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

    Research output: Contribution to journalArticleResearchpeer-review

    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

    Cite this

    Kantarjian, Hagop M ; Martinelli, Giovanni ; Jabbour, Elias ; Quintas-Cardama, Alfonso ; Ando, Kiyoshi ; Bay, Jacquesolivier ; Wei, Andrew ; Gropper, Stefanie ; Papayannidis, Cristina ; Owen, Kate ; Pike, Laura ; Schmitt, Nicola ; Stockman, Paul ; Giagounidis, Aristoteles Achilles Nikolaus. / 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. In: Cancer. 2013 ; Vol. 119, No. 14. pp. 2611 - 2619.
    @article{666a1dd42f37437489e71213aa6f448f,
    title = "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",
    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",
    author = "Kantarjian, {Hagop M} and Giovanni Martinelli and Elias Jabbour and Alfonso Quintas-Cardama and Kiyoshi Ando and Jacquesolivier Bay and Andrew Wei and Stefanie Gropper and Cristina Papayannidis and Kate Owen and Laura Pike and Nicola Schmitt and Paul Stockman and Giagounidis, {Aristoteles Achilles Nikolaus}",
    year = "2013",
    doi = "10.1002/cncr.28113",
    language = "English",
    volume = "119",
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    publisher = "John Wiley & Sons",
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    Kantarjian, HM, Martinelli, G, Jabbour, E, Quintas-Cardama, A, Ando, K, Bay, J, Wei, A, Gropper, S, Papayannidis, C, Owen, K, Pike, L, Schmitt, N, Stockman, P & Giagounidis, AAN 2013, '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', Cancer, vol. 119, no. 14, pp. 2611 - 2619. https://doi.org/10.1002/cncr.28113

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

    In: Cancer, Vol. 119, No. 14, 2013, p. 2611 - 2619.

    Research output: Contribution to journalArticleResearchpeer-review

    TY - JOUR

    T1 - 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

    AU - Kantarjian, Hagop M

    AU - Martinelli, Giovanni

    AU - Jabbour, Elias

    AU - Quintas-Cardama, Alfonso

    AU - Ando, Kiyoshi

    AU - Bay, Jacquesolivier

    AU - Wei, Andrew

    AU - Gropper, Stefanie

    AU - Papayannidis, Cristina

    AU - Owen, Kate

    AU - Pike, Laura

    AU - Schmitt, Nicola

    AU - Stockman, Paul

    AU - Giagounidis, Aristoteles Achilles Nikolaus

    PY - 2013

    Y1 - 2013

    N2 - 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

    AB - 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

    UR - http://onlinelibrary.wiley.com/doi/10.1002/cncr.28113/pdf

    U2 - 10.1002/cncr.28113

    DO - 10.1002/cncr.28113

    M3 - Article

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    SP - 2611

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    JO - Cancer

    JF - Cancer

    SN - 0008-543X

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