使用Enzalutamide合併雄性素剝奪療法

治療符合台灣健保給付條件之高風險轉移性去勢敏感性攝護腺癌之經驗

陳米妮¹、張延驊^{1, 2}、黃志賢^{1, 2}、鍾孝仁^{1, 2}、林志杰^{1, 2}、黃奕燊^{1, 2}、魏子鈞^{1, 2}、黃子豪^{1, 2}、

陳威任^{1, 2}、顧明軒^{1, 2}、許自翔^{1, 2}、蔡承翰^{1, 2}、黃逸修^{1, 2}

¹ 台北榮民總醫院泌尿部；² 國立陽明交通大學醫學院泌尿學科 書田泌尿科學研究中心

Real-world Clinical Outcomes and Safety of Enzalutamide Plus ADT in High-Risk Metastatic Castration-Sensitive Prostate Cancer Under Taiwan’s NHI Criteria

Minnie Chen¹, Yen-Hwa Chang^{1, 2}, William J.S. Huang^{1, 2}, Hsiao-Jen Chung^{1, 2}, Chih-Chieh Lin^{1, 2},

I-Shen Huang^{1, 2}, Tzu-Chun Wei^{1, 2}, Tzu-Hao Huang^{1, 2}, Wei-Jen Chen^{1, 2}, Ming-Hsuan Ku^{1, 2},

Tzu-Hsiang Hsu^{1, 2}, Cheng-Han Tsai^{1, 2}, Eric Yi-Hsiu Huang^{1, 2}

¹ Department of Urology, Taipei Veterans General Hospital;

² Department of Urology, College of Medicine and Shu-Tien Urological Research Center, National Yang Ming Chiao Tung University, Taipei, Taiwan

Purpose

Enzalutamide combined with androgen deprivation therapy (ADT) has been shown to significantly improve overall survival in patients with metastatic castration-sensitive prostate cancer (mCSPC). Since March 1^st, 2022, Taiwan’s National Health Insurance (NHI) has reimbursed enzalutamide for patients with high-risk mCSPC, as defined by a revised set of criteria: Gleason score ≥8, three or more bone metastases including at least one in the appendicular skeleton, or the presence of visceral metastasis. This study aimed to describe the real-world clinical experience using enzalutamide under these criteria in a tertiary referral center.

Materials and Methods

Between April 2022 and August 2025, we retrospectively reviewed patients treated at Taipei Veterans General Hospital who met the NHI's revised definition of high-risk mCSPC and received enzalutamide plus ADT under NHI reimbursement. Clinical outcomes, biochemical responses, and treatment-emergent adverse events (AEs) were assessed during routine outpatient follow-up throughout the treatment period.

Results

A total of 50 patients were included. Among them, 44 (88%) had a Gleason score ≥8, 40 (80%) had ≥3 bone metastases with least one located in the appendicular skeleton, and 9 (18%) presented with  visceral metastases, predominantly in the lungs (n=7). Only 2 patients (4%) met all three high-risk criteria. As of July 2025, with a median follow-up duration of 24.95 months (IQR: 9.37 months), 11 patients discontinued enzalutamide due to disease progression or PSA relapse. Meanwhile, 34 patients (68%) remained on treatment, with a median treatment duration of 25.58 months. The PSA response rate at 3 months—defined as a ≥50% decline from baseline—was 74%.

The most common AEs were fatigue, elevated liver enzymes, and anemia. Six patients (12%) discontinued treatment due to fatigue or lethargy. Five patients (10%) experienced elevated liver enzymes. Six cases (12%) of grade 2 were reported, and no grade 3 or higher AEs occurred.

Conclusions

Our real-world experience suggests that enzalutamide provides robust PSA responses with manageable toxicity in high-risk mCSPC patients. A small proportion of patients (N=11) discontinued treatment due to AEs. Continued follow-up is warranted to assess long-term survival outcomes and treatment durability in this population.