PURPOSE Cisplatin plus fluorouracil (CF) has long been a standard of care for metastatic esophageal cancer. This study aimed to demonstrate the superiority of docetaxel administered once every 2 weeks plus CF (bDCF) over CF in terms of overall survival (OS). PATIENTS AND METHODS We conducted a multicenter, randomized controlled phase III study. Patients age 20-75 years with metastatic or recurrent esophageal squamous cell carcinoma or adenocarcinoma who had not received systemic therapy for metastatic disease were included in this study. Patients were randomly assigned to the CF arm (cisplatin 80 mg/m 2 once on day 1 and fluorouracil 800 mg/m 2 continuously on days 1-5, every 28 days) or bDCF arm (docetaxel 30 mg/m 2 once on days 1 and 15 in addition to CF, once every 28 days). The primary end point was OS. RESULTS Overall, 240 patients were randomly assigned to bDCF (n = 121) or CF (n = 119). The median follow-up period was 15.3 months (IQR, 8.9-26.2). The median OS was 16.2 (95% CI, 13.8 to 20.4) and 14.8 (95% CI, 11.6 to 18.3) months in the bDCF and CF arms, respectively (hazard ratio HR, 0.90 95% CI, 0.68 to 1.19; P = .23). The median progression-free survival was 6.0 and 5.2 months in the bDCF and CF arms, respectively (HR, 0.68 95% CI, 0.52 to 0.88). Major grade 3 or 4 adverse events observed in the bDCF and CF arms were neutropenia (45 38% and 32 27%), anorexia (30 25% and 19 16%), fatigue (12 10% and 18 15%), and hyponatremia (16 13% and 16 14%). There were no treatment-related deaths. CONCLUSION Docetaxel added to CF once every 2 weeks did not improve OS when used as first-line chemotherapy in patients with metastatic or recurrent esophageal cancer.
Tsushima et al. (2025) studied this question.