A phase II trial of preoperative combined-modality therapy for localized esophageal carcinoma: Initial results

Objective: We sought to evaluate treatment response to a novel combined-modality treatment regimen for localized esophageal carcinoma. Methods: Localized esophageal carcinoma was confirmed with endoscopic ultrasonography, computed tomography, and positron emission tomography before induction therapy. This therapy consisted of combined cisplatin/paclitaxel (cisplatin, 75 mg/m(2) paclitaxel, 175 mg/m(2) : 2 cycles. 3-hour infusion) for weeks 1 and 4, combined cisplatin (30 mg . m(2). wk(-1)) and paclitaxel (30-80 mg . m(-2) . wk(-1), 96-hour infusion) with concurrent radiation (external beam, 1.8 Gy/d total, 50.4 Gy) for weeks 7 to 12, and esophagectomy for week 16 after restaging confirmed resectability. Results: Forty-one patients (36 men) with adenocarcinoma (n = 25) or squamous cell carcinoma (n = 16) were enrolled. Thirty-six patients completed treatment, of whom 34 (85%) had locally advanced disease of clinical stage T3-4 N0-1. Symptoms resolved or improved in 35 (92%) of 38 patients after induction chemotherapy. Fourteen (35%) and 10 (24%) patients experienced grade III/IV myelosuppression during induction chemotherapy and chemoradiation. respectively. Two (5%) had grade III and none had grade IV esophagitis during chemoradiation. Only 2 (5%) patients required enteral feeding-tube support during therapy, Of 33 R0 resections, 9 (26%) had complete pathologic disease, and 4 (12%) had microscopic residual disease. Major (eg. anastomotic response, delayed stricture. and respiratory failure) postoperative morbidity occurred in 13 (36%) of 36 patients. Operative mortality was 5.5% (2/36). Conclusion: This regimen of induction Concurrent chemoradiation followed by surgical intervention for esophageal carcinoma produces rapid dysphagia relief with initial chemotherapy. has a high overall response rate, and has acceptable toxicity levels.