Spotlight on nilotinib in the treatment of chronic myelogenous leukemia

References

• Tasigna (nilotinib) [package insert]. East Hanover, NJ: Novartis Pharmaceuticals; 2014.
   Google Scholar
• Holland J, Tanaka C, Zhou W, Sethuraman V, Heuman DM, Schran H. Pharmacokinetics of nilotinib in subjects with normal or impaired hepatic function. Blood. 2007;110:2379.
   Web of Science ®Google Scholar
• Kantarjian H, Giles F, Wunderle L, et al. Nilotinib in imatinib-resistant CML and Philadelphia chromosome-positive ALL. N Engl J Med. 2006;354:2542–2551.
   PubMed Web of Science ®Google Scholar
• Kantarjian HM, Giles F, Gattermann N, et al. Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance. Blood. 2007;110:3540–3546.
   PubMed Web of Science ®Google Scholar
• le Coutre P, Ottmann OG, Giles F, et al. Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia. Blood. 2008;111:1834–1839.
   PubMed Web of Science ®Google Scholar
• Kantarjian HM, Giles FJ, Bhalla KN, et al. Update on imatinib-resistant chronic myeloid leukemia patients in chronic phase (CML-CP) on nilotinib therapy at 24 months: clinical response, safety, and long-term outcomes. Blood. 2009;114:1129.
   Google Scholar
• Giles FJ, le Coutre PD, Pinilla-Ibarz J, et al. Nilotinib in imatinib-resistant or imatinib-intolerant patients with chronic myeloid leukemia in chronic phase: 48-month follow-up results of a phase II study. Leukemia. 2013;27:107–112.
   PubMed Web of Science ®Google Scholar
• Giles FJ, Kantarjian H, le Coutre PD, et al. Use of nilotinib to induce responses with 24-month (mo) minimum follow-up in patients (pts) with chronic myeloid leukemia in blast crisis (CML-BC) resistant to or intolerant of imatinib. J Clin Oncol. 2010;28:6510.
   Web of Science ®Google Scholar
• Ottmann O, Kantarjian H, Larson R, et al. A phase II study of nilotinib, a novel tyrosine kinase inhibitor administered to imatinib resistant or intolerant patients with chronic myelogenous leukemia (CML) in blast crisis (BC) or relapsed/refractory Ph+ acute lymphoblastic leukemia (ALL). Blood. 2006;108:1862.
   Web of Science ®Google Scholar
• Giles FJ, le Coutre P, Bhalla KN, et al. Nilotinib therapy after dasatinib failure in patients with imatinib-resistant or -intolerant chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast crisis (BC). Blood. 2007;110:1029.
   Web of Science ®Google Scholar
• Garg RJ, Kantarjian H, O’Brien S, et al. The use of nilotinib or dasatinib after failure to 2 prior tyrosine kinase inhibitors: long-term follow-up. Blood. 2009;114:4361–4368.
   PubMed Web of Science ®Google Scholar
• Cortes J E, Jones D, O’Brien S, et al. Nilotinib as front-line treatment for patients with chronic myeloid leukemia in early chronic phase. J Clin Oncol. 2010;28:392–397.
   PubMed Web of Science ®Google Scholar
• Saglio G, Kim DW, Issaragrisil S, et al. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med. 2010;362:2251–2259.
   PubMed Web of Science ®Google Scholar
• Kantarjian HM, Hochhaus A, Saglio G, et al. Nilotinib versus imatinib for the treatment of patients with newly diagnosed chronic phase, Philadelphia chromosome-positive, chronic myeloid leukaemia: 24-month minimum follow-up of the phase 3 randomised ENESTnd trial. Lancet Oncol. 2011;12:841–851.
   PubMed Web of Science ®Google Scholar
• Larson RA, Hochhaus A, Hughes TP, et al. Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up. Leukemia. 2012;26:2197–2203.
