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

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.