Evaluation of the Initial Dose and Therapeutic Effect of Cabazitaxel in Japanese Patients

Emi Morimoto, K. Shimizu, M. Takagi, Y. Kondo, Yoshihiro Sakajo, K. Fujita, Y. Itami, H. Momose, Shuya Hirao, K. Nishimura
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Abstract

Cabazitaxel (CBZ), used for castration-resistant prostate cancer, has a high frequency of severe myelosuppression. Pegfilgrastim is administered to prevent febrile neutropenia (FN);however, it may still occur, and in many cases, the CBZ dose is reduced for safety considerations. Therefore, a retrospective survey was conducted to investigate the impact of the initial CBZ dose of 25 mg/m 2 on the myelosuppression status, relative dose intensity (RDI), prostate-specific antigen (PSA) response rate, treatment duration , and overall survival (OS) in Japanese patients. In the 25 mg/m 2 group, 6 patients had neutropenia higher than grade 3 (100 % ) and 1 patient had FN. There were 26 patients in the reduced-dose group, and neutropenia of ≥ grade 3 was observed in 5 patients (19 % ). The frequency of neutropenia was significantly higher in patients aged ≥ 74 years ( P = 0.017). The 25 mg/m 2 group had significantly higher RDI (median: 96 % vs 67 % , P = 0.016) and PSA response rate (50 % vs 19 % , P = 0.043) than the reduced-dose group. In contrast, there was no difference between the two groups in terms of treatment duration (median: 5.9 vs 3.3 months, P = 0.220) and OS (median: 10 vs 13.5 months, P = 0.552). The risk of developing ≥ grade 3 neutropenia was low, and no impact on the OS was observed in the reduced-dose CBZ group. It is recommended to reduce the initial dose of CBZ from 25 mg/m 2 to 20 mg/m 2 in Japanese patients.
日本患者卡巴他赛初始剂量及疗效评价
卡巴他赛(CBZ),用于去势抵抗性前列腺癌,有严重骨髓抑制的高频率。Pegfilgrastim用于预防发热性中性粒细胞减少症(FN);然而,它仍然可能发生,并且在许多情况下,出于安全考虑,减少CBZ剂量。因此,本研究对日本患者进行回顾性调查,研究初始CBZ剂量为25mg / m2对骨髓抑制状态、相对剂量强度(RDI)、前列腺特异性抗原(PSA)应答率、治疗持续时间和总生存期(OS)的影响。在25 mg/ m2组中,6例患者中性粒细胞减少高于3级(100%),1例患者发生FN。减剂量组26例,5例(19%)出现中性粒细胞减少≥3级。年龄≥74岁的患者出现中性粒细胞减少的频率明显较高(P = 0.017)。25 mg/ m2组的RDI(中位数:96% vs 67%, P = 0.016)和PSA反应率(50% vs 19%, P = 0.043)均显著高于低剂量组。相比之下,两组在治疗持续时间(中位数:5.9 vs 3.3个月,P = 0.220)和OS(中位数:10 vs 13.5个月,P = 0.552)方面没有差异。减剂量CBZ组发生≥3级中性粒细胞减少的风险较低,对OS无影响。在日本患者中,建议将CBZ的初始剂量从25mg / m2减少到20mg / m2。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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