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阿维鲁单抗作为转移性 Merkel 细胞癌二线或后线治疗:利用与法国国家医疗保健数据库相关联的 CARADERM 数据库分析法国真实世界结局。

Avelumab as second-line or later treatment in patients with metastatic Merkel cell carcinoma: Analysis of real-world outcomes in France using the CARADERM database linked to the French national healthcare database.

机构信息

Lille University, INSERM U 1189, CHU de Lille, CARADERM network, Lille Cedex, France.

CHU Ambroise-Paré, Boulogne-Billancourt, France.

出版信息

Eur J Cancer. 2024 Sep;209:114261. doi: 10.1016/j.ejca.2024.114261. Epub 2024 Aug 3.

DOI:10.1016/j.ejca.2024.114261
PMID:39128185
Abstract

AIM

Avelumab has been approved worldwide for treatment of metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer. This study evaluated outcomes in patients with mMCC in France who received avelumab as second-line or later (2L+) treatment in routine clinical practice.

METHODS

This retrospective, noninterventional study evaluated all patients diagnosed with mMCC using two databases: CARADERM (French national database of rare dermatological cancers) and SNDS (national healthcare database), identified via probabilistic linkage. Eligible patients initiated avelumab as 2L+ treatment between August 2016 and December 2019 and were followed for 24 months. The primary endpoint was overall survival (OS) at 24 months.

RESULTS

Overall, 180 patients who received 2L+ avelumab were identified (112 from CARADERM, 68 after SNDS linkage). Median age at diagnosis was 74.0 years and 177 (98.3 %) had received chemotherapy alone as first-line treatment. Median follow-up was 13.1 months. Median OS from start of avelumab was 14.6 months (95 % CI, 9.9-21.3) in the overall population, 15.9 months (95 % CI, 8.6-28.3) in CARADERM patients, and 13.3 months (95 % CI, 6.7-19.1) in non-CARADERM patients. OS rates at 12 and 24 months were 53.8 % (95 % CI, 46.2 %-60.8 %) and 40.5 % (95 % CI, 33.2 %-47.6 %), respectively. In evaluable patients (CARADERM database), median progression-free survival was 3.6 months (95 % CI, 2.7-7.5) and the objective response rate was 55.3 % (95 % CI, 45.3-65.4), including complete response in 31.9 %.

CONCLUSIONS

Real-world outcomes with 2L+ avelumab treatment for mMCC are consistent with clinical trial findings, supporting the recommendation of avelumab as a standard of care.

摘要

目的

avelumab 已在全球范围内获批用于治疗转移性 Merkel 细胞癌(mMCC),这是一种罕见且侵袭性很强的皮肤癌。本研究评估了法国在常规临床实践中接受avelumab 二线或后线(2L+)治疗的 mMCC 患者的结局。

方法

这是一项回顾性、非干预性研究,使用两个数据库(法国罕见皮肤病数据库 CARADERM 和国家医疗保健数据库 SNDS)通过概率链接评估所有诊断为 mMCC 的患者。符合条件的患者在 2016 年 8 月至 2019 年 12 月期间接受 2L+avelumab 治疗,并随访 24 个月。主要终点为 24 个月时的总生存期(OS)。

结果

共确定了 180 名接受 2L+avelumab 治疗的患者(112 名来自 CARADERM,68 名来自 SNDS 链接)。中位诊断年龄为 74.0 岁,177 名(98.3%)患者曾单独接受化疗作为一线治疗。中位随访时间为 13.1 个月。总体人群中avelumab 起始后的中位 OS 为 14.6 个月(95%CI,9.9-21.3),CARADERM 患者为 15.9 个月(95%CI,8.6-28.3),非 CARADERM 患者为 13.3 个月(95%CI,6.7-19.1)。12 个月和 24 个月时的 OS 率分别为 53.8%(95%CI,46.2%-60.8%)和 40.5%(95%CI,33.2%-47.6%)。在可评估患者(CARADERM 数据库)中,中位无进展生存期为 3.6 个月(95%CI,2.7-7.5),客观缓解率为 55.3%(95%CI,45.3%-65.4%),包括完全缓解率 31.9%。

结论

2L+avelumab 治疗 mMCC 的真实世界结局与临床试验结果一致,支持将 avelumab 推荐为标准治疗。

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