title: Safety and efficacy of the combination of pegylated interferon-α2b and dasatinib in newly diagnosed chronic-phase chronic myeloid leukemia patients.
abstract: Dasatinib (DAS) and interferon-α have antileukemic and immunostimulatory effects and induce deep responses in chronic myeloid leukemia (CML). We assigned 40 newly diagnosed chronic-phase CML patients to receive DAS 100 mg o.d. followed by addition of pegylated interferon-α2b (PegIFN) after 3 months (M3). The starting dose of PegIFN was 15 μg/week and it increased to 25 μg/week at M6 until M15. The combination was well tolerated with manageable toxicity. Of the patients, 84% remained on PegIFN at M12 and 91% (DAS) and 73% (PegIFN) of assigned dose was given. Only one patient had a pleural effusion during first year, and three more during the second year. After introduction of PegIFN we observed a steep increase in response rates. Major molecular response was achieved in 10%, 57%, 84% and 89% of patients at M3, M6, M12 and M18, respectively. At M12, MR(4) was achieved by 46% and MR(4.5) by 27% of patients. No patients progressed to advanced phase. In conclusion, the combination treatment appeared safe with very promising efficacy. A randomized comparison of DAS±PegIFN is warranted.
authors.affiliation: Department of Hematology, St Olavs Hospital, Trondheim, Norway.|Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.
authors.forename: H
authors.initials: H
authors.lastname: Hjorth-Hansen
authors.affiliation: Department of Hematology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: J
authors.initials: J
authors.lastname: Stentoft
authors.affiliation: Department of Hematology and Vascular Disorders, Skåne University Hospital, Lund, Sweden.
authors.forename: J
authors.initials: J
authors.lastname: Richter
authors.affiliation: Hematology Research Unit Helsinki, University of Helsinki and Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.
authors.forename: P
authors.initials: P
authors.lastname: Koskenvesa
authors.affiliation: Department of Hematology, Uppsala University Hospital, Uppsala, Sweden.
authors.forename: M
authors.initials: M
authors.lastname: Höglund
authors.affiliation: Department of Medical and Health Sciences, Linköping University, Department of Hematology, County Council of Östergötland, Linköping, Sweden.
authors.forename: A
authors.initials: A
authors.lastname: Dreimane
authors.affiliation: Hematology Research Unit Helsinki, University of Helsinki and Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.
authors.forename: K
authors.initials: K
authors.lastname: Porkka
authors.affiliation: Department of Hematology, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
authors.forename: T
authors.initials: T
authors.lastname: Gedde-Dahl
authors.affiliation: Department of Internal Medicine, Hematology Section, Haukeland University Hospital and Department of Clinical Science, University of Bergen, Bergen, Norway.
authors.forename: B T
authors.initials: BT
authors.lastname: Gjertsen
authors.affiliation: Department of Hematology, University Hospital of North Norway, Tromsø, Norway.
authors.forename: F X
authors.initials: FX
authors.lastname: Gruber
authors.affiliation: Department of Hematology, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.
authors.forename: L
authors.initials: L
authors.lastname: Stenke
authors.affiliation: Department of Internal Medicine, Sunderbysjukhuset, Luleå, Sweden.
authors.forename: K M
authors.initials: KM
authors.lastname: Eriksson
authors.affiliation: Department of Hematology, Umeå University Hospital, Umeå, Sweden.
authors.forename: B
authors.initials: B
authors.lastname: Markevärn
authors.affiliation: Hematology Research Unit Helsinki, University of Helsinki and Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.
authors.forename: A
authors.initials: A
authors.lastname: Lübking
authors.affiliation: Department of Hematology, Odense University Hospital, Odense, Denmark.
authors.forename: H
authors.initials: H
authors.lastname: Vestergaard
authors.affiliation: Department of Hematology, Roskilde Hospital, Roskilde, Denmark.
authors.forename: L
authors.initials: L
authors.lastname: Udby
authors.affiliation: Department of Hematology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.
authors.forename: O W
authors.initials: OW
authors.lastname: Bjerrum
authors.affiliation: Department of Statistics, Uppsala University, Uppsala, Sweden.
authors.forename: I
authors.initials: I
authors.lastname: Persson
authors.affiliation: Hematology Research Unit Helsinki, University of Helsinki and Department of Hematology, Helsinki University Hospital Comprehensive Cancer Center, Helsinki, Finland.|Department of Clinical Chemistry, University of Helsinki, Helsinki, Finland.
authors.forename: S
authors.initials: S
authors.lastname: Mustjoki
authors.affiliation: Department of Hematology, Uppsala University Hospital, Uppsala, Sweden.
authors.forename: U
authors.initials: U
authors.lastname: Olsson-Strömberg
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use / Q000633:toxicity*; D000069439:Dasatinib / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D015466:Leukemia, Myeloid, Chronic-Phase / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010996:Pleural Effusion; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011994:Recombinant Proteins / Q000008:administration & dosage; D012074:Remission Induction; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b; D000069439:Dasatinib