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抗程序性细胞死亡蛋白 1 治疗在转移性肢端和转移性黏膜黑色素瘤患者中的疗效。

The efficacy of anti-programmed cell death protein 1 therapy among patients with metastatic acral and metastatic mucosal melanoma.

机构信息

Department of Melanoma Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA.

Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan.

出版信息

Cancer Med. 2021 Apr;10(7):2293-2299. doi: 10.1002/cam4.3781. Epub 2021 Mar 8.

Abstract

BACKGROUND

Anti-programmed cell death protein 1 (PD-1) antibodies are a standard treatment for metastatic melanoma patients. However, the understanding of the efficacy of anti-PD-1 for acral melanoma (AM) and mucosal melanoma (MM) is limited as these subtypes are relatively rare compared to cutaneous melanoma (CM).

METHODS

This single institution, retrospective cohort study included patients with advanced AM and MM who underwent anti-PD-1 therapy for metastatic melanoma between 2012 and 2018. Objective responses were determined using the investigator-assessed Response Evaluation Criteria in Solid Tumors version 1.1. Progression-free survival (PFS) and overall survival (OS) were assessed using the Kaplan-Meier method. A Cox regression analysis was performed to identify the factors associated with survival outcomes.

RESULTS

Ninety-seven patients were identified, 38 (39%) with AM and 59 (61%) with MM. The objective response rates (ORRs) were 21.0% and 15.2% in patients with AM and MM, respectively. The median PFS and OS were 3.6 and 25.7 months for AM patients, and 3.0 and 20.1 months for MM patients, respectively. Elevated serum lactate dehydrogenase (LDH) (AM: hazard ratio [HR], 0.22; 95% confidence interval [CI], 0.06-0.87; p = 0.03, MM: HR, 0.20; 95% CI, 0.08-0.53; p = 0.001) was significantly associated with shorter OS for both subtypes.

CONCLUSIONS

The ORR, PFS, and OS with anti-PD-1 therapy were poor in patients with AM and MM compared to those previously reported clinical trials for nonacral CM. High serum LDH was associated with significantly shorter OS.

摘要

背景

抗程序性细胞死亡蛋白 1(PD-1)抗体是转移性黑色素瘤患者的标准治疗方法。然而,由于与皮肤黑色素瘤(CM)相比,肢端黑色素瘤(AM)和黏膜黑色素瘤(MM)等亚型相对较少,因此对其使用抗 PD-1 治疗的疗效的了解有限。

方法

本单机构回顾性队列研究纳入了 2012 年至 2018 年间接受抗 PD-1 治疗转移性黑色素瘤的晚期 AM 和 MM 患者。采用研究者评估的实体瘤反应评估标准 1.1 确定客观缓解率(ORR)。采用 Kaplan-Meier 法评估无进展生存期(PFS)和总生存期(OS)。采用 Cox 回归分析确定与生存结果相关的因素。

结果

共确定了 97 例患者,其中 38 例(39%)为 AM,59 例(61%)为 MM。AM 和 MM 患者的 ORR 分别为 21.0%和 15.2%。AM 患者的中位 PFS 和 OS 分别为 3.6 个月和 25.7 个月,MM 患者的中位 PFS 和 OS 分别为 3.0 个月和 20.1 个月。血清乳酸脱氢酶(LDH)升高(AM:风险比 [HR],0.22;95%置信区间 [CI],0.06-0.87;p=0.03,MM:HR,0.20;95% CI,0.08-0.53;p=0.001)与两种亚型的 OS 显著缩短相关。

结论

与非肢端 CM 的先前临床试验相比,AM 和 MM 患者使用抗 PD-1 治疗的 ORR、PFS 和 OS 较差。高血清 LDH 与 OS 显著缩短相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb2c/7982611/4e89ae87e7c0/CAM4-10-2293-g001.jpg

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