   PubMed Web of Science ®Google Scholar
• Politi J, Shah NP. What does a deep molecular response signify? J Clin Oncol. 2014;32:471–474.
   Web of Science ®Google Scholar
• Hughes TP, Saglio G, Kantarjian HM, et al. Early molecular response predicts outcomes in patients with chronic myeloid leukemia in chronic phase treated with frontline nilotinib or imatinib. Blood. 2014;123:1353–1360.
   PubMed Web of Science ®Google Scholar
• Radich J. Stem cell transplant for chronic myeloid leukemia in the imatinib era. Semin Hematol. 2010;47:354–361.
   PubMed Web of Science ®Google Scholar
• Gratwohl A, Brand R, Apperley J, et al. Allogeneic hematopoietic stem cell transplantation for chronic myeloid leukemia in Europe 2006: transplant activity, long-term data and current results. An analysis by the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation (EBMT). Haematologica. 200691:513–521.
   PubMed Web of Science ®Google Scholar
• Oyekunle A, Klyuchnikov E, Ocheni S, et al. Challenges for allogeneic hematopoietic stem cell transplantation in chronic myeloid leukemia in the era of tyrosine kinase inhibitors. Acta Haematol. 2011;126:30–39.
   PubMed Web of Science ®Google Scholar
• Klyuchnikov E, Schafhausen P, Kröger N, et al. Second-generation tyrosine kinase inhibitors in the post-transplant period in patients with chronic myeloid leukemia or Philadelphia-positive acute lymphoblastic leukemia. Acta Haematol. 2009;122:6–10.
   PubMed Web of Science ®Google Scholar
• Andolina JR, Neudorf SM, Corey SJ. How I treat childhood CML. Blood. 2012;119:1821–1830.
   PubMed Web of Science ®Google Scholar
• de la Fuente J, Baruchel A, Biondi A, et al. Managing children with chronic myeloid leukaemia (CML): recommendations for the management of CML in children and young people up to the age of 18 years. Br J Haematol. Epub June 30, 2014.
   Google Scholar
• Ampatzidou M, Papadhimitriou SI, Goussetis E, Panagiotou JP, Papadakis V, Polychronopoulou S. Chronic myeloid leukemia (CML) in children: classical and newer therapeutic approaches. Pediatr Hematol Oncol. 2012;29:389–394.
   PubMed Web of Science ®Google Scholar
• Wayne AS, Macedo C, Szczudlo T, et al. Nilotinib treatment in pediatric patients (pts) with Philadelphia chromosome-positive (Ph+) leukemia refractory to prior tyrosine kinase inhibitor (TKI) therapy: results from Nilotinib compassionate use program. Blood. 2008;112:4264. Abstract.
   Google Scholar
• Novartis Pharmaceuticals. A pharmacokinetic (PK) study of nilotinib in pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) or acute lymphoblastic leukemia (ALL). Available from: https://clinicaltrials.gov/ct2/show/NCT01077544?term=NCT01077544. NLM identifier: NCT01077544. Accessed July 24, 2014.
   Google Scholar
• Narayanan KR, Bansal D, Walia R, et al. Growth failure in children with chronic myeloid leukemia receiving imatinib is due to disruption of GH/IGF-1 axis. Pediatr Blood Cancer. 2013;60:1148–1153.
   PubMed Web of Science ®Google Scholar
• Ulmer A, Tabea Tauer J, Glauche I, Jung R, Suttorp M. TK inhibitor treatment disrupts growth hormone axis: clinical observations in children with CML and experimental data from a juvenile animal model. Klin Padiatr. 2013;225:120–126.
   PubMed Web of Science ®Google Scholar
• Haouala A, Widmer N, Duchosal MA, Montemurro M, Buclin T, Decosterd LA. Drug interactions with the tyrosine kinase inhibitors imatinib, dasatinib, and nilotinib. Blood. 2011;117:e75–e87.
