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.

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.

• Authors: 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
• Journal: Clinical lymphoma, myeloma & leukemia (Clin Lymphoma Myeloma Leuk) Vol. 16 Issue 3 Pg. 152-62 (Mar 2016) ISSN: 2152-2669 [Electronic] United States
• PMID: 26796981 (Publication Type: Journal Article, Research Support, N.I.H., Extramural)
• Copyright: Copyright © 2016 Elsevier Inc. All rights reserved.

Chemical References

• Antineoplastic Agents
• Pyrimidines
• nilotinib
• Dasatinib

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (adverse effects, therapeutic use)
• Dasatinib (administration & dosage, adverse effects, therapeutic use)
• Female
• Follow-Up Studies
• Humans
• Kidney Diseases (complications, diagnosis)
• Kidney Function Tests
• Leukemia, Myeloid, Chronic-Phase (complications, drug therapy, mortality)
• Liver Diseases (complications, diagnosis)
• Liver Function Tests
• Male
• Middle Aged
• Pyrimidines (administration & dosage, adverse effects, therapeutic use)
• Treatment Outcome
• Young Adult