[Randomized study of preoperative chemotherapy in squamous cell cancer of the esophagus. CAO Esophageal Cancer Study Group].

Only 46 of 77 patients with potentially resectable squamous cell carcinoma of the esophagus who were asked to participate in a phase-III trial to be treated by either immediate surgery (n = 24) or surgery plus preoperative chemotherapy (n = 22) agreed to randomization. A priori 13 patients chose chemotherapy before surgery and 18 patients only surgery. The complete chemotherapy program consisted of three cycles with 5-FU (1g/m2/d x 5) and cisplatin (20 mg/m2/d x 5). The response rate (CR and PR) to chemotherapy was 47%. Side effects of therapy were higher than expected, based on results of previous phase-II studies. Two drug related deaths were observed. The resectability rate for patients in the operation-only group was 80 and 70% for patients receiving chemotherapy. The postoperative rate of septic complications (41 vs. 26%) and respiratory disorders (37 vs. 26%) were higher for patients with preoperative chemotherapy in comparison to the only surgically treated controls. Surgery related mortality was increased in the chemotherapy group (18%) compared to the controls (10%). Patients responding to preoperative chemotherapy had a prolonged survival (median 13 months) when compared with non-responders (median 5 months), but the median survival for the chemotherapy group and the only-surgery group was identical (10 months). We conclude, that the preoperative chemotherapy regime used in this multi-institutional trial neither influences resectability, nor increases overall survival of patients with localized esophageal cancer. However, preoperative chemotherapy was associated with considerable side effects and a high postoperative mortality.

RCT Entities:   Population Interventions Outcomes