MAYER, Jiří, Christopher ARTHUR, Jacques DELAUNAY, Grzegorz MAZUR, Xavier G. THOMAS, Agnieszka WIERZBOWSKA, Farhad RAVANDI, Erhan BERRAK, Mark JONES, Yuhan LI and Hagop M. KANTARJIAN. Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics. BMC Cancer. London: BioMed Central, 2014, vol. 14, No 69, p. 1-9. ISSN 1471-2407. doi:10.1186/1471-2407-14-69.
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Basic information
Original name Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics
Authors MAYER, Jiří (203 Czech Republic, guarantor, belonging to the institution), Christopher ARTHUR (36 Australia), Jacques DELAUNAY (250 France), Grzegorz MAZUR (616 Poland), Xavier G. THOMAS (250 France), Agnieszka WIERZBOWSKA (616 Poland), Farhad RAVANDI (840 United States of America), Erhan BERRAK (840 United States of America), Mark JONES (840 United States of America), Yuhan LI (840 United States of America) and Hagop M. KANTARJIAN (840 United States of America).
Edition BMC Cancer, London, BioMed Central, 2014, 1471-2407.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30200 3.2 Clinical medicine
Country of publisher United Kingdom of Great Britain and Northern Ireland
Confidentiality degree is not subject to a state or trade secret
Impact factor Impact factor: 3.362
RIV identification code RIV/00216224:14110/14:00075094
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1186/1471-2407-14-69
UT WoS 000332490000001
Keywords in English Decitabine; Acute Myelocytic Leukemia; Elderly; Treatment
Tags 11 02 2014, EL OK, podil
Tags International impact, Reviewed
Changed by Changed by: Ing. Mgr. Věra Pospíšilíková, učo 9005. Changed: 23. 10. 2014 16:51.
Abstract
Background Compared with younger patients, older adults with acute myeloid leukemia (AML) generally have poorer survival outcomes and less benefit from clinical trials. A recent phase 3 trial demonstrated a trend toward improved overall survival (OS) with decitabine, a hypomethylating agent, compared with treatment choice of either cytarabine or supportive care (7.7 months, 95% CI: 6.2-9.2 vs 5.0 months, 95% CI: 4.3-6.3, respectively) in older adults with newly diagnosed AML. The current analyses investigated prognostic factors for outcomes in this trial and examined OS and responses in prespecified subgroups. Methods A multivariate Cox proportional hazards model was used to investigate effects of demographic and baseline characteristics, including age, sex, cytogenetic risk, AML type, ECOG Performance Status, geographic region, bone marrow blasts, platelets, and white blood cells on OS, based on mature data. Similar analyses were conducted with a logistic regression model to predict response rates. Prespecified subgroup analyses were performed for OS and response rates, also using mature data. Conclusion Response to decitabine in AML is associated with known prognostic factors related to both patient demographics and disease characteristics.
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