Adjuvant therapy with anti-PD-1 antibody vs targeted therapy for patients with resected stage Ⅲ malignant melanoma: a real-world data analysis from China centers

Abstract

Background and purpose: Anti-programmed death-1 (anti-PD-1) adjuvant therapy and targeted therapy have resulted in longer recurrence-free survival (RFS) for malignant melanoma patients in clinical trials. However, the efficacy of adjuvant anti-PD-1 therapy in Chinese melanoma patients has not been previously reported. The purpose of this study was to retrospectively analyze the RFS in Chinese resected stage Ⅲ malignant melanoma patients treated with adjuvant anti-PD-1 therapy and to preliminarily compare it with BRAFV600 inhibitor vemurafenib. Methods: This study retrospectively collected the information of 120 patients with resected stage Ⅲ malignant melanoma from three major cancer centers in China from August 30, 2018 to August 30, 2020. These patients received adjuvant pembrolizumab/toripalimab or vemurafenib. RFS rates were assessed by Kaplan-Meier curves and log-rank tests were used to examined differences. Results: Among the 90 patients with stage Ⅲ malignant melanoma receiving adjuvant anti-PD-1 therapy, the median-RFS (mRFS) was 16 months (95% CI: 14-18 months); the 12-month RFS rate was 69.5% (95% CI: 64.6%-74.4%) and the 24-month RFS rate was 45.8% (95% CI: 40.5%-51.1%). The mRFS for 30 patients who received vemurafenib was 18 months (95% CI: 10-21 months), the 12-month RFS rate was 62.8% (95% CI: 54.0%-71.6%), and the 24-month RFS rate was 32.9% (95% CI: 27.1%-44.7%). In the stratified analysis, firstly, there was no difference in RFS between anti-PD-1 therapy group and vemurafenib group. Secondly, the BRAFV600E mutation status may did not affect the RFS of anti-PD-1 therapy. In addition, in this study, for the patients with BRAFV600E mutation, the RFS showed no difference between these patients received anti-PD-1 therapy or vemurafenib. Finally, although the RFS was better in patients with cutaneous melanoma than in patients with acral and worst in patients of unknown origin, the data for adjuvant therapy in China were still poor. Conclusion: These are the real-world data from adjuvant anti-PD-1 therapy in patients with resected stage Ⅲ cutaneous and acral melanoma patients in China. In our study, adjuvant anti-PD-1 therapy is indistinguishable from vemurafenib indicates more combination therapies are needed to improve outcome in China.

Keywords

• |melanoma|adjuvant therapy|anti-programmed death-1 therapy|braf mutation|recurrence-free survival