文章：

欧洲真实世界环境中帕博利珠单抗辅助治疗III期黑色素瘤的应用

Adjuvant Use of Pembrolizumab for Stage III Melanoma in a Real-World Setting in Europe

原文发布日期：22 October 2024

DOI: 10.3390/cancers16213558

类型: Article

开放获取: 是

英文摘要：

Background: Although data on patients treated with pembrolizumab are available from clinical trials and single-country real-world reports, to our knowledge no multi-country real-world studies have investigated the use of pembrolizumab as an adjuvant treatment for stage III melanoma. Methods: We used the European Melanoma Registry (EUMelaReg), a disease entity-based registry specific for melanoma, to examine treatment and outcomes for adult patients with stage III melanoma with lymph node involvement who had complete resection and received adjuvant treatment with pembrolizumab. The primary objectives were to describe the demographic and clinical characteristics of the included patients as well as time on adjuvant pembrolizumab treatment (TOT), real-world recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) from adjuvant pembrolizumab initiation. Secondary objectives were time to next treatment (TTNT) after adjuvant use of pembrolizumab, next-line therapy for stage III and unresectable stage IV melanoma and overall survival (OS) from initiation of pembrolizumab. Results: Patients were stratified according to age, sex, BRAF status, number of positive lymph nodes and disease substage. Median TOT was 11.1 (9.2–11.5) months, median RFS was 29.6 [18.7–not reached (NR)] months and median DMFS was 32.4 (22.7–NR) months. TTNT was 29.9 (22.2–NR) months, while median OS was not reached. Conclusions: The results of this study offer insights into the real-world use of pembrolizumab as an adjuvant therapy for melanoma in Europe.

摘要翻译： 

背景：尽管临床试验和单国真实世界研究报告提供了帕博利珠单抗治疗患者的数据，但据我们所知，目前尚无多国真实世界研究探讨帕博利珠单抗作为III期黑色素瘤辅助治疗的应用情况。方法：我们利用欧洲黑色素瘤登记系统（EUMelaReg）——一个专门针对黑色素瘤的疾病实体登记库，对淋巴结受累、已完成完全切除并接受帕博利珠单抗辅助治疗的III期黑色素瘤成年患者的治疗及结局进行分析。主要研究目标包括描述纳入患者的人口统计学与临床特征、帕博利珠单抗辅助治疗持续时间（TOT）、以及自帕博利珠单抗辅助治疗开始后的真实世界无复发生存期（RFS）和无远处转移生存期（DMFS）。次要目标涵盖帕博利珠单抗辅助治疗后的至下次治疗时间（TTNT）、针对III期及不可切除IV期黑色素瘤的后续治疗方案，以及自帕博利珠单抗治疗开始后的总生存期（OS）。结果：患者按年龄、性别、BRAF状态、阳性淋巴结数量和疾病亚期进行分层。中位TOT为11.1（9.2–11.5）个月，中位RFS为29.6[18.7–未达到（NR）]个月，中位DMFS为32.4（22.7–NR）个月。TTNT为29.9（22.2–NR）个月，而中位OS尚未达到。结论：本研究结果为帕博利珠单抗在欧洲作为黑色素瘤辅助治疗的真实世界应用提供了重要参考。

原文链接：

Adjuvant Use of Pembrolizumab for Stage III Melanoma in a Real-World Setting in Europe