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document
Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer : phase III trial results . PURPOSE Docetaxel and capecitabine , a tumor-activated oral fluoropyrimidine , show high single-agent efficacy in metastatic breast cancer ( MBC ) and synergy in preclinical studies . This international phase III trial compared efficacy and tolerability of capecitabine/docetaxel therapy with single-agent docetaxel in anthracycline-pretreated patients with MBC . PATIENTS AND METHODS Patients were randomized to 21-day cycles of oral capecitabine 1,250 mg/m ( 2 ) twice daily on days 1 to 14 plus docetaxel 75 mg/m ( 2 ) on day 1 ( n = 255 ) or to docetaxel 100 mg/m ( 2 ) on day 1 ( n = 256 ) . RESULTS Capecitabine/docetaxel resulted in significantly superior efficacy in time to disease progression ( TTP ) ( hazard ratio , 0.652 ; 95 % confidence interval [ CI ] , 0.545 to 0.780 ; P =.0001 ; median , 6.1 v 4.2 months ) , overall survival ( hazard ratio , 0.775 ; 95 % CI , 0.634 to 0.947 ; P =.0126 ; median , 14.5 v 11.5 months ) , and objective tumor response rate ( 42 % v 30 % , P =.006 ) compared with docetaxel . Gastrointestinal side effects and hand-foot syndrome were more common with combination therapy , whereas myalgia , arthralgia , and neutropenic fever/sepsis were more common with single-agent docetaxel . More grade 3 adverse events occurred with combination therapy ( 71 % v 49 % , respectively ) , whereas grade 4 events were slightly more common with docetaxel ( 31 % v 25 % with combination ) . CONCLUSION The significantly superior TTP and survival achieved with the addition of capecitabine to docetaxel 75 mg/m ( 2 ) , with the manageable toxicity profile , indicate that this combination provides clear benefits over single-agent docetaxel 100 mg/m ( 2 ) . Docetaxel/capecitabine therapy is an important treatment option for women with anthracycline-pretreated MBC .
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Intervention_Pharmacological
capecitabine
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Intervention_Pharmacological
docetaxel combination therapy
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Intervention_Pharmacological
Docetaxel
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Intervention_Pharmacological
capecitabine
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Intervention_Pharmacological
capecitabine/docetaxel therapy
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Intervention_Pharmacological
single-agent docetaxel
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Intervention_Pharmacological
capecitabine
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
Capecitabine/docetaxel
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
combination therapy
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Intervention_Pharmacological
single-agent docetaxel
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
addition of capecitabine to docetaxel
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Intervention_Pharmacological
single-agent docetaxel
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Intervention_Pharmacological
Docetaxel/capecitabine therapy
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Outcome_Mortality
survival
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Outcome_Other
efficacy and tolerability
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Outcome_Other
efficacy
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Outcome_Physical
time to disease progression ( TTP )
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Outcome_Mortality
overall survival
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Outcome_Physical
objective tumor response rate
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Outcome_Adverse-effects
Gastrointestinal side effects and hand-foot syndrome
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Outcome_Adverse-effects
myalgia , arthralgia
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Outcome_Adverse-effects
neutropenic fever/sepsis
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Outcome_Adverse-effects
grade 3 adverse events
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Outcome_Adverse-effects
grade 4 events
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Outcome_Mortality
TTP and survival
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Outcome_Physical
toxicity profile
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Participant_Condition
anthracycline-pretreated patients with advanced breast cancer
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Participant_Condition
anthracycline-pretreated patients with MBC
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Participant_Sex
women
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Participant_Condition
anthracycline-pretreated MBC