|Table of Contents|

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

Journal Of Modern Oncology[ISSN:1672-4992/CN:61-1415/R]

Issue:
2025 01
Page:
81-84
Research Field:
Publishing date:

Info

Title:
Real world clinical observation on the efficacy and safety of darolutamide in the treatment of metastatic hormone-sensitive prostate cancer
Author(s):
ZHI Bin1; YU Shuanbao2; CUI Keke2; FAN Yafeng2; TAO Jin2; ZHANG Xuepei2
1.Department of Pharmacy;2.Department of Urology,the First Affiliated Hospital of Zhengzhou University,Henan Zhengzhou 450052,China.
Keywords:
metastatic hormone-sensitive prostate cancer; darolutamide; real world study; prostate-specific antigen
PACS:
R737.25
DOI:
10.3969/j.issn.1672-4992.2025.01.013
Abstract:
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 PSA50 and PSA90 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 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 safety profile.

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河南省高等学校重点科研项目(编号：22A320028)
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