Key clinical point: Patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (ERBB2−, aka HER2-) advanced breast cancer (BC) reported greater clinical benefits with oral vinorelbine + cyclophosphamide + capecitabine (VEX) regimen vs intravenous paclitaxel without experiencing unmanageable adverse events (AE).
Major finding: Oral metronomic VEX vs intravenous paclitaxel significantly improved the median time to treatment failure (8.3 vs 5.7 months; hazard ratio [HR] 0.61; P = .008) and median progression-free survival (11.1 vs 6.9 months; HR 0.67; P = .03). Although the frequency of targeted grade 3 or 4 AE was higher in the VEX vs paclitaxel group (42.9% vs 28.6%), they were mostly manageable.
Study details: Findings are from the phase 2 METEORA-II study including 140 patients with ER+/ERBB2− metastatic BC who were treated with ≥ 1 line of chemotherapy and were randomly assigned to receive oral VEX or weekly intravenous paclitaxel in 4-week cycles.
Disclosures: This study was funded by Pierre-Fabre Pharma Srl and other sources. Some authors declared receiving grants, personal fees, consulting fees, funding, speaker honoraria, and having other ties with various sources, including the funding agencies.
Source: Munzone E et al for the International Breast Cancer Study Group (IBCSG). Efficacy of metronomic oral vinorelbine, cyclophosphamide, and capecitabine vs weekly intravenous paclitaxel in patients with estrogen receptor-positive, ERBB2-negative metastatic breast cancer: Final results from the phase 2 METEORA-II randomized clinical trial. JAMA Oncol. 2023 (Jul 13). doi: 10.1001/jamaoncol.2023.2150