医学
恩扎鲁胺
多西紫杉醇
内科学
前列腺癌
安慰剂
肿瘤科
随机对照试验
强的松
癌症
化疗
病理
雄激素受体
替代医学
作者
Nicholas J. Vogelzang,Tomasz M. Beer,Winald R. Gerritsen,Stéphane Oudard,Paweł Wiechno,Bożena Kukiełka-Budny,Vladimír Šámal,Jaroslav Hájek,Susan Feyerabend,Vincent Khoo,Arnulf Stenzl,Tibor Csőszi,Zoran Filipovic,Frederico Gonçalves,A. A. Prokhorov,Eric Cheung,Arif Hussain,Nuno Sousa,Amit Bahl,Syed A. Hussain,Harald Fricke,Pavla Kadlecová,Tomáš Scheiner,Roman Korolkiewicz,Jiřina Bartůňková,Radek Špíšek,NULL AUTHOR_ID
出处
期刊:JAMA Oncology
[American Medical Association]
日期:2022-04-01
卷期号:8 (4): 546-546
被引量:29
标识
DOI:10.1001/jamaoncol.2021.7298
摘要
DCVAC/PCa is an active cellular immunotherapy designed to initiate an immune response against prostate cancer.To evaluate the efficacy and safety of DCVAC/PCa plus chemotherapy followed by DCVAC/PCa maintenance treatment in patients with metastatic castration-resistant prostate cancer (mCRPC).The VIABLE double-blind, parallel-group, placebo-controlled, phase 3 randomized clinical trial enrolled patients with mCRPC among 177 hospital clinics in the US and Europe between June 2014 and November 2017. Data analyses were performed from December 2019 to July 2020.Eligible patients were randomized (2:1) to receive DCVAC/PCa (add-on and maintenance) or placebo, both in combination with chemotherapy (docetaxel plus prednisone). The stratification was applied according to geographical region (US or non-US), prior therapy (abiraterone, enzalutamide, or neither), and Eastern Cooperative Oncology Group performance status (0-1 or 2). DCVAC/PCa or placebo was administered subcutaneously every 3 to 4 weeks (up to 15 doses).The primary outcome was overall survival (OS), defined as the time from randomization until death due to any cause, in all randomized patients. Survival was compared using 2-sided log-rank test stratified by geographical region, prior therapy with abiraterone and/or enzalutamide, and Eastern Cooperative Oncology Group performance status.A total of 1182 men with mCRPC (median [range] age, 68 [46-89] years) were randomized to receive DCVAC/PCa (n = 787) or placebo (n = 395). Of these, 610 (81.8%) started DCVAC/PCa, and 376 (98.4%) started placebo. There was no difference in OS between the DCVAC/PCa and placebo groups in all randomized patients (median OS, 23.9 months [95% CI, 21.6-25.3] vs 24.3 months [95% CI, 22.6-26.0]; hazard ratio, 1.04; 95% CI, 0.90-1.21; P = .60). No differences in the secondary efficacy end points (radiological progression-free survival, time to prostate-specific antigen progression, or skeletal-related events) were observed. Treatment-emergent adverse events related to DCVAC/PCa or placebo occurred in 69 of 749 (9.2%) and 48 of 379 (12.7%) patients, respectively. The most common treatment-emergent adverse events (DCVAC/PCa [n = 749] vs placebo [n = 379]) were fatigue (271 [36.2%] vs 152 [40.1%]), alopecia (222 [29.6%] vs 130 [34.3%]), and diarrhea (206 [27.5%] vs 117 [30.9%]).In this phase 3 randomized clinical trial, DCVAC/PCa combined with docetaxel plus prednisone and continued as maintenance treatment did not extend OS in patients with mCRPC and was well tolerated.ClinicalTrials.gov Identifier: NCT02111577.