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 .
NSABP B-38: Definitive analysis of a randomized adjuvant trial comparing dose-dense (DD) AC→paclitaxel (P) plus gemcitabine (G) with DD AC→P and with docetaxel, doxorubicin, and cyclophosphamide (TAC) in women with operable, node-positive breast cancer.
LBA1000 Background : The primary aims were to determine whether adjuvant DD AC→PG will be superior to DD AC→P as well as to TAC in DFS and to compare the relative DFS of TAC and DD AC→P. Secondary endpoints include survival and toxicity . METHODS From Nov 3 , 2004 to May 3 , 2007 , 4894 women were r and omized ; 1630 to TAC ( docetaxel [ T ] 75 mg/m2 , doxorubicin [ A ] 50 mg/m2 , cyclophosphamide [ C ] 500 mg/m2 q3 wks x 6 ) , 1634 to DD AC→P ( A 60 mg/m2 and C 600 mg/m2 q2 wks x 4 followed by P 175 mg/m2 q2 wks x 4 ) , and  1630 to DD AC→PG ( A 60 mg/m2 and C 600 mg/m2 q2 wks x 4 → P 175 mg/m2 + G 2000 mg/m2q2 wks x 4 ) . Primary G-CSF support was required and erythropoiesis-stimulating agents ( ESA ) were used at investigator discretion . 52 % were postmenopausal , 65 % had 1 - 3 positive nodes , and 80 % had HR+ breast cancer . Log-rank tests were used for pair-wise comparisons of the primary ( DFS ) and secondary ( OS ) endpoints among the three treatment arms . RESULTS With 64 months median follow-up , 5-year DFS in DD AC→PG group was 80.6 % compared with 82.2 % in DD AC→P group ( HR=1.1 ; p=0.27 ) and 80.1 % ( HR=0.97 ; p=0.71 ) in TAC group . 5-year OS was 90.8 % in DD AC→PG group as compared with 89.1 % ( HR=.89 ; p=0.25 ) in DD AC→P group and 89.6 % ( HR=0.90 ; p=0.32 ) in TAC group . HR for DFS and OS  of DD AC→P vs. TAC were 0.89 ( p=0.14 ) and 1.01 ( p=0.92 ) respectively . Toxicities for TAC , DD AC→P , DD AC→PG , respectively : febrile neutropenia ( Gr 3/4 : 9 % , 4 % , 4 % [ p<0.001 ] ) , sensory neuropathy ( Gr 3/4 : < 1 % , 7 % , 6 % [ p<0.001 ] ) , diarrhea ( Gr 3/4 : 8 % , 2 % , 2 % [ p<0.001 ] ) . Hgb was < 10 in 12 % , 26 % , 33 % with ESA use in 35.2 % , 47 % , 51.6 % and transfusions in 3.7 % , 6.3 % , 9.4 % . Deaths on treatment : N=13 , 5 , 7 ( p=0.2 ) . AML/MDS N=5 , 8 , 11 . All cycles completed in 91 % for TAC and 88 % for DD regimens . CONCLUSIONS Addition of G to DD AC→P did not improve outcomes . No significant differences in efficacy endpoints were identified between DD AC→P and TAC , though toxicity profiles differed . FUNDING NCI PHS U10-CA-37377 , -69974 , -12027 , -69651 and NCCTG U10-CA25224 , with additional funding from Eli Lilly & Company , 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 .