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 .
First analysis of SWOG S0221: A phase III trial comparing chemotherapy schedules in high-risk early breast cancer.
1004 Background : AC+G ( doxorubicin 24 mg/m2/week x 15 , cyclophosphamide 60 mg/m2/day po , and filgrastim daily except on the days of doxorubicin administration ) produced encouraging results in a SWOG Phase II trial of pre-operative chemotherapy in locally advanced breast cancer . S0221 is a SWOG-coordinated Phase III adjuvant chemotherapy intergroup trial in node-positive and high-risk node-negative operable breast cancer , which hypothesized that the AC+G regimen is superior to ddAC ( doxorubicin 60 mg/m2 , cyclophosphamide 600 mg/m2 IV and pegfilgrastim q 2 weeks x 6 ) and that weekly paclitaxel is superior to q 2 week paclitaxel . METHODS Between December 2003 and November 2010 , 2716 patients were r and omized in a 2x2 factorial design to 1 ) AC+G vs ddAC and 2 ) paclitaxel 80 mg/m2/week x 12 vs paclitaxel 175 mg/m2 q 2 weeks x 6 . If there was no significant interaction between the factors , the trial was powered to find a disease-free survival hazard ratio ( HR ) ≤ 0.82 for weekly vs q 2 week for each factor . RESULTS By September 8 , 2010 , 349 events ( 161 ddAC , 188 AC+G ) had occurred among 2,477 patients with follow-up , prompting the first planned interim analysis at 30 % of the expected events . The arms were balanced for st and ard prognostic factors , and a Cox model adjusting for the paclitaxel arms had a HR = 1.21 ( 95 % CI 0.98 - 1.50 ; p=0.071 ) favoring ddAC . The prescribed boundary for futility was the 99.5 % CI ( 0.90 - 1.64 ) excluding the original alternative hypothesis that HR=0.82 . No boundary was crossed for the paclitaxel comparison and there was no significant interaction of the two factors . Therefore , the Data Safety and Monitoring Committee recommended stopping r and omization to the AC+G arms due to futility . Analyses by nodal- , hormone-receptor- , and HER2 status found no subset in which AC+G appeared superior . S0221 has re-opened and r and omizes patients to the two paclitaxel arms after only 4 cycles of ddAC . CONCLUSIONS Accrual will continue to 3,250 patients and ancillary studies remain ongoing . We conclude that AC+G is not superior to ddAC x 6 , and do not recommend AC+G for routine use . Support : NCI grants CA32102 , CA38926 , CA21115 , CA21076 , CA77597 , CA25224 , CA77202 , CCSRI15469 , and Amgen ,
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 .