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Avelumab治疗晚期或转移性尿路上皮癌可显著延长生存期
作者:小柯机器人 发布时间:2020/9/22 14:21:21

英国伦敦玛丽皇后大学Thomas Powles团队研究了Avelumab治疗晚期或转移性尿路上皮癌的疗效。2020年9月18日,该研究发表在《新英格兰医学杂志》上。

基于铂的化疗是晚期尿路上皮癌的一线治疗标准,但无进展生存期和总生存期受到化疗耐药性的限制。

在这项临床3期试验中,研究组招募了700例无法切除的局部晚期或转移性尿路上皮癌患者,这些患者在接受一线化疗(吉西他滨+顺铂或卡铂,4-6个周期)后没有疾病进展,将其随机分组,分别接受最佳支持治疗添加或不添加Avelumab(Avelumab组和对照组)。主要终点为总体生存期,次要终点为无进展生存期和安全性。

Avelumab组的总生存期显著长于对照组,其1年总生存率为71.3%,显著高于对照组(58.4%),中位总生存期分别为21.4个月和14.3个月。Avelumab还显著延长了PD-L1阳性人群的总体生存期,其1年总生存率为79.1%,显著高于对照组(60.4%)。

在总体人群中,Avelumab组的中位无进展生存期为3.7个月,显著长于对照组(2.0个月);PD-L1阳性人群中分别为5.7个月和2.1个月,差异显著。Avelumab组中全因不良事件发生率为98.0%,对照组为77.7%;3级及以上不良事件发生率分别为47.4%和25.2%。

研究结果表明,对于尿路上皮癌一线化疗尚未进展的患者而言,最佳支持治疗联合Avelumab维持可显著延长患者的生存期。

附:英文原文

Title: Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma | NEJM

Author: Thomas Powles, M.D.,, Se Hoon Park, M.D., Ph.D.,, Eric Voog, M.D.,, Claudia Caserta, M.D.,, Begoa P. Valderrama, M.D.,, Howard Gurney, M.D.,, Haralabos Kalofonos, M.D., Ph.D.,, Sinia Radulovi, M.D., Ph.D.,, Wim Demey, M.D.,, Anders Ullén, M.D., Ph.D.,, Yohann Loriot, M.D., Ph.D.,, Srikala S. Sridhar, M.D.,, Norihiko Tsuchiya, M.D.,, Evgeny Kopyltsov, M.D.,, Cora N. Sternberg, M.D.,, Joaquim Bellmunt, M.D., Ph.D.,, Jeanny B. Aragon-Ching, M.D.,, Daniel P. Petrylak, M.D.,, Robert Laliberte, M.S.,, Jing Wang, Ph.D.,, Bo Huang, Ph.D.,, Craig Davis, Ph.D.,, Camilla Fowst, M.D.,, Nuno Costa, M.D.,, John A. Blake-Haskins, Pharm.D.,, Alessandra di Pietro, M.D., Ph.D.,, and Petros Grivas, M.D., Ph.D.

Issue&Volume: 2020-09-18

Abstract:

Background

Platinum-based chemotherapy is standard-of-care first-line treatment for advanced urothelial carcinoma. However, progression-free survival and overall survival are limited by chemotherapy resistance.

Methods

In a phase 3 trial, we randomly assigned patients with unresectable locally advanced or metastatic urothelial cancer who did not have disease progression with first-line chemotherapy (four to six cycles of gemcitabine plus cisplatin or carboplatin) to receive best supportive care with or without maintenance avelumab. The primary end point was overall survival, assessed among all patients who underwent randomization (overall population) and among those with tumors positive for programmed cell death ligand 1 (PD-L1). Secondary end points included progression-free survival and safety.

Results

Among all 700 patients who underwent randomization, the addition of maintenance avelumab to best supportive care significantly prolonged overall survival as compared with best supportive care alone (control). Overall survival at 1 year was 71.3% in the avelumab group and 58.4% in the control group (median overall survival, 21.4 months vs. 14.3 months; hazard ratio for death, 0.69; 95% confidence interval [CI], 0.56 to 0.86; P=0.001). Avelumab also significantly prolonged overall survival in the PD-L1–positive population; overall survival at 1 year was 79.1% in the avelumab group and 60.4% in the control group (hazard ratio, 0.56; 95% CI, 0.40 to 0.79; P<0.001). The median progression-free survival was 3.7 months in the avelumab group and 2.0 months in the control group in the overall population (hazard ratio for disease progression or death, 0.62; 95% CI, 0.52 to 0.75) and 5.7 months and 2.1 months, respectively, in the PD-L1–positive population (hazard ratio, 0.56; 95% CI, 0.43 to 0.73). The incidence of adverse events from any cause was 98.0% in the avelumab group and 77.7% in the control group; the incidence of adverse events of grade 3 or higher was 47.4% and 25.2%, respectively.

Conclusions

Maintenance avelumab plus best supportive care significantly prolonged overall survival, as compared with best supportive care alone, among patients with urothelial cancer who had disease that had not progressed with first-line chemotherapy.

DOI: 10.1056/NEJMoa2002788

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2002788

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home