He Dalin, Sun Zhongquan, Guo Jianming, Zhang Zhigen, Shan Yuxi, Ma Lulin, Li Hanzhong, Jin Jie, Huang Yiran, Xiao Jiaquan, Wei Qiang, Ye Dingwei
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Huadong Hospital Affiliated to Fudan University, Shanghai, China.
Asia Pac J Clin Oncol. 2019 Jun;15(3):144-150. doi: 10.1111/ajco.13142. Epub 2019 Mar 15.
To investigate the use of docetaxel for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in real-world clinical practice in China.
This single-arm, prospective, observational study was conducted at 32 study centers in China and included male patients aged ≥18 years with histologically confirmed prostate cancer who received ≥1 dose of docetaxel following failure of hormonal therapy (disease progression with serum testosterone <50 ng/dL). The primary aim was to investigate patterns of docetaxel treatment.
Overall 403 patients were included between August 2011 and June 2016; patients initiated docetaxel after failure of first- (42.2% [170]), second- (31.0% [125]) and ≥third-line (12.7% [51]) hormonal therapy, estramustine (11.4% [46]) or other (2.7% [11]). The planned cycles of docetaxel therapy were completed by 30.8% of patients, and the mean (SD) number of cycles received was 4.4 (2.86). Median overall survival (mOS) was 22.4 (95% CI, 20.4-25.8) months and the prostate-specific antigen (PSA) response rate in patients with available data was 70.9% (168/237), with no differences in mOS and PSA response rates between treatment settings. Subgroup analysis revealed higher mOS in patients without visceral metastasis versus those with such metastases (22.9 vs. 17.4 months; P = 0.022). No new safety signals were observed and the most common adverse events associated with docetaxel were granulocytopenia (5%) and leukopenia (4.5%).
Data from this study showed that around three-quarters of Chinese patients with mCRPC treated with docetaxel initiated treatment following first- or second-line hormonal therapy and no new safety signals were observed.
探讨多西他赛在中国真实世界临床实践中治疗转移性去势抵抗性前列腺癌（mCRPC）的应用情况。
本单臂、前瞻性、观察性研究在中国32个研究中心开展，纳入年龄≥18岁、经组织学确诊为前列腺癌且在激素治疗失败（血清睾酮<50 ng/dL且疾病进展）后接受≥1剂多西他赛治疗的男性患者。主要目的是研究多西他赛的治疗模式。
2011年8月至2016年6月期间共纳入403例患者；患者在一线（42.2%[170例]）、二线（31.0%[125例]）和≥三线（12.7%[51例]）激素治疗、雌莫司汀（11.4%[46例]）或其他治疗（2.7%[11例]）失败后开始使用多西他赛。30.8%的患者完成了多西他赛治疗的计划周期，接受的平均（标准差）周期数为4.4（2.86）。中位总生存期（mOS）为22.4（95%CI，20.4 - 25.8）个月，有可用数据的患者中前列腺特异性抗原（PSA）缓解率为70.9%（168/237），不同治疗背景下的mOS和PSA缓解率无差异。亚组分析显示，无内脏转移患者的mOS高于有内脏转移患者（22.9个月对17.4个月；P = 0.022）。未观察到新的安全信号，与多西他赛相关的最常见不良事件为粒细胞减少（5%）和白细胞减少（4.5%）。
本研究数据表明，约四分之三接受多西他赛治疗的中国mCRPC患者在一线或二线激素治疗后开始治疗，且未观察到新的安全信号。
