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
- 16 July 2020
- journal article
- research article
- Published by Taylor & Francis Ltd in Leukemia & Lymphoma
- Vol. 61 (12), 2821-2830
- https://doi.org/10.1080/10428194.2020.1786556
Abstract
The combination of Imatinib (IM) and hydroxyurea (HU) was explored for the treatment of chronic myelogenous leukemia (CML). 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. 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). IM/HU combination was more potent in selectively inhibiting CML cells in vitro, but not superior to IM in vivo. (NCT02480608)This publication has 36 references indexed in Scilit:
- Chronic myeloid leukemia: 2020 update on diagnosis, therapy and monitoringAmerican Journal of Hematology, 2020
- European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemiaLeukemia, 2020
- De-escalation of tyrosine kinase inhibitor therapy before complete treatment discontinuation in patients with chronic myeloid leukaemia (DESTINY): a non-randomised, phase 2 trialThe Lancet Haematology, 2019
- Imatinib discontinuation in chronic myeloid leukaemia patients with undetectable BCR-ABL transcript level: A systematic review and a meta-analysisEuropean Journal of Cancer, 2017
- Long-Term Outcomes of Imatinib Treatment for Chronic Myeloid LeukemiaThe New England Journal of Medicine, 2017
- Treatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom studyLeukemia, 2017
- Discontinuation of dasatinib or nilotinib in chronic myeloid leukemia: interim analysis of the STOP 2G-TKI studyBlood, 2017
- Long-Term Follow-Up of the French Stop Imatinib (STIM1) Study in Patients With Chronic Myeloid LeukemiaJournal of Clinical Oncology, 2017
- Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trialThe Lancet Oncology, 2010
- Activity of a Specific Inhibitor of the BCR-ABL Tyrosine Kinase in the Blast Crisis of Chronic Myeloid Leukemia and Acute Lymphoblastic Leukemia with the Philadelphia ChromosomeThe New England Journal of Medicine, 2001