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


Authors: Bains, M. S.; Stojadinovic, A.; Minsky, B.; Rusch, V.; Turnbull, A.; Korst, R.; Ginsberg, R.; Kelsen, D. P.; Ilson, D. H.
Article Title: 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/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 · m2 · 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.
Keywords: adult; cancer chemotherapy; clinical article; treatment outcome; aged; middle aged; clinical trial; fatigue; carcinoma, squamous cell; cisplatin; multimodality cancer therapy; paclitaxel; cancer radiotherapy; preoperative care; combined modality therapy; cancer staging; neurotoxicity; cancer palliative therapy; adenocarcinoma; nephrotoxicity; phase 2 clinical trial; bone marrow suppression; blood toxicity; esophagitis; mucosa inflammation; antineoplastic combined chemotherapy protocols; diagnostic imaging; postoperative complication; dysphagia; gastrointestinal toxicity; esophagus resection; surgical mortality; phase 1 clinical trial; esophagus carcinoma; esophageal neoplasms; ototoxicity; humans; human; male; female; priority journal; article
Journal Title: Journal of Thoracic and Cardiovascular Surgery
Volume: 124
Issue: 2
ISSN: 0022-5223
Publisher: Mosby Elsevier  
Date Published: 2002-08-01
Start Page: 270
End Page: 277
Language: English
DOI: 10.1067/mtc.2002.122545
PUBMED: 12167786
PROVIDER: scopus
DOI/URL:
Notes: Export Date: 14 November 2014 -- Source: Scopus
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MSK Authors
  1. Robert J Korst
    30 Korst
  2. Valerie W Rusch
    761 Rusch
  3. Bruce Minsky
    306 Minsky
  4. Robert J Ginsberg
    178 Ginsberg
  5. David H Ilson
    359 Ilson
  6. Manjit S Bains
    295 Bains
  7. David P Kelsen
    487 Kelsen