Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy
In: Blood, Jg. 124 (2014-08-28), Heft 9, S. 1426-1433
serialPeriodical
Zugriff:
Treatment outcomes for older patients with acute myeloid leukemia (AML) have remained dismal. This randomized, phase 2 trial in AML patients not considered suitable for intensive induction therapy compared low-dose cytarabine (LDAC) with or without volasertib, a highly potent and selective inhibitor of polo-like kinases. Eighty-seven patients (median age 75 years) received LDAC 20 mg twice daily subcutaneously days 1-10 or LDAC + volasertib 350 mg IV days 1 + 15 every 4 weeks. Response rate (complete remission and complete remission with incomplete blood count recovery) was higher for LDAC + volasertib vs LDAC (31.0% vs 13.3%; odds ratio, 2.91; P = .052). Responses in the LDAC + volasertib arm were observed across all genetic groups, including 5 of 14 patients with adverse cytogenetics. Median event-free survival was significantly prolonged by LDAC + volasertib compared with LDAC (5.6 vs 2.3 months; hazard ratio, 0.57; 95% confidence interval, 0.35-0.92; P = .021); median overall survival was 8.0 vs 5.2 months, respectively (hazard ratio, 0.63; 95% confidence interval, 0.40-1.00; P = .047). LDAC + volasertib led to an increased frequency of adverse events that was most pronounced for neutropenic fever/infections and gastrointestinal events; there was no increase in the death rate at days 60 + 90. This study was registered at www.clinicaltrials.gov as #NCT00804856.
Titel: |
Randomized, phase 2 trial of low-dose cytarabine with or without volasertib in AML patients not suitable for induction therapy
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Autor/in / Beteiligte Person: | Döhner, Hartmut ; Lübbert, Michael ; Fiedler, Walter ; Fouillard, Loic ; Haaland, Alf ; Brandwein, Joseph M. ; Lepretre, Stephane ; Reman, Oumedaly ; Turlure, Pascal ; Ottmann, Oliver G. ; Müller-Tidow, Carsten ; Krämer, Alwin ; Raffoux, Emmanuel ; Döhner, Konstanze ; Schlenk, Richard F. ; Voss, Florian ; Taube, Tillmann ; Fritsch, Holger ; Maertens, Johan |
Zeitschrift: | Blood, Jg. 124 (2014-08-28), Heft 9, S. 1426-1433 |
Veröffentlichung: | 2014 |
Medientyp: | serialPeriodical |
ISSN: | 0006-4971 (print) ; 1528-0020 (print) |
DOI: | 10.1182/blood-2014-03-560557 |
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