Carboplatin plus taxanes are non-inferior to epirubicin plus cyclophosphamide followed by taxanes as adjuvant chemotherapy for early triple-negative breast cancer

• Published in: Breast cancer research and treatment 2020-07, Vol.182 (1), p.67-77
• Main Authors: Du, Feng, Wang, Wenmiao, Wang, Yongsheng, Li, Ming, Zhu, Anjie, Wang, Jiayu, Cai, Ruigang, Ma, Fei, Fan, Ying, Li, Qing, Zhang, Pin, Todorovic, Vladimir, Yuan, Peng, Xu, Binghe
• Format: Article
• Language: English
• Subjects: Adjuvant treatment; Alopecia; Anthracycline; Anthracyclines; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Breast cancer; Cancer; Cancer research; Carboplatin; Carboplatin - administration & dosage; Care and treatment; Chemotherapy; Chemotherapy, Adjuvant - mortality; Clinical Trial; Cyclophosphamide; Cyclophosphamide - administration & dosage; Docetaxel - administration & dosage; Epirubicin; Epirubicin - administration & dosage; Equivalence Trials as Topic; Female; Follow-Up Studies; Gene mutations; Humans; Medicine; Medicine & Public Health; Metastases; Metastasis; Middle Aged; Oncology; Paclitaxel; Paclitaxel - administration & dosage; Patients; PD-L1 protein; Platinum; Prognosis; Prospective Studies; Rankings; Surgery; Survival; Survival Rate; Taxanes; Thrombocytopenia; Triple Negative Breast Neoplasms - drug therapy; Triple Negative Breast Neoplasms - pathology; Tumors
• ISSN: 0167-6806; 1573-7217
• DOI: 10.1007/s10549-020-05648-9

Purpose Platinum plays an important role in the treatment of triple-negative breast cancer (TNBC) in neoadjuvant and metastatic settings. However, its role in an adjuvant setting remains unclear. Methods In this non-inferior randomized phase 2 trial, we randomly assigned 308 chemotherapy-naive patients with histologically confirmed TNBC after primary surgery to receive either six cycles of TP (docetaxel: 75 mg/m 2 or paclitaxel 175 mg/m 2 d1; carboplatin AUC = 5, day 1), or four cycles of EC (epirubicin: 90 mg/m 2 ; cyclophosphamide: 600 mg/m 2 , day 1) followed by four cycles of T (docetaxel: 75 mg/m 2 or paclitaxel 175 mg/m 2 , day 1). The primary end point was the disease-free survival (DFS) rate at 5 years. Both regimens were repeated every 3 weeks. The prognostic and predictive value of germline breast cancer gene mutations and programmed death ligand-1 (PD-L1) expression was evaluated. Results At a median follow-up of 66.9 months, the 5-year DFS rate was 85.8% in the EC-T arm, and 84.4% in the TP arm (p non-inferiority = 0.034, p log-rank = 0.712). The 5-year overall survival (OS) rate was 94.4% in the EC-T arm and 93.5% in the TP arm ( p  = 0.770). Patients in the TP arm showed better compliance and experienced significantly lower frequencies of G3/4 neutrocytopenia and G3/4 alopecia, but higher rates of G1–4 thrombocytopenia than those in the EC-T arm. Patients with PD-L1 expressing tumors showed significantly improved DFS and OS. Conclusions This study indicates that carboplatin plus taxanes could be a feasible adjuvant chemotherapy for patients with early TNBC who are cannot tolerate intensive chemotherapy with anthracycline.