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document
[ Safety of adjuvant dose-dense chemotherapy with paclitaxel and epirubicin for high-risk breast cancer ] . OBJECTIVE To investigate the safety and tolerance of adjuvant dose-dense chemotherapy with paclitaxel and epirubicin for high-risk breast cancer . METHODS From January 2004 to December 2006 , 101 patients with high-risk breast cancer after surgical resection were enrolled into this study . The patients were divided into two groups : dose-dense and regular groups . Each patient received 6 cycles of chemotherapy with intravenous administration of paclitaxel ( 175 mg/m2 , on D3 ) and epirubicin ( 60 mg/m2 , on Dl and D2 ) . The dose-dense group had repeated treatment every two weeks , while the regular group repeated it every three weeks . G-CSF was used in a dose of 3 microg/kg on D5-D9 during each cycle in the dose-dense group . While in the regular group , it was used only under the condition that grade II neutropenia occurred . RESULTS The toxicity could be evaluated in 101 patients . Major grade II-IV toxicities included : neutropenia , nausea , vomiting and alopecia . The incidence of grade III-IV neutropenia was 16.0 % in the dose-dense group versus 54.9 % in the regular group ( P = 0.000 ) ; postponing of chemotherapy was 2.4 % versus 6.0 % ( P = 0.027 ) . Ninety-eight patients completed the chemotherapy as planed . After a median follow-up of 24 months , the median DFS and OS were not reached . The relapse-free rate and survival rate were 89.8 % and 100 % in the dose-dense group , which were 87.8 % and 93.9 % in the regular group . The relapse-free rate of the high-risk patients in the dose-dense group was 86.8 % versus 81.3 % in the regular group , and the corresponding survival rate was 100 % versus 90.6 % . CONCLUSION Adjuvant dose-dense chemotherapy with paclitaxel and epirubicin is safe , tolerable and promising for high-risk breast cancer .
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Intervention_Pharmacological
adjuvant dose-dense chemotherapy with paclitaxel and epirubicin
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Intervention_Pharmacological
adjuvant dose-dense chemotherapy with paclitaxel and epirubicin
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Intervention_Pharmacological
6 cycles of chemotherapy with intravenous administration of paclitaxel ( 175 mg/m2 , on D3 ) and epirubicin ( 60 mg/m2 , on Dl and D2 ) .
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Intervention_Control
dose-dense group had repeated treatment every two weeks
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Intervention_Educational
regular group repeated it every three weeks
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Intervention_Pharmacological
G-CSF was used in a dose of 3 microg/kg on D5-D9
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Intervention_Pharmacological
Adjuvant dose-dense chemotherapy with paclitaxel and epirubicin
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Outcome_Other
safety and tolerance
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Outcome_Adverse-effects
toxicity
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Outcome_Adverse-effects
Major grade II-IV toxicities included : neutropenia
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Outcome_Adverse-effects
nausea
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Outcome_Adverse-effects
vomiting and alopecia
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Outcome_Physical
grade III-IV neutropenia
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Outcome_Physical
median DFS and OS
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Outcome_Mortality
relapse-free rate and survival rate
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Participant_Condition
high-risk breast cancer
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Participant_Condition
high-risk breast cancer
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Participant_Sample-size
101 patients
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Participant_Condition
high-risk breast cancer after surgical resection
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Participant_Sample-size
101 patients
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Participant_Sample-size
Ninety-eight patients completed the
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Participant_Condition
high-risk breast cancer