A randomized trial of chemoradiotherapy versus surgery alone in patients with resectable esophageal cancer

Abstract

4530 Background: The aim of this study was to compare survival in a randomized phase III trial of chemoradiotherapy (CHRT) versus surgery alone for localized resectable oesophageal cancer. Methods: Between 2000 and 2004, 91 patients with oesophageal cancer were enrolled in a Scandinavian multicenter study. Patients with resectable oesophageal squamous cell carcinoma (50%) or adenocarcinoma (50%) were randomized to chemoradiotherapy (CHRT) or surgery alone. Chemotherapy (CHT) was given in 3 cycles with cisplatin 100 mg/m2, day 1 and 5-fluorouracil 750 mg/m2/24 hours, infusion day 1–5, every three weeks. After one induction chemotherapy course, radiotherapy including the primary tumour and defined locoregional lymph nodes, was given concomitant with the following CHT cycles, to a total dose of 64 Gy, in 32 fractions. Surgery was performed according to Ivor Lewis and lymph nodes resected with standard two-field technique. Results: At a median follow-up of 51.8 month’s 65 deaths are noted. In the chemoradiation group 50% of the patients accomplished therapy according to protocol, 40% were treated with modifications of the protocol and radical resection was performed 76% of the patients. Median survival was 12.8 months for chemoradiation and 15.8 months for the surgery group. There was no significant difference in 1-year survival 56% and 55% for CHRT and surgery, respectively. By two years, survival curves diverge and 2-years survival was 37% (CI 95%: 23–51%) for the CHRT group and 25% (CI 95%: 12–39%) for the surgery group. At four years, survival was 29% for CHRT versus 23% for surgery (CI 95% CHRT: 16–43%, CI 95% Surgery: 10–36%). Both treatments were well tolerated and no treatment related deaths were recorded in any of the treatment arms. Most deaths were due to tumor disease (66%) in both groups. Conclusions: No statistically significant differences between the treatment arms were seen and survival results are equal to earlier reported. Both treatment arms were well tolerated. No significant financial relationships to disclose.