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Phase I study of recombinant leukocyte a interferon (IFN‐α2A, roferon‐A) with doxorubicin in advanced malignant disease

Twenty‐six patients with advanced cancer received monthly intramuscular recombinant leukocyte A interferon (IFN‐α2A), 12 × 106 U/m2 daily × 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 α‐fetoprotein reduction from 39,000 to 299 ng/ml. For Phase II investigations, the authors recommend the above IFN‐α2A 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 myelo‐suppression.