Concurrent chemoradiotherapy with twice weekly paclitaxel and cisplatin followed by esophagectomy for locally advanced esophageal cancer.
BACKGROUND: To test the feasibility of incorporating a twice-weekly paclitaxel (Taxol) and cisplatin regimen into concurrent chemoradiotherapy (CCRT), followed by surgery, for patients with locally advanced esophageal cancer. PATIENTS AND METHODS: Patients with operable T3N0-1M0 or T1-3N1M0 esophageal cancer were enrolled. The CCRT regimen included paclitaxel (35 mg/m2 1 h on days 1 and 4/week), cisplatin (15 mg/m2 1 h on days 2 and 5/week), and radiotherapy (2 Gy on days 1-5/week). When the accumulated radiation dose reached 40 Gy, the feasibility of esophagectomy was evaluated in all patients. In patients for whom esophagectomy was not feasible, CCRT was continued to a dose of 60 Gy. RESULTS: The majority of 97 patients enrolled had squamous cell carcinoma on histology (95%) and T3N1 disease by endoscopic ultrasonographic staging (90%). All patients received CCRT to 40 Gy. Sixty-one patients underwent surgery, and 26 patients continued definitive CCRT to 60 Gy. The intention-to-treat pathological complete response rate was 25% [24/97, 95% confidence interval (CI) 16-33]. At a median follow-up of 25.3 months, the median progression-free and overall survival was 15.6 and 28.8 months, respectively. The most common grade 3/4 toxic effects were leukopenia (30%), thrombocytopenia (10%), and diarrhea (15%). CONCLUSIONS: CCRT with a twice-weekly paclitaxel and cisplatin regimen followed by esophagectomy is an active treatment of locally advanced esophageal cancer.