title: A prospective randomized comparison of single-agent interferon (IFN)-alpha with the combination of IFN-alpha and low-dose IFN-gamma in chronic myelogenous leukaemia.
abstract: In patients with previously untreated chronic myelogenous leukaemia (CML) the efficacy of single-agent interferon (IFN)-alpha at an initial dose of 4 x 10(6) U/m2 (arm A) was compared with the combined administration of the identical dose IFN-alpha plus a total dose of 50 micrograms IFN-gamma (arm B). 51 patients entered this study between April 1987 and October 1989; the analysis was performed in March 1991 and was focused on response rates and toxicity. 54% of patients on arm A and 56% of arm B patients attained haematologic remission. 29% of patients on arm A and 24% of arm B patients had partial haematologic remission. A decrease in Philadelphia chromosome (Ph)-positive metaphases of more than 10% was only seen in patients who had achieved complete haematologic normalization. In 21% of patients on arm A and 20% of arm B patients, the percentage of Ph-positive cells declined to less than 35%. Toxicity was different between the two study groups with more pronounced hepatotoxicity observed in patients treated with IFN-alpha alone. Among the patients receiving both IFNs, alpha and gamma, there were 2 fatal infectious complications. This serious toxicity in conjunction with lack of a clinically meaningful difference between the two treatment schedules has led us to terminate the study. In conclusion, the addition of low-dose IFN-gamma failed to improve the efficacy of IFN-alpha in this study.
authors.affiliation: Department of Internal Medicine, University of Essen, Federal Republic of Germany.
authors.forename: O
authors.initials: O
authors.lastname: Kloke
authors.forename: U
authors.initials: U
authors.lastname: Wandl
authors.forename: B
authors.initials: B
authors.lastname: Opalka
authors.forename: T
authors.initials: T
authors.lastname: Moritz
authors.forename: M
authors.initials: M
authors.lastname: Nagel-Hiemke
authors.forename: T
authors.initials: T
authors.lastname: Franz
authors.forename: R
authors.initials: R
authors.lastname: Becher
authors.forename: H
authors.initials: H
authors.lastname: Hirche
authors.forename: S
authors.initials: S
authors.lastname: Seeber
authors.forename: N
authors.initials: N
authors.lastname: Niederle
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007371:Interferon-gamma / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy / Q000628:therapy*; D011446:Prospective Studies; D011994:Recombinant Proteins; D012074:Remission Induction
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D007371:Interferon-gamma