title: Randomized study of the duration of treatment with interferon alfa-2B in patients with hairy cell leukemia.
abstract: Several previous studies have demonstrated that both partially purified and recombinant alpha-interferons (alpha-IFNs) have high response rates in advanced hairy cell leukemia. However, the optimal dose and duration of therapy have not yet been defined. In this study, 90 patients were randomized after 12 months of IFN alfa-2b therapy with a standard dose of 2 X 10(6) U/m2 sc three times weekly to either no further therapy or an additional 6 months of therapy (18 mo total). There was no significant difference in the peripheral blood cell counts between the two groups (when analyzed) dating from the end of IFN therapy rather than from the time of randomization. Eighteen evaluable patients relapsed and were re-treated with IFN: 11 in the no-further-therapy group and 7 in the treated group. No patient was resistant to re-treatment with IFN. There was a significantly greater incidence of fatigue in the treated group (44% vs. 21%; P = .02) during the first 6 postrandomization months. We conclude that the duration of IFN therapy does not influence the clinical course after therapy is discontinued, but responses are maintained while patients receive therapy. However, because of a high incidence of fatigue with prolonged therapy and the ability to reinduce a second response, we recommend that IFN therapy be discontinued after 12 months in asymptomatic patients.
authors.affiliation: Joint Section of Hematology/Oncology, University of Chicago Medical Center IL 60627.
authors.forename: H M
authors.initials: HM
authors.lastname: Golomb
authors.forename: M J
authors.initials: MJ
authors.lastname: Ratain
authors.forename: A
authors.initials: A
authors.lastname: Fefer
authors.forename: J
authors.initials: J
authors.lastname: Thompson
authors.forename: D W
authors.initials: DW
authors.lastname: Golde
authors.forename: H
authors.initials: H
authors.lastname: Ozer
authors.forename: C
authors.initials: C
authors.lastname: Portlock
authors.forename: R
authors.initials: R
authors.lastname: Silber
authors.forename: J
authors.initials: J
authors.lastname: Rappeport
authors.forename: E
authors.initials: E
authors.lastname: Bonnem
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D007370:Interferon Type I / Q000009:adverse effects / Q000627:therapeutic use*; D007943:Leukemia, Hairy Cell / Q000628:therapy*; D011897:Random Allocation; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D013997:Time Factors
chemical_list: D007370:Interferon Type I; D011994:Recombinant Proteins