125 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

J Brown; A Miller; K Moxley; F Backes; C Nagel; D Bender; D Miller; M Powell; S Westin; A Bonebrake; C Muller; A Alvarez Secord; E Crane; J Schorge; W Tew; A Sood; C Aghajanian

doi:10.1136/ijgc-2020-IGCS.107

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125 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

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125 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

J Brown, A Miller, K Moxley, F Backes, C Nagel, D Bender, D Miller, M Powell, S Westin, A Bonebrake, …

International journal of gynecological cancer, Vol.30(Suppl 3), pp.A56-A56

11/2020

DOI: 10.1136/ijgc-2020-IGCS.107

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Abstract

ObjectivesTo determine the progression free survival (PFS) of paclitaxel and carboplatin (PC) versus bleomycin, etoposide, and cisplatin (BEP) for treatment of newly diagnosed Stage IIA-IV or recurrent chemotherapy-naive ovarian sex cord-stromal tumors (SCST).MethodsThis study was a phase II, open-label, noninferiority trial. Eligible women with SCST were equally randomized to 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 targeted 128 patient accrual and PFS hazard ratio (HR)=0.67 provided 85% power to exclude noninferiority margin HR=1.10.Results63 patients were accrued at the interim futility analysis (31 PC and 32 BEP). Median age was 48 years. 87% had granulosa cell tumors. 37% had measurable disease. The DSMB closed the study early for futility of PC. The futility analysis was supported by 21/16 PFS events on the PC/BEP arms respectively, with an estimated HR=1.12 [95% CI: 0.58 to 2.16]. Median PFS was 27.7 months [7.4 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%). Differences included infections (0 vs 10%), low neutrophil count (65% vs 84%), and low WBC (22 vs 40%). One death NOS occurred on PC.ConclusionsCompared to BEP, PC failed to improve PFS in ovarian SCSTs. PC showed a more favorable side effect profile.

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Title: Subtitle: 125 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
Creators: J Brown - Levine Cancer Institute
A Miller - NRG Oncology
K Moxley - University of Oklahoma
F Backes - The Ohio State University
C Nagel - Case Western Reserve University
D Bender - University of Iowa
D Miller - The University of Texas Southwestern Medical Center
M Powell - Washington University Medical Center
S Westin - The University of Texas MD Anderson Cancer Center
A Bonebrake - Cancer Research for the Ozarks
C Muller - University of New Mexico
A Alvarez Secord - Duke University
E Crane - Levine Cancer Institute
J Schorge - Tufts University
W Tew - Memorial Sloan Kettering Cancer Center
A Sood - The University of Texas MD Anderson Cancer Center
C Aghajanian - Memorial Sloan Kettering Cancer Center
Resource Type: Abstract
Publication Details: International journal of gynecological cancer, Vol.30(Suppl 3), pp.A56-A56
DOI: 10.1136/ijgc-2020-IGCS.107
ISSN: 1048-891X
eISSN: 1525-1438
Language: English
Date published: 11/2020
Academic Unit: Obstetrics and Gynecology
Record Identifier: 9984316890102771

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