[Efficacy and safety of neoadjuvant apatinib in combination with dose-dense paclitaxel and carboplatin in locally advanced triple negative breast cancer patients].

Objective: To observe the short-term efficacy and safety of apatinib in combination with dose-dense paclitaxel and carboplatin in locally advanced triple-negative breast cancer (TNBC) patients. Methods: From September 2018 to September 2019, 17 stage Ⅱ/Ⅲ TNBC patients were enrolled in this single arm, single center prospective phase Ⅱ study. They received neoadjuvant treatment of apatinib 250 mg per day, paclitaxel 175 mg/m(2) on 1(st) day and a dose of carboplatin according to the area under curve (AUC)=4 on 2(nd) day, every 14 days as a cycle. Results: By January 2020, 16 cases completed 4-7 cycles of apatinib treatment and 4-8 cycles of chemotherapy. The median cycles of apatinib treatment and chemotherapy were 5 cycles and 6 cycles, respectively. Two cases achieved complete responses (CR), 12 achieved partial responses (PR), 2 achieved stable diseases (SD) and no progressive disease was observed. The objective response rate (ORR) was 87.5%, disease control rate (DCR) was 100%. By January 2020, among 12 patients who received surgery, 8 achieved pathologic complete response (pCR, 66.7%). The grade Ⅲ/Ⅳ adverse events included: neutropenia, thrombocytopenia in 3 cases (18.8%) each, anemia, fatigue, arrhythmia and alanine aminotransferase (ALT) elevation in 1 case each. Apatinib was interrupted in 5 cases, and was discontinued in 3 cases; chemotherapy dosage was reduced in 1 case. Conclusion: Apatinib in combination with dose-dense paclitaxel and carboplatin neoadjuvant therapy are effective and well tolerated in locally advanced TNBC patients.