台灣非轉移性去勢抗性前列腺癌患者使用Darolutamide之真實世界應用數據：單一醫學中心經驗

莊惠娟¹、曾文歆^1,2、李高漢¹、黃冠華¹、邱文祥³

¹台南永康奇美醫院 外科部 泌尿科；²國立中山大學生物醫學研究所；³台北新光吳火獅紀念醫院 泌尿科

Real-World Application of Darolutamide in Non-Metastatic Castration-Resistant Prostate Cancer in Taiwan: A Single-Center Experience

Hui-Chuan Chuang¹、Wen-Hsin Tseng²、Kau-Han-Lee²、Steven K. Huang²、Allen W.Chiu³

¹Division of Urology, Department of Surgery, Chi Mei Medical Center, Tainan, Taiwan;

²Institute of Biomedical Science, National Sun Yat-Sen University, Kaohsiung, Taiwan;

³Department of Urology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.

Purpose:

Prostate cancer ranks as the fifth most prevalent cancer among men in Taiwan. It presents a significant mortality risk when progressing to metastatic disease. The potent androgen receptor inhibitor, darolutamide, has been approved for the treatment of non-metastatic castrate-resistant prostate cancer (nmCRPC) based on the results of the ARAMIS trial. Studies have shown that reductions in prostate-specific antigen (PSA) to undetectable levels (≤0.2 ng/mL) or a decline of ≥90% from the baseline are associated with improved oncological outcomes, including metastasis-free survival and overall survival.

Materials and Methods:

This single-center retrospective study aimed to evaluate the PSA response and safety profile of darolutamide in high-risk nmCRPC patients in Taiwan, characterized by a PSA doubling time (PSADT) of 10 months or less. From January 2021 to July 2023, 17 nmCRPC patients with a median age of 70 (interquartile range: 57-88) were eligible to receive darolutamide.

Results:

Treatment modalities prior to darolutamide included only upfront systemic hormonal therapy in 5 patients (29%), and other 4 patients (24%) combined with definitive radiotherapy, and 7 patients (41%) underwent with radical prostatectomy. The median baseline PSA was 45.2 ng/mL when diagnosis, and PSADT was 4.2 months at the initiation of darolutamide treatment. Patients demonstrated rapid PSA50 (≥50% decline from baseline) and PSA90 responses within 3 months, with 63% reaching an undetectable PSA level within this timeframe. The median time to PSA nadir among these patients was 3 months. Those with a baseline PSA value <6 ng/mL or a PSADT >5 months had a higher proportion of reaching undetectable PSA levels in our study. Stable disease was observed in 14 patients; however, 3 patients ultimately discontinued darolutamide treatment due to general malaise and the adverse effects of nausea and vomiting.

Conclusion:

In conclusion, nmCRPC patients treated with darolutamide achieved rapid and significant PSA responses, despite initial androgen deprivation therapy (ADT) already reducing PSA levels substantially. Throughout the course of darolutamide treatment, patients exhibited safety and good tolerability.