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 .
S0221: Comparison of two schedules of paclitaxel as adjuvant therapy for breast cancer.
CRA1008 Background : 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 1 ) the weekly AC+G regimen is superior to ddAC x 6 and 2 ) 12 weeks of weekly paclitaxel ( wP ) is superior to q 2 week paclitaxel x 6 ( ddP ) . METHODS Between December 2003 and November 2010 , 2,716 patients were r and omized in a 2 x 2 factorial design to 1 ) AC+G vs ddAC and 2 ) P 80 mg/m2/week x 12 vs P 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 . At the first interim analysis , the AC r and omization was halted for futility , and S0221 was closed to accrual 10 November 2010 . S0221 reopened 15 December 2010 , after which time all patients received 4 cycles of ddAC and r and omization to P weekly x 12 and ddP x 6 continued . Accrual halted at a total of 3,294 in January 2012 . RESULTS By September 7 , 2012 , 487 events and 340 deaths had occurred , prompting the third planned interim analysis . The Data Safety and Monitoring Committee recommended reporting the results since the futility boundary was crossed . A Cox model adjusting for the AC arms had a HR = 1.08 ( 95 % CI 0.90 - 1.28 ; p=0.42 ) , with the 99.5 % CI excluding the original alternative hypothesis that the HR=0.82 . There was no significant interaction of the two factors . Estimated 5-year progression-free survivals were 82 % for weekly P and 81 % for ddP. Toxicity data were available for 1,385 patients treated with ddP and 1,367 treated with weekly P. Grade 5 toxicity occurred in 4 patients on ddP and 2 on weekly P. Percent grade 3 - 4 toxicity per arm are shown in the Table . CONCLUSIONS Either ddPx6 or weekly P x 12 are acceptable schedules of P administration . The differences in leukopenia likely reflect ascertainment bias against weekly P. If this is accepted , weekly P x 12 produces less overall toxicity than 6 cycles of ddP. Support : NCI grants CA32102 , CA38926 , CA21115 , CA21076 , CA77597 , CA25224 , CA77202 , CCSRI15469 , and Amgen , Inc. CLINICAL TRIAL INFORMATION NCT00070564 . [ Table : see text ]
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 .