Trastuzumab Administered Concurrently Or Sequentially With Anthracycline-containing Adjuvant Regimen For HER-2Positive Breast Cancer

Objective To investigate the safety and efficacy of trastuzumab anthracycline-containing adjuvant chemotherapy with trastuzumab concurrently or sequentially in HER-2postive breast cancer patients.Methods It was a prospective, randomized and controlled trial. Each patient underwent breast modified radical surgery or conservative surgery,with HER-2positive breast cancer regardless of hormone receptor status.Participants were randomized to receive trastuzumab administered concurrently or sequentially with anthracycline-containing adjuvant regimen. The primary endpoint was cardiac function,while the second endpoints were disease-free survival (DFS) and overall survival (OS).Each arm was followed up every3month.Cardiac function and prognosis information was acquired by telephone,including no events,death,local recurrence and distant metastasis.Statistical analysis was conducted by spss17.0.T test,X2test and Fisher exact test,Kaplan-Meier method were engaged in mean comparision,comparision of count data and analysis of survival data respectively.Results One hundred and ninty-six breast cancer patients were enrolled and randomized in this trial. Ninty-eight participants received trastuzumab administered concurrently with nthracycline-containing adjuvant regimen with others was allocated to control group. As for asymptomatic decrease in left ventricular ejection fraction (LVEF),there was no difference between concurrent and sequential group in cardiac event rates (11.2%vs15.3%, P=0.400), neither was LVEF values at basline or at3,6,9,12and24months after administration of chemotheray (P>0.05).5patients (5.1%) and11patients (11.2%) develop local recurrences or distant metastases in concurrent and sequential group respectively.There was no statistically significant difference between two groups in terms of DFS (P=0.485) and death rate.Conclusions Trastuzumab administered concurrently with anthracycline could be considered as an safe adjuvant regimen for HER-2positive breast cancer without compromise of cardiac function.Further research should focus on the relationship between efficacy and timing of trastuzumab administration.