Abstract | BACKGROUND: METHODS: Twenty-one patients with advanced neuro-endocrine tumors (14 with carcinoid tumors, 7 with islet cell carcinomas) were treated with alpha-IFN and 5-FU in a Phase II study. 5-Fluorouracil was administered by intravenous bolus injection at an initial dose of 400 mg/m2/day for 5 consecutive days. After a 1-week break, 5-FU then was administered weekly by intravenous bolus at a dose of 750 mg/m2. Alpha interferon administration was begun on Day 1 of 5-FU at a daily dose of 3 x 10(6) U subcutaneously and continued for the duration of the trial. RESULTS: Of the 14 carcinoid patients with carcinoid tumors, 1 experienced a partial response (7%; 95% confidence interval [CI] 0-20%) that lasted for 6 months. Eight of the patients with carcinoid tumors achieved stable disease for a median of 6 months (range, 2-10 months). One of the patients with islet cell tumors (14%; 95% CI 0-39%) achieved a partial response that persisted after 8 months; 4 patients with islet cell tumors had stable disease for a median of 13 months (range, 4-27+ months). Even at this relatively low dose of alpha-IFN, 14 of 21 patients required a dose reduction in the alpha-IFN (13 for fatigue, 1 for ataxia). Three patients experienced myelosuppression of greater than Grade 3, and three patients had diarrhea of greater than Grade 3. One patient experienced dose-limiting hand-foot syndrome. CONCLUSIONS: These results suggest that the combination of 5-FU and alpha-IFN does not have any clear superiority over the individual agents alone; 5-FU appears to reduce patient tolerance of alpha-IFN when given on a daily schedule. Further investigations are needed to identify active agents in the treatment of neuroendocrine malignancies.
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Authors | L Saltz, N Kemeny, G Schwartz, D Kelsen |
Journal | Cancer
(Cancer)
Vol. 74
Issue 3
Pg. 958-61
(Aug 01 1994)
ISSN: 0008-543X [Print] United States |
PMID | 8039124
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Interferon-alpha
- Fluorouracil
|
Topics |
- Adenoma, Islet Cell
(therapy)
- Adult
- Aged
- Carcinoid Tumor
(therapy)
- Drug Administration Schedule
- Drug Therapy, Combination
- Female
- Fluorouracil
(administration & dosage, adverse effects)
- Humans
- Interferon-alpha
(administration & dosage, adverse effects)
- Male
- Middle Aged
- Pancreatic Neoplasms
(therapy)
- Treatment Outcome
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