基于真实世界数据分析达罗他胺治疗转移性激素敏感性前列腺癌的疗效及安全性  

Real world clinical observation on the efficacy and safety of darolutamide in the treatment of metastatic hormone-sensitive prostate cancer

作　　者：郅彬 于栓宝 崔渴科 范雅峰 陶金[2] 张雪培[2] ZHI Bin;YU Shuanbao;CUI Keke;FAN Yafeng;TAO Jin;ZHANG Xuepei(Department of Pharmacy,the First Affiliated Hospital of Zhengzhou University,Henan Zhengzhou 450052,China;Department of Urology,the First Affiliated Hospital of Zhengzhou University,Henan Zhengzhou 450052,China)

机构地区：[1]郑州大学第一附属医院药学部,河南郑州450052 [2]郑州大学第一附属医院泌尿外科,河南郑州450052

出　　处：《现代肿瘤医学》2025年第1期81-84,共4页Journal of Modern Oncology

基　　金：河南省高等学校重点科研项目(编号:22A320028)。

摘　　要：目的:评价真实世界中达罗他胺联合雄激素剥夺治疗(androgen deprivation therapy,ADT)转移性激素敏感性前列腺癌(metastatic hormone-sensitive prostate cancer,mHSPC)患者的疗效及安全性。方法:回顾性收集2022年02月至2023年10月在我院接受达罗他胺联合ADT的38例mHSPC患者的临床资料、治疗方案、药物不良反应及随访结果,分析真实世界条件下前列腺特异性抗原(prostate-specific antigen,PSA)的缓解率。结果:该研究共纳入38例转移性激素敏感性前列腺癌患者,其中22(58%)例患者行机器人或腹腔镜前列腺癌根治术,1(3%)例患者行经会阴前列腺不可逆电穿孔治疗术,其余15(39%)例患者未行手术治疗。骨扫描示38例患者均存在骨转移,术后病理示21例患者淋巴结转移。使用达罗他胺并雄激素受体阻断剂3个月后,PSA_(50)和PSA_(90)的缓解率分别为100%(38/38)和97%(37/38);随访期间,PSA的不可测率为92%(35/38);1(3%)例患者出现PSA进展。不良反应主要有疲乏7(18%)例、潮热5(13%)例、血脂升高3(8%)例、血糖升高2(5%)例、四肢疼痛1(3%)例,无Ⅲ级以上不良反应发生。结论:达罗他胺联合雄激素剥夺治疗转移性激素敏感性前列腺癌患者具有良好的PSA缓解率和疗效,且安全性良好。Objective:To evaluate the efficacy and safety of darolutamide combined with androgen deprivation therapy(ADT)in patients with metastatic hormone-sensitive prostate cancer(mHSPC)in the real world.Methods:We retrospectively collected clinical data,treatment regimens,adverse drug reactions,and follow-up results of 38 patients with mHSPC who received darolutamide combined with ADT at our hospital from February 2022 to October 2023,and analyzed the prostate-specific antigen(PSA)response rate under real-world conditions.Results:A total of 38 patients with mHSPC were included.Among them,22 patients(58%)underwent robot-assisted or laparoscopic radical prostatectomy,1 patient(3%)received perineal irreversible prostate electroperforation therapy,and the remaining 15 patients(39%)did not undergo surgical treatment.Bone scans revealed bone metastases in all 38 patients,and postoperative pathology showed lymph node metastases in 21 patients.After 3 months of treatment with darolutamide and ADT,the PSA_(50)and PSA_(90)response rates were 100%(38/38)and 97%(37/38),respectively.During follow-up,the rate of undetectable PSA was 92%(35/38),and only 1 patient(3%)experienced PSA progression.The adverse reactions mainly included fatigue(7 cases,18%),hot flashes(5 cases,13%),elevated blood lipids(3 cases,8%),elevated blood glucose(2 cases,5%),and limb pain(1 case,3%),with no gradeⅢor higher adverse reactions observed.Conclusion:Darolutamide combined with ADT has a good PSA response rates and efficacy in patients with mHSPC,with a favorable safety profile.

关 键 词：转移性激素敏感性前列腺癌 达罗他胺 真实世界研究 前列腺特异抗原 

分 类 号：R737.25[医药卫生—肿瘤]