title: Continuous oral cytarabine ocfosfate with interferon-alpha-2b for patients with newly diagnosed chronic myeloid leukaemia: a pilot study.
abstract: Recombinant(R) interferon alpha (r-IFN-alpha) has been shown to be an effective drug for chronic myeloid leukaemia (CML). However, higher response rates can be achieved using cytarabine along with r-IFN-alpha. YNK01 is a derivative of cytosine arabinoside for oral administration. So far, the only published experience with continuous YNK01 was in advanced CML (10 cases). We have performed a pilot study to evaluate the efficacy and toxicity of the combined therapy r-IFN-alpha and daily oral YNK01 in patients with newly diagnosed Ph+ CML. Ten previously untreated patients were included in the study. Among those patients evaluable for cytogenetic response, 87% (seven out of eight) reached a major cytogenetic response with four reaching complete cytogenetic response (50%). The most significant side-effects were gastrointestinal. Macrocytic anaemia was observed in three patients. In conclusion, continuous oral administration of YNK01 in combination with IFN-alpha is safe and can result in high-cytogenetic response rates.
authors.affiliation: Servicio de Hematología, Hospital Universitario de Salamanca, Salamanca, Spain. concarol@gugu.usal.es
authors.forename: M C
authors.initials: MC
authors.lastname: del Cañizo
authors.forename: M P
authors.initials: MP
authors.lastname: Fisac
authors.forename: J
authors.initials: J
authors.lastname: Galende
authors.forename: J A
authors.initials: JA
authors.lastname: Hurtado
authors.forename: M J
authors.initials: MJ
authors.lastname: Moro
authors.forename: J A
authors.initials: JA
authors.lastname: Rodriguez
authors.forename: J M
authors.initials: JM
authors.lastname: Rivas
authors.forename: M D
authors.initials: MD
authors.lastname: Tabernero
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001088:Arabinonucleotides / Q000009:adverse effects / Q000627:therapeutic use*; D003568:Cytidine Monophosphate / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy*; D015466:Leukemia, Myeloid, Chronic-Phase / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D001088:Arabinonucleotides; D007166:Immunosuppressive Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; C061162:1-arabinofuranosylcytosine-5'-stearylphosphate; D003568:Cytidine Monophosphate