Biweekly vs Triweekly Cabazitaxel in Older Patients With Metastatic Castration-Resistant Prostate Cancer

医学 多西紫杉醇 前列腺癌 卡巴齐塔塞尔 内科学 中性粒细胞减少症 发热性中性粒细胞减少症 紫杉烷 养生 肿瘤科 恩扎鲁胺 泼尼松龙 雄激素剥夺疗法 癌症 乳腺癌 化疗 雄激素受体
作者
Stéphane Oudard,Raffaele Ratta,Éric Voog,Philippe Barthélémy,Antoine Thiery-Vuillemin,Mostefa Bennamoun,Ali Hasbini,Kaïs Aldabbagh,Carolina Saldana,Emmanuel Sevin,Éric Amela,Gunhild von Amsberg,Nadine Houédé,Dominique Besson,Susan Feyerabend,Martin Boegemann,David Pfister,Martin Schostak,Olivier Huillard,Frédéric Di Fiore,Amandine Quivy,Carsten Lange,Letuan Phan,Houda Belhouari,Yohann Tran,Salma Kotti,Carole Hélissey
出处
期刊:JAMA Oncology [American Medical Association]
卷期号:9 (12): 1629-1629 被引量:4
标识
DOI:10.1001/jamaoncol.2023.4255
摘要

Many patients 65 years or older with metastatic castration-resistant prostate cancer (mCRPC) are denied taxane chemotherapy because this treatment is considered unsuitable.To determine whether biweekly cabazitaxel (CBZ), 16 mg/m2 (biweekly CBZ16), plus prophylactic granulocyte colony-stimulating factor (G-CSF) at each cycle reduces the risk of grade 3 or higher neutropenia and/or neutropenic complications (eg, febrile neutropenia, neutropenic infection, or sepsis) compared with triweekly CBZ, 25 mg/m2 (triweekly CBZ25), plus G-CSF (standard regimen).A total of 196 patients 65 years or older with progressive mCRPC were enrolled in this prospective phase 3 randomized clinical trial conducted in France (18 centers) and Germany (7 centers) between May 5, 2017, and January 7, 2021. All patients had received docetaxel and at least 1 novel androgen receptor-targeted agent.Patients were randomly assigned 1:1 to receive biweekly CBZ16 plus G-CSF and daily prednisolone (experimental group) or triweekly CBZ25 plus G-CSF and daily prednisolone (control group).The primary end point was the occurrence of grade 3 or higher neutropenia measured at nadir and/or neutropenic complications.Among 196 patients (97 in the triweekly CBZ25 group and 99 in the biweekly CBZ16 group), the median (IQR) age was 74.6 (70.4-79.3) years, and 181 (92.3%) had an Eastern Cooperative Oncology Group performance status of 0 or 1. The median (IQR) follow-up duration was 31.3 (22.5-37.5) months. Relative dose intensities were comparable between groups (median [IQR], 92.7% [83.7%-98.9%] in the triweekly CBZ25 group vs 92.8% [87.0%-98.9%] in the biweekly CBZ16 group). The rate of grade 3 or higher neutropenia and/or neutropenic complications was significantly higher with triweekly CBZ25 vs biweekly CBZ16 (60 of 96 [62.5%] vs 5 of 98 [5.1%]; odds ratio, 0.03; 95% CI, 0.01-0.08; P < .001). Grade 3 or higher adverse events were more common with triweekly CBZ25 (70 of 96 [72.9%]) vs biweekly CBZ16 (55 of 98 [56.1%]). One patient (triweekly CBZ25 group) died of a neutropenic complication.In this randomized clinical trial, compared with the standard regimen, biweekly CBZ16 plus G-CSF significantly reduced by 12-fold the occurrence of grade 3 or higher neutropenia and/or neutropenic complications, with comparable clinical outcomes. The findings suggest that biweekly CBZ16 regimen should be offered to patients 65 years or older with mCRPC for whom the standard regimen is unsuitable.ClinicalTrials.gov Identifier: NCT02961257.
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