At the recent ASCO annual meeting in Chicago, Janice Mehnert, MD, of Rutgers Cancer Institute of New Jersey, spoke with MedPage Today about immune checkpoint and BRAF/MEK therapy for patients, and the continuing importance of clinical trials to determine the best treatment options for patients.
Following is a transcript of her remarks:
This is an important conversation to have because we don't have randomized, head-to-head data comparing these two options. At this point in time, we're making clinical decisions based on extensive consultations with our patients and an explicit understanding between patient and doctor regarding side effects and efficacy. It's also important to take into account patient-specific factors such as cost, convenience, schedule of administration, and any existing comorbid conditions.
Both approaches, immune checkpoint therapy and targeted therapy, do show a benefit in relapse-free survival. The curves are slightly different in that the BRAF- and MEK-targeted therapy appears to have larger differences within the first year. Immune checkpoint therapy is perhaps a bit smaller, although they seem to be more sustained over time. I think what's important to consider are things like an IV infusion versus pills that can be taken at home, which factors into patient convenience. The number of doctor visits where patients will be required to come into the office with each therapy can vary -- most important, again, is a firm understanding of the side effect profile of these agents.
What we're trying to do is cure patients who currently do not have active disease, so that's a reduction in risk of recurrence. Yet, some of the side effects, especially from immune checkpoint therapy, can be permanent. Patients need to have a full understanding of how their lives could possibly change if, in fact, they sustain some of these side effects -- that's a very important and time-consuming conversation for us to have. We need to take time with our patients. We need to be sensitive to the fact that these discussions will be lengthy, and we need to work with them to come to a plan that meets their goals and our goals, as well as trying to keep them disease-free.
In general, this dilemma is only for patients who have the BRAF mutation, because we wouldn't consider prescribing the therapy if they did not. However, the question of which patients within the early-stage subset, meaning stage II patients, can actually require treatment is not yet answered, and that's going to be a subject of ongoing clinical trials.
In terms of other markers within the stage III population for which these approaches currently have FDA approval, biomarkers are the holy grail. We're not there yet. That's what our challenge is going to have to be. Is it a risk score that we'll be able to get off of pretreatment tumor tissue? Is it a peripheral blood sample which will monitor BRAF tumor levels within the blood? These are open research questions we're working on.
We have an ongoing plan for a phase III trial ... that does interdigitate a targeted therapy and immunotherapy schedule. I think it's an important question to ask, because while it may be subjecting patients to different side effects at once, if it results in superior efficacy, then it's an important thing that we'll need to know.