Abstract
Cabazitaxel with abiraterone versus abiraterone alone randomized trial for extensive disease following docetaxel: The CHAARTED2 trial of the ECOG-ACRIN Cancer Research Group (EA8153)
Journal of clinical oncology, Vol.42(17_suppl), pp.LBA5000-LBA5000
06/10/2024
DOI: 10.1200/JCO.2024.42.17_suppl.LBA5000
Abstract
LBA5000 Background: The E3805 (CHAARTED) trial showed a significant survival benefit from early treatment with chemohormonal therapy (ADT + Docetaxel) in patients (pts) with high-volume metastatic hormone-sensitive prostate cancer (HSPC). However, most pts will develop castration-resistant disease (CRPC) and will require additional systemic therapy. We hypothesized that additional treatment with chemohormonal therapy in the CRPC setting will improve outcomes. Methods: EA8153 (CHAARTED2) is a prospective randomized phase II open label trial. Two hundred twenty-three (223) pts with metastatic CRPC previously treated with ADT + docetaxel for HSPC were randomized (1:1) to abiraterone/prednisone plus cabazitaxel 25 mg/m 2 for up to 6 cycles (n = 111) or abiraterone/prednisone alone (n = 112). Stratification factors included ECOG performance status (PS) of 0 vs. 1-2, time from initiation of ADT to development of CRPC of <12 vs. > 12 months, and presence vs. absence of visceral metastases. The primary trial endpoint is progression-free survival (PFS), defined as time from randomization to radiographic progression, symptomatic deterioration requiring discontinuation of treatment, or death. Key secondary endpoints include time to PSA progression (TTPP), overall survival (OS), and safety. Results: After a median follow-up of 47.3 (0-61.2) months, median PFS was longer for the cabazitaxel + abiraterone/prednisone arm vs. abiraterone/prednisone alone arm (14.9 months [95% CI 9.9-18.6] vs. 9.9 months [95% CI, 7.0-12.6], P = 0.049; hazard ratio [HR] 0.73, 80% CI 0.59-0.90). The advantage with the combination was more pronounced in patients < 65 years of age (15.6 vs. 9.8 months, P = 0.08), ECOG PS of 0 (20.9 vs. 10.1 months, P = 0.01), time to CRPC of < 12 months (12.9 vs. 5.1 months, P = 0.006), and absence of visceral metastases (18.1 vs. 10.1 months, P = 0.01). Median TTPP was also longer in the combination vs. the monotherapy arm (10 months [95% CI 8.5-13.5] vs. 6.1 months [95% CI 4.4-8], P = 0.002). No difference in OS was observed between the 2 arms in the interim analysis (25.0 vs. 26.9 months, P = 0.67). More grade >3 side effects were noted in the combination arm, as expected from use of cabazitaxel. Conclusions: The addition of cabazitaxel to abiraterone/prednisone significantly prolonged PFS in patients with metastatic CRPC who previously received ADT + docetaxel for HSPC compared to abiraterone/prednisone alone. No significant OS difference was noted between the two arms, but the study was not powered for this endpoint. Clinical trial: NCT03419234. Support: CA180820, CA180794, CA180799, CA180802; and Genzyme Corporation, a subsidiary of Sanofi S.A. Clinical trial information: NCT03419234 .
Details
- Title: Subtitle
- Cabazitaxel with abiraterone versus abiraterone alone randomized trial for extensive disease following docetaxel: The CHAARTED2 trial of the ECOG-ACRIN Cancer Research Group (EA8153)
- Creators
- Christos Kyriakopoulos - University of Wisconsin Carbone Cancer CenterYu-Hui Chen - Dana-Farber Cancer InstituteRobert Jeraj - University of Wisconsin–MadisonFenghai Duan - Brown UniversityJun Luo - Johns Hopkins UniversityEmmanuel S. Antonarakis - University of MinnesotaAbhishek Tripathi - City Of Hope National Medical CenterDavid Kosoff - University of Wisconsin Carbone Cancer CenterRohan Garje - University of Iowa Hospitals and ClinicsRussell Kent Pachynski - Washington University in St. LouisRahul Atul Parikh - University of Kansas Medical CenterAndrea Harzstark - Kaiser Permanente San Francisco Medical CenterNabil Adra - Indiana University HealthBenjamin L. Maughan - University of UtahYousef Zakharia - University of IowaPaul Gettys Corn - The University of Texas MD Anderson Cancer CenterGlenn Liu - University of Wisconsin Carbone Cancer CenterMichael Anthony Carducci - Sidney Kimmel Comprehensive Cancer Center
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.42(17_suppl), pp.LBA5000-LBA5000
- Publisher
- LIPPINCOTT WILLIAMS & WILKINS
- DOI
- 10.1200/JCO.2024.42.17_suppl.LBA5000
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Grant note
No Statement Available
- Language
- English
- Date published
- 06/10/2024
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984649044702771
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