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).


CONCLUSIONS
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.
Bains
Manjit S
MS
Thoracic Services, Department of Surgery, The Gastrointestinal Oncology Service, the Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA. bainsm@mskcc.org
Stojadinovic
Alexander
A
Minsky
Bruce
B
Rusch
Valerie
V
Turnbull
Alan
A
Korst
Robert
R
Ginsberg
Robert
R
Kelsen
David P
DP
Ilson
David H
DH
D000230:Adenocarcinoma / Q000175:diagnosis / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003952:Diagnostic Imaging; D004938:Esophageal Neoplasms / Q000175:diagnosis / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D016896:Treatment Outcome
D017239:Paclitaxel; D002945:Cisplatin