阿比特龙联合泼尼松治疗非转移性去势抵抗性前列腺癌的对比研究

目的 评估和比较阿比特龙联合泼尼松和多西他赛联合泼尼松在治疗非转移性去势抵抗性前列腺癌（nm-CRPC）中的疗效和安全性。方法 收集经病理证实的78例nm-CRPC患者资料,其中接受阿比特龙联合泼尼松方案治疗的39例患者为治疗组、接受多西他赛联合泼尼松方案治疗的39例患者为对照组。以病灶影像学出现转移为主要研究终点,Kaplan-Meier法分析2组患者的无进展生存情况,同时监测2组治疗前后血清前列腺特异性抗原（PSA）水平变化,计算2组PSA反应率,并以原发病灶客观缓解率（ORR）和疾病控制率（DCR）作为次要观察指标,观察2组治疗期间3级或以上不良反应的发生情况。结果 治疗组18个月无进展生存率为34%、中位无进展生存期12个月,对照组无进展生存率为8%、中位无进展生存期9个月,治疗组无进展生存率高于对照组（P < 0.05）。治疗后,2组患者血清PSA水平均比治疗前有不同程度下降,其中治疗组血清PSA水平低于对照组（P均< 0.05）。治疗组的PSA反应率为69%,高于对照组的46% （P < 0.05）。治疗后,治疗组ORR为79%、DCR为92%,对照组相应为56%、74%,治疗组的ORR和DCR均高于对照组（P均< 0.05）。治疗过程中,2组患者均出现了不同程度的不良反应,但均无发生需停药情况, 2组患者3级及以上主要不良反应总发生率比较差异无统计学意义（P > 0.05）。结论 阿比特龙联合泼尼松治疗nm-CRPC的效果优于多西他赛联合泼尼松,可考虑作为国人nm-CRPC治疗策略的其中一个选择。

Comparison of efficacy and safety of combination of abiraterone and prednisone in treatment of non-metastatic castration-resistant prostate cancer

Objective To evaluate and compare the efficacy and safety between the combination of abiraterone and prednisone and the combination of docetaxel and prednisone in the treatment of non-metastatic castration-resistant prostate cancer （nm-CRPC）. Methods Clinical data of 78 patients pathologically diagnosed with nm-CRPC were collected. According to the treatment methods, 39 patients treated with abitirone combined with prednisone were assigned into the treatment group, and the remaining 39 cases treated with docetaxel combined with prednisone were allocated into the control group. The incidence of metastasis detected by imaging examination was considered as the main endpoint of the study. The progression-free survival between two groups was analyzed by Kaplan-Meier estimates. Meanwhile, the changes of serum prostate-specific antigen （PSA） levels before and after treatment were monitored, and the PSA response rate between two groups was calculated. The objective response rate （ORR） and disease control rate （DCR） of primary lesions were used as the secondary observation indexes. The incidence of grade 3 or above adverse events was observed between two groups throughout the treatment. Results The progression-free survival in the treatment group was 34% and the median progression-free survival was 12 months, significantly longer than 8% and 9 months in the control group （P < 0.05）. After corresponding treatment, the serum PSA levels in both groups were decreased to varying degree. The serum PSA level in the treatment group was significantly lower than that in the control group （all P < 0.05）. The PSA response rate in the treatment group was significantly higher than that in the control group （69% vs 46%, P < 0.05）. After corresponding treatment, the ORR of primary lesions in the treatment group was 79% and the DCR was 92%, significantly higher compared with 56% and 74% in the control group （both P < 0.05）. During the course of treatment, patients in two groups developed adverse events to varying extent, whereas no patient terminated the drug use. The overall incidence of major adverse reactions （grade 3 or above） did not significantly differ between two groups （P > 0.05）. Conclusion Abiraterone combined with prednisone yields higher efficacy in the treatment of nm-CRPC compared with docetaxel combined with prednisone, which can be considered as one of the therapeutic options for nm-CRPC in Chinese population.