Would you offer adjuvant immunotherapy in an elderly patient with stage IIB desmoplastic melanoma post resection with underlying autoimmune disease?

As discussed with our desmoplastic melanoma expert at The Ohio State University, Kari L. Kendra, MD -

"Because some patients are potentially "cured" with surgical resection alone and this patient has an autoimmune disease, would not treat in the adjuvant setting.

If there is local recurrence, would recommend 3 cycles of pembrolizumab, then resect followed by close monitoring and treat the autoimmune illness as needed. If the patient recurs distally, then would recommend pembrolizumab until the patient has no evidence of disease (most require 6 months or less) or until disease stabilization."

Patients with autoimmune disease on active immunosuppression are usually excluded from all clinical trials. Even the percentage of patients with autoimmune disease who do not require immunosuppression is much less in clinical trials to draw any significant conclusions.

Hence, to answer this question we would have to think about the pros and cons of offering treatment to such a patient. Both adjuvant studies, KEYNOTE-716 and CheckMate76K, showed RFS and DMFS benefits of adjuvant therapy in patients with stage 2b melanoma. However, to date, no adjuvant therapy has shown an OS benefit.

The risk of grade 3 and 4 irAE is ~20% in both studies. However, retrospective data sets show that in patients with autoimmune disease, the risk of irAE is almo...

In case patients like this with autoimmune disorders need to be considered for immunotherapy in the future, our site (Ohio State University Comprehensive Cancer Center) has an ongoing NCI-sponsored study under our UM1 grant called "AIM-NIVO" (nivolumab in autoimmune disease).

The AIM-NIVO study is intended to teach us more about the effect of PD1 on patients with cancer and autoimmune disease. This population was historically excluded from IO studies, and there is a knowledge gap.

The enrolled patients will receive q4weekly nivolumab monotherapy provided by the study at no cost. The eligible tumor types are determined on a case-by-case basis NOT limited to FDA approval.

The autoimmune diseases include but are not limited to DM/SSc, RA, SLE...

I would not offer adjuvant therapy, but carefully monitor the patient. If disease recur, then I would treat with neoadjuvant immunotherapy in first line prior to other mechanical removal of the recurrent tumor.