In a Chinese phase III trial (RJBC 1501) reported in the Journal of Clinical Oncology, Chen et al found that the addition of carboplatin to adjuvant epirubicin plus cyclophosphamide followed by taxane chemotherapy significantly improved disease-free survival in patients with early-stage triple-negative breast cancer (TNBC).
Study Details
In the open-label multicenter trial, 786 patients who underwent complete resection were randomly assigned between March 2016 and March 2023 to receive epirubicin plus cyclophosphamide followed by a taxane (initially paclitaxel, with docetaxel permitted after protocol amendment) with (EC-TCb, n = 395) or without (EC-T, n = 391) carboplatin. Initial treatment in the control group consisted of epirubicin at 90 mg/m2 and cyclophosphamide at 600 mg/m2 on day 1 every 3 weeks for four cycles, followed by paclitaxel at 80 mg/m2 on days 1, 8, and 15 every 3 weeks for four cycles. In the carboplatin group, patients received the same EC regimen for four cycles, followed by paclitaxel at 80 mg/m2 and carboplatin at area under the curve (AUC) = 2.0 on days 1, 8, and 15 every 4 weeks for four cycles. Approximately three-quarters of patients in each group received docetaxel as their taxane instead of paclitaxel. In the EC-T group, docetaxel was given at 80 to 100 mg/m2 on day 1 every 3 weeks for four cycles; in the carboplatin group, patients received docetaxel at 75 mg/m2 and carboplatin at AUC = 5.0 to 6.0 on day 1 every 3 weeks for four cycles. The primary endpoint of the trial was disease-free survival.
Key Findings
After a median follow-up of 4.52 years (interquartile range = 2.83–6.06 years), disease-free survival events had occurred in 41 patients in the EC-TCb group vs 62 in the EC-T group (hazard ratio [HR] = 0.66, 95% confidence interval [CI] = 0.44–0.97, P = .034). Disease-free survival rates at 3 years were 93.1% vs 89.8%, respectively.
Distant disease–free survival events occurred in 28 patients in the EC-TCb group vs 44 in the EC-T group (HR = 0.61, 95% CI = 0.38–0.98, P = .040). Death occurred in 7 patients in the EC-TCb group vs 18 in the EC-T group (HR for overall survival = 0.39, 95% CI = 0.16–0.94, P = .029).
Grade 3 or 4 adverse events occurred in 49.9% of the EC-TCb group vs 38.7% of the EC-T group. The most common were neutropenia (47.0%), thrombocytopenia (4.5%), and febrile neutropenia (2.3%) in the EC-TCb group, and neutropenia (37.8%) and febrile neutropenia (2.6%) in the EC-T group. No treatment-related deaths were reported.
The investigators concluded: “Adding carboplatin to adjuvant EC-T chemotherapy significantly improves [disease-free survival, distant disease-free survival, and overall survival] in patients with early-stage TNBC. Although increased hematologic toxicity was observed, no new safety signals emerged.”
Kunwei Shen, MD, of the Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the Natural Science Foundation of Shanghai Science and Technology Committee and others. For full disclosures of the study authors, visit ascopubs.org.
