Longer trastuzumab duration ( hera : 2 years vs. 1 year ) showed no improvement in dfs or os and a higher rate of cardiac events .
In the neoadjuvant setting ( neoaltto , GeparQuinto , Neosphere ) , trastuzumab alone or in combination with another anti-her2 agent ( lapatinib , pertuzumab ) was compared with either lapatinib or pertuzumab alone and showed superior or equivalent rates of pathologic complete response .
In the adjuvant setting , lapatinib alone or in combination with trastuzumab , compared with trastuzumab alone ( altto ) or with placebo ( teach ) , was not superior in dfs .
BACKGROUND This systematic review addresses the question " What is the optimal targeted therapy for female patients with early-stage human epidermal growth factor receptor 2 (her2)-positive breast cancer ? "
2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial
BACKGROUND Trastuzumab has established efficacy against breast cancer with overexpression or amplification of the HER2 oncogene . The st and ard of care is 1 year of adjuvant trastuzumab , but the optimum duration of treatment is unknown . We compared 2 years of treatment with trastuzumab with 1 year of treatment , and up date d the comparison of 1 year of trastuzumab versus observation at a median follow-up of 8 years , for patients enrolled in the HERceptin Adjuvant ( HERA ) trial . METHODS The HERA trial is an international , multicentre , r and omised , open-label , phase 3 trial comparing treatment with trastuzumab for 1 and 2 years with observation after st and ard neoadjuvant chemotherapy , adjuvant chemotherapy , or both in 5102 patients with HER2-positive early breast cancer . The primary endpoint was disease-free survival . The comparison of 2 years versus 1 year of trastuzumab treatment involved a l and mark analysis of 3105 patients who were disease-free 12 months after r and omisation to one of the trastuzumab groups , and was planned after observing at least 725 disease-free survival events . The up date d intention-to-treat comparison of 1 year trastuzumab treatment versus observation alone in 3399 patients at a median follow-up of 8 years ( range 0 - 10 ) is also reported . This study is registered with Clinical Trials.gov , number NCT00045032 . FINDINGS We recorded 367 events of disease-free survival in 1552 patients in the 1 year group and 367 events in 1553 patients in the 2 year group ( hazard ratio [ HR ] 0·99 , 95 % CI 0·85 - 1·14 , p=0·86 ) . Grade 3 - 4 adverse events and decreases in left ventricular ejection fraction during treatment were reported more frequently in the 2 year treatment group than in the 1 year group ( 342 [ 20·4 % ] vs 275 [ 16·3 % ] grade 3 - 4 adverse events , and 120 [ 7·2 % ] vs 69 [ 4·1 % ] decreases in left ventricular ejection fraction , respectively ) . HRs for a comparison of 1 year of trastuzumab treatment versus observation were 0·76 ( 95 % CI 0·67 - 0·86 , p<0·0001 ) for disease-free survival and 0·76 ( 0·65 - 0·88 , p=0·0005 ) for overall survival , despite crossover of 884 ( 52 % ) patients from the observation group to trastuzumab therapy . INTERPRETATION 2 years of adjuvant trastuzumab is not more effective than is 1 year of treatment for patients with HER2-positive early breast cancer . 1 year of treatment provides a significant disease-free and overall survival benefit compared with observation and remains the st and ard of care . FUNDING F Hoffmann-La Roche ( Roche )
Longer trastuzumab duration ( hera : 2 years vs. 1 year ) showed no improvement in dfs or os and a higher rate of cardiac events .
In the neoadjuvant setting ( neoaltto , GeparQuinto , Neosphere ) , trastuzumab alone or in combination with another anti-her2 agent ( lapatinib , pertuzumab ) was compared with either lapatinib or pertuzumab alone and showed superior or equivalent rates of pathologic complete response .
In the adjuvant setting , lapatinib alone or in combination with trastuzumab , compared with trastuzumab alone ( altto ) or with placebo ( teach ) , was not superior in dfs .
BACKGROUND This systematic review addresses the question " What is the optimal targeted therapy for female patients with early-stage human epidermal growth factor receptor 2 (her2)-positive breast cancer ? "