A pilot study of combination therapy with interferon-alpha-2a and 5-fluorouracil in metastatic carcinoid and malignant endocrine pancreatic tumours.
BACKGROUND
In view of the encouraging single agent response rates to interferon and 5-fluorouracil (5-FU) in malignant carcinoid and endocrine pancreatic tumours and the theoretical benefits of combination therapy 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.


METHODS
Patients were treated with 5-FU 750 mg/m2 by intravenous bolus every week and 3 Mega Units of recombinant interferon-alpha-2a subcutaneously 3 times per week increasing, as tolerated, to 6 then 9 MU. Fifteen patients were entered into the study.


RESULTS
One patient died suddenly of an unrelated illness and is not assessed. None of the remaining 14 patients had radiological evidence of response to treatment, although 6 had stable disease lasting for 7 to 64 weeks (median 40 weeks). Two patients did have biochemical evidence of a response, i.e., a 50% reduction in baseline urinary 5HIAA for 26 and 52 weeks. Treatment toxicity was significant. Six patients stopped treatment prematurely because of either nausea and/or diarrhoea. Overall treatment duration ranged from 4 to 64 weeks (median 7.5 weeks).


CONCLUSIONS
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.
Hughes
M J
MJ
Medical Oncology Unit, Beatson Oncology Centre, Glasgow, U.K.
Kerr
D J
DJ
Cassidy
J
J
Soukop
M
M
McGregor
K
K
Blackburn
N
N
Yosef
H
H
Kaye
S B
SB
D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002276:Carcinoid Tumor / Q000188:drug therapy* / Q000556:secondary*; D004334:Drug Administration Schedule; D004357:Drug Synergism; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010865:Pilot Projects; D011994:Recombinant Proteins; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D005472:Fluorouracil