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Phase III trial of induction gemcitabine or paclitaxel plus carboplatin followed by paclitaxel consolidation in ovarian cancer . OBJECTIVE The safety and efficacy of gemcitabine plus carboplatin ( GC ) or paclitaxel plus carboplatin ( TC ) induction regimens with or without paclitaxel consolidation therapy were assessed in ovarian cancer ( OC ) . METHODS Patients with stage IC-IV OC were randomized to either GC ( gemcitabine 1,000 mg/m ( 2 ) , days 1 and 8 , plus carboplatin area under the curve [ AUC ] 5 , day 1 ) or TC ( paclitaxel 175 mg/m ( 2 ) plus carboplatin AUC 6 , day 1 ) every 21 days for up to six cycles . Patients with complete response ( CR ) were allowed optional consolidation with paclitaxel 135 mg/m ( 2 ) every 28 days for ≤ 12 months . Patients without CR received single-agent crossover therapy at induction doses/schedules until CR , disease progression ( PD ) , or unacceptable toxicity . PD or death in 636 patients was required to compare induction arms with 80 % statistical power for progression-free survival ( PFS ) , the primary endpoint . RESULTS Randomized induction therapy was received by 820 of 919 patients enrolled ; 352 patients with CR received paclitaxel consolidation whereas 155 patients without CR received single-agent crossover therapy . PFS was similar for GC and TC ( median , 20.0 and 22.2 months , respectively ; P=.199 ) . Despite high censoring rates ( > 52 % ) , overall survival was longer for TC ( median , 57.3 versus 43.8 months for GC ; P=.013 ) . Controlling for patient characteristics including performance status , residual tumor size , and tumor stage , there was no statistical difference in a multivariate analysis ( HR=1.22 ; 95 % CI=0.99-1.52 ; P=.067 ) . CONCLUSIONS GC does not improve PFS over TC as first-line induction chemotherapy in OC . Although favoring TC , overall survival analyses were limited by the study design and high censoring rates .
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Intervention_Pharmacological
induction gemcitabine
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Intervention_Pharmacological
paclitaxel plus carboplatin followed by paclitaxel consolidation
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Intervention_Pharmacological
gemcitabine plus carboplatin ( GC ) or paclitaxel plus carboplatin ( TC ) induction regimens with or without paclitaxel
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Intervention_Pharmacological
GC ( gemcitabine
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Intervention_Pharmacological
plus carboplatin
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Intervention_Pharmacological
TC ( paclitaxel
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Intervention_Pharmacological
plus carboplatin AUC 6
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Intervention_Pharmacological
paclitaxel
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Outcome_Physical
complete response ( CR )
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Participant_Condition
ovarian cancer
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Participant_Condition
ovarian cancer ( OC ) .
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Participant_Condition
Patients with stage IC-IV OC
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Participant_Condition
Patients with complete response ( CR )
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Participant_Condition
toxicity
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Participant_Sample-size
636
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Participant_Sample-size
820
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Participant_Sample-size
919
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Participant_Sample-size
352
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Participant_Sample-size
155