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.