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J Thorac Cardiovasc Surg 2002;124:270-277
© 2002 The American Association for Thoracic Surgery

General Thoracic Surgery (GTS)

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

From Thoracic^a and Gastric and Mixed Tumor Services,^b Department of Surgery, The Gastrointestinal Oncology Service, the Department of Medicine,^c and the Department of Radiation Oncology,^d Memorial Sloan-Kettering Cancer Center, New York, NY.

This trial was supported in part by National Cancer Institute grant UO166913.

Received for publication May 14, 2001. Revisions requested June 22, 2001; revisions received Dec 5, 2001. Accepted for publication Dec 7, 2001. Address for reprints: Manjit S. Bains, MD, Attending Surgeon, Division of Thoracic Surgery, Department of Surgery, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021 (E-mail: bainsm{at}mskcc.org).

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/m²; paclitaxel, 175 mg/m²; 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.

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