恩扎卢胺治疗转移性去势抵抗性前列腺癌的疗效分析

Efficacy of enzalutamide in treatment of metastatic castration-resistant prostate cancer

摘要:

目的 探讨恩扎卢胺作为转移性去势抵抗前列腺癌（metastatic castration-resistant prostate cancer，mCRPC）的一线治疗和阿比特龙耐药后的二线治疗的疗效和安全性。方法 回顾性分析2019年12月至2023年3月陆军军医大学第一附属医院收治的26例mCRPC患者的临床资料。综合患者血清前列腺特异性抗原（prostate specific antigen，PSA）等生化指标、影像学复查结果及治疗期间随访记录，分析患者的PSA应答、PSA进展及影像学进展等情况，以及患者治疗期间的不良事件。结果 接受恩扎卢胺治疗的mCRPC患者总计26例，其中作为mCRPC一线治疗患者13例，服用醋酸阿比特龙治疗后出现耐药从而接受恩扎卢胺作为mCRPC二线治疗的患者13例，所有患者中位随访时间为14（4，23）个月，mCRPC一线治疗患者的PSA应答率为100%（13/13），明显高于二线治疗患者[53.8%（7/13）]，差异有统计学意义（χ²=7.800，P=0.005）。mCRPC一线治疗患者中位PSA无进展生存时间和中位无影像学生存时间分别为18.6个月和20.5个月，mCRPC二线治疗患者中位PSA无进展生存时间和中位无影像学生存时间分别为17.4个月和19.5个月。恩扎卢胺治疗患者的主要不良反应为疲乏（17/26）、潮热（3/26）和药物性肝损害（1/26），患者整体耐受性较好。结论 mCRPC患者进行恩扎卢胺治疗后可有效获得PSA应答，延缓肿瘤进展，作为一线治疗整体效果优于作为阿比特龙耐药的二线治疗，总体药物不良反应可耐受。

Abstract:

Objective To investigate the efficacy and safety of enzalutamide as the first-line therapy for metastatic castration-resistant prostate cancer（mCRPC） and as the second-line therapy after abiraterone resistance in the real-world setting.Methods A retrospective analysis was performed for the clinical data of 26 patients with mCRPC who were admitted to The First Affiliated Hospital of Army Medical University from December 2019 to March 2023. Based on the biochemical parameters including serum prostate-specific antigen（PSA），imaging reexamination results，and follow-up records during treatment，the patients were analyzed in terms of PSA response，PSA progression，and radiographic progression，and adverse events during treatment were reported.Results A total of 26 patients with mCRPC received enzalutamide treatment，among whom 13 patients received enzalutamide as the first-line therapy for mCRPC and 13 patients who developed resistance to abiraterone acetate received enzalutamide as the second-line therapy for mCRPC. The patients had a median follow-up time of 14（4，23） months，and the patients receiving first-line therapy had a significantly higher PSA response rate than those receiving second-line therapy（100% vs. 53.8%，χ²=7.800，P=0.005）. The patients receiving the first-line therapy for mCRPC had a median PSA progression-free survival time of 18.6 months and a median radiographic progression-free survival time of 20.5 months，while the patients receiving the second-line therapy for mCRPC had a median PSA progression-free survival time of 17.4 months and a median radiographic progression-free survival time of 19.5 months. The main adverse reactions observed in the patients receiving enzalutamide included fatigue（17/26），hot flashes（3/26），and drug-induced liver injury（1/26），which had good overall tolerability in patients.Conclusion Enzalutamide treatment in mCRPC patients can effectively achieve PSA response and delay tumor progression. Enzalutamide as the first-line therapy has better overall efficacy than it as the second-line therapy after abiraterone resistance，with tolerable drug-related adverse events.