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

Koji Sasaki, Amit Lahoti, Elias Jabbour, Preetesh Jain, Sherry Pierce, Gautam Borthakur, Naval Daver, Tapan Kadia, Naveen Pemmaraju, Alessandra Ferrajoli, Susan O'Brien, Hagop Kantarjian, Jorge Cortes

Research output: Contribution to journalArticle

6 Scopus citations

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 languageEnglish (US)
Pages (from-to)152-162
Number of pages11
JournalClinical Lymphoma, Myeloma and Leukemia
Volume16
Issue number3
DOIs
StatePublished - Mar 1 2016
Externally publishedYes

Keywords

  • CML
  • Dasatinib
  • Liver dysfunction
  • Nilotinib
  • Renal dysfunction

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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