Preliminary exploration of the efficacy and safety of darolutamide in the treatment of metastatic hormone-sensitive prostate cancer
10.3760/cma.j.cn112330-20231208-00177
- VernacularTitle: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
- Author:
Zekun XIN
1
;
Shuyu ZHANG
;
Yuqiang SHI
;
Zhentao LEI
;
Kai LE
;
Jie XIONG
;
Lin YANG
;
Shenghan WANG
;
Qiang GAO
;
Bao ZHANG
Author Information
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
- Publication Type:Journal Article
- Keywords:
Prostatic neoplasms;
Carcinoma;
Darolutamide;
Prostate specific antigen
- From:
Chinese Journal of Urology
2025;46(3):188-191
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the efficacy and safety of darolutamide in the treatment of patients with metastatic hormone-sensitive prostate cancer.Methods:A 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.Results:All 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.Conclusions:Darolutamide could rapidly control and significantly reduce PSA levels in prostate cancer patients, with a favorable safety profile.
