5-FLUOROURACIL AND CISPLATIN AS PALLIATIVE TREATMENT OF ADVANCED ESOPHAGEAL SQUAMOUS-CELL CARCINOMA - A MULTICENTER RANDOMIZED CONTROLLED TRIAL

Objective: To compare chemotherapy with no chemotherapy as palliative treatment for oesophageal squamous cell carcinoma. Design: Randomised study. Setting: Multicentre trial in France. Subjects: Of 161 patients with histologically confirmed oesophageal squamous cell carcinoma loc ated more than 5 cm from the mouth of the oesophagus, five were withdr awn because of protocol violation. The remaining 156 patients, 149 men and 7 women, mean (SD) age 58 (9) years range 36 to 77, were randomly allocated to either a control group without chemotherapy (n = 84) or a group treated by chemotherapy (n = 72). Patients were divided into f our strata: I = complete resection of the tumour but with lymph node i nvolvement (n = 62); II = incomplete resection of tumour leaving gross tumour behind (n = 58); III = no resection because of local or region al invasion (n = 22); and TV = no resection because of distant metasta sis (n = 14). Exclusion criteria were histologically confirmed tracheo bronchial involvement, oesophagotracheal fistula, Karnosky score<50, c erebral metastases, or hepatic metastases occupying more than 30% of t he liver, peritoneal carcinomatosis, associated or previously treated ear-nose-throat carcinoma, or complete resection of tumour without lym ph node involvement. Interventions: 5 fluorouracil (5FU) and cisplatin (CDDP) were given in 5-day courses, once every 28 days, for a maximum of eight cycles. 5 FU 1g/m(2), was infused for 24 hours after a water overload, during five days. Cisplatin was given either in one dose of 100 mg/m(2) at the beginning of the cycle or 20 mg/m(2)/day over thre e hours for five days. Duration of treatment ranged from 6-8 months. O utcome measures.: Median and actuarial survival. The subsidiary endpoi nt was quality of survival judged by complications of treatment, swall owing disorders, and the duration of ability to feed normally. Results : There was no difference in survival, either overall (median = 12 mon ths) or in any of the strata. There were however significantly more pa tients with neurological (p < 0.003), haematological (p < 0.0001), and renal (p < 0.0002) complications in the treated group compared with t he control group. Four patients (6%) died of complications of chemothe rapy. The course of swallowing disorders did not differ between the tw o groups. The duration of autonomous oral feeding was exactly the same in both groups (median = 10.5 months). Conclusion: The results sugges t that 5FU and CDDP do not help in patients with squamous cell carcino ma of the oesophagus whether or not the tumour has been resected.