In general , single-agent chemotherapy is not recommended for the adjuvant treatment of breast cancer in any patient population .
Anthracycline-taxane-based polychemotherapy regimens are , overall , considered superior to earlier-generation regimens and have the most significant impact on patient survival outcomes .
Regimens with varying anthracycline and taxane doses and schedules are options ; in general , paclitaxel given every 3 weeks is inferior .
Evidence does not support the use of bevacizumab in the adjuvant setting ; other systemic therapy agents such as metformin and vaccines remain investigatory .
BACKGROUND The Program in Evidence -Based Care ( pebc ) of Cancer Care Ontario recently created an evidence -based consensus guideline on the systemic treatment of early breast cancer .
The evidence for the guideline was compiled using a systematic review to answer the question " What is the optimal systemic therapy for patients with early-stage , operable breast cancer , when patient and disease factors are considered ? "
The question was addressed in three parts : cytotoxic chemotherapy , endocrine treatment , and human epidermal growth factor receptor 2 (her2)-directed therapy .
Adjuvant docetaxel, doxorubicin, and cyclophosphamide in node-positive breast cancer: 10-year follow-up of the phase 3 randomised BCIRG 001 trial.
BACKGROUND We compared st and ard adjuvant anthracycline chemotherapy with anthracycline-taxane combination chemotherapy in women with operable node-positive breast cancer . Here we report the final , 10-year follow-up analysis of disease-free survival , overall survival , and long-term safety . METHODS BCIRG 001 was an open label , phase 3 , multicentre trial in which 1491 patients aged 18 - 70 years with node-positive , early breast cancer and a Karnofsky score of 80 % or more were r and omly assigned to adjuvant treatment with docetaxel , doxorubicin , and cyclophosphamide ( TAC ) or fluorouracil , doxorubicin , and cyclophosphamide ( FAC ) every 3 weeks for six cycles . R and omisation was stratified according to institution and number of involved axillary lymph nodes per patient ( one to three vs four or more ) . Disease-free survival was the primary endpoint and was defined as the interval between r and omisation and breast cancer relapse , second primary cancer , or death , whichever occurred first . Efficacy analyses were based on the intention-to-treat principle . BCIRG 001 is registered with Clinical Trials.gov , number NCT00688740 . FINDINGS Enrolement took place between June 11 , 1997 and June 3 , 1999 ; 745 patients were assigned to receive TAC and 746 patients were assigned to receive FAC .  After a median follow-up of 124 months ( IQR 90 - 126 ) , disease-free survival was 62 % ( 95 % CI 58 - 65 ) for patients in the TAC group and 55 % ( 51 - 59 ) for patients in the FAC group ( hazard ratio [ HR ] 0·80 , 95 % CI 0·68 - 0·93 ; log-rank p=0·0043 ) . 10-year overall survival was 76 % ( 95 % CI 72 - 79 ) for patients in the TAC group and 69 % ( 65 - 72 ) for patients in the FAC group ( HR 0·74 , 0·61 - 0·90 ; log-rank p=0·0020 ) . TAC improved disease-free survival  relative to FAC irrespective of nodal , hormone receptor , and HER2 status , although not all differences were significant in these subgroup analyses . Grade 3 - 4 heart failure occurred in 26 ( 3 % ) patients in the TAC group and 17 ( 2 % ) patients in the FAC group , and caused death in two patients in the TAC group and four patients in the FAC group . A substantial decrease in left ventricular ejection fraction ( defined as a relative decrease from baseline of 20 % or more ) was seen in 58 ( 17 % ) patients who received TAC and 41 ( 15 % ) patients who received FAC . Six patients who received TAC developed leukaemia or myelodysplasia , as did three patients who received FAC . INTERPRETATION Our results provide evidence that the initial therapeutic outcomes seen at the 5-year follow-up with a docetaxel-containing adjuvant regimen are maintained at 10 years . However , a substantial percentage of patients had a decrease in left ventricular ejection fraction , probably caused by anthracycline therapy , which warrants further investigation . FUNDING Sanofi
In general , single-agent chemotherapy is not recommended for the adjuvant treatment of breast cancer in any patient population .
Anthracycline-taxane-based polychemotherapy regimens are , overall , considered superior to earlier-generation regimens and have the most significant impact on patient survival outcomes .
Regimens with varying anthracycline and taxane doses and schedules are options ; in general , paclitaxel given every 3 weeks is inferior .
Evidence does not support the use of bevacizumab in the adjuvant setting ; other systemic therapy agents such as metformin and vaccines remain investigatory .
BACKGROUND The Program in Evidence -Based Care ( pebc ) of Cancer Care Ontario recently created an evidence -based consensus guideline on the systemic treatment of early breast cancer .
The evidence for the guideline was compiled using a systematic review to answer the question " What is the optimal systemic therapy for patients with early-stage , operable breast cancer , when patient and disease factors are considered ? "
The question was addressed in three parts : cytotoxic chemotherapy , endocrine treatment , and human epidermal growth factor receptor 2 (her2)-directed therapy .