Randomized trial of preoperative chemoradiation versus surgery alone in patients with locoregional esophageal carcinoma

Purpose: A pilot study of 43 patients with potentially resectable esophagea l carcinoma treated with an intensive regimen of preoperative chemoradiatio n with cisplatin, fluorouracil, and vinblastine before surgery showed a med ian survival of 29 months in comparison with the la-month median survival o f 100 historical controls treated with surgery alone at the same institutio n. We designed a randomized trial to compare survival for patients treated with this preoperative chemoradiation regimen versus surgery alone. Materials and Methods: One hundred patients with esophageal carcinoma were randomized to receive either surgery alone (arm I) or preoperative chemorad iation (arm II) with cisplatin 20 mg/m(2)/d on days 1 through 5 and 17 thro ugh 21, fluorouracil 300 mg/ m(2)/d on days 1 through 21, and vinblastine 1 mg/ m(2)/d on days 1 through 4 and 17 through 20. Radiotherapy consisted o f 1.5-Gy fractions twice daily, Monday through Friday over 21 days, to a to tal dose of 45 Gy. Transhiatal esophagectomy with a cervical esophagogastri c anastomosis was performed on approximately day 42. Results: At median follow-vp of 8.2 years, there is no significant differen ce in survival between the treatment arms. Median survival is 17.6 months i n arm I and 16.9 months in arm II. Survival at 3 years was 16% in arm I and 30% in arm II (P =.15), This study was statistically powered to detect a r elatively large increase in median survival from 1 year to 2.2 years, with at least 80% power. Conclusion: This randomized trial of preoperative chemoradiation versus sur gery alone for patients with potentially resectable esophageal carcinoma di d not demonstrate a statistically significant survival difference. J Clin O ncol 19:305-313. (C) 2001 by American Society of Clinical Oncology.