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Phase III trial of gemcitabine plus docetaxel versus capecitabine plus docetaxel with planned crossover to the alternate single agent in metastatic breast cancer . BACKGROUND Safety and efficacy of gemcitabine plus docetaxel ( GD ) and capecitabine plus docetaxel ( CD ) were compared in patients with metastatic breast cancer , where the alternate crossover monotherapy ( GD→C or CD→G ) was predetermined . PATIENTS AND METHODS Patients were randomly assigned to 3-week cycles of either gemcitabine 1000 mg/m ( 2 ) on days 1 and 8 plus docetaxel 75 mg/m ( 2 ) on day 1 or capecitabine 1000 mg/m ( 2 ) twice daily on days 1-14 plus docetaxel 75 mg/m ( 2 ) day 1 . Upon progression , patients received crossover monotherapy . Primary end point was time to progression ( TtP ) . Secondary end points evaluated overall response rate ( ORR ) , overall survival ( OS ) , and adverse events ( AEs ) . RESULTS Despite over-accrual of 475 patients , the trial matured with only 324 of 385 planned TtP events due to patient discontinuations . Human epidermal growth factor receptor 2 status was not captured in this study . More CD patients ( 28 % ) discontinued due to AEs than GD patients ( 18.0 % , P = 0.009 ) . TtP [ hazard ratio ( HR ) = 1.101 , 95 % confidence interval ( CI ) 0.885-1.370 , P = 0.387 ] and OS ( HR = 1.031 , 95 % CI 0.830-1.280 , P = 0.785 ) were not significantly different comparing GD and CD . ORR was not statistically different ( P = 0.239 ) comparing GD ( 72 of 207 , 34.8 % ) and CD ( 78 of 191 , 40.8 % ) . TtP , OS , and ORR were not significantly different comparing crossover groups . GD caused greater fatigue , hepatotoxicity , neutropenia , and thrombocytopenia but not febrile neutropenia ; CD caused more hand-foot syndrome , gastrointestinal toxicity , and mucositis . CONCLUSIONS GD and CD produced similar efficacy and toxicity profiles consistent with prior clinical experience .
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Intervention_Pharmacological
gemcitabine plus docetaxel
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Intervention_Pharmacological
capecitabine plus docetaxel
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Intervention_Pharmacological
gemcitabine plus docetaxel ( GD )
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Intervention_Pharmacological
capecitabine plus docetaxel ( CD )
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Outcome_Other
Safety and efficacy
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Participant_Condition
metastatic breast cancer .
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Participant_Condition
metastatic breast cancer
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Participant_Sample-size
475
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Participant_Sample-size
324 of 385