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Low serum alpha‐fetoprotein level in patients with hepatocellular carcinoma as a predictor of response to 5‐fu and interferon‐alpha‐2b
Author(s) -
Patt Yehuda Z.,
Pazdur Richard,
Smith Ruth,
Levin Bernard,
Roh Mark,
Yoffe Boris,
Noonan Christine A.,
Charnsangavej Chusilp,
Fischer Harold,
Cleary Karen
Publication year - 1993
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19931101)72:9<2574::aid-cncr2820720911>3.0.co;2-l
Subject(s) - medicine , gastroenterology , nausea , mucositis , hepatocellular carcinoma , vomiting , regimen , alpha interferon , toxicity , progressive disease , interferon alfa , chemotherapy , interferon , cancer , immunotherapy , immunology
Background . A Phase II clinical trial was conducted to evaluate the efficacy of intravenous fluorouracil (5‐FU) and subcutaneous recombinant interferon‐alpha‐2b (rIFN‐α‐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 (IV) infusion (dose = 750 mg/m 2 ) for 5 consecutive days. rIFN‐α‐2b was administered subcutaneously (SC) (dose = 5 × 10 6 um/m 2 ) 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, thrombo‐cytopenia, granulocytopenia, neurologic toxicity, and nausea and vomiting were not commonly seen. Conclusions . The regimen of IV 5‐FU and SC rIFN‐α‐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 in effective in patients with HCC who had high levels of serum AFP or extensive liver disease.