Taguchi Satoru, Onozawa Mizuki, Hinotsu Shiro, Kawai Taketo, Mitomi Takeshi, Uno Satoshi, Kume Haruki
Department of Urology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Japan Study Group of Prostate Cancer (J-CaP) Research Society, Japan.
Jpn J Clin Oncol. 2023 Oct 4;53(10):957-965. doi: 10.1093/jjco/hyad068.
This multicenter, retrospective, observational study investigated baseline characteristics and clinical outcomes in patients with hormone-sensitive prostate cancer who received primary androgen deprivation therapy, using Japan Study Group of Prostate Cancer registry data.
Among patients in the Japan Study Group of Prostate Cancer registry, those who initiated primary androgen deprivation therapy and were aged 20 years or older were enrolled in this study. The primary endpoint was time to disease progression, defined as time from primary androgen deprivation therapy initiation to either prostate-specific antigen or clinical progression. Secondary endpoints included prostate-specific antigen progression-free survival, prostate-specific antigen response (90% or greater reduction from baseline) and distribution of second-line treatment.
Of the 2494 patients (goserelin, n = 564; leuprorelin, n = 1148; surgical castration, n = 161; degarelix, n = 621), those who received degarelix had higher prostate-specific antigen levels and Gleason scores and were at a more advanced clinical stage than those receiving goserelin or leuprorelin. The median time to disease progression (identical to the prostate-specific antigen progression-free survival result) was not reached for goserelin and leuprorelin, 52.7 months for surgical castration and 54.0 months for degarelix. Although baseline prostate-specific antigen values in the degarelix cohort were higher than those of the leuprorelin or goserelin cohorts, prostate-specific antigen responses were not different among the three cohorts. Regarding second-line treatment, the largest patient group received degarelix followed by leuprorelin (n = 195).
This study clarified patient characteristics and long-term effectiveness of primary androgen deprivation therapy in real-world clinical practice. Japanese urologists appear to select appropriate primary androgen deprivation therapy based on patient background and tumour characteristics, with degarelix largely reserved for higher risk patients.
本多中心、回顾性观察研究利用日本前列腺癌研究组登记数据，调查接受一线雄激素剥夺治疗的激素敏感性前列腺癌患者的基线特征和临床结局。
在日本前列腺癌研究组登记的患者中，纳入开始一线雄激素剥夺治疗且年龄在20岁及以上的患者。主要终点为疾病进展时间，定义为从一线雄激素剥夺治疗开始至前列腺特异性抗原或临床进展的时间。次要终点包括无前列腺特异性抗原进展生存期、前列腺特异性抗原反应（较基线降低90%或更多）以及二线治疗的分布情况。
在2494例患者中（戈舍瑞林，n = 564；亮丙瑞林，n = 1148；手术去势，n = 161；地加瑞克，n = 621），接受地加瑞克治疗的患者前列腺特异性抗原水平和 Gleason评分更高，临床分期也比接受戈舍瑞林或亮丙瑞林治疗的患者更晚。戈舍瑞林和亮丙瑞林组未达到疾病进展的中位时间（与无前列腺特异性抗原进展生存期结果相同），手术去势组为52.7个月，地加瑞克组为54.0个月。尽管地加瑞克队列的基线前列腺特异性抗原值高于亮丙瑞林或戈舍瑞林队列，但三组之间的前列腺特异性抗原反应并无差异。关于二线治疗，接受地加瑞克治疗的患者组最大，其次是亮丙瑞林（n = 195）。
本研究阐明了一线雄激素剥夺治疗在真实世界临床实践中的患者特征和长期疗效。日本泌尿外科医生似乎根据患者背景和肿瘤特征选择合适的一线雄激素剥夺治疗，地加瑞克主要用于高风险患者。
