Stage I of a phase 2 study assessing the efficacy, safety, and tolerability of barasertib (AZD1152) versus low-dose cytosine arabinoside in elderly patients with acute myeloid leukemia

Hagop M Kantarjian, Giovanni Martinelli, Elias Jabbour, Alfonso Quintas-Cardama, Kiyoshi Ando, Jacquesolivier Bay, Andrew Wei, Stefanie Gropper, Cristina Papayannidis, Kate Owen, Laura Pike, Nicola Schmitt, Paul Stockman, Aristoteles Achilles Nikolaus Giagounidis

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    Abstract

    In this phase 2 study, the authors evaluated the efficacy, safety, and tolerability of the Aurora B kinase inhibitor barasertib compared with low-dose cytosine arabinoside (LDAC) in patients aged =60 years with acute myeloid leukemia (AML). METHODS Patients were randomized 2:1 to receive either open-label barasertib 1200 mg (as a 7-day intravenous infusion) or LDAC 20 mg (subcutaneously twice daily for 10 days) in 28-day cycles. The primary endpoint was the objective complete response rate (OCRR) (complete responses [CR] plus confirmed CRs with incomplete recovery of neutrophils or platelets [CRi] according to Cheson criteria [also requiring reconfirmation of CRi =21 days after the first appearance and associated with partial recovery of platelets and neutrophils]). Secondary endpoints included overall survival (OS) and safety. RESULTS In total, 74 patients (barasertib, n = 48; LDAC, n = 26) completed =1 cycle of treatment. A significant improvement in the OCRR was observed with barasertib (35.4 vs 11.5 ; difference, 23.9 ; 95 confidence interval, 2.7 -39.9 ; P
    Original languageEnglish
    Pages (from-to)2611 - 2619
    Number of pages9
    JournalCancer
    Volume119
    Issue number14
    DOIs
    Publication statusPublished - 2013

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