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转移性黑色素瘤患者因客观反应或不良反应停用抗PD-1免疫治疗后的真实世界生存情况:一项回顾性研究

Real-World Survival in Patients with Metastatic Melanoma after Discontinuation of Anti-PD-1 Immunotherapy for Objective Response or Adverse Effects: A Retrospective Study.

作者信息

Valentin Julie, Ferté Thomas, Dorizy-Vuong Valérie, Dousset Léa, Prey Sorilla, Dutriaux Caroline, Pham-Ledard Anne, Beylot-Barry Marie, Gérard Emilie

机构信息

Department of Dermatology, Hôspital Saint André, University Hospital of Bordeaux, Bordeaux, France.

Bordeaux Hospital University Center, Pôle de Santé Publique, Service D'information Médicale, Unité Informatique et Archivistique Médicales, F-33000 Bordeaux, France.

出版信息

J Oncol. 2021 Apr 27;2021:5524685. doi: 10.1155/2021/5524685. eCollection 2021.

Abstract

OBJECTIVE

Anti-PD-1 has dramatically improved the survival of patients with advanced melanoma. However, there is a lack of data on maintenance of the response after treatment discontinuation. We aimed to evaluate the progression-free survival (PFS) of patients with metastatic melanoma after anti-PD-1 interruption for objective response (OR) or limiting toxicity during clinical trials.

METHODS

All patients with advanced melanoma who stopped single-agent anti-PD-1 antibodies for objective response or toxicity were included between April 2014 and January 2019 in our institution (data cut-off, September 10th, 2019). Clinical and biological factors associated with relapse were studied.

RESULTS

The median follow-up after introduction of treatment was 36.5 months [4.6-62.4], and the median follow-up after discontinuation of treatment was 15.7 months (2.5-45.1). Out of 65 patients, 28 patients stopped immunotherapy for limiting adverse effects (AEs) (43.1%), 25 for complete response (CR) (38.4%), and 12 for partial response (PR) or long-term stable disease (SD) (18.5%). Twelve patients relapsed (18.5%) after a median time of 9 months [1.9-40.9 months]. Seven relapsed after discontinuation for AEs, 3 after discontinuation for CR, and 2 after discontinuation for PR/SD. The median PFS after therapy discontinuation was not reached. No statistical association was found between recurrence and age, sex, increased LDH, BRAF status, presence of brain metastases, previous treatments, radiotherapy, or time on anti-PD-1 treatment.

CONCLUSION

This cohort shows a global recurrence rate of 18.5% and confirms a long-lasting response after anti-PD-1 cessation regardless of the cause of discontinuation.

摘要

目的

抗程序性死亡蛋白1(Anti-PD-1)显著提高了晚期黑色素瘤患者的生存率。然而,关于治疗中断后反应维持的数据却很缺乏。我们旨在评估在临床试验中因客观缓解(OR)或限制毒性而中断抗PD-1治疗后转移性黑色素瘤患者的无进展生存期(PFS)。

方法

2014年4月至2019年1月期间,我们机构纳入了所有因客观缓解或毒性而停止使用单药抗PD-1抗体的晚期黑色素瘤患者(数据截止日期为2019年9月10日)。研究了与复发相关的临床和生物学因素。

结果

开始治疗后的中位随访时间为36.5个月[4.6 - 62.4],治疗中断后的中位随访时间为15.7个月(2.5 - 45.1)。65例患者中,28例因限制不良反应(AEs)而停止免疫治疗(43.1%),25例因完全缓解(CR)而停止(38.4%),12例因部分缓解(PR)或长期疾病稳定(SD)而停止(18.5%)。12例患者复发(18.5%),中位复发时间为9个月[1.9 - 40.9个月]。7例在因AEs停药后复发,3例在因CR停药后复发,2例在因PR/SD停药后复发。治疗中断后的中位PFS未达到。在复发与年龄、性别、乳酸脱氢酶升高、BRAF状态、脑转移的存在、既往治疗、放疗或抗PD-1治疗时间之间未发现统计学关联。

结论

该队列显示总体复发率为(18.5%),并证实无论停药原因如何,抗PD-1停药后反应持久。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f2d4/8096591/aacd5b1f0c61/JO2021-5524685.001.jpg

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