Hata Kenichi, Hashimoto Masaki, Takahashi Yusuke, Saito Shun, Kawaharada Ayaka, Enei Yuki, Tanaka Masatoshi, Sakanaka Keigo, Takahashi Kazuhiro, Hisakane Akira, Yanagisawa Takafumi, Tsuzuki Shunsuke, Honda Mariko, Furuta Akira, Miki Kenta, Kimura Takahiro
Department of Urology, Atsugi City Hospital.
Department of Urology, Jikei University of Medicine.
Nihon Hinyokika Gakkai Zasshi. 2024;115(1):11-20. doi: 10.5980/jpnjurol.115.11.
(Objective) This study aimed at evaluating the efficacy and safety of upfront docetaxel (DTX) treatment and androgen deprivation therapy (ADT) in male patients with high-volume metastatic castration-sensitive prostate cancer (HV-mCSPC). (Methods) This retrospective study was conducted using the medical records of 30 patients treated for HV-mCSPC by using upfront DTX treatment along with ADT at Atsugi City Hospital between December 2015 and December 2022. The patient characteristics, demographics, oncological outcomes, adverse events, and sequential therapy were evaluated. (Results) Thirty patients were included in the final analysis. The median patient age and prostate-specific antigen at diagnosis were 73 years (range, 53-83 years) and 250 mg/ml (range, 0.54-3,817 ng/ml), respectively. The completion rate of six cycles of upfront DTX treatment was 86.7%. The median progression-free survival was 24 months; the median overall survival was not reached, and the 5-year survival rate was 71.5%. Alopecia was the most frequent non-hematological adverse event (60%) followed by fatigue (53.3%). Overall, adverse events of grade 3 or higher occurred in 46.7% of the patients, with neutropenia being the most frequent. The incidence of neutropenia of grade 3 or higher was significantly lower in the group receiving primary prophylaxis with long-acting granulocyte colony-stimulating factor (7.7% vs. 75%, P = 0.009). Abiraterone was the most frequently administered sequential treatment in 12 patients (60%). (Conclusion) In the triplet combination treatment era, upfront DTX treatment and ADT for patients with HV-mCSPC was safe as primary prophylaxis for severe neutropenia and effective as an upfront treatment. However, it should be selected if its effectiveness is superior to triplet treatment considering adverse events, cost-effectiveness, and quality of life.
（目的）本研究旨在评估一线多西他赛（DTX）治疗联合雄激素剥夺治疗（ADT）在高负荷转移性去势敏感性前列腺癌（HV-mCSPC）男性患者中的疗效和安全性。（方法）本回顾性研究采用了2015年12月至2022年12月间在厚木市医院接受一线DTX治疗联合ADT治疗的30例HV-mCSPC患者的病历。评估了患者特征、人口统计学、肿瘤学结局、不良事件和序贯治疗情况。（结果）30例患者纳入最终分析。诊断时患者的中位年龄和前列腺特异性抗原分别为73岁（范围53 - 83岁）和250 mg/ml（范围0.54 - 3817 ng/ml）。一线DTX治疗六个周期的完成率为86.7%。中位无进展生存期为24个月；中位总生存期未达到，5年生存率为71.5%。脱发是最常见的非血液学不良事件（60%），其次是疲劳（53.3%）。总体而言，46.7%的患者发生3级或更高等级的不良事件，其中中性粒细胞减少最为常见。接受长效粒细胞集落刺激因子一级预防的组中，3级或更高等级中性粒细胞减少的发生率显著更低（7.7%对75%，P = 0.009）。阿比特龙是12例患者（60%）中最常使用的序贯治疗药物。（结论）在三联联合治疗时代，一线DTX治疗联合ADT用于HV-mCSPC患者对严重中性粒细胞减少作为一级预防是安全的，作为一线治疗是有效的。然而，考虑到不良事件、成本效益和生活质量，如果其有效性优于三联治疗，则应选择该治疗方案。
