TY - JOUR
T1 - Phase III Randomized Trial of Maintenance Taxanes Versus Surveillance in Women with Advanced Ovarian/Tubal/Peritoneal Cancer
T2 - A Gynecologic Oncology Group 0212:NRG Oncology Study
AU - Copeland, Larry J.
AU - Brady, Mark F.
AU - Burger, Robert A.
AU - Rodgers, William H.
AU - Huang, Helen Q.
AU - Cella, David
AU - O'Malley, David M.
AU - Street, Daron G.
AU - Tewari, Krishnansu S.
AU - Bender, David P.
AU - Morris, Robert T.
AU - Lowery, William J.
AU - Miller, David S.
AU - Dewdney, Summer B.
AU - Spirtos, Nick M.
AU - Lele, Shashikant B.
AU - Guntupalli, Saketh
AU - Ueland, Frederick R.
AU - Glaser, Gretchen E.
AU - Mannel, Robert S.
AU - Disaia, Philip J.
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2022/12/10
Y1 - 2022/12/10
N2 - PURPOSETo 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.METHODSWomen 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.RESULTSBetween 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.CONCLUSIONMaintenance 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.
AB - PURPOSETo 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.METHODSWomen 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.RESULTSBetween 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.CONCLUSIONMaintenance 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.
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U2 - 10.1200/JCO.22.00146
DO - 10.1200/JCO.22.00146
M3 - Article
C2 - 35759733
AN - SCOPUS:85141991858
SN - 0732-183X
VL - 40
SP - 4119
EP - 4128
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 35
ER -