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

Abstract

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.