ⅡB-ⅢD期黑色素瘤患者术后辅助PD-1抗体对比高剂量干扰素:一项回顾性队列研究OA北大核心CSTPCD

Objective:To explore the efficacy and safety of PD-1 antibody versus high-dose interferon in the adjuvant treatment of stage ⅡB-ⅢD melanoma patients after surgery.Methods:Clinical data of patients with stage ⅡB-ⅢD cutaneous and acral melanoma admitted into Nanjing Drum Tower Hospital,the affiliated hospital of Nanjing University Medical School between September 2013 and September 2022 were retrospectively collected.All patients received high-dose interferon(HDI)or PD-1 antibody as adjuvant therapy after surgery.Univariate survival analysis was performed and survival curves were plotted by the Kaplan-Meier method;Log-Rank method was used to analyze and assess whether the differences in RFS,DMFS,and OS between the groups were statistically significant,and prognostic factors were evaluated by univariate and multivariate Cox regression.Results:A total of 91 patients were enrolled in this study with a median follow-up of 31.0 months.The median RFS was 29.2 and 32.3 months in the HDI group and the PD-1 antibody group,respectively,and the difference was not statistically significant(HR=0.90,95%CI[0.50,1.64];P=0.736).The median DMFS and the median OS in the HDI group were 36.0 and 109.2 months respectively,and neither was reached in the PD-1 antibody group(both P>0.05).The most common site of first distant metastasis in both groups was the lung,and there was no statistically significant difference in the incidence of distant metastasis at any site(P>0.05).By univariate Cox analysis,compared with PD-1,antibody HDI reduced the risk of distant metastasis in patients with BRAFV600E/K mutations(HR=10.03,95%CI[1.10,91.35];P=0.041).Subgroup analyses showed that in patients with cutaneous and acral melanoma,the difference in RFS between the HDI group and the PD-1 antibody group was not statistically significant(both P>0.05).The incidence of adverse reactions in the HDI group and the PD-1 antibody group was 83.3%and 79.1%,respectively,most of which were grade 1 or 2.No deaths related to adverse reactions occurred in both groups.Conclusion:In this study,there was no statistically significant difference in clinical efficacy and safety between PD-1 antibody and HDI adjuvant therapy for malignant melanoma patients.Patients with BRAFV600E/K mutations may benefit more from HDI.Numerous prospective studies are needed to further explore the optimal adjuvant treatment options for melanoma patients in Asian populations.