5-FLUOROURACIL AND CISPLATIN THERAPY AFTER PALLIATIVE SURGICAL RESECTION OF SQUAMOUS-CELL CARCINOMA OF THE ESOPHAGUS - A MULTICENTER RANDOMIZED TRIAL

Background The curative rate of surgical resection of squamous cell ca rcinoma of the esophagus is low. Reports on the efficacy of preoperati ve and postoperative chemotherapy are conflicting or have included lim ited disease or radical surgery alone. Objective The authors' objectiv e was to study the results of chemotherapy on the duration and quality of survival in patients who have undergone palliative surgical resect ion for esophageal squamous cell carcinoma. Patients and Methods Of 12 4 patients with histologically proven esophageal squamous cell carcino ma situated more than 5 cm from the upper end of the esophagus, 4 pati ents were withdrawn for failure to comply with the protocol. The remai ning 120 patients, 116 males and 4 females (mean age, 57 +/- 9 years), were randomly assigned to either a control group who were to receive no chemotherapy (68 patients) or to a group who were to be treated wit h chemotherapy (52 patients). Patients were subdivided into two strata as follows: (1) stratum I, complete resection of the tumor with lymph node involvement (62 patients) and (2) stratum II, incomplete resecti on leaving macroscopic tumor tissue in situ or with metastases. Noninc lusion criteria were histologically proven tracheobronchial involvemen t, esotracheal fistula, major alteration of general health status (Kar nofsky score <50), cerebral or extensive (>30% of parenchyma) hepatic metastasis, peritoneal carcinomatosis, associated or previously treate d upper airway cancer, or, conversely, complete resection of tumor wit hout lymph node involvement. Chemotherapy was given in 5-day courses, every 28 days, with a maximum of 8 courses. Cisplatin was administered either as a single dose of 100 mg/m(2) at the beginning of the course or as 20 mg/m(2)/day for 5 days given over 3 hours. 5-Fluorouracil (5 -FU) (100mg/m(2)/day) was infused over 24 hours for 5 days. The durati on of treatment ranged from 6 to 8 months. The main aim was to establi sh median survival and actuarial survival curves. The subsidiary aim w as to evaluate quality of survival as judged by complications due to t reatment and the duration of autonomous oral feeding, that is, without palliative endoscopic treatment. No difference in survival was noted between the two groups, overall (median, 14 months), or between the st rata. Conversely, significantly more patients in the treated group had hematologic, neurologic, and renal complications compared with the co ntrol group, Four patients died of complications of chemotherapy. The duration of autonomous oral alimentation was exactly the same in both groups (median, 121/2 months). Conclusion The results oi this study su ggest that 5-FU and cisplatin are not useful for patients with squamou s cell carcinoma of the esophagus who have not undergone curative rese ction.