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document
Weekly docetaxel with or without gemcitabine as second-line chemotherapy in paclitaxel-pretreated patients with metastatic breast cancer : a randomized phase II study conducted by the Hellenic Co-Operative Oncology Group . OBJECTIVE A randomized phase II trial was conducted to test whether the addition of gemcitabine to weekly docetaxel could improve the objective response rate and survival outcomes as second-line chemotherapy in patients with metastatic breast cancer who have failed a paclitaxel-containing regimen . METHODS Patients were randomized to receive either weekly docetaxel 40 mg/m ( 2 ) ( group A , n = 34 ) or the combination of weekly docetaxel 35 mg/m ( 2 ) with gemcitabine 600 mg/m ( 2 ) ( group B , n = 41 ) . Three consecutive weekly infusions followed by a 1-week rest period represented 1 chemotherapy cycle . RESULTS The objective response rate was 18 % and 27.5 % in group A and B , respectively ( p = 0.413 ) . No statistically significant differences were demonstrated in terms of median overall survival and time to disease progression . The rate and grade 3 and 4 neutropenia were higher in group B ( 23 vs. 3 % ) . CONCLUSIONS The weekly administration of docetaxel and gemcitabine did not result in superior clinical outcomes over weekly docetaxel .
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
gemcitabine
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Intervention_Pharmacological
second-line chemotherapy
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Intervention_Pharmacological
paclitaxel-pretreated
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Intervention_Pharmacological
gemcitabine
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
paclitaxel-containing
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Intervention_Pharmacological
docetaxel 40 mg/m ( 2 )
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Intervention_Pharmacological
docetaxel 35 mg/m ( 2 ) with gemcitabine
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Intervention_Pharmacological
chemotherapy
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Intervention_Pharmacological
docetaxel
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Intervention_Pharmacological
gemcitabine
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Outcome_Physical
objective response rate
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Outcome_Mortality
survival outcomes
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Outcome_Other
objective response rate
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Outcome_Mortality
median overall survival
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Outcome_Physical
time to disease progression
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Outcome_Physical
rate and grade 3 and 4 neutropenia
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Outcome_Physical
clinical outcomes
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Participant_Condition
paclitaxel-pretreated patients
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Participant_Condition
metastatic breast cancer
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Participant_Condition
metastatic breast cancer
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Participant_Condition
failed a paclitaxel-containing regimen