{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T11:13:24Z","timestamp":1790766804642,"version":"4.1.0"},"reference-count":24,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"35","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2022,12,10]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p> Women diagnosed with O\/PC\/FT cancer who attained clinical complete response after first-line platinum-taxane\u2013based chemotherapy were randomly allocated 1:1:1 to S or maintenance, P 135 mg\/m<jats:sup>2<\/jats:sup> once every 28 days for 12 cycles, or PP at the same dose and schedule. Overall survival (OS) was the primary efficacy end point. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.22.00146","type":"journal-article","created":{"date-parts":[[2022,6,27]],"date-time":"2022-06-27T19:59:34Z","timestamp":1656359974000},"page":"4119-4128","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":8,"title":["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"],"prefix":"10.1200","volume":"40","clinical-trial-number":[{"clinical-trial-number":"nct00108745","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6204-0962","authenticated-orcid":false,"given":"Larry J.","family":"Copeland","sequence":"first","affiliation":[{"name":"The Ohio State University, James Cancer Hospital, Columbus, 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