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A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapy-naïve patients with mCRPC in China, Malaysia, Thailand and Russia

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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 [i]Department of Urology, Sichuan Academy of Medical Science & Sichuan Provincial People’s Hospital, Chengdu, Sichuan, China [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

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关键词： Abiraterone Chemotherapy-naïve Metastatic castration-resistant prostate cancer Prednisone Prostate specific antigen

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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-naïve, asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) patients from China, Malaysia, Thailand and Russia. Methods Adult chemotherapy-naïve 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). Abiraterone-treated 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 prednisone-treated 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-naïve men with mCRPC, consistent with global study, thus supporting use of abiraterone in this patient population. © 2017 Editorial Office of Asian Journal of Urology

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大类 | 3 区医学

小类 | 4 区泌尿学与肾脏学

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第一作者机构： [a]Department of Urology, Fudan University Shanghai Cancer Center, Shanghai, China

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通讯机构： [k]Department of Urology, Changhai Hospital, Second Military Medical University, Shanghai, China

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A phase 3, double-blind, randomized placebo-controlled efficacy and safety study of abiraterone acetate in chemotherapy-naïve patients with mCRPC in China, Malaysia, Thailand and Russia

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