Modern Approach to Melanoma Adjuvant Treatment with Anti-PD1 Immune Check Point Inhibitors or BRAF/MEK Targeted Therapy: Multicenter Real-World Report

SIMPLE SUMMARY: Performing this real-world analysis, we intended to see if postoperative (adjuvant) systemic treatment outcomes in a Polish melanoma patient population are comparable to the results from international trials based on which the treatment was registered worldwide. We intended to provide evidence on the efficacy and safety of postoperative melanoma treatment from everyday practice. We have shown that the type of surgical procedure on the lymph nodes prior to adjuvant treatment does not influence the outcome of that treatment. Our results support a de-escalation of surgery approach in melanoma patients. We support the value of adjuvant treatment for melanoma patients selected according to new guidelines implemented in parallel to the registration process. Analyzing the recorded side effects of adjuvant systemic treatment in our group of patients, we have noticed that severe complications worsen survival, giving us an indication not to treat by all means despite toxicity, particularly since it is a complementary to surgery treatment. ABSTRACT: Background: The landscape of melanoma management changed as randomized trials have launched adjuvant treatment. Materials and Methods: An analysis of data on 248 consecutive melanoma stage III and IV patients given adjuvant therapy in eight centers (February 2019 to January 2021) was conducted. Results: The analyzed cohort comprised 147 melanoma patients given anti-PD1 (33% nivolumab, 26% pembrolizumab), and 101 (41%) were given dabrafenib plus trametinib (DT). The 2-year overall survival (OS), relapse-free survival (RFS), and distant-metastases-free survival (DMFS) rates were 86.7%, 61.4%, and 70.2%, respectively. The disease stage affected only the RFS rate; for stage IV, it was 52.2% (95% CI: 33.4–81.5%) vs. 62.5% (95% CI: 52.3–74.8%) for IIIA-D, p = 0.0033. The type of lymph node surgery before adjuvant therapy did not influence the outcomes. Completion of lymph node dissection cessation after positive SLNB did not affect the results in terms of RFS or OS. Treatment-related adverse events (TRAE) were associated with longer 24-month RFS, with a rate of 68.7% (55.5–84.9%) for TRAE vs. 56.6% (45.8–70%) without TRAE, p = 0.0031. For TRAE of grade ≥ 3, a significant decline in OS to 60.6% (26.9–100%; p = 0.004) was observed. Conclusions: Melanoma adjuvant therapy with anti-PD1 or DT outside clinical trials appears to be effective and comparable with the results of registration studies. Our data support a de-escalating surgery approach in melanoma treatment.