Abstract background While neo-adjuvant anthracycline and taxane-based chemotherapy remains the standard of care for locally advanced TNBC, the optimal chemotherapy regimen is debatable. Anlotinib, a novel multi-target tyrosine kinase inhibitor that effectively inhibits VEGFR, FGFR, c-KIT, c-MET, and RET, monotherapy has been proven effective in HER-2 negative metastatic breast cancer. This study aims to evaluate the efficacy and safety of anlotinib combined with TEC in neo-adjuvant treatment for locally advanced TNBC, and to evaluate the value of predicting pathological response by multi-point core needle biopsy during neo-adjuvant therapy. method This study retrospectively analyzed 18 patients (Pts) with locally advanced triple-negative breast cancer who received anlotinib combined with TEC neo-adjuvant therapy and surgical treatment from August 2020 to January 2022 in the Breast Diagnosis and Treatment Center of Anhui Cancer Hospital. Pts with clinical stage IIb/III TNBC were to be treated with 6 cycles of anlotinib (12mg, d1-14, q3w) plus 6 cycles of docetaxel (75 mg/m2, d1, q3w), Epirubicin (90 mg/m2, d1, q3w) and cyclophosphamide (600 mg/m2, d1, q3w) followed by surgery. Before the fifth cycle of treatment, ultrasound-guided multi-point Core needle biopsy was performed to evaluate the efficacy of neo-adjuvant therapy and predict the pathological complete response, as well as to guide the selection of surgical methods. The primary endpoint was pathological complete response (pCR, ypT0/is). Result Eighteen pts, the median age was 48 years (range, 23-60), were included in the statistical analysis. All patients completed 6 cycles of anlotinib combined with TEC neo-adjuvant therapy followed by radical mastectomy for breast cancer. Regarding pathological response, there were 4 (22.2%), 2 (11.1%), and 12 (66.7%) patients realizing Miller-Payne grade G3, G4, and G5, respectively. Besides, 12 (66.7%) patients achieved pCR. Additionally, the accuracy of multi-point core needle biopsy in predicting pCR was 94.4% in the interval between neo-adjuvant therapy. The grade 3 or 4 AEs were neutropenia and thrombocytopenia in 3 cases each, anemia, arrhythmia, and ALT increased in cases 1 case each. One patient dropped out of the group due to tumor rupture and bleeding. conclusion Anlotinib combined with TEC as neo-adjuvant therapy showed manageable toxicity and promising antitumor activity for locally advanced TNBC. It is safe, reliable, feasible and accurate to evaluate the efficacy of neo-adjuvant therapy and to predict pathological complete response by multi-point core needle biopsy. It means that the clinical evaluation of neo-adjuvant therapy can transition from imaging evaluation to pathological evaluation, which is helpful for the choice of surgical methods. Citation Format: Kuojun Ren, Shikai Hong, Zhengzhi Zhu, Shengying Wang, Jianjun Liu, Hong Gao, Shuhan Wang. The Efficacy of Anlotinib Combined with TEC in Neo-adjuvant Treatment for Triple-Negative Breast Cancer and The Value of Multi-point Core Needle Biopsy in Prediction of Pathologic Complete Remission: A Retrospective analysis [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-01-08.
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