Adverse events associated with tyrosine kinase inhibitors for the treatment of chronic myeloid leukemia

References

• Goldman JM, Melo JV, et al. Chronic myeloid leukemia – advances in biology and new approaches to treatment. N Engl J Med. 2003;349:1451–1464.
   PubMed Web of Science ®Google Scholar
• Hantschel O, Superti-Furga G. Regulation of the c-Abl and Bcr-Abl tyrosine kinases. Nat Rev Mol Cell Biol. 2004;5:33–44.
   PubMed Web of Science ®Google Scholar
• Faderl S, Talpaz M, Estrov Z, et al. Chronic myelogenous leukemia: biology and therapy. Ann Intern Med. 1999;131:207–219.
   PubMed Web of Science ®Google Scholar
• Melo JV, Deininger MW. Biology of chronic myelogenous leukemia-signaling pathways of initiation and transformation. Hematol Oncol Clin North Am. 2004;18:545–568.
   PubMed Web of Science ®Google Scholar
• Sattler M, Griffin JD. Molecular mechanisms of transformation by the BCR-ABL oncogene. Semin Hematol. 2003;40:4–10.
   PubMed Web of Science ®Google Scholar
• Yeung DT, Hughes TP. Therapeutic targeting of BCR-ABL: prognostic markers of response and resistance mechanism in chronic myeloid leukaemia. Crit Rev Oncog. 2012;17:17–30.
   PubMedGoogle Scholar
• Deininger MW, Buchdunger E, Druker BJ. The development of imatinib as a therapeutic agent for chronic myeloid leukaemia. Blood. 2005;105:2640–2653.
   PubMed Web of Science ®Google Scholar
• O’Brien SG, Guilhot F, Goldman JM, et al. International randomized study of interferon versus STI571 (IRIS) 7-year follow-up: sustained survival, low rate of transformation and increased rate of major molecular response (MMR) in patients (pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CMLCP) treated with imatinib (IM). Blood. 2008;112. abstr 186.
   Web of Science ®Google Scholar
• Deininger MW, O’Brien SG, Guilhot F, et al. International randomized study of interferon vs STI571 (IRIS) 8-year follow-up: sustained survival and low risk for progression or events in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) treated with imatinib. Blood. 2009;114. abstr 1126.
   Web of Science ®Google Scholar
• Shah NP, Kim DW, Kantarjian H, et al. Potent, transient inhibition of BCR-ABL with dasatinib 100 mg daily achieves rapid and durable cytogenetic responses and high transformation-free survival rates in chronic phase chronic myeloid leukemia patients with resistance, suboptimal response or intolerance to imatinib. Haematologica. 2010;95:232–240.
   PubMed Web of Science ®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
• Kantarjian HM, Shah NP, Cortes JP, et al. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2012;119:1123–1129.
   PubMed Web of Science ®Google Scholar
• Kantarjian H, Kim DW, Issagrisil S, et al. ENESTnd 4-year update: continued superiority of nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP). Blood. 2012;120:1676.
   Web of Science ®Google Scholar
• Breccia M, Binotto G. Bosutinib for chronic myeloid leukemia. Rare Cancers Ther. 2015;3:35–46.
   PubMedGoogle Scholar
• Breccia M, Alimena G. Second-generation tyrosine kinase inhibitors (TKI) as salvage therapy for resistant or intolerant patients to prior TKIs. Mediterr J Hematol Infect Dis. 2014;6:e2014003.
   PubMedGoogle Scholar
• Guerin A, Chen L, Ionescu-Ittu R, et al. Impact of low-grade adverse events on health-related quality of life in adult patients receiving imatinib or nilotinib for newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase. Curr Med Res Opin. 2014;30:2317–2328.
   PubMed Web of Science ®Google Scholar
• Abdel-Rahman O, Fouad M. Systemic therapy options for advanced gastrointestinal stromal tumors beyond first-line imatinib: a systematic review. Future Oncol. 2015;11:1829–1843.
   PubMed Web of Science ®Google Scholar
• Hughes TP, Hochhaus A, Branford S, et al. Long-term prognostic significance of early molecular response to imatinib in newly diagnosed chronic myeloid leukemia: an analysis from the International Randomized Study of Interferon and STI571 (IRIS). Blood. 2010;116:3758–3765.
   PubMed Web of Science ®Google Scholar
• Kalmanti L, Saussele S, Lauseker M, et al. Safety and efficacy of imatinib in CML over a period of 10 years: data from the randomized CML-study IV. Leukemia. 2015;29:1123–1132.
   PubMed Web of Science ®Google Scholar
• Hochhaus A, O’Brien SG, Guilhot F, et al. Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia. Leukemia. 2009;23:1054–1061.
