Usui Kimitsugu, Kubo Hayato, Matsumoto Takahiro, Aigase Tomohiko, Suzuki Atsuto, Kishida Takeshi, Nakaigawa Noboru
Division of Urology, Kanagawa Cancer Center, Kanagawa, Japan.
Int Urol Nephrol. 2025 Apr 26. doi: 10.1007/s11255-025-04465-7.
To evaluate the efficacy and safety of triplet therapy in patients with metastatic hormone-sensitive prostate cancer (mHSPC), focusing on older adults, in a real-world clinical setting.
In this retrospective, single-center study, we analyzed data from 21 patients with mHSPC (median age: 71 years) treated with androgen deprivation therapy (ADT), docetaxel, and darolutamide. Relative (≥ 90% reduction from baseline) and absolute (PSA < 0.2 ng/mL) prostate-specific antigen (PSA) response rates over 6 months were assessed, along with adverse event (AE) profiles.
At 6 months, the absolute PSA response rate was 71.4%, while the relative PSA response rate reached 100% by 3 months. Treatment-related toxicity was notable, with AEs observed in 95.2% of the patients, predominantly neutropenia. Patients aged ≥ 80 years had significantly higher treatment interruption rates for both docetaxel and darolutamide compared with those aged ≤ 79 years. Nonetheless, PSA response rates were comparable between the age groups. Neutrophil recovery time was significantly prolonged in patients aged ≥ 80 years compared to those aged ≤ 79 years.
Triplet therapy effectively reduces PSA in patients with mHSPC, including older adults. However, the high incidence of severe AEs, particularly in older adults, underscores the need for individualized treatment strategies. Despite these challenges, careful management of toxicities makes this regimen viable in clinical practice. These findings emphasize the importance of real-world data in optimizing therapy for aging populations and may serve as a basis for future prospective studies comparing triplet and doublet therapies across diverse patient cohorts.
在真实世界临床环境中,评估三联疗法对转移性激素敏感性前列腺癌(mHSPC)患者的疗效和安全性,重点关注老年患者。
在这项回顾性单中心研究中,我们分析了21例接受雄激素剥夺治疗(ADT)、多西他赛和达罗他胺治疗的mHSPC患者(中位年龄:71岁)的数据。评估了6个月内的相对(较基线降低≥90%)和绝对(PSA<0.2 ng/mL)前列腺特异性抗原(PSA)反应率,以及不良事件(AE)情况。
6个月时,绝对PSA反应率为71.4%,而相对PSA反应率在3个月时达到100%。治疗相关毒性较为显著,95.2%的患者出现AE,主要为中性粒细胞减少。与年龄≤79岁的患者相比,年龄≥80岁的患者多西他赛和达罗他胺的治疗中断率显著更高。尽管如此,各年龄组之间的PSA反应率相当。与年龄≤79岁的患者相比,年龄≥80岁的患者中性粒细胞恢复时间显著延长。
三联疗法可有效降低mHSPC患者(包括老年患者)的PSA水平。然而,严重AE的高发生率,尤其是在老年患者中,凸显了个体化治疗策略的必要性。尽管存在这些挑战,但对毒性的谨慎管理使该方案在临床实践中可行。这些发现强调了真实世界数据在优化老年人群治疗中的重要性,并可能为未来比较不同患者队列三联疗法和双联疗法的前瞻性研究提供依据。