Abstract | BACKGROUND: A Phase II clinical trial was conducted to evaluate the efficacy of intravenous fluorouracil (5-FU) and subcutaneous recombinant interferon-alpha-2b (rIFN-alpha-2b) in the treatment of hepatocellular carcinoma (HCC) and to define factors that might be predictive of a response to treatment. METHODS: Twenty-nine patients were registered on the protocol. 5-FU was administered as a continuous intravenous (i.v.) infusion (dose = 750 mg/m2) for 5 consecutive days. rIFN-alpha-2b was administered subcutaneously (SC) (dose = 5 x 10(6) um/m2) once a day on days 1, 3, and 5 of the 5-FU infusion. The treatment was repeated at 14-day intervals. Responses were assessed at the end of one course of therapy, which was equivalent to four treatments. RESULTS: Of the 28 patients evaluable for response, 5 (18%) had a partial response, and 1 (4%) had a minor response. Responses lasted from more than 2 to more than 24 months (median, 11.5 months). Ten (36%) patients experienced no response, and 12 (43%) had progressive disease. The 6 responders were part of a group of 16 patients who had pretreatment levels of serum alpha-fetoprotein (AFP) of 50 ng/ml or less and a group of 8 whose tumors involved 50% or less of the liver parenchyma. Mucositis, which occurred in 54% of the patients, was the most common toxicity associated with the treatment regimen. Diarrhea and dermatitis were observed in 16% and 17% of the patients, respectively; fatigue, thrombocytopenia, granulocytopenia, neurologic toxicity, and nausea and vomiting were not commonly seen. CONCLUSIONS: The regimen of i.v. 5-FU and SC rIFN-alpha-2b was well tolerated and induced durable partial response in 31% (5 of 16) of patients with HCC who had low levels of serum AFP and in those with 50% or less of liver replacement. In contrast, the treatment regimen was ineffective in patients with HCC who had high levels of serum AFP or extensive liver disease.
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Authors | Y Z Patt, B Yoffe, C Charnsangavej, R Pazdur, H Fischer, K Cleary, M Roh, R Smith, C A Noonan, B Levin |
Journal | Cancer
(Cancer)
Vol. 72
Issue 9
Pg. 2574-82
(Nov 01 1993)
ISSN: 0008-543X [Print] United States |
PMID | 7691392
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Biomarkers
- Interferon alpha-2
- Interferon-alpha
- Recombinant Proteins
- alpha-Fetoproteins
- Fluorouracil
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Topics |
- Adolescent
- Adult
- Aged
- Biomarkers
(blood)
- Carcinoma, Hepatocellular
(blood, therapy)
- Chemotherapy, Adjuvant
- Female
- Fluorouracil
(administration & dosage, therapeutic use)
- Humans
- Interferon alpha-2
- Interferon-alpha
(administration & dosage, therapeutic use)
- Male
- Middle Aged
- Recombinant Proteins
(therapeutic use)
- Remission Induction
- Survival Analysis
- alpha-Fetoproteins
(analysis)
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