First-line treatment of advanced/metastatic melanoma with anti-PD-1 antibodies: multicenter experience in Poland

Lay abstract This study analyzed the effectiveness of anti-PD-1 treatment, antibodies that improve the body's immunity and activate T lymphocytes. Activated T lymphocytes can inhibit or kill cancer cells. The study involved 499 people with advanced (unable to be removed by surgery) or metastatic (the cancer cells have spread to other organs) melanoma. The study showed that the overall survival of patients was 19.9 months and was slightly worse than the results presented in clinical trials. The study also assessed the safety of anti-PD-1 therapy. The use of anti-PD-1 in everyday practice has contributed to the reduction of severe toxicities associated with the use of immunotherapy. Aim: To evaluate treatment results in advanced/metastatic melanoma patients treated with anti-PD-1 immunotherapy in routine practice in oncology centers in Poland. Methods: Multicenter retrospective analysis included 499 patients with unresectable/metastatic (stage IIIC-IV) melanoma treated with anti-PD-1 in first-line therapy. Results: Estimated median overall survival (OS) and progression-free survival (PFS) were 19.9 and 7.9 months, respectively. Multivariate analysis confirmed that ECOG 0, no brain metastases, normal lactate dehydrogenase level and occurrence of immune-related adverse events (irAEs) were statistically significantly associated with improved OS and PFS. Any irAE occurred in 24% of patients. Grade 3 or Grade 4 irAEs occurred in 6% of patients. Conclusion: Analysis revealed a slightly worse OS in real-world treatment in comparison to clinical trials (KEYNOTE-006 and CheckMate 066). Polish population treatment results are similar to other studies of real-world data. PFS and ORR are similar in our research and clinical trials.