阿帕鲁胺联合多西他赛治疗转移性去势抵抗性前列腺癌患者的临床研究

Clinical trial of apalutamide combined with docetaxel in the treatment of metastatic castration-resistant prostate cancer

目的观察阿帕鲁胺联合多西他赛治疗转移性去势抵抗性前列腺癌(mCRPC)的疗效。方法于本院进行治疗的126例mCRPC患者,分为对照组和试验组。2组均进行多西他赛+泼尼松龙的化疗方案:第1天,多西他赛75 mg·m^(-2),静脉滴注;泼尼松龙5 mg·d^(-1),每天2次。试验组在此基础上服用阿帕鲁胺240 mg·d^(-1)。治疗连续4个化疗周期后,评估2组治疗效果,检测mCRPC患者血清指标[前列腺特异性抗原(PSA),睾酮(T)],观察治疗药物的安全性,根据患者的生存情况进行生存分析。结果对照组和试验组,各63例。治疗后,对照组和试验组的客观缓解率(ORR)分别为49.18%(30例/61例)和67.74%(42例/62例);PSA水平分别为(14.52±3.43)和(11.39±2.96)ng·mL^(-1),T水平为(0.91±0.11)和(0.64±0.09)ng·mL^(-1),上述指标对照组和试验组比较,差异均有统计学意义(均P<0.05)。2组各项Ⅰ、Ⅱ级药物不良反应比较,差异无统计学意义(P>0.05)。对照组和试验组1年生存率分别为72.13%(44例/61例)和88.71%(55例/62例),平均生存时间为(10.96±0.23)个月和(11.78±0.08)个月,差异有统计学意义(P<0.05)。2组1年生存曲线经Log-Rank检验,差异有统计学意义(P<0.05)。结论阿帕鲁胺联合多西他赛能够提高mCRPC的临床疗效,改善PSA、T水平,药物不良反应可耐受,对mCRPC具有一定的生存优势。

Objective To investigate the efficacy of apalutamide combined with docetaxel in the treatment of metastatic castration-resistant prostate cancer(mCRPC).MethodssA total of 126 patients with mCRPC who were treated in our hospital were selected and divided into control group and treatment group.Both groups were treated with docetaxe1l+prednisolonechemotherapyregimen:docetaxel 75 mg·m^(-2),dl,intravenous drip,prednisolone 5 mg·d^(-1),twice a day).Treatment group was given apalutamide(240 mg·d^(-1))on this basis.After 4 consecutive cycles of chemotherapy,the therapeutic effects of the two groups were evaluated,and the serum markers of mCRPC patients[prostate-specific antigen(PSA),testosterone(T)]were detected.The safety of the treatment drugs was observed,and the survival analysis was carried out according to the survival of the patients.Results There were 63 cases in each group.After treatment,the objective remission rate(ORR)of control group and treatment group were 49.18%(30 cases/61 cases)and 67.74%(42 cases/62 cases);PSA levels were(14.52±3.43),(11.39±2.96)ng·mL^(-l);T levels were(0.91±0.11),(0.64±0.09)ng·mL^(-1).There were statistically significant differences in the above indicators between control group and treatment group(all P<0.05).There was no significant difference in the grade I and I adverse drug reactions between the two groups(P>0.05).The 1-year survival rates of control group and treatment group were 72.13%(44 cases/61 cases)and 88.71%(55 cases/62 cases);the average survival time were(10.96±0.23)and(11.78±0.08)months,with statistically significant difference(P<0.05).The 1-year survival curves of the two groups were tested by Log-Rank,and the difference was statistically significant(P<0.05).Conclusion Apalutamide combined with docetaxel can improve the clinical efficacy of mCRPC,improve the levels of PSA and T,the adverse drug reactions are tolerable,and have certain survival advantages for mCRPC.