Abstract P4-14-08: Apatinib combined with docetaxel and platinum as neoadjuvant treatment for triple-negative/HER2-positive breast cancer: A randomized, open-label, multicenter, phase 2 trial

Abstract

Abstract Background: Breast cancer is the most common cancer affecting women. Compared with other molecular subtypes, the triple-negative, HER2-positive breast cancer which have strong aggressiveness, high malignancy, poor prognosis and limited treatment. Neoadjuvant treatment can improved pathological complete response (pCR) outcomes, which pCR is associated with substantially improved outcomes in patients with triple-negative/HER2-positive. Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2 (VEGFR2), which is inhibits tumor angiogenesis.Xichun Hu and colleagues previously showed apatinib promising anti-tumour activity and acceptable tolerability in patients with triple-negative/non-tripe-negative metastatic breast cancer (MBC) in phase 2 trials. Objective: To evaluate the efficacy and safety of apatinib combined with docetaxel and platinum as neoadjuvant treatment for triple-negative/HER2-positive breast cancer. Method: Eligible women (aged ≥18 years) had stage IIb-IIIc triple-negative/HER2-positive breast cancer. Patients were randomly assigned to experimental group (docetaxel 75mg/m2 d1, carboplatin AUC=6 d1/cisplatin 75 mg/m2 d1/lobaplatin 30 mg/m2 d1, apatinib 500mg qd po) or control group (docetaxel 75mg/m2 d1, carboplatin AUC=6 d1/cisplatin 75 mg/m2 d1/lobaplatin 30mg/m2 d1), HER-2 positive patients were treated with trastuzumab. The primary end points were pathological complete response (pCR). The second endpoint includes the objective response rate (ORR) and adverse events (AEs). Results: Between September 2017 and March 2019, 20 patients were enrolled (Apatinib group, n=12; control group, n=8). The pCR was 75% in apatinib group versus 50% in control group, The ORR was 91.7% versus 75%. The triple-negative patients pCR was 75% versus 50%, ORR was 100% versus 66.7%; The HER2-positive patients pCR was 100% versus 50%, ORR was 100% versus 80%. The most common Grade 1 or 2 adverse events included fatigue (42.8%), hand-foot syndrome (33.3%), digestive tract reaction (26.9%), hypertension (23.8%) in apatinib group, digestive tract reaction (58.3%), neutropenia (37.5%) in control group. The Grade 3 adverse events included hand-foot syndrome (4.7%), rash (4.7%), hypertension (4.7%) in apatinib group. No deaths were reported during neoadjuvant treatment. Conclusion: Apatinib combined with docetaxel and platinum for neoadjuvant treatment can improved the pCR and ORR, and safety is tolerable. The therapeutic regime may be an option for triple-negative/HER2-positive breast cancer. Citation Format: Yunjiang Liu, Shuo Zhang. Apatinib combined with docetaxel and platinum as neoadjuvant treatment for triple-negative/HER2-positive breast cancer: A randomized, open-label, multicenter, phase 2 trial [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-14-08.