   PubMed Web of Science ®Google Scholar
• Nicolini FE, Turkina A, Shen ZX, et al. Expanding Nilotinib Access in Clinical Trials (ENACT): an open-label, multicenter study of oral nilotinib in adult patients with imatinib-resistant or imatinib-intolerant Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase. Cancer. 2012;118:118–126.
   PubMed Web of Science ®Google Scholar
• Tasigna (nilotinib) [Risk Evaluation and Mitigation Strategies (REMS)]. East Hanover, NJ: Novartis Pharmaceuticals; 2010.
   Google Scholar
• Fujita K, Sugiyama M, Akiyama Y, Ando Y, Sasaki Y. The small-molecule tyrosine kinase inhibitor nilotinib is a potent noncompetitive inhibitor of the SN-38 glucuronidation by human UGT1A1. Cancer Chemother Pharmacol. 2011;67:237–241.
   PubMed Web of Science ®Google Scholar
• Cortes JE, Hochhaus A, le Coutre PD, et al. Minimal cross-intolerance with nilotinib in patients with chronic myeloid leukemia in chronic or accelerated phase who are intolerant to imatinib. Blood. 2011;117:5600–5606.
   PubMed Web of Science ®Google Scholar
• Alzamora MT, Forés R, Baena-Díez JM, et al. The peripheral arterial disease study (PERART/ARTPER): prevalence and risk factors in the general population. BMC Public Health. 2010;10:38.
   PubMed Web of Science ®Google Scholar
• Kim TD, Rea D, Schwarz M, et al. Peripheral artery occlusive disease in chronic phase chronic myeloid leukemia patients treated with nilotinib or imatinib. Leukemia. 2013;27:1316–1321.
   PubMed Web of Science ®Google Scholar
• Quintás-Cardama A, Kantarjian H, O’Brien S, et al. Pleural effusion in patients with chronic myelogenous leukemia treated with dasatinib after imatinib failure. J Clin Oncol. 2007;25:3908–3914.
   PubMed Web of Science ®Google Scholar
• Gugliotta G, Castagnetti F, Fogli M, Cavo M, Baccarani M, Rosti G. Impact of comorbidities on the treatment of chronic myeloid leukemia with tyrosine-kinase inhibitors. Expert Rev Hematol. 2013;6:563–574.
   PubMed Web of Science ®Google Scholar
• Goldman J. Monitoring minimal residual disease in BCR-ABL-positive chronic myeloid leukemia in the imatinib era. Curr Opin Hematol. 2005;12:33–39.
   PubMed Web of Science ®Google Scholar
• Jabbour E, Kantarjian HM, Jones D, et al. Imatinib mesylate dose escalation is associated with durable responses in patients with chronic myeloid leukemia after cytogenetic failure on standard-dose imatinib therapy. Blood. 2009;113:2154–2160.
   PubMed Web of Science ®Google Scholar
• Apperley JF. Part I: Mechanisms of resistance to imatinib in chronic myeloid leukaemia. Lancet Oncol. 2007;8:1018–1029.
   PubMed Web of Science ®Google Scholar
• National Comprehensive Cancer Network. Chronic Myelogenous Leukemia. Fort Washington (PA): NCCN; 2014.
   Google Scholar
• Wu EQ, Johnson S, Beaulieu N. Healthcare resource utilization and costs associated with non-adherence to imatinib treatment in chronic myeloid leukemia patients. Curr Med Res Opin. 2010;26:61–69.
   PubMed Web of Science ®Google Scholar
• Wu EQ, Guerin A, Yu AP, Bollu VK, Guo A, Griffin JD. Retrospective real-world comparison of medical visits, costs, and adherence between nilotinib and dasatinib in chronic myeloid leukemia. Curr Med Res Opin. 2010;26:2861–2869.
   PubMed Web of Science ®Google Scholar
• Pavey T, Hoyle M, Ciani O, et al. Dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia: systematic reviews and economic analyses. Health Technol Assess. 2012;16:iii–iv, 1–277.
   Web of Science ®Google Scholar