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

Abstract

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.

• Authors: M Findlay, D Cunningham, A Norman, J Mansi, M Nicolson, T Hickish, V Nicolson, A Nash, N Sacks, H Ford
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 5 Issue 7 Pg. 609-16 (Sep 1994) ISSN: 0923-7534 [Print] England
• PMID: 7993836 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Epirubicin
• Cisplatin
• Fluorouracil

Topics

• Adenocarcinoma (drug therapy, mortality)
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Chi-Square Distribution
• Cisplatin (administration & dosage, adverse effects)
• Drug Administration Schedule
• Epirubicin (administration & dosage, adverse effects)
• Esophageal Neoplasms (drug therapy, mortality)
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Humans
• Infusions, Intravenous
• Male
• Middle Aged
• Prognosis
• Regression Analysis
• Remission Induction
• Stomach Neoplasms (drug therapy, mortality)
• Survival Rate