5-Fluorouracil and cisplatin therapy after palliative surgical resection of squamous cell carcinoma of the esophagus. A multicenter randomized trial. French Associations for Surgical Research.

BACKGROUND: The curative rate of surgical resection of squamous cell carcinoma of the esophagus is low. Reports on the efficacy of preoperative and postoperative chemotherapy are conflicting or have included limited disease or radical surgery alone. OBJECTIVE: The authors' objective was to study the results of chemotherapy on the duration and quality of survival in patients who have undergone palliative surgical resection for esophageal squamous cell carcinoma. PATIENTS AND METHODS: Of 124 patients with histologically proven esophageal squamous cell carcinoma situated more than 5 cm from the upper end of the esophagus, 4 patients were withdrawn for failure to comply with the protocol. The remaining 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 with 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 resection leaving macroscopic tumor tissue in situ or with metastases. Noninclusion criteria were histologically proven tracheobronchial involvement, esotracheal fistula, major alteration of general health status (Karnofsky score <50), cerebral or extensive (>30% of parenchyma) hepatic metastasis, peritoneal carcinomatosis, associated or previously treated upper airway cancer, or, conversely, complete resection of tumor without 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/m2 at the beginning of the course or as 20 mg/m2/day for 5 days given over 3 hours. 5- Fluorouracil (5-FU) (100 mg/m2/day) was infused over 24 hours for 5 days. The duration of treatment ranged from 6 to 8 months. The main aim was to establish median survival and actuarial survival curves. The subsidiary aim was to evaluate quality of survival as judged by complications due to treatment 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 strata. Conversely, significantly more patients in the treated group had hematologic, neurologic, and renal complications compared with the control group. Four patients died of complications of chemotherapy. The duration of autonomous oral alimentation was exactly the same in both groups (median, 12 + months). CONCLUSION: The results of this study suggest that 5-FU and cisplatin are not useful for patients with squamous cell carcinoma of the esophagus who have not undergone curative resection.