   PubMed Web of Science ®Google Scholar
• Gambacorti-Passerini C, Antolini L, et al. Multicenter independent assessment of outcomes in chronic myeloid leukemia patients treated with imatinib. J Natl Cancer Inst. 2011;103:553–561.
   PubMed Web of Science ®Google Scholar
• Baccarani M, Druker BJ, Branford S, et al. Long-term response to imatinib is not affected by the initial dose in patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: final update from the Tyrosine Kinase Inhibitor Optimization and Selectivity (TOPS) study. Inter J Hematol. 2014;99:616–624.
   PubMed Web of Science ®Google Scholar
• Helhmann R, Muller MC, Lauseker M, et al. Deep molecular response is reached by the majority of patients treated with imatinib, predicts survival, and is achieved more quickly by optimized high-dose imatinib: results from the randomized CML-study IV. J Clin Oncol. 2014;32:415–423.
   PubMed Web of Science ®Google Scholar
• Hahn EA, Glendenning GA, Sorensen MV, et al. Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine: results from the IRIS Study. J Clin Oncol. 2003;21:2138–2146.
   PubMed Web of Science ®Google Scholar
• Efficace F, Baccarani M, Breccia M, et al. Health-related quality of life in chronic myeloid leukemia patients receiving long-term therapy with imatinib compared with the general population. Blood. 2011;118:4554–4560.
   PubMed Web of Science ®Google Scholar
• Cornelison M, Jabbour EJ, Welch MA. Managing side effects of tyrosine kinase inhibitor therapy to optimize adherence in patients with chronic myeloid leukemia: the role of the midlevel practitioner. J Support Oncol. 2012;10:14–24.
   PubMedGoogle Scholar
• Orphanos GS, Ioannidis GN, Ardavanis AG. Cardiotoxicity induced by tyrosine kinase inhibitors. Acta Oncol. 2009;48:964–970.
   PubMed Web of Science ®Google Scholar
• Kerkelä R, Grazette L, Yacobi R, et al. Cardiotoxicity of the cancer therapeutic agent imatinib mesylate. Nat Med. 2006;12:908–916.
   PubMed Web of Science ®Google Scholar
• Hatfield A, Owen S, Pilot PR. In reply to ‘Cardiotoxicity of the cancer therapeutic agent imatinib mesylate’. Nat Med. 2007;13:15–16.
   PubMed Web of Science ®Google Scholar
• Breccia M, Cannella L, Frustaci A, et al. Cardiac events in imatinib mesylate-treated chronic myeloid leukemia patients: a single institution experience. Leuk Res. 2008;32:835–836.
   PubMed Web of Science ®Google Scholar
• Atallah E, Durand J-B, Kantarjian H, et al. Congestive heart failure is a rare event in patients receiving imatinib therapy. Blood. 2007;110:1233–1237.
   PubMed Web of Science ®Google Scholar
• Ribeiro AL, Marcolino MS, Bittencourt HN, et al. An evaluation of the cardiotoxicity of imatinib mesylate. Leuk Res. 2008;32:1809–1814.
   PubMed Web of Science ®Google Scholar
• Wolf A, Couttet P, Dong M, et al. Imatinib does not induce cardiotoxicity at clinically relevant concentrations in preclinical studies. Leuk Res. 2010;34:1180–1188.
   PubMed Web of Science ®Google Scholar
• Le Coutre PD, Giles FJ, Pinilla-Ibarz J, et al. Nilotinib in imatinib-resistant or intolerant patients with chronic myeloid leukemia in chronic phase: 48-month follow-up results of a phase 2 study. Blood. 2011;118:3770.
   Web of Science ®Google Scholar
• Rosti G, Palandri F, Castagnetti F, et al. Nilotinib for the frontline treatment of h+ chronic myeloid leukemia. Blood. 2009;114:4933–4938.
   PubMed Web of Science ®Google Scholar
• Quintas Cardama A, Kantarjian H, Luthra R, et al. Efficacy of frontline nilotinib therapy in patients with newly diagnosed philadelphia chromosome-positive chronic myeloid leukemia in early chronic phase. Blood. 2011;118:454.
   Web of Science ®Google Scholar
• Larson RA, Kim DW, et al. ENESTnd 5-year (y) update: long-term outcomes of patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) treated with frontline nilotinib (NIL) versus imatinib (IM). J Clin Oncol. 2014;32:5s.
   Google Scholar
• Saglio G, Larson RA, Hughes TP, et al. Efficacy and safety of nilotinib in chronic phase (CP) chronic myeloid leukemia (CML) patients (Pts) with type 2 diabetes in the ENESTnd trial. Blood. 2010;116. abst 3430.
