Long term follow-up of neoadjuvant chemotherapy with or without anthracyclines in the presence of trastuzumab in patients with HER2-positive breast cancer

BackgroundBecause Pertuzumab hasn't been approved in China until 2020y, trastuzumab has been standard neoadjuvant treatment for HER2-positive breast cancer. But we don't know which is the optimal chemotherapy in the trastuzumab-based HER2-blockade. We designed this clinical trial to compare efficacy and safety between anthracycline and carboplatin in combination with docetaxel and trastuzumab as neoadjuvant therapy. Now we reported the long-term follow-up data.MethodsFrom Apr, 2013 to Apr, 2019, 128 patients were enrolled. 63 patients were randomly assigned to the ATH-TH (doxorubicin/docetaxel/trastuzumab) group and 65 to the TCH (docetaxel/carboplatin/trastuzumab)group. The treatment plan is showed as following, 1. TCH group: Trastuzumab combined with carboplatin and docetaxel, total 6 cycles; 2. ATH-TH group: Trastuzumab combined with doxorubicin and docetaxel 4 cycles, followed by Trastuzumab plus docetaxel 4 cycles. Primary endpoint was pCR (ypT0/is/ypN0). Second endpoints included safety, event-free and overall survial (EFS and OS).ResultsBaseline Patients' characteristics were well balanced between ATH-TH group and TCH group: median age 50y/48y, hormone receptor positive 44.4% vs 46.2%, â… -â…¢A stage 79.4% VS 86.2%, IIIB-IIIC stage 20.6% VS 13.8%. The pCR rate was no significant difference (P=0.592) in ATH-TH 54.0% (95% CI:41.3%-66.6%) and TCH group 49.2% (95% CI :36.7%-61.7%). Seven-year EFS estimates were 85.6% for ATH-TH and 88.4% for TCH (p=0.767, HR=1.17, 95% CI: 0.42-3.21). Seven-year OS estimates were 94.4% for ATH-TH and 94.4%for TCH (p=0.691, HR=1.35, 95% CI: 0.31-5.90). Patients who achieved a pCR had improved EFS (p<0.001) and OS (p=0.003) compared with those who did not. The most common adverse events were hematologic toxicities. ATH-TH group had higher 3/4 grade leukocyte decrease rates than TCH group (91.9% VS 44.6%, p<0.001), ATH-TH group had more FN than (32.8% VS 3.1%, p<0.001).ConclusionsThis is the first prospective randomised trial comparing neoadjuvant therapy regimen ATH-TH with TCH in HER2-positive breast cancer of pCR and long-term survival data. We acquired similar pCR rate, seven-year EFS and OS but less toxicity in TCH group compared with ATH-TH.Clinical trial identificationNCT02510781.Legal entity responsible for the studyThe Fifth Medical Center of Chinese PLA General Hospital.FundingBeijing Municipal Natural Science Foundation.DisclosureAll authors have declared no conflicts of interest.