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Annals of Oncology 5:609-616, 1994
© 1994 European Society for Medical Oncology


research-article

A phase II study in advanced gastro-esophageal cancer using epirubicin and cisplatin in combination with continuous infusion 5-fluorouracil (ECF)

M. Findlay1,2, D. Cunningham1,2,, A. Norman1, J. Mansi3, M. Nicolson1,2, T. Hickish1,2, V. Nicolson1, A. Nash1, N. Sacks1, H. Ford1, R. Carter4 and A. Hill1,2

1The GI Unit, Royal Marsden Hospital Sutton, Surrey
2The Cancer Research Campaign Section of Medicine, Institute of Cancer Research Sutton, Surrey
3St. George's Hospital London
4Department of Histopathology, Royal Marsden Hospital Sutton, Surrey, UK

Correspondence to: David Cunningham, M.D., FRCP, The GI unit, Royal Marsden Hospital, Downs Road, Sutton, Surrey SM2 5PT, U.K.

PURPOSE:: A phase II study was performed in patients with unresectable or metastatic gastric cancer evaluating the efficacy of a new chemotherapy schedule combining epirubicin and cisplatin with a continuous ambulatory infusion of 5-fluorouracil (ECF).

PATIENTS AND METHODS:: One hundred thirty-nine consecutive, previously untreated patients were given ECF. Of these, 128 had measurable disease. Epirubicin (50 mg/m2 i.v.) and cisplatin (60 mg/m2 i.v.) were administered every three weeks for 8 cycles during a 21 week continuous i.v. infusion of 5-fluorouracil (200 mg/m2/day). In total 773 cycles of chemotherapy were given.

RESULTS:: Objective tumour responses was seen in 91 (71%) of the 128 patients with measurable disease, of which 15 (12%) had a complete response. Twenty patients with locally advanced disease responding to ECF had attempted resection of the primary - 11 (55%) were completely removed, 4 of these had no residual tumour in the resected specimen. The overall median survival was 8.2 months with 1 and 2 year survivals of 30% and 10% respectively. Grade 3 or 4 emesis occurred in 13%, stomatitis in 7%, diarrhoea in 4%, infection in 6%, leucopenia in 21% and thrombocytopenia in 8% of patients. Myelosuppression delayed treatment in 39 (5%) of the 773 cycles. Six of the 139 patients (4.3%) had treatment related deaths. There was no measurable reduction in quality of life during chemotherapy, while 67% of the 66 patients with dysphagia had complete resolution of this symptom.

CONCLUSIONS:: The ECF regimen displays high anti-tumour activity with moderate toxicity in patients with gastric cancer and in some cases enabled resection of previously inoperable tumours.

chemotherapy, gastro-oesophageal cancer


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