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

Authors

Jubilee Brown
Austin Miller
Laura L Holman
Floor Backes
Christa Nagel
David Bender
David S Miller
Matthew A Powell
Shannon N Westin
Albert Bonebrake
Carolyn Y Muller
Angeles Alvarez Secord
Erin Crane
John Schorge
William P Tew
Anil K Sood
Michael A Bookman
Carol Aghajanian
David M Gershenson

Language

English

Publication Date

11-1-2024

Journal

Gynecologic Oncology

DOI

10.1016/j.ygyno.2024.09.002

PMID

39265466

PMCID

PMC12204228

PubMedCentral® Posted Date

6-27-2025

PubMedCentral® Full Text Version

Author MSS

Abstract

Objectives: 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).

Methods: 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.

Results: 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%).

Conclusions: 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.

Keywords

Adult, Aged, Female, Humans, Middle Aged, Young Adult, Antineoplastic Combined Chemotherapy Protocols, Bleomycin, Carboplatin, Cisplatin, Etoposide, Neoplasm Recurrence, Local, Ovarian Neoplasms, Paclitaxel, Progression-Free Survival, Sex Cord-Gonadal Stromal Tumors

Published Open-Access

yes

Recommended Citation

Brown, Jubilee; Miller, Austin; Holman, Laura L; et al., "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" (2024). Faculty, Staff and Student Publications. 6560.
https://digitalcommons.library.tmc.edu/uthgsbs_docs/6560