Phase I study of recombinant leukocyte A interferon (IFN-alpha 2A, Roferon-A) with doxorubicin in advanced malignant disease.
Twenty-six patients with advanced cancer received monthly intramuscular recombinant leukocyte A interferon (IFN-alpha 2A), 12 X 10(6) U/m2 daily X 5 with escalating doses of doxorubicin, 25 to 40 mg/m2 on day 3. As anticipated, dose-limiting toxicities were an influenza-type syndrome and myelosuppression. A clinically meaningful and dramatic partial response of hepatocellular carcinoma persisted for 11.5 months associated with an alpha-fetoprotein reduction from 39,000 to 299 ng/ml. For Phase II investigations, the authors recommend the above IFN-alpha 2A dose with doxorubicin, 40 mg/m2, in patients with a performance score of 0 or 1 and no prior chemotherapy or significant radiation therapy which would enhance myelosuppression.
Creagan
E T
ET
Division of Medical Oncology, Mayo Clinic, Rochester, Minnesota 55905.
Frytak
S
S
Long
H J
HJ
Kvols
L K
LK
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D007970:Leukopenia / Q000139:chemically induced; D008113:Liver Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D011994:Recombinant Proteins; D013964:Thyroid Neoplasms / Q000188:drug therapy; D000509:alpha-Fetoproteins / Q000378:metabolism
D007370:Interferon Type I; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D000509:alpha-Fetoproteins; D004317:Doxorubicin