Author(s): Larry J. Copeland, MD1;Mark F. Brady, PhD2;Robert A. Burger, MD3;William H. Rodgers, MD4;Helen Q. Huang, MS2;David Cella, PhD5;David M. O’Malley, MD1;Daron G. Street, MD6;Krishnansu S. Tewari, MD7;David P. Bender, MD8;Robert T. Morris, MD9;William J. Lowery, MD10;David S. Miller, MD11;Summer B. Dewdney, MD12;Nick M. Spirtos, MD13;Shashikant B. Lele, MD14;Saketh Guntupalli, MD15;Frederick R. Ueland, MD16;Gretchen E. Glaser, MD17;Robert S. Mannel, MD6;and Philip J. DiSaia, MD7,†
PURPOSE
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.
METHODS
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/m2 once every 28 days for 12 cycles, or PP at the same dose and schedule. Overall survival (OS) was the primary efficacy end point.
RESULTS
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% v S: 11%). Grade 2 or worse neurologic adverse events occurred more often with taxane treatment (PP: 46%, P: 36% v 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; P = .343) and for PP, it was 1.033 (95% CI, 0.862 to 1.24; P = .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; P = .006 for P and hazard ratio = 0.854; 95% CI, 0.729 to 1.00; P = .055 for PP.
CONCLUSION
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.
Author Affiliations
1The Ohio State University, James Cancer Hospital, Columbus, OH2Roswell Park Comprehensive Cancer Center, State University of New York at Buffalo, Buffalo, NY3University of Pennsylvania, Philadelphia, PA4Weill Cornell Medical College, New York, NY5Northwestern University, Chicago, IL6The University of Oklahoma, Oklahoma City, OK7UC Irvine Medical Center, Orange, CA8University of Iowa Hospitals and Clinics, Iowa City, IA9Barbara Ann Karmanos Cancer Institute, Detroit, MI10Murtha Cancer Center, Walter Reed National Military Medical Center, Chicago, IL11The University of Texas Southwestern Medical Center, Dallas, TX12Rush University Medical Center, Chicago, IL13Women’s Cancer Center, Las Vegas, NV14Roswell Park Comprehensive Cancer Center, Buffalo, NY15University of Colorado Denver, Aurora, CO16University of Kentucky Medical Center, Lexington, KY17Carilion Clinic, Roanoke, VA†Deceased.
