Real world clinical observation on the efficacy and safety of darolutamide in the treatment of metastatic hormone-sensitive prostate cancer
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.Meth-ods: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 laparoscop-ic radical prostatectomy,1 patient(3％)received perineal irreversible prostate electroperforation therapy,and the re-maining 15 patients(39％)did not undergo surgical treatment.Bone scans revealed bone metastases in all 38 pa-tients,and postoperative pathology showed lymph node metastases in 21 patients.After 3 months of treatment with da-rolutamide and ADT,the PSA50 and PSA90 response rates were 100％(38/38)and 97％(37/38),respectively.Dur-ing follow-up,the rate of undetectable PSA was 92％(35/38),and only 1 patient(3％)experienced PSA progres-sion.The adverse reactions mainly included fatigue(7 cases,18％),hot flashes(5 cases,13％),elevated blood lip-ids(3 cases,8％),elevated blood glucose(2 cases,5％),and limb pain(1 case,3％),with no grade Ⅲ or higher adverse reactions observed.Conclusion:Darolutamide combined with ADT has a good PSA response rates and efficacy in patients with mHSPC,with a favorable safetv profile.
metastatic hormone-sensitive prostate cancerdarolutamidereal world studyprostate-specific antigen
万方数据
维普
