达罗他胺治疗转移性激素敏感性前列腺癌的疗效和安全性  

Preliminary exploration of the efficacy and safety of darolutamide in the treatment of metastatic hormone-sensitive prostate cancer

作　　者：辛泽昆 张书瑜 史玉强 雷振涛 乐凯 熊杰 杨林 王升晗 高强 张保 Xin Zekun;Zhang Shuyu;Shi Yuqiang;Lei Zhentao;Le Kai;Xiong Jie;Yang Lin;Wang Shenghan;Gao Qiang;Zhang Bao(Department of Urology,Beijing Aerospace Central Hospital,Peking University Aerospace Clinical College,Beijing 100049,China;First Clinical Medical College,Nanchang University,Nanchang 330006,China)

机构地区：[1]北京大学航天临床医学院、航天中心医院泌尿外科,北京100049 [2]南昌大学第一临床医学院,南昌330006

出　　处：《中华泌尿外科杂志》2025年第3期188-191,共4页Chinese Journal of Urology

基　　金：航天医疗健康科技集团有限公司科研项目重点项目(2023YK21)。

摘　　要：目的探讨转移性激素敏感性前列腺癌患者应用达罗他胺的疗效和安全性。方法回顾性分析2022年1—12月航天中心医院收治的17例前列腺癌患者的临床资料。中位年龄70(56,92)岁。治疗前前列腺特异性抗原(PSA)63.50(29.16,700.74)ng/ml。16例Gleason评分≥8分。11例为高肿瘤负荷(≥4个骨转移和/或内脏转移),其中9例伴全身多处骨转移;6例为低肿瘤负荷,其中2例伴3处骨转移,1例伴1处骨转移。应用达罗他胺600 mg,2次/日;联合戈舍瑞林10.8 mg皮下注射,1次/12周治疗。观察患者用药后2周以及1、2、3、6个月PSA降幅。记录达到PSA水平下降50%(PSA50)、下降90%(PSA90),以及PSA≤0.2 ng/ml的时间。记录药物不良反应。结果本组17例均获得随访,中位随访时间11.4(8.9,15.3)个月。患者用药后2周,以及1、2、3、6个月中位PSA较基线降幅分别为83.33%、95.37%、96.71%、97.22%、99.10%。达到PSA50、PSA90,以及PSA≤0.2 ng/ml的中位时间分别为1.3(0.9,1.7)、1.7(1.2,2.4)、3.6(2.9,4.5)个月。高肿瘤负荷组中,6例有骨转移患者治疗后骨转移病灶缓解。仅1例出现左上肢丘疹,为1级不良反应,外用氢化可的松乳膏3 d后皮疹消失。结论达罗他胺能快速控制、深度降低前列腺癌患者的PSA水平,并且安全性良好。ObjectiveTo investigate the efficacy and safety of darolutamide in the treatment of patients with metastatic hormone-sensitive prostate cancer.MethodsA retrospective analysis was conducted on 17 cases of prostate cancer patients who received treatment with darolutamide in combination with ADT at our hospital from January to December 2022.The median age was 70(range:56 to 92)years old.The median pre-treatment prostate-specific antigen(PSA)level was 63.50(range:29.16 to 700.74)ng/ml.Sixteen cases had a Gleason score of 8 or above,and 11 cases were classified as high tumor burden(with four or more bone metastases and/or visceral metastases).The patients were treated with darolutamide in combination with goserelin(10.8 mg,subcutaneous injection,every 12 weeks).The decrease in PSA levels was observed at 2 weeks and at 1,2,3,and 6 months post-treatment.The time to achieve a 50%decrease in PSA level(PSA50),a 90%decrease(PSA90),and a PSA level of≤0.2 ng/ml was recorded.Adverse drug reactions were also documented.ResultsAll the 17 patients were followed up and continued to receive darolutamide at our center without any loss to follow-up.The median follow-up time was 11.4(8.9,15.3)months.It showed a median PSA decrease from baseline of 83.33%at 2 weeks,95.37%at 1 month,96.71%at 2 months,97.22%at 3 months,and 99.10%at 6 months.The median time to achieve PSA50,PSA90,and PSA≤0.2 ng/ml were 1.3(0.9,1.7)months,1.7(1.2,2.4)months,and 3.6(2.9,4.5)months respectively.Six patients with bone metastases experienced relief of metastatic lesions after treatment.Only one patient developed papules on the left upper limb,which were assessed as grade 1 rash,and the rash disappeared after three days treatment of topical application of hydrocortisone cream.ConclusionsDarolutamide could rapidly control and significantly reduce PSA levels in prostate cancer patients,with a favorable safety profile.

关 键 词：前列腺肿瘤 癌 达罗他胺 前列腺特异性抗原 

分 类 号：R737.25[医药卫生—肿瘤]