Randomized trial of preoperative chemoradiation versus surgery alone in patients with locoregional esophageal carcinoma.
Publication/Presentation Date
1-15-2001
Abstract
PURPOSE: A pilot study of 43 patients with potentially resectable esophageal carcinoma treated with an intensive regimen of preoperative chemoradiation with cisplatin, fluorouracil, and vinblastine before surgery showed a median survival of 29 months in comparison with the 12-month median survival of 100 historical controls treated with surgery alone at the same institution. 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 chemoradiation (arm II) with cisplatin 20 mg/m2/d on days 1 through 5 and 17 through 21, fluorouracil 300 mg/m2/d on days 1 through 21, and vinblastine 1 mg/m2/d on days 1 through 4 and 17 through 20. Radiotherapy consisted of 1.5-Gy fractions twice daily, Monday through Friday over 21 days, to a total dose of 45 Gy. Transhiatal esophagectomy with a cervical esophagogastric anastomosis was performed on approximately day 42.
RESULTS: At median follow-up of 8.2 years, there is no significant difference in survival between the treatment arms. Median survival is 17.6 months in 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 relatively 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 surgery alone for patients with potentially resectable esophageal carcinoma did not demonstrate a statistically significant survival difference.
Volume
19
Issue
2
First Page
305
Last Page
313
ISSN
0732-183X
Published In/Presented At
Urba, S. G., Orringer, M. B., Turrisi, A., Iannettoni, M., Forastiere, A., & Strawderman, M. (2001). Randomized trial of preoperative chemoradiation versus surgery alone in patients with locoregional esophageal carcinoma. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 19(2), 305–313. https://doi.org/10.1200/JCO.2001.19.2.305
Disciplines
Medicine and Health Sciences
PubMedID
11208820
Department(s)
Department of Medicine
Document Type
Article