Journal article
Results of a randomized phase II trial of paclitaxel and carboplatin versus bleomycin, etoposide and cisplatin for newly diagnosed and recurrent Chemonaive stromal ovarian tumors: An NRG oncology/gynecologic oncology group study14
Gynecologic oncology, Vol.190, pp.283-290
11/2024
DOI: 10.1016/j.ygyno.2024.09.002
PMCID: PMC12204228
PMID: 39265466
Abstract
To assess the efficacy and toxicity of paclitaxel and carboplatin (PC) compared to bleomycin, etoposide, and cisplatin (BEP) for treatment of newly diagnosed Stage IIA-IV or recurrent chemotherapy-naive ovarian sex cord-stromal tumors (SCST).
This phase II noninferiority trial randomly assigned patients to receive PC (6 cycles P 175 mg/m2 and C AUC = 6 IV every 3 weeks), or BEP (4 cycles B 20 units/m2 IV push day 1, E 75 mg/m2 IV days 1–5, and cisplatin 20 mg/m2 IV days 1–5 every 3 weeks). The primary endpoint was progression- free survival (PFS). This trial is registered with ClinicalTrials.gov, NCT01042522.
At the interim analysis, 63 patients (31 PC and 32 B.P. had accrued between Feb 8, 2010 and Apr 30, 2020. Median age was 48 years. 87% had granulosa cell tumors. 37% had measurable disease. The DSMB closed accrual early for futility of PC arm. The futility analysis was supported by an estimated HR = 1.11 [95% CI: 0.57 to 2.13] which exceeded the pre-determined threshold for non-inferiority (1.10). Median PFS was 27.7 months [11.2 to 41.0] for PC and 19.7 months for BEP [95% CI: 10.4–52.7]. PC patients had fewer grade 3 or higher adverse events (PC 77% vs BEP 90%).
The study met its pre-specified criterion for stopping early for futility and so failed to demonstrate non-inferiority of PC versus BEP in ovarian SCSTs, in a non-inferiority test with a hazard ratio margin of 1.1. Both PC and BEP may be considered in patients with advanced/recurrent SCST.
•Paclitaxel and carboplatin (PC) are well tolerated in patients with sex cord-stromal ovarian tumors (SCSTs).•Both PC and bleomycin/etoposide/cisplatin are regimens to be considered for patients with advanced/recurrent SCSTs.•No significant differences in outcomes or adverse effects were detected between these two regimens.
Details
- Title: Subtitle
- Results of a randomized phase II trial of paclitaxel and carboplatin versus bleomycin, etoposide and cisplatin for newly diagnosed and recurrent Chemonaive stromal ovarian tumors: An NRG oncology/gynecologic oncology group study14
- Creators
- Jubilee Brown - Levine Cancer InstituteAustin Miller - Roswell Park Comprehensive Cancer CenterLaura L. Holman - University of Oklahoma Health Sciences CenterFloor Backes - The Ohio State UniversityChrista Nagel - Case Western Reserve UniversityDavid Bender - University of IowaDavid S. Miller - The University of Texas Southwestern Medical CenterMatthew A. Powell - Washington University in St. LouisShannon N. Westin - The University of Texas MD Anderson Cancer CenterAlbert Bonebrake - Cancer Research for the OzarksCarolyn Y. Muller - University of New MexicoAngeles Alvarez Secord - Duke UniversityErin Crane - Levine Cancer InstituteJohn Schorge - University of Tennessee Health Science CenterWilliam P. Tew - Memorial Sloan Kettering Cancer CenterAnil K. Sood - The University of Texas MD Anderson Cancer CenterMichael A. Bookman - Kaiser PermanenteCarol Aghajanian - Memorial Sloan Kettering Cancer CenterDavid M. Gershenson - The University of Texas MD Anderson Cancer Center
- Resource Type
- Journal article
- Publication Details
- Gynecologic oncology, Vol.190, pp.283-290
- DOI
- 10.1016/j.ygyno.2024.09.002
- PMID
- 39265466
- PMCID
- PMC12204228
- NLM abbreviation
- Gynecol Oncol
- ISSN
- 0090-8258
- eISSN
- 1095-6859
- Publisher
- Elsevier Inc
- Number of pages
- 8
- Grant note
- National Cancer Institute: 1 U10.CA180822, U10CA180868 NRG Oncology Operations: U10CA180868
This study was supported by National Cancer Institute grants to NRG Oncology SDMC (1 U10.CA180822) and NRG Oncology Operations (U10CA180868) .The following NRG Oncology Group member institutions participated in the primary treatment studies: University of Oklahoma Health Sciences Center; Ohio State University Comprehensive Cancer Center; Case Western Reserve University; University of Iowa Hospitals and Clinics; University of Texas Southwestern Medical Center; Washington University School of Medicine; MD Anderson Cancer Center; Cancer Research for the Ozarks NCORP; University of New Mexico (NM Minority-Underserved NCORP) ; Duke University Medical Center; Carolinas Medical Center/Levine Cancer Institute; University of Michigan Health System - Cancer Center; Alexian Brothers Medical and Cancer Center; University of Colorado Cancer Center - Anschutz Cancer Pavilion; University of North Carolina at Chapel Hill; Rush University Medical Center; University of New Mexico; Fox Chase Cancer Center; Women's Cancer Center of Nevada; University of Chicago; The Hospital of Central Connecticut; Evanston CCOP - NorthShore University Health System; and Georgia Cares Minority Underserved NCORP.
- Language
- English
- Date published
- 11/2024
- Academic Unit
- Obstetrics and Gynecology
- Record Identifier
- 9984704828202771
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