A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapy naive patients with mCRPC in China, Malaysia, Thailand and Russia
机构：[a]Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China[b]Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China[c]Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China[d]Guangzhou First Municipal People’s Hospital, Guangzhou, Guangdong, China[e]Department of Urology, Russian Academy of Medical Sciences, Moscow, Russia[f]Department of Urology, Cancer Institute (Hospital), Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China[g]Department of Oncology, Moscow Oncology Research Institute, Moscow, Russia[h]Department of Stomatology, Beijing Friendship Hospital, Capital Medical University, Beijing, China首都医科大学附属北京友谊医院[i]Department of Urology, Sichuan Academy of Medical Science & Sichuan Provincial People’s Hospital, Chengdu, Sichuan, China四川省人民医院[j]Department of Oncology, Peking Union Medical College Hospital, Beijing, China[k]Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China[l]Department of Oncology, Janssen Research & Development, Beerse, Belgium[m]Department of Medical Oncology, Janssen Research & Development, San Diego, CA, USA[n]Department of Urology, Janssen Research & Development, Beijing, China
Objective: This double-blind, placebo-controlled phase 3 study was designed to compare efficacy and safety of abiraterone acetate + prednisone (abiraterone) to prednisone alone in chemotherapy-naive, asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) patients from China, Malaysia, Thailand and Russia. Methods: Adult chemotherapy-naive patients with confirmed prostate adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade 0-1, ongoing androgen deprivation (serum testosterone < 50 ng/dL) with prostate specific antigen (PSA) or radiographic progression were randomized to receive abiraterone acetate (1000 mg, QD) + prednisone (5 mg, BID) or placebo + prednisone (5 mg, BID), until disease progression, unacceptable toxicity or consent withdrawal. Primary endpoint was improvements in time to PSA progression (TTPP). Results: Totally, 313 patients were randomized (abiraterone: n = 157; prednisone: n = 156); and baseline characteristics were balanced. At clinical cut-off (median follow-up time: 3.9 months), 80% patients received treatment (abiraterone: n = 138, prednisone: n = 112). Median time to PSA progression was not reached with abiraterone versus 3.8 months for prednisone, attaining 58% reduction in PSA progression risk (HR = 0.418; p < 0.0001). Abirateronetreated patients had higher confirmed PSA response rate (50% vs. 21%; relative odds = 2.4; p < 0.0001) and were 5 times more likely to achieve radiographic response than prednisonetreated patients (22.9% vs. 4.8%, p = 0.0369). Median survival was not reached. Most common (>= 10% abiraterone vs. prednisone-treated) adverse events: bone pain (7% vs. 14%), pain in extremity (6% vs. 12%), arthralgia (10% vs. 8%), back pain (7% vs. 11%), and hypertension (15% vs. 14%). Conclusion: Interim analysis confirmed favorable benefit-to-risk ratio of abiraterone in chemotherapy-naive men with mCRPC, consistent with global study, thus supporting use of abiraterone in this patient population. (C) 2017 Editorial Office of Asian Journal of Urology. Production and hosting by Elsevier B.V. This is an open access article under the CC BY-NC-ND license.
基金：
The study was funded by Janssen Research & Development,
LLC, who was responsible for study design and data
collection, analysis, and its interpretation.
第一作者机构：[a]Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China
通讯作者：
推荐引用方式(GB/T 7714)：
Dingwei Ye,Yiran Huang,Fangjian Zhou,et al.A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapy naive patients with mCRPC in China, Malaysia, Thailand and Russia[J].ASIAN JOURNAL OF UROLOGY.2017,4(2):75-85.doi:10.1016/j.ajur.2017.01.002.
APA：
Dingwei Ye,Yiran Huang,Fangjian Zhou,Keji Xie,Vsevolod Matveev...&Yinghao Sun.(2017).A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapy naive patients with mCRPC in China, Malaysia, Thailand and Russia.ASIAN JOURNAL OF UROLOGY,4,(2)
MLA：
Dingwei Ye,et al."A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapy naive patients with mCRPC in China, Malaysia, Thailand and Russia".ASIAN JOURNAL OF UROLOGY 4..2(2017):75-85
