What do you tell patients with Stage IIA melanoma who are worried about their risk of recurrence?
Dr. Jason Luke: So, we commonly don’t think of Stage IIA as high risk relative to Stage IIB and IIC. And that’s because we see, when we look at long-term outcomes, the risk of recurrence for Stage IIA is quite a bit lower than for Stage IIB and Stage IIC.
Now, of course, we know there are some people who will have a recurrence in Stage IIA. We just aren’t really good yet at figuring out who exactly they’re going to be. And there are some tests that are out there that propose to predict this, although they’re not FDA-approved. So, for people who are anxious in this regard, there are some tests we can do. And then the question becomes if they are deemed to be high risk, then what do you do? Well, then we probably watch people more closely during active surveillance. We make sure that they’re really following up with dermatology and medical oncology for evaluation more frequently. But we would still say that there’s not clear evidence that giving a drug would help in that situation with Stage IIA. And in fact, we’d really run a high risk of causing more harm than good. And so that’s the thing to chat through.
With that said, some patients with Stage IIA melanoma were studied in the adjuvant setting https://clinicaltrials.gov/ct2/show/NCT04309409. For example, the nivolumab study included patients with IIA melanoma. So, it may be worth keeping your eye out for additional clinical trial options if you are very motivated to reduce the risk of recurrence. But, right now, there are no active adjuvant trials for patients with Stage IIA melanoma.
Luke JJ, Rutkowski P, Queirolo P, et al. Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial. Lancet. 2022;399(10336):1718-1729. doi:10.1016/S0140-6736(22)00562-1
U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Supplemental Biologics License Application and European Medicines Agency Validates Application for Opdivo (nivolumab). Press Release. February 28, 2022. Available at: https://news.bms.com/news/corporate-financial/2023/U.S.-Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-Supplemental-Biologics-License-Application-and-European-Medicines-Agency-Validates-Application-for-Opdivo-nivolumab-/default.aspx
Bristol Myers Squibb announces adjuvant treatment with Opdivo (nivolumab) demonstrated statistically significant and clinically meaningful improvement in recurrence-free survival (RFS) in patients with Stage IIB-C melanoma in the CheckMate 76K trial. Press Release. September 15, 2022. Available at: https://news.bms.com/news/details/2022/Bristol-Myers-Squibb-Announces-Adjuvant-Treatment-with-Opdivo-nivolumab-Demonstrated-Statistically-Significant-and-Clinically-Meaningful-Improvement-in-Recurrence-Free-Survival-RFS-in-Patients-with-Stage-IIBC-Melanoma-in-the-CheckMate–76K-Trial/default.aspx