Abstract

Of 77 patients with potentially resectable squamous cell carcinoma of the esophagus who were asked to participate in a phase III trial of treatment with either immediate surgery (n = 24) or surgery plus preoperative chemotherapy (n = 22), only 46 agreed to randomization. A priori, 13 patients chose chemotherapy before surgery and 18 patients chose surgery only. The complete chemotherapy program consisted of three cycles with fluorouracil, 1 g/m2 per day for 5 days, and cisplatin, 20 mg/m2 per day for 5 days. The response rate to chemotherapy was 50% (17 of 34 patients). 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 surgery only group was 79% (33 of 42 patients) compared with 70% (19 of 27 patients) for patients receiving chemotherapy. The postoperative rates of septic complications (41% [11 of 27 patients] vs 26% [11 of 42 patients]) and respiratory disorders (48% [13 of 27 patients] vs 31% [13 of 42 patients]) were higher for patients with preoperative chemotherapy than for those treated with surgery only. Surgery-related mortality was increased in the chemotherapy group (19% [five of 27 patients]) compared with the surgery only group (10% [four of 42 patients]). Patients responding to preoperative chemotherapy had prolonged survival (median, 13 months) compared with nonresponders (median, 5 months), but the median survival for the chemotherapy group and the surgery only group was identical (10 months). We conclude that the preoperative chemotherapy regime used in this multi-institutional trial neither influences resectability nor increases the overall survival of patients with localized esophageal cancer. However, preoperative chemotherapy is associated with considerable side effects and a high postoperative mortality rate.