轉移性去勢抗性攝護腺癌病人於化療前使用Enzalutamide之預後因子評估
—臺灣群體研究
余秉軒1、林子平1,2,3、陳威任1,2,3、黃子豪1,2,3、魏子鈞1,2,3、黃奕燊1,2,3、范玉華1,2,3、
林志杰1,2,3、黃逸修1,2,3、鍾孝仁1,2,3、郭俊逸1,2,3、張延驊1,2,3、林登龍1,2,3、黃志賢1,2,3
1臺北榮總泌尿部;2國立陽明大學醫學系泌尿學科;3國立陽明大學書田泌尿科學研究中心
Factor Evaluation of Chemotherapy-Naïve Enzalutamide on Castration- Resistant Prostate Cancer Patients—Taiwanese Cohort
Ping-Hsuan Yu1, Tzu-Ping Lin1,2,3, Wei-Ren Chen1,2,3, Tzu-Hao Huang1,2,3, Tzu-Chun Wei1,2,3,
I-shen Huang1,2,3, Yu-Hua Fan1,2,3, Chih-Chieh Lin1,2,3, Eric Yi-Hsiu Huang1,2,3,
Hsiao-Jen Chung1,2,3, Junne-Yih Kuo1,2,3, Yen-Hwa Chang1,2,3, Alex T.L. Lin1,2,3,
William J.S. Huang1,2,3
1 Department of Urology, Taipei Veterans General Hospital;
2 Department of Urology, School of Medicine, National Yang-Ming University;
3Shu-Tien Urological Science Research Center, National Yang-Ming University
Purpose: According to the PREVAIL trial, enzalutamide prolongs progression-free survival and overall survival in chemo-naïve castration resistant prostate cancer (CRPC) patients. Since the PREVAIL trial is mainly of a Caucasian-based dataset, we would like to study the treatment results in chemo-naïve settings in Taiwanese patients. We also evaluated possible predictive factors of the treatment results.
Materials and Methods: Data of chemo-naïve CRPC patients treated with enzalutamide in Taipei Veterans General Hospital were reviewed from September 2017 to December 2019. Clinical parameters analyzed include Gleason grouping, baseline PSA level, PSA decline percentage, concurrent analgesic agents, PSA doubling time, and PSA velocity. Endpoints of interest are radiographic progression free survival (rPFS), and overall survival (OS). Kaplan-Meier and Cox regression were used for statistical analysis.
Results: Forty-four patients were recruited, with a mean age of 80.16±9.82 years old and average follow-up time 17.28±7.59 months. If biochemical response occurred, the average time from the first dose of enzalutamide to the PSA nadir is 4.96±5.26 months. Until Dec. 31st 2019, there were still 15 patients remained enzalutamide while the other 29 patients stopped taking it.
Patients without analgesics usage have significant longer rPFS (rPFS: 15.754 vs 9.909, p=0.046), but not longer OS (OS: 21.642 vs 18.256, p=0.389). Baseline PSA, PSA decline percentage, and initial Gleason score grouping do not show significant impacts on rPFS or OS (Baseline PSA: rPFS p=0.161, OS p=0.745; PSA decline percentage: rPFS p=0.134, OS p=0.397; Gleason grouping: rPFS p=0.548, OS p=0.933). Those with PSA doubling time longer than three months have significant longer rPFS (rPFS: 17.389 vs 10.389, p=0.033), and those with PSA velocity less than 10 ng/ml per month have significant longer rPFS as well (rPFS: 17.071 vs 8.792, p=0.008).
Conclusions: Among these potential predictive factors in chemo-naïve enzalutamide for the Taiwanese population, patients with analgesics usage, PSA doubling time less than three months, and PSA velocity more than 10 ng/ml per month have significant shorter radiographic progression-free survival. None of these factors has significant impact on overall survival.