阿帕他胺治疗转移性激素敏感性前列腺癌的回顾性病例系列研究

Apalutamide for the treatment of metastatic hormone-sensitive prostate cancer：a retrospective case series study

摘要:

目的 评估四川省成都地区转移性激素敏感性前列腺癌（metastatic hormone-sensitive prostate cancer，mHSPC）使用雄激素剥夺治疗（androgen deprived therapy，ADT）联合阿帕他胺治疗的前列腺特异抗原（prostate specific antigen，PSA）的缓解率。方法 回顾性分析2021年1月至2022年3月于成都地区4家三甲医院泌尿外科使用阿帕他胺联合ADT治疗的mHSPC患者，观察患者治疗1个月与3个月后的PSA50、PSA90缓解率及不良反应发生情况。结果 共纳入81例mHSPC患者，治疗1个月后，PSA50、PSA90缓解率分别为81.48%和48.15%，3例（3.7%）患者PSA值≤0.2 ng/mL。治疗3个月后，PSA50、PSA90缓解率分别为97.53%和86.42%，35例（43.21%）患者PSA值≤0.2 ng/mL。常见的不良反应包括皮疹（28.40%），疲乏（23.46%），腹泻（6.17%），高血压（2.47%）。3级以上不良反应为皮疹（4.93%）和疲乏（2.47%）。结论 成都地区mHSPC患者数据显示接受ADT联合阿帕他胺治疗具有较好的PSA缓解率及耐受性，可作为中国mHSPC患者的治疗方案之一。

Abstract:

Objective To evaluate the prostate-specific antigen（PSA） response rates in patients with metastatic hormone-sensitive prostate cancer（mHSPC） who received androgen deprivation therapy（ADT） combined with apalutamide in Chengdu，Sichuan Province，China.Methods A retrospective analysis was performed on the clinical data of patients with mHSPC who were treated with apalutamide combined with ADT in the Department of Urological Surgery of four grade A tertiary hospitals in Chengdu from January 2021 to March 2022. The main outcomes were the response rates of PSA50 and PSA90 and the incidence of adverse reactions after 1 month and 3 months of treatment.Results A total of 81 patients with mHSPC were included in this study. After 1 month of treatment，the response rates of PSA50 and PSA90 were 81.48% and 48.15%，respectively，and PSA≤0.2 ng/mL was found in 3 patients（3.7%）. After 3 months of treatment，the response rates of PSA50 and PSA90 were 97.53% and 86.42%，respectively，and PSA≤0.2 ng/mL was found in 35 patients（43.21%）. Frequently reported adverse reactions included rash（28.40%），fatigue（23.46%），diarrhea（6.17%），and hypertension（2.47%）. The adverse events of grade 3 or higher were rash（4.93%） and fatigue（2.47%）.Conclusion The real-world data of patients with mHSPC in Chengdu show that ADT combined with apalutamide yield favorable PSA response rates and are well-tolerated，making it suitable to be used as one of the treatment options for patients with mHSPC in China.