Feng Du1,2, Wenmiao Wang3, Yongsheng Wang4, Ming Li5, Anjie Zhu1, Jiayu Wang1, Ruigang Cai1, Fei Ma1, Ying Fan1, Qing Li1, Pin Zhang1, Vladimir Todorovic6, Peng Yuan7, Binghe Xu8. 1. National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. 2. Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The VIPII Gastrointestinal Cancer Division of Medical Department, Peking University Cancer Hospital and Institute, Beijing, 100142, China. 3. Department of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. 4. Shandong Cancer Hospital/Institute, Jinan, 250117, Shandong, China. 5. Beijing Luhe Hospital, Capital Medical University, Beijing, 101100, China. 6. Clinical Centre of MontenegroClinic for Oncology and Radiotherapy, Podgorica, Montenegro. 7. National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. yuanpeng01@hotmail.com. 8. National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100021, China. xubingheBM@163.com.
Abstract
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/m2 or paclitaxel 175 mg/m2 d1; carboplatin AUC = 5, day 1), or four cycles of EC (epirubicin: 90 mg/m2; cyclophosphamide: 600 mg/m2, day 1) followed by four cycles of T (docetaxel: 75 mg/m2 or paclitaxel 175 mg/m2, 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 withanthracycline.
RCT Entities:
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/m2 or paclitaxel 175 mg/m2 d1; carboplatin AUC = 5, day 1), or four cycles of EC (epirubicin: 90 mg/m2; cyclophosphamide: 600 mg/m2, day 1) followed by four cycles of T (docetaxel: 75 mg/m2 or paclitaxel 175 mg/m2, 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.
Entities:
Keywords:
Adjuvant chemotherapy; BRCA mutation; PD-L1; Platinum; Triple-negative breast cancer
Authors: Miguel Martin; Rocio Ramos-Medina; Rebeca Bernat; Jose Angel García-Saenz; Maria Del Monte-Millan; Enrique Alvarez; Maria Cebollero; Fernando Moreno; Eva Gonzalez-Haba; Oscar Bueno; Paula Romero; Tatiana Massarrah; Isabel Echavarria; Yolanda Jerez; Blanca Herrero; Ricardo Gonzalez Del Val; Nerea Lobato; Patricia Rincon; Maria Isabel Palomero; Ivan Marquez-Rodas; Santiago Lizarraga; Fernando Asensio; Sara Lopez-Tarruella Journal: Sci Rep Date: 2021-03-29 Impact factor: 4.379
Authors: Neha Pathak; Aparna Sharma; Arunmozhimaran Elavarasi; Jeeva Sankar; S V S Deo; Daya N Sharma; Sandeep Mathur; Sudhir Kumar; Chandra P Prasad; Akash Kumar; Atul Batra Journal: Breast Date: 2022-04-15 Impact factor: 4.254