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document
Gemcitabine and split-dose paclitaxel or docetaxel in metastatic breast cancer : a randomised phase II study . PURPOSE The purpose was to evaluate the activity and toxicity of split-dose paclitaxel or docetaxel in combination with gemcitabine in patients with metastatic breast cancer ( MBC ) who had previously received anthracyclines . PATIENTS AND METHODS A total of 210 patients were randomly assigned to one of three treatment arms : gemcitabine 1,250 mg/m ( 2 ) Days 1 and 8 and paclitaxel 175 mg/m ( 2 ) as a 3-h infusion on Day 1 ( GP1 ) ; gemcitabine 1,000 mg/m ( 2 ) Days 1 and 8 and paclitaxel 100 mg/m ( 2 ) as a 1-h infusion on Days 1 and 8 ( GP2 ) ; gemcitabine 1,000 mg/m ( 2 ) Days 1 and 8 and docetaxel 40 mg/m ( 2 ) as a 1-h infusion on Days 1 and 8 ( GD ) . Cycles were repeated every 3 weeks . RESULTS For the 204 patients evaluable for response assessment , the response rates were 48.6 % for GP1 , 52.2 % for GP2 , and 52.3 % for GD . Median response duration , time to treatment failure , and time to progression ( TTP ) were similar in each arm . Median TTP for GP1 , GP2 and GD was 7.5 , 7.0 and 7.4 months , respectively . For the 208 patients evaluable for safety , the most common grade 3/4 toxicity for each regimen was neutropaenia , with 64 % , 57 % , and 68 % for GP1 , GP2 , and GD , respectively . Grade 4 neutropaenia , grade 3/4 anaemia , febrile neutropaenia , and diarrhoea were more common in the docetaxel arm , as was the use of intravenous antibiotics and blood transfusions . CONCLUSION The study confirmed the high activity of gemcitabine-taxane combinations in MBC . Split-dose paclitaxel had similar activity and toxicity to the 3-weekly administration . The split-dose docetaxel regimen had similar activity to the paclitaxel combinations though associated with higher toxicity .
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Intervention_Pharmacological
Gemcitabine
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Intervention_Pharmacological
paclitaxel
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
split-dose paclitaxel
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
combination with gemcitabine
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Intervention_Pharmacological
gemcitabine 1,250 mg/m ( 2 ) Days 1 and 8 and paclitaxel 175 mg/m ( 2 ) as a 3-h infusion on Day 1 ( GP1 )
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Intervention_Pharmacological
gemcitabine 1,000 mg/m ( 2 ) Days 1 and 8 and paclitaxel 100 mg/m ( 2 ) as a 1-h infusion on Days 1 and 8 ( GP2 )
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Intervention_Pharmacological
gemcitabine 1,000 mg/m ( 2 ) Days 1 and 8 and docetaxel 40 mg/m ( 2 ) as a 1-h infusion on Days 1 and 8 ( GD
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Intervention_Pharmacological
gemcitabine-taxane combinations
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Intervention_Pharmacological
paclitaxel
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
paclitaxel combinations
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Outcome_Other
activity and toxicity
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Outcome_Physical
response rates
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Outcome_Other
Median response duration
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Outcome_Other
time to treatment failure
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Outcome_Other
time to progression ( TTP )
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Outcome_Other
safety
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Outcome_Other
toxicity
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Outcome_Adverse-effects
neutropaenia
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Outcome_Adverse-effects
neutropaenia
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Outcome_Adverse-effects
anaemia
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Outcome_Adverse-effects
febrile neutropaenia
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Outcome_Adverse-effects
diarrhoea
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Outcome_Other
toxicity
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Participant_Condition
metastatic breast cancer
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Participant_Sample-size
210
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Participant_Sample-size
204
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Participant_Sample-size
208