Urabe Fumihiko, Kagawa Hirokazu, Yanagisawa Takafumi, Takahashi Hidetsugu, Hashimoto Masaki, Hara Shuhei, Fukuokaya Wataru, Imai Yu, Iwatani Kosuke, Igarashi Taro, Atsuta Mahito, Tashiro Kojiro, Murakami Masaya, Tsuzuki Shunsuke, Yanada Brendan A, Yamamoto Toshihiro, Hata Kenichi, Yamada Hiroki, Miki Jun, Kimura Takahiro
Department of Urology, The Jikei University School of Medicine, Tokyo, Japan.
Department of Urology, Jike the 3 Hospital, Tokyo, Japan.
Prostate Int. 2025 Mar;13(1):41-48. doi: 10.1016/j.prnil.2024.11.003. Epub 2024 Nov 22.
To compare adverse event (AE) profiles between patients with prostate cancer receiving triplet therapy (docetaxel, androgen receptor signaling inhibitors [ARSIs], and androgen deprivation therapy [ADT]) and those receiving docetaxel-based therapy (docetaxel and ADT). Additionally, we sought to identify risk factors for severe AEs associated with these treatment regimens.
In this retrospective, multicenter study, we included 359 patients diagnosed with metastatic castration-sensitive prostate cancer (mCSPC) or metastatic castration-resistant prostate cancer (mCRPC) who were treated with docetaxel. We analyzed patient demographics, hematologic and non-hematologic AEs, and risk factors for severe AEs. Logistic regression models were used to assess risk factors.
There were no significant differences in the incidence of ≥ grade 3 neutropenia or febrile neutropenia (FN) between the triplet and docetaxel-based therapy groups when stratified by the use of primary prophylaxis. Non-hematologic AEs, especially fatigue, were more frequent in the mCRPC group compared to the triplet therapy group. Primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) significantly reduced the risk of severe neutropenia (odds ratio [OR] 0.092, < 0.001) and FN (OR 0.13, = 0.007).
This study represents the first real-world analysis comparing the adverse event profiles of triplet therapy and docetaxel-based therapy in Japanese patients with mCSPC, as well as docetaxel-based therapy in those with mCRPC. No significant difference in severe AEs was observed between the therapies. Primary prophylaxis with G-CSF proved critical in reducing severe neutropenia and FN, underscoring its importance in enhancing the safety and efficacy of docetaxel-based therapies.
比较接受三联疗法（多西他赛、雄激素受体信号抑制剂[ARSIs]和雄激素剥夺疗法[ADT]）的前列腺癌患者与接受基于多西他赛的疗法（多西他赛和ADT）的患者之间的不良事件（AE）情况。此外，我们试图确定与这些治疗方案相关的严重AE的危险因素。
在这项回顾性多中心研究中，我们纳入了359例被诊断为转移性去势敏感性前列腺癌（mCSPC）或转移性去势抵抗性前列腺癌（mCRPC）并接受多西他赛治疗的患者。我们分析了患者的人口统计学特征、血液学和非血液学AE以及严重AE的危险因素。采用逻辑回归模型评估危险因素。
在使用一级预防进行分层时，三联疗法组和基于多西他赛的疗法组之间≥3级中性粒细胞减少或发热性中性粒细胞减少（FN）的发生率没有显著差异。与三联疗法组相比，mCRPC组的非血液学AE，尤其是疲劳，更为常见。使用粒细胞集落刺激因子（G-CSF）进行一级预防显著降低了严重中性粒细胞减少（优势比[OR]0.092，<0.001）和FN（OR 0.13，=0.007）的风险。
本研究首次对日本mCSPC患者的三联疗法和基于多西他赛的疗法以及mCRPC患者的基于多西他赛的疗法的不良事件情况进行了真实世界分析。两种疗法之间未观察到严重AE的显著差异。G-CSF一级预防在降低严重中性粒细胞减少和FN方面被证明至关重要，凸显了其在提高基于多西他赛的疗法安全性和有效性方面重要性。
