoimmunotherapy approach or a targeted-agent approach.

We’re going to see information in the plenary session that that exact question is being addressed in a study where patients get either ibrutinib, ibrutinib and rituximab, or bendamustine and rituximab. The findings of the study, and this is kind of somewhat an older population, is that the progression-free survival would appear to favor those patients treated with ibrutinib compared with chemoimmunotherapy.

But if you dive a little bit deeper and look at the different types of subgroups—and as we begin to talk about personalized medicine, there are some markers where the benefit of ibrutinib over chemoimmunotherapy is very clear—there are other groups where you can make an argument for a fixed-duration chemoimmunotherapy-based approach.

When you get to the relapsed setting, it really does tend to favor more of the novel targeted therapies, such as ibrutinib or venetoclax, compared with chemotherapy-based treatment.

How has the era of personalized medicine changed the way you think about treatment for patients with CLL?

Personalized medicine is a complex topic because what it generally refers to is a notion that you might find some feature or marker that’s unique to a patient and then select therapy on the basis of that marker. In the case of chronic lymphocytic leukemia, the disease is divided primarily into 2 groups of patients: those who have what’s called a mutated B-cell receptor and those who have an unmutated B-cell receptor.

In this case, mutation is good. It means you tend to have a slower-growing disease, fewer high-risk genetic markers for chemotherapy resistance, and so forth. So, by looking at the IGHV [immunoglobulin heavy chain variable] mutation or the B-cell receptor mutation status, those patients who have mutated disease are generally those patients who are going to benefit from a chemoimmunotherapy approach, whereas the patients who are unmutated are going to clearly benefit more from the novel targeted agent approach.

I think that there is debate, frank debate within the field, even amongst those who know the disease best, as to whether or not those patients with the mutated disease should get ibrutinib [Imbruvica] or chemoimmunotherapy, and I think that in a lot of cases, that would be subject to patient preference.

Robert M. Rifkin, MD, FACP, Medical Director, Biosimilars; Associate Chair, Hematology Research, McKesson Specialty Health 

What are the most recent treatment advances in multiple myeloma?

This year’s [American Society of Hematology Annual Meeting & Exposition had] many significant advances in multiple myeloma. Everybody will hear a lot about CAR [chimeric antigen receptor] T-cell therapy, but unfortunately, we’re not curing anybody with that and the responses are lasting sometimes long, sometimes short. Another big focus will be the bispecific antibodies, or the BiTE molecules. Several of these are in development, early clinical trials.

Probably the hottest target of the whole meeting will be the BCMA target in multiple myeloma, which is the B-cell maturation antigen. So, there will also be many presentations on agents directed for BCMA, some monoclonal antibodies, some antibody-drug conjugates. So, it’s exciting, in terms of the advances that we’ve made.

In terms of new drug approvals, it’s not quite the banner year it was a year ago, but [there’re] still many new agents entering the market and many exciting things to come.

How are these advances impacting clinical outcomes?

So, a lot of these are really new. In most of the trials, we barely know progression-free survival. There will be some early overall survival data being presented with new chemotherapy regimens, but we really have to wait and see the impact. I think it will also be extraordinarily important to control cost as all of these new agents come out.

There was one oral presentation on a quadruple combination of therapy, which works very, very nicely, but there was little, if any, mention of the financial impact on the patient and the healthcare system. So, in multiple myeloma, we’re going to have to get more responsible as all of these new agents march quickly to the forefront.

Alison J. Moskowitz, MD, Medical Oncologist, Clinical Director, Lymphoma Inpatient Unit, Memorial Sloan Kettering Cancer Center

How important is it to engage patients with Hodgkin lymphoma so that they understand their diagnosis and their treatment options?

I think it’s incredibly important that patients understand their diagnosis and what the treatment options are and what their prognosis is. I think that the treatment options that we have to offer patients are often not straightforward and not black-and-white where there’s one right or wrong answer. Some of it really has to depend upon the patient’s own values and their own choices.

One example of that is when we are offering patients with early-stage Hodgkin lymphoma a treatment approach where we’re going to consider either combined modality therapy, where we include radiation therapy, or chemotherapy alone. That is an important discussion to have with the patients, because the cure rate with chemotherapy alone for early-stage Hodgkin lymphoma is not as high as when we use combined modality therapy. But by eliminating the radiation, we are reducing long-term toxicity. But there’s a small group of patients who are going to relapse and then going to need much more intense chemotherapy and a stem cell transplant in order to cure their disease at that point.

 
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