PROGRESS REPORT OF COMBINED CHEMORADIOTHERAPY VERSUS RADIOTHERAPY ALONE IN PATIENTS WITH ESOPHAGEAL CANCER - AN INTERGROUP STUDY

Purpose: The present intergroup phase III randomized study compared co mbined chemotherapy (CT) plus radiotherapy (RT) treatment versus RT on ly in patients with locally advanced esophageal cancer. Materials and Methods: Two courses of chemotherapy during 50 Gy RT followed by addit ional two courses of the same CT, versus 64 Gy RT alone were investiga ted. CT consisted of cisplatin 75 mg/m(2) and fluorouracil (5FU) 1,000 mg/m(2)/d on days 1 to 4 every 4 weeks with RT and every 3 weeks post -RT. The main objective of the study was to compare overall survival b etween the two randomized treatment groups. Patients were stratified b y tumor size, histology, and degree of weight loss. Results: Sixty-two assessable patients were randomized to receive RT alone, and 61 to th e combined arm, Patients characteristics were as follows: squamous cel l cancer, 90% versus 85%; weight loss greater than 10 lb, 61% versus 6 9%; and tumor size, greater than or equal to 5 cm, 82% versus 80% on t he PT and CT-RT arms, respectively, Systemic side effects, which consi sted of nausea, vomiting, and renal and myelosuppression, occurred mor e frequently on the combined arm, while local side effects were simila r in both groups, With a minimum follow-up time of 5 years for all pat ients, the median survival duration was 14.1 months and the 5-year sur vival rate was 27% in the combined treatment group, while the median s urvival duration was 9.3 months with no patients olive at 5 years in t he RT-alone group (P < .0001). Additional patients (69) were treated w ith the same combined therapy and were analyzed. The results of the la st group confirmed all of the results obtained with combined CT-RT in the randomized trial, with a median survival duration of 17.2 months a nd 3-year survival rate of 30%. Conclusion: We conclude that cisplatin and 5FU infusion given during and post-RT of 50 Gy is statistically s uperior to standard 64-Gy RT alone in patients with locally advanced e sophageal cancer. (C) 1997 by American Society of Clinical Oncology.