OPTIMAL: a multinational phase III study of oral paclitaxel (DHP107) versus intravenous weekly paclitaxel in HER2-negative recurrent or metastatic breast cancer

作者：B. Xu, H. Jeong, T. Sun, J. Sohn, Q. Zhang, S. Kostic, X. Wang, Z. Tong, S. Wang, J. Wang, W. Li, K.S. Lee, Y.W. Moon, M.J. Kang, X Hu, T.Y. Kim, D. Milenković, J.H. Seo, J.H. Kim, J. W. Lee, S-B. Kim · 发表于：Annals of Oncology · 年份：2026 · DOI：10.1016/j.annonc.2026.03.002 · 研究领域：Cancer Treatment and Pharmacology、HER2/EGFR in Cancer Research、Advanced Breast Cancer Therapies

BACKGROUND: Intravenous (i.v.) paclitaxel (Taxol) requires prolonged infusion and is associated with hypersensitivity reactions and peripheral neuropathy. This study evaluated the efficacy and safety of DHP107, a novel oral formulation of paclitaxel, compared with i.v. paclitaxel in patients with HER2-negative, recurrent, or metastatic breast cancer. PATIENTS AND METHODS: i.v. on days 1, 8, and 15) in a 28-day cycle. The primary endpoint was investigator-assessed progression-free survival (PFS) in the per-protocol set (PPS). Secondary endpoints included independent central review-assessed PFS, overall survival (OS), tumor response, quality of life, and safety. RESULTS: Between January 2018 and December 2023, 549 patients were randomly assigned to receive either DHP107 (n = 277) or paclitaxel (n = 272); 519 patients were included in the PPS. DHP107 demonstrated noninferiority in PFS with a median PFS of 10.0 months compared with 8.5 months for paclitaxel (hazard ratio [HR] 0.869; 95% confidence interval [CI] 0.707-1.068). The median OS was 32.6 months for DHP107 and 31.8 months for paclitaxel (HR 0.967, 95% CI 0.762-1.227). DHP107 was associated with higher rates of neutropenia, febrile neutropenia, nausea, diarrhea, and vomiting, whereas peripheral neuropathy and hypersensitivity reactions were more common with paclitaxel. No treatment-related death occurred in the DHP107 group, and one (0.4%) in the paclitaxel group. Quality of life was comparable between the two groups. CON...