Randomized phase 2 Cabazitaxel dose individualization and Neutropenia prevention Trial (CAINTA) in patients with metastatic castration-resistant prostate cancer

Aurelius Omlin, Richard Cathomas, Gunhild von Amsberg, Christoph Reuter, Susan Feyerabend, Wolfgang Loidl, Martin Boegemann, Anja Lorch, Axel Heidenreich, Igor Tsaur, Julian Larcher-Senn, Stefan Buck, Ron H J Mathijssen, Ulrich Jaehde, Silke Gillessen, Markus Joerger*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

PURPOSE: There is ongoing controversy about the recommended dose of cabazitaxel in patients with metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND METHODS: This multicenter phase II open-label, randomized, parallel-group study compared 3-weekly cabazitaxel at 25 mg/m2 (conventional arm A) with cabazitaxel therapeutic drug monitoring (experimental arm B) in mCRPC. The primary objective was to improve the clinical feasibility rate (CFR), defined as the absence of grade 4 neutropenia or thrombocytopenia, any thrombocytopenia with bleeding, febrile neutropenia, severe nonhematologic toxicity, withdrawal for cabazitaxel-related toxicity, or death. A total of 60 patients had to be randomized to detect a difference in CFR of 35% (power 80%, two-sided alpha 10%). RESULTS: A total of 40 patients were randomized to arm A and 33 patients to arm B. CFR was 69.4% in arm A and 64.3% in arm B (P = 0.79). Week-12 PSA response was 38.5% in both arms. A radiological response by RECIST v.1.1 was seen in 3 (9.7%) patients in arm A versus 6 (23.1%) patients in arm B (P = 0.28), disease progression was higher in arm A compared with arm B (61.3% vs. 30.8%, P = 0.05). Median progression-free survival was longer in arm B compared with arm A (9.5 vs. 4.4 months; HR = 0.46; P = 0.005). Median overall survival was higher in arm B compared with arm A (16.2 vs. 7.3 months; HR = 0.33; P < 0.0001). CONCLUSIONS: Pharmacokinetic-guided dosing of cabazitaxel in patients with mCRPC is feasible and improves clinical outcome due to individual dose escalations in 55% of patients.

Original languageEnglish
Pages (from-to)1887-1893
Number of pages7
JournalClinical Cancer Research : an official journal of the American Association for Cancer Research
Volume29
Issue number10
DOIs
Publication statusPublished - 15 May 2023

Bibliographical note

Funding Information:
This study has been conducted by the Central European Society for Anticancer Drug Research (CESAR) in collaboration with the Swiss Group for Clinical Cancer Research (SAKK) and financially supported by Sanofi-Aventis.

Publisher Copyright:
© 2023 American Association for Cancer Research.

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