No advantage of Imatinib in combination with hydroxyurea over Imatinib monotherapy: a study of the East German Study Group (OSHO) and the German CML study group

Lange, Thoralf; Niederwieser, Christian; Gil, Arthur; Krahl, Rainer; von Grünhagen, Ulrich; Deininger, Michael; Pfirrmann, Markus und Niederwieser, Dietger (2020): No advantage of Imatinib in combination with hydroxyurea over Imatinib monotherapy: a study of the East German Study Group (OSHO) and the German CML study group. In: Leukemia & Lymphoma, Bd. 61, Nr. 12: S. 2821-2830

Abstract

INTRODUCTION The combination of Imatinib (IM) and hydroxyurea (HU) was explored for the treatment of chronic myelogenous leukemia (CML). METHOD After in~vitro testing and a phase I study (n = 20), 59 patients were randomized in the IM/HU and 29 in the IM arm. According to protocol, 49 propensity-score matched IM patients were included from the CML-IV study. RESULTS Additive specific inhibition of CML cells by IM/HU was detected in~vitro. HU 500 mg qd in combination with IM 400 mg qd proved feasible in the phase I study. Overall, no significant difference with respect to major molecular response (MMR) at 18 months (IM/HU and IM 66%; primary endpoint) was observed. Significant differences were noted for MMR at 6 months (p = 0.04) and for cumulative incidences of adverse events (p = 0.03) in favor of IM monotherapy (secondary endpoints). CONCLUSION IM/HU combination was more potent in selectively inhibiting CML cells in~vitro, but not superior to IM in~vivo. (NCT02480608).

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin > Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• Bemerkung: Vollständige Autorenliste s. Volltext
• Sprache: Englisch