   PubMed Web of Science ®Google Scholar
• Rea D, Gautier JF, Breccia M, et al. Incidence of hyperglycemia by 3 years in patients (Pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) treated with nilotinib (NIL) or imatinib (IM) in ΕΝΕSΤnd. Blood. 2012;120:1686.
   Web of Science ®Google Scholar
• Racil Z, Razga F, Drapalova J, et al. Mechanism of impaired glucose metabolism during nilotinib therapy in patients with chronic myelogenous leukemia. Haematologica. 2013;98:e124–e126.
   PubMed Web of Science ®Google Scholar
• Breccia M, Alimena G, Cannella L, et al. Nilotinib therapy does not induce consistent modifications of cholesterol metabolism resulting in clinical consequences. Leuk Res. 2011;35:e215–e216.
   Google Scholar
• Hiwase DK, Yeung DT, Carne L, et al. Hypercholesterolemia in imatinib intolerant/resistant CML-CP patients treated with nilotinib: a retrospective analysis. Blood. 2013;122:1503.
   Web of Science ®Google Scholar
• Rea D, Mirault T, Cluzeau T, et al. Early onset hypercholesterolemia induced by the 2nd-generation tyrosine kinase inhibitor nilotinib in patients with chronic phase-chronic myeloid leukemia. Haematologica. 2014;99:1197–1203.
   PubMed Web of Science ®Google Scholar
• Giles FJ, O’Dwyer M, Swords R. Class effects of tyrosine kinase inhibitors in the treatment of chronic myeloid leukemia. Leukemia. 2009;23:1698–1707.
   PubMed Web of Science ®Google Scholar
• Gugliotta G, Castagnetti F, et al. Long-term outcome of a phase 2 trial with nilotinib 400 mg twice daily in first-line treatment of chronic myeloid leukemia. Haematologica. 2015;100:1146–1150.
   PubMed Web of Science ®Google Scholar
• Hochhaus A, Rosti G, Cross NC, et al. Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the European ENEST1st study. Leukemia. 2016;30:57–64.
   Web of Science ®Google Scholar
• Aichberger KJ, Herndlhofer S, Schernthaner GH, et al. Progressive peripheral arterial occlusive disease and other vascular events during nilotinib therapy in CML. Am J Hematol. 2011;86:533–539.
   PubMed Web of Science ®Google Scholar
• Le Coutre P, Rea D, Abruzzese E, et al. Severe peripheral arterial disease during nilotinib therapy. J Natl Cancer Inst. 2011;103:1347–1348.
   PubMed Web of Science ®Google Scholar
• Giles FJ, Mauro MJ, Hong F, et al. Rates of peripheral arterial occlusive disease in patients with chronic myeloid leukemia in the chronic phase treated with imatinib, nilotinib, or non-tyrosine kinase therapy: a retrospective cohort analysis. Leukemia. 2013;27:1310–1315.
   PubMed Web of Science ®Google Scholar
• Kim TD, Rea D, Le Coutre PD, 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
• Breccia M, Molica M, Zacheo I, et al. Application of systematic coronary risk evaluation chart to identify chronic myeloid leukemia patients at risk of cardiovascular diseases during nilotinib treatment. Ann Hematol. 2015;94:393–397.
   PubMed Web of Science ®Google Scholar
• Rea D, Mirault T, Raffoux E, et al. Usefulness of the 2012 European CVD risk assessment model to identify patients at high risk of cardiovascular events during nilotinib therapy in chronic myeloid leukemia. Leukemia. 2015;29:1206–1209.
   PubMed Web of Science ®Google Scholar
• Breccia M, Salaroli A, Molica M, et al. Systematic review of dasatinib in chronic myeloid leukemia. Onco Targets Ther. 2013;6:257–265.
   PubMed Web of Science ®Google Scholar
• Rea D, Vellenga E, Junghan C, et al. Six-year follow-up of patients with imatinib-resistant or imatinib-intolerant chronic phase chronic myeloid leukemia (CML-CP) receiving dasatinib. Haematologica. 2012;97:199.
   Google Scholar
• Kantarjian HM, Shah NP, Cortes JE, et al. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2012;119:1123–1129.
   PubMed Web of Science ®Google Scholar
• Chen R, Wang F, Zhang X, et al. Severe thrombocytopenia after dasatinib treatment in a patient with Philadelphia chromosome-positive chronic myeloid leukemia. Onco Targets Ther. 2015;8:955–957.
   PubMed Web of Science ®Google Scholar
• Futosi K, Németh T, Pick R, et al. Dasatinib inhibits proinