Randomized Trial of Preoperative Chemoradiation Versus Surgery Alone in Patients With Locoregional Esophageal Carcinoma

TLDR

The study was a randomized trial comparing survival in patients with potentially resectable esophageal carcinoma treated with preoperative chemoradiation versus surgery alone. One hundred patients were randomized to either surgery alone or to preoperative chemoradiation with cisplatin, fluorouracil, vinblastine and 45 Gy radiotherapy, followed by transhiatal esophagectomy around day 42, with the study powered to detect a median survival increase from 1 to 2.2 years. The trial found no statistically significant survival benefit from preoperative chemoradiation, with median survivals of 17.6 months (surgery) versus 16.9 months (chemoradiation) and 3‑year survivals of 16% versus 30% (P = 0.15).

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/m 2 /d on days 1 through 5 and 17 through 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 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.