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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
Author(s) -
KIoke O.,
Wandl U.,
Opalka B.,
Moritz T.,
NagelHiemke M.,
Franz T.,
Becher R.,
Hirche H.,
Seeber S.,
Niederle N.
Publication year - 1992
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/j.1600-0609.1992.tb00572.x
Subject(s) - medicine , toxicity , alpha interferon , gastroenterology , alpha (finance) , interferon alfa , interferon gamma , surgery , interferon , immunology , cytokine , construct validity , patient satisfaction
In patients with previously untreated chronic myelogenous leukaemia (CML) the efficacy of single‐agent interferon (IFN)‐alpha at an initial dose of 4 times 10 6 U/m 2 (arm A) was compared with the combined administration of the identical dose IFN‐alpha plus a total dose of 50 μg 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.