Interferon alpha‐2a and 5‐fluorouracil for advanced colorectal carcinoma assessment of activity and toxicity

• Published in: Cancer Vol. 66; no. 12; pp. 2470 - 2475
• Main Authors: Kemeny, Nancy, Younes, Anas, Seiter, Karen, Kelsen, David, Sammarco, Patricia, Adams, Lynn, Derby, Susan, Murray, Peggy, Houston, Collette
• Format: Journal Article
• Language: English
• Published: New York Wiley Subscription Services, Inc., A Wiley Company 15.12.1990
• Subjects: Adult; Aged; Colorectal Neoplasms - drug therapy; Colorectal Neoplasms - pathology; Colorectal Neoplasms - therapy; Drug Therapy, Combination; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Fluorouracil - therapeutic use; Humans; Infusions, Intravenous; Interferon alpha-2; Interferon-alpha - administration & dosage; Interferon-alpha - adverse effects; Interferon-alpha - therapeutic use; Male; Middle Aged; Recombinant Proteins
• DOI: 10.1002/1097-0142(19901215)66:12<2470::AID-CNCR2820661205>3.0.CO;2-Y
• ISSN: 0008-543X

Preclinical data showed that the cytotoxic effects of 5‐fluorouracil (5‐FU) are augmented by interferon (IFN). in a small study, 13 of 17 patients with advanced colorectal cancer responded to a regimen of 5‐FU with IFN. Using the same dose and schedule as in this pilot study, 38 previously untreated patients with metastatic colorectal carcinoma were treated with continuous intravenous (IV) infusion of 5‐FU 750 mg/m2 daily for 5 days, followed by weekly bolus 5‐FU at 750 mg/m2 and subcutaneous IFN at 9 million units three times per week. of 35 evaluable patients, nine (26%) had a partial response (95% confidence limit, 11% to 41%), with a median response duration of 7.5 months (range, 4.4 to > 11.7 months). Seven patients (20%) had a minor response, and ten (28%) had stable disease. the most common toxicities observed were stomatitis (52%) and diarrhea (43%). Neurotoxicity was seen in 34% of patients and consisted of gait disturbance, dizziness, confusion, memory loss, and dementia. Because of toxicity, 84% of patients required a reduction of the IFN dose by at least 50%, and 63% required reduction of the 5‐FU dose by at least 25%. Although the combination of 5‐FU and IFN in patients with advanced colorectal carcinoma has some activity, the regimen was toxic, and the observed response rate (26%) was not substantially superior to alternative 5‐FU programs.