Capecitabine combined with docetaxel versus vinorelbine followed by capecitabine maintenance medication for first-line treatment of patients with advanced breast cancer: Phase 3 randomized trial.

摘要: BACKGROUND In this prospective study, progression-free survival (PFS) and the safety profiles of docetaxel/capecitabine (TX) vinorelbine/capecitabine (NX) followed by capecitabine maintenance therapy were compared in patients with metastatic breast cancer. METHODS Patients advanced cancer randomly assigned to a TX group (n = 104) an NX 102), both which included medication. The primary endpoint was (PFS). RESULTS The trial met its closed accrual subsequent interim analysis. Forty-eight (46.2%) 42 (41.2%) received median PFS (8.4 vs 7.1 months; P .0026; 95% confidence interval, 1.18-2.3; hazard ratio, 1.65), response duration (7.8 6.6 .0451), overall (OS) (35.3 19.8 .1349; 0.88-2.47; 1.48) appeared be longer those group, although difference did reach not statistical significance. Patients aged ≥40 years who postmenopausal presented visceral metastases more likely benefit from regimen terms OS, whereas positive hormone receptor human epidermal growth factor 2 status or history taxane treatments affect differences OS between groups. Hand-foot syndrome occurred frequently than (47% 16.7%; < .0001), but frequencies other minor adverse effects similar groups. CONCLUSIONS A for medication led regimen, even had previously (neo)adjuvant settings. Cancer 2015. © 2015 American Society. 2015;121:3435–43.