Phase II clinical trial of pazopanib in patients with acute myeloid leukemia (AML), relapsed or refractory or at initial diagnosis without an intensive treatment option (PazoAML)

• Verfasst von: Keßler, Torsten [VerfasserIn]
• Verfasst von: Müller-Tidow, Carsten [VerfasserIn]
• Titel: Phase II clinical trial of pazopanib in patients with acute myeloid leukemia (AML), relapsed or refractory or at initial diagnosis without an intensive treatment option (PazoAML)
• Verf.angabe: Torsten Kessler, Steffen Koschmieder, Christoph Schliemann, Martina Crysandt, Jan-Henrik Mikesch, Saskia von Stillfried, Matthias Stelljes, Michele Pohlen, Georg Lenz, Anna Kirsch, Kerstin Vehring, Eva Wardelmann, Wolfgang Hartmann, Eike Bormann, Joachim Gerss, Tim H. Brümmendorf, Carsten Müller-Tidow, Wolfgang E. Berdel
• E-Jahr: 2019
• Jahr: 21 March 2019
• Umfang: 9 S.
• Fussnoten: Gesehen am 14.06.2019
• Titel Quelle: Enthalten in: Annals of hematology
• Ort Quelle: Berlin : Springer, 1955
• Jahr Quelle: 2019
• Band/Heft Quelle: 98(2019), 6, Seite 1393-1401
• ISSN Quelle: 1432-0584
• DOI: doi:10.1007/s00277-019-03651-9
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: Acute myeloid leukemia
• Sach-SW: AML
• Sach-SW: Pazopanib
• Sach-SW: Phase II study
• K10plus-PPN: 1667485679

Abstract

We evaluated pazopanib (800 mg orally QD) in patients not eligible for intensive treatment with relapsed/refractory AML or at initial diagnosis. Patients receiving pazopanib for > 14 days were analyzed for safety, tolerability, and efficacy. Co-primary endpoints were cumulative response rate and reduction of bone marrow microvessel density. Twenty patients (median age 76 years, range 52-86) were treated. Fifteen had relapsed/refractory and five had newly diagnosed AML. Median ECOG performance status was 1 (range 1-3). Four patients had adverse, 15 intermediate, and 1 patient favorable cytogenetic/molecular risk (ELN 2010 criteria). The safety profile of pazopanib was as reported. The most common adverse events of any grade were gastrointestinal. Two patients achieved PR (blast reduction > 50%), 14 stable disease (SD), and 4 progressive disease. Median PFS was 65 days (95% CI 29-105). After the end of the study, 1 CRi and 1 CRp occurred on demethylating agents, and 1 CR upon alloSCT. In these patients, SD and improved general condition on pazopanib allowed therapy escalation. Median OS for the overall study population was 191 days (95% CI 87-435) and 1-year survival was 35%. There was no significant change in microvessel density. Clinical trial information: NCT01361334.