Journal article
Phase III Randomized Trial of Maintenance Taxanes Versus Surveillance in Women With Advanced Ovarian/Tubal/Peritoneal Cancer: A Gynecologic Oncology Group 0212:NRG Oncology Study
Journal of clinical oncology, Vol.40(35), pp.4119-4129
12/10/2022
DOI: 10.1200/JCO.22.00146
PMCID: PMC9746779
PMID: 35759733
Abstract
To compare taxane maintenance chemotherapy, paclitaxel (P) and paclitaxel poliglumex (PP), with surveillance (S) in women with ovarian, peritoneal, or fallopian tube (O/PC/FT) cancer who attained clinical complete response after first-line platinum-taxane therapy.
Women diagnosed with O/PC/FT cancer who attained clinical complete response after first-line platinum-taxane-based chemotherapy were randomly allocated 1:1:1 to S or maintenance, P 135 mg/m
once every 28 days for 12 cycles, or PP at the same dose and schedule. Overall survival (OS) was the primary efficacy end point.
Between March 2005 and January 2014, 1,157 individuals were enrolled. Grade 2 or worse GI adverse events were more frequent among those treated with taxane (PP: 20%, P: 27%
S: 11%). Grade 2 or worse neurologic adverse events occurred more often with taxane treatment (PP: 46%, P: 36%
S: 14%). At the fourth scheduled interim analysis, both taxane regimens passed the OS futility boundary and the Data Monitoring Committee approved an early release of results. With a median follow-up of 8.1 years, 653 deaths were reported; none were attributed to the study treatment. Median survival durations were 58.3, 56.8, and 60.0 months for S, P, and PP, respectively. Relative to S, the hazard of death for P was 1.091 (95% CI, 0.911 to 1.31;
= .343) and for PP, it was 1.033 (95% CI, 0.862 to 1.24;
= .725). The median times to first progression or death (PFS) were 13.4, 18.9, and 16.3 months for S, P, and PP, respectively. Hazard ratio = 0.801; 95% CI, 0.684 to 0.938;
= .006 for P and hazard ratio = 0.854; 95% CI, 0.729 to 1.00;
= .055 for PP.
Maintenance therapy with P and PP did not improve OS among patients with newly diagnosed O/tubal/peritoneal cancer, but may modestly increase PFS. GI and neurologic toxicities were more frequent in the taxane treatment arms.
Details
- Title: Subtitle
- Phase III Randomized Trial of Maintenance Taxanes Versus Surveillance in Women With Advanced Ovarian/Tubal/Peritoneal Cancer: A Gynecologic Oncology Group 0212:NRG Oncology Study
- Creators
- Larry J Copeland - The Ohio State UniversityMark F Brady - Roswell Park Comprehensive Cancer Center, State University of New York at Buffalo, Buffalo, NYRobert A Burger - University of PennsylvaniaWilliam H Rodgers - Weill Cornell Medical College, New York, NYHelen Q Huang - Roswell Park Comprehensive Cancer Center, State University of New York at Buffalo, Buffalo, NYDavid Cella - Northwestern UniversityDavid M O'Malley - The Ohio State UniversityDaron G Street - University of OklahomaKrishnansu S Tewari - University of California, IrvineDavid P Bender - University of IowaRobert T Morris - The Barbara Ann Karmanos Cancer InstituteWilliam J Lowery - Walter Reed National Military Medical CenterDavid S Miller - The University of Texas Southwestern Medical CenterSummer B Dewdney - Rush University Medical CenterNick M Spirtos - Women's Cancer Center, Las Vegas, NVShashikant B Lele - Roswell Park Comprehensive Cancer Center, Buffalo, NYSaketh Guntupalli - University of Colorado DenverFrederick R Ueland - University of KentuckyGretchen E Glaser - Carilion ClinicRobert S Mannel - University of OklahomaPhilip J DiSaia - Deceased
- Resource Type
- Journal article
- Publication Details
- Journal of clinical oncology, Vol.40(35), pp.4119-4129
- DOI
- 10.1200/JCO.22.00146
- PMID
- 35759733
- PMCID
- PMC9746779
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Grant note
- U10 CA180822 / NCI NIH HHS UG1 CA233191 / NCI NIH HHS
- Language
- English
- Date published
- 12/10/2022
- Academic Unit
- Obstetrics and Gynecology
- Record Identifier
- 9984321879502771
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