Linked Life Data

11960335

Source:http://linkedlifedata.com/resource/pubmed/id/11960335

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2002-4-17
pubmed:abstractText
Cytarabine ocfosfate (YNK01) is a prodrug analogue of cytarabine which is resistant to systemic deamination after oral administration. Following initial studies indicating significant anti-tumour activity of YNK01 a phase II trial was initiated in order to assess the tolerability and efficacy of a combination of this agent with interferon alpha-2b (IFN-alpha2b) in recently diagnosed chronic phase CML patients (n = 98). The treatment was subdivided into cycles consisting of 4 weeks of continuous administration of IFN-alpha-2b (3 MU/m(2)/day 1st week and then 5 MU/m(2)/day) and 14 days of oral YNK01 (600 mg/day 1st cycle). At the end of each cycle the dose of YNK01 was adjusted according to the blood count observed during the previous 4 weeks. The median time from diagnosis to inclusion in the trial was 2 months (range 6 days to 7.5 months). At 12 weeks, 62 patients (63%; 95% CI, 54-73) achieved a complete hematological response. At 24 weeks, of 98 patients, two achieved a complete cytogenetic response, 14 a partial response (16% major cytogenetic response rate; 95% CI, 9-24) and 34 a minor response; 19 patients were not evaluable for cytogenetic response. During the trial, 20 patients progressed to accelerated (6) or blastic phases (14). The median time to progression was 15 months (range 2-38 months). At 3 years the overall survival was 79% (95% CI, 70-88). Although the complete hematological response rate compared favorably with the 40% response rate previously obtained with the subcutaneous formulation of Ara-c, the cytogenetic response rate was less than expected. Most of the patients experienced side-effects and all permanently stopped YNK01. Although the combination seems attractive the initial dose of 600 mg per day is probably too high and should be reconsidered in further trials.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Apr
pubmed:issn
0887-6924
pubmed:author
pubmed:issnType
Print
pubmed:volume
16
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
573-80
pubmed:dateRevised
2011-11-17
pubmed:meshHeading
pubmed-meshheading:11960335-Administration, Oral, pubmed-meshheading:11960335-Adolescent, pubmed-meshheading:11960335-Adult, pubmed-meshheading:11960335-Aged, pubmed-meshheading:11960335-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:11960335-Arabinonucleotides, pubmed-meshheading:11960335-Cytidine Monophosphate, pubmed-meshheading:11960335-Dose-Response Relationship, Drug, pubmed-meshheading:11960335-Female, pubmed-meshheading:11960335-Follow-Up Studies, pubmed-meshheading:11960335-Humans, pubmed-meshheading:11960335-Interferon-alpha, pubmed-meshheading:11960335-Leukemia, Myelogenous, Chronic, BCR-ABL Positive, pubmed-meshheading:11960335-Leukemia, Myeloid, Chronic-Phase, pubmed-meshheading:11960335-Male, pubmed-meshheading:11960335-Middle Aged, pubmed-meshheading:11960335-Prognosis, pubmed-meshheading:11960335-Recombinant Proteins, pubmed-meshheading:11960335-Risk Factors, pubmed-meshheading:11960335-Survival Rate
pubmed:year
2002
pubmed:articleTitle
Results of a phase II trial of a combination of oral cytarabine ocfosfate (YNK01) and interferon alpha-2b for the treatment of chronic myelogenous leukemia patients in chronic phase.
pubmed:affiliation
Division of Hematology, University Hospital of Strasbourg, France.
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, Non-U.S. Gov't, Clinical Trial, Phase II