CML-CP Patients With Mild to Moderate Renal, Liver Dysfunction Can Safely Receive Frontline TKIs
Patients with chronic myeloid leukemia in chronic phase and renal or liver impairment can safely receive frontline dasatinib or nilotinib.
Patients with chronic myeloid leukemia in chronic phase (CML-CP) and mild to moderate renal or liver impairment can safely receive frontline dasatinib or nilotinib and can achieve response rates similar to those without organ dysfunction, a study published in the journal Clinical Lymphoma, Myeloma, & Leukemia has shown.1
There have been limited data on the safety and efficacy of frontline nilotinib and dasatinib in patients with newly diagnosed CML-CP with pre-existing liver and/or renal impairment.
Therefore, researchers sought to analyze the response rates, survival rates, and adverse event rates of 215 patients with CML-CP with or without renal and/or liver dysfunction who had received 1 of the 2 tyrosine kinase inhibitors (TKIs).
Of those, 6 dasatinib-treated patients had mild renal dysfunction and 13 had mild liver impairment; 8 nilotinib-treated patients had mild renal insufficiency, 1 had moderate renal dysfunction, and 9 had mild liver impairment.
Results showed that after a median follow-up of 49 months, there were no significant differences in the rate of complete cytogenetic response, major molecular response, or deep molecular response.
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The study also demonstrated that patients with baseline renal dysfunction who were treated with dasatinib or nilotinib had a greater incidence of transient reversible acute kidney injury (P = .011 and P < .001, respectively). Further, nilotinib-treated patients with renal insufficiency had a higher risk of bleeding (P < .001).
- Sasaki K, Lahoti A, Jabbour E, et al. Clinical safety and efficacy of nilotinib or dasatinib in patients with newly diagnosed chronic-phase chronic myelogenous leukemia and pre-existing liver and/or renal dysfunction. Clin Lymphoma Myeloma Leuk. 2016;16(3):152-162.