BACKGROUND: Despite considerable improvement in the treatment of advanced @entity43 , the optimization of efficacy and tolerability remains an important issue. Therefore, we performed a randomized, phase III non-inferiority trial comparing @entity1311 plus @entity900 (PT) with @entity1311 plus @entity3003 (TC) in @entity1 with advanced @entity43 . METHODS: A total of 798 @entity1 with International Federation of Gynecology and Obstetrics stage IIB-IV were randomly assigned to receive six courses of either PT or TC at 3-week intervals. The primary endpoint was the proportion of @entity1 without progression at 2 years. Secondary endpoints included @entity137 , response to treatment, quality of life, and overall and progression-free survival time. Quality of life was evaluated using the European Organization for Research and Treatment of @entity5 quality-of-life questionnaire (QLQ)-C30, version 2.0. Survival curves were calculated using the Kaplan-Meier method, and hazard ratios were estimated using the Cox proportional hazards model. RESULTS: The proportion of @entity1 without progression at 2 years was not statistically significantly different between the two treatment arms (40.0% for PT versus 37.5% for TC, difference = 2.5%, one-sided 95% confidence interval [CI] = - infinity to 8.2%). Median progression-free survival time in the TC arm (17.2 months, 95% CI = 15.2 to 19.3 months) and the PT arm (19.1 months, 95% CI = 16.7 to 21.5 months) were also not statistically significantly different; the same was true of median overall survival time (43.3 months, 95% CI = 37.2 to 47.8 months versus 44.1 months, 95% CI = 40.2 to 49.4 months, for the TC and PT arms, respectively). The TC regimen was associated with a higher frequency of @entity1503 , but a lower frequency of @entity344 , than the PT regimen. Mean global quality-of-life scores at the end of treatment were statistically significantly better in the TC arm than in the PT arm (65.25 versus 51.97, respectively; difference = -13.28, 95% CI = -18.88 to -7.68). CONCLUSION: The TC regimen achieved comparable efficacy to the PT regimen but was associated with better tolerability and quality of life, and should, therefore, be considered as an important alternative for standard first-line chemotherapy in @entity1 with advanced @entity43 .

A randomized clinical trial of XXXX / @entity1311 versus @entity3003 / @entity1311 as first-line treatment of @entity43 .

@entity43 :: ('MESH:D010051', 'Disease') :: ['ovarian cancer'] @entity1 :: ('9606', 'Species') :: ['patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity5 :: ('MESH:D009369', 'Disease') :: ['Cancer'] @entity3003 :: ('MESH:D016190', 'Chemical') :: ['carboplatin'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity1311 :: ('MESH:D017239', 'Chemical') :: ['paclitaxel'] @entity344 :: ('MESH:D005767', 'Disease') :: ['gastrointestinal and neurologic toxicity'] @entity1503 :: ('MESH:D006402', 'Disease') :: ['hematologic toxicity']
@entity900 :: (MESH:D002945,Chemical) :: ['cisplatin']
