Abstract
Background The safety and efficacy of front-line nilotinib and dasatinib in patients with newly diagnosed chronic-phase chronic myelogenous leukemia (CML-CP) with pre-existing liver and/or renal dysfunction are unknown. Patients and Methods We analyzed the adverse event rates, response rates, and survival rates of 215 patients with CML-CP with or without renal and/or liver dysfunction who had been treated with front-line nilotinib (n = 108) or dasatinib (n = 107). Results The overall median follow-up period was 49 months. At baseline, 6 dasatinib-treated patients (6%) had mild renal dysfunction and 13 (12%) had mild liver dysfunction. Also, 8 nilotinib-treated patients (7%) had mild renal dysfunction, 1 (1%) moderate renal dysfunction, and 9 (8%) mild liver dysfunction. No significant differences were found in the rate of complete cytogenetic response, major molecular response, or molecular response by a 4.5 log reduction on the international scale between the organ function cohorts. Dasatinib- or nilotinib-treated patients with baseline renal dysfunction had a greater incidence of transient reversible acute kidney injury (P =.011 and P <.001), and nilotinib-treated patients with renal dysfunction had a greater incidence of bleeding (P <.001). Conclusion Patients with CML-CP and mild to moderate renal or liver dysfunction can be safely treated with front-line dasatinib or nilotinib and can achieve response rates similar to those of patients with CML-CP without organ dysfunction.
Original language | English (US) |
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Pages (from-to) | 152-162 |
Number of pages | 11 |
Journal | Clinical Lymphoma, Myeloma and Leukemia |
Volume | 16 |
Issue number | 3 |
DOIs | |
State | Published - Mar 1 2016 |
Keywords
- CML
- Dasatinib
- Liver dysfunction
- Nilotinib
- Renal dysfunction
ASJC Scopus subject areas
- Hematology
- Oncology
- Cancer Research
MD Anderson CCSG core facilities
- Clinical Trials Office