Commentary
Video
Jorge Nieva, MD, explores the challenges of translating biomarker testing into treatment decisions for non–small cell lung cancer (NSCLC), the role of repeat testing in detecting resistance mutations, and the importance of equitable access to molecular diagnostics in value-based care settings.
At a recent Institute for Value-Based Medicine® event, Jorge Nieva, MD, associate professor of clinical medicine at Keck School of Medicine of the University of Southern California in Los Angeles, discussed the increasing complexity of non–small cell lung cancer (NSCLC) care and the implications for both specialists and community oncologists. He highlighted the challenges of translating biomarker results into treatment decisions when rare molecular subtypes require familiarity with therapies that many clinicians may use only once or twice in their careers.
Nieva also emphasized the role of repeat biomarker testing in identifying resistance mutations, the importance of real-world evidence in guiding treatment beyond the clinical trial setting, and the need to ensure equity in access to molecular testing across care environments.
This transcript was lightly edited; captions were auto-generated.
Transcript
Once biomarker results are available, what challenges still exist in translating those findings into treatment decisions?
One of the things that's happened with lung cancer is it's become tremendously complex. When it stopped being one disease and started being 10 different diseases with 10 different treatment pathways, knowing the right thing to do has become more difficult for practitioners that see a low volume of patients with these particularly rare diseases. For somebody in academia like me, it's easy. I'm a lung cancer specialist. I see lung cancer all day long, and I'm familiar with all the different subtypes. But for my friend who's a general oncologist who practices in North Carolina, he sees a lot of tobacco-related lung cancer and doesn’t see a lot of the non-smoking–related lung cancers, because there are a lot of smokers where he lives. He doesn’t really have an opportunity to gain experience with all the different varieties of cell-signaling therapies that are available.
While he knows that somebody with a ROS1 rearrangement may need some kind of special drug, maybe he's not used any of the drugs for ROS1 rearrangements, or maybe hasn’t used them in the last 3 years. He has a learning curve, as he’s prescribing drugs that maybe it’s the only time he’s prescribed them. I think that will be a challenge moving forward. As we become more specialized and more personalized, it also means that your doctor may be less experienced with the drug that is being prescribed than you would like. I think it’s going to be important for us to have good informatics tools that educate both patients and clinicians on what’s really to be expected. We have to have a better understanding of the idiosyncrasies of some of these newer drugs that are prescribed in very low amounts across the country.
Under what circumstances does repeat biomarker testing create the most value in guiding treatment?
There are a number of lung cancer types that will develop resistance mutations, and pharma and academia are working diligently to find the best treatments for each individual resistance mechanism. Repeat testing is valuable, because for a subset of patients, it will tell us what the best next treatment is. Of course, for a lot of lung cancer types, it’s going to have relatively low yield in terms of finding something that’s going to be actionable in the second or third line. I think it’s really going to be a challenge from a value standpoint to know how much testing do we do to pick up rare things.
Hopefully, with time, the cost of testing comes down and this becomes less important. I think it’ll also be important for industry and academic partners to develop the kinds of clinical trials and the kinds of real-world evidence that shows such strategies are valuable. Given the rarity with which many of these things occur, clinical trials may not be feasible, and so I do think we’re going to have to rely on real-world evidence to give us the answers of the right thing to do in many of these situations.
What are you looking forward to discussing in the IVBM panel?
One of the things that my panel is going to address is issues around equity for some of these testing programs. I think we need to be very careful when thinking about how patients are treated who essentially have unlimited resources—which, for many patients, simply means Medicare, or Medicare with a supplement, or a PPO [preferred provider organization]—and people who are receiving their care in value-based environments. We need to find ways of making sure that those patients who are being treated in value-based systems are not being shortchanged of the most valuable thing that they can have, which is a good understanding of the molecular genomics of their underlying cancer.
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