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 -/ - TNBC patients were enrolled in this single arm, single center prospective phase - study. They received neoadjuvant treatment of apatinib 250 mg per day, paclitaxel 175 mg/ m2 on 1st day and a dose of carboplatin according to the area under curve (AUC)= 4 on 2nd 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 -/ - 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.