A PILOT-STUDY OF COMBINATION THERAPY WITH INTERFERON-ALPHA-2A AND 5-FLUOROURACIL IN METASTATIC CARCINOID AND MALIGNANT ENDOCRINE PANCREATICTUMORS

Background: Ln view of the encouraging single agent response rates to interferon and 5-fluorouracil (5-FU) in malignant carcinoid and endocr ine pancreatic tumours and the theoretical benefits of combination the rapy with 5-FU and interferon in other tumours a study was designed to look at the feasibility of this combination, given for 12 months, in these tumours. Patients and methods: Patients were treated with 5-FU 7 50 mg/m(2) by intravenous bolus every week and 3 Mega Units of recombi nant interferon-alpha-2a subcutaneously 3 times per week increasing, a s tolerated, to 6 then 9 MU. Fifteen patients were entered into the st udy. Results: One patient died suddenly of an unrelated illness and is not assessed. None of the remaining 14 patients had radiological evid ence of response to treatment, although 6 had stable disease lasting f or 7 to 64 weeks (median 40 weeks). Two patients did have biochemical evidence of a response, i.e., a 50% reduction in baseline urinary 5HIA A for 26 and 52 weeks. Treatment toxicity was significant. Six patient s stopped treatment prematurely because of either nausea and/or diarrh oea. Overall treatment duration ranged from 4 to 64 weeks (median 7.5 weeks). Conclusion: Overall we found the treatment to be disappointing in terms of tolerance and response rate and do not recommend its use in malignant carcinoid or endocrine pancreatic tumours.