Intensified neoadjuvant platinum based chemotherapy regimen for locally advanced triple negative breast cancer

Introduction: The high proliferative potential of triple negative breast cancer (TNBC) determines the importance of intensifying neoadjuvant chemotherapy regimens. Patients and methods: 80 patients (pts) with locally advanced TNBC (stages IIIA, IIIB, IIIC) were included in a nonrandomized single-arm phase II study. All pts received neoadjuvant chemotherapy: doxorubicin 40 mg/m2 IV, paclitaxel 160 mg/m2 IV, cisplatin 50 mg/m2 IV; all drugs were administered on the 1st day. It was planned to conduct 8 courses with an interval of 2 weeks (with colony-stimulating factors) followed by surgical treatment and pathological assessment. The primary end point was the rate of pathological complete response (pCR); the second end points were 5-year overall survival (OS), disease-free survival (DFS) and toxicity. Statistical hypothesis: it was expected that the use of a new intensified regimen of neoadjuvant chemotherapy would increase the incidence of pCR from 40% to 60%. Given the level of type 1 error (α = 0,05) and type 2 error (β = 0,2), 77 pts had to be included in the study. Under these conditions, the power of the study was 80%. Results: the rate of pCR was 62.5% (95% CI 50,9–73,1); 5-year OS – 74%, 5-year DFS – 69%. The main toxicity was: anemia (98.7% pts, including gr. 3 – 37,5% pts); neutropenia (85.0% pts, including gr. 3–4 – 57,5% pts; febrile neutropenia – 3,7% pts); nausea (100% pts, including gr. 3 – 3,8% pts), polyneuropathy (50.0% pts, including gr. 3 – 8,7% pts). Conclusion: the rate of pCR was 62.5%, which corresponds to the statistical hypothesis with the stated frequency of this indicator of more than 60%. High efficacy and controlled toxicity allow us to consider the studied regimen as one of the possible options for neoadjuvant chemotherapy for locally advanced TNBC