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

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 · 发表于：JAMA Oncology · 年份：2023 · DOI：10.1001/jamaoncol.2023.4255 · 被引用次数：23 · 研究领域：Prostate Cancer Treatment and Research、Prostate Cancer Diagnosis and Treatment、Cancer, Lipids, and Metabolism

Importance: Many patients 65 years or older with metastatic castration-resistant prostate cancer (mCRPC) are denied taxane chemotherapy because this treatment is considered unsuitable. Objective: 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). Design, Setting, and Participants: 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. Interventions: 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). Main Outcome and Measures: The primary end point was the occurrence of grade 3 or higher neutropenia measured at nadir and/or neutropenic complications. Results: 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 p...