Zhou Tie, Zeng Shu-xiong, Ye Ding-wei, Wei Qiang, Zhang Xu, Huang Yi-ran, Ye Zhang-qun, Yang Yong, Zhang Wei, Tian Ye, Zhou Fang-jian, Jie Jin, Chen Shi-ping, Sun Yan, Xie Li-ping, Yao Xing, Na Yan-qun, Sun Ying-hao
Department of Urology, Changhai Hospital, The Second Military Medical University, 168 Changhai Road, Shanghai 200433, P.R. China.
Department of Urology, Shanghai Cancer Center, Fudan University, Shanghai, P.R. China.
PLoS One. 2015 Jan 27;10(1):e0117002. doi: 10.1371/journal.pone.0117002. eCollection 2015.
To explore the feasibility and efficacy of docetaxel plus prednisone for Chinese population with metastatic castration refractory prostate cancer (mCRPC).
A total of 228 patients recruited from 15 centers were randomized to receive 10 cycles of D3P arm (docetaxel: 75 mg/m2, intravenous infusion, every three weeks; Prednisone 10mg orally given daily) or M3P arm (mitoxantrone: 12 mg/m2, intravenous infusion, every three weeks; Prednisone 10mg orally given daily). Primary end point was overall survival, and secondary end points were events progression-free survival (PFS), response rate, response duration. Quality of life (QoL) was also assessed in both treatment groups.
The median overall survival was 21.88 months in D3P arm and 13.67 months in M3P arm (P = 0.0011, hazard ratio = 0.63, 95% confidence interval, 0.46-0.86). Subgroup analysis was consistent with the results of overall analysis. Events progression-free survival (pain, PSA, tumor and disease) were significantly improved in D3P arm compared with M3P arm. PSA response rate was 35.11% for patients treated by D3P arm and 19.39% for M3P arm (P = 0.0155). Pain response rate was higher in D3P arm (61.11%, P = 0.0011) than in M3P (23.08%) arm. No statistical differences were found between D3P arm and M3P arm for QoL, tumor response rate and response duration of PSA and pain. The tolerability and overall safety of D3P arm were generally comparable to that of M3P arm.
Compared with M3P arm, D3P arm significantly prolonged overall survival for the Chinese patients with mCRPC and improved the response rate for PSA and pain.
clinicaltrials.gov NCT00436839.
探讨多西他赛联合泼尼松治疗中国转移性去势抵抗性前列腺癌（mCRPC）患者的可行性和疗效。
从15个中心招募的228例患者被随机分为接受10个周期的D3P组（多西他赛：75mg/m²，静脉输注，每三周一次；泼尼松每日口服10mg）或M3P组（米托蒽醌：12mg/m²，静脉输注，每三周一次；泼尼松每日口服10mg）。主要终点为总生存期，次要终点为无进展生存期（PFS）、缓解率、缓解持续时间。两个治疗组均评估了生活质量（QoL）。
D3P组的中位总生存期为21.88个月，M3P组为13.67个月（P = 0.0011，风险比 = 0.63，95%置信区间，0.46 - 0.86）。亚组分析与总体分析结果一致。与M3P组相比，D3P组的无进展生存期（疼痛、前列腺特异抗原、肿瘤和疾病）显著改善。D3P组治疗患者的前列腺特异抗原缓解率为35.11%，M3P组为19.39%（P = 0.0155）。D3P组的疼痛缓解率（61.11%，P = 0.0011）高于M3P组（23.08%）。D3P组和M3P组在生活质量、肿瘤缓解率以及前列腺特异抗原和疼痛的缓解持续时间方面未发现统计学差异。D3P组的耐受性和总体安全性与M3P组总体相当。
与M3P组相比，D3P组显著延长了中国mCRPC患者的总生存期，并提高了前列腺特异抗原和疼痛的缓解率。
clinicaltrials.gov NCT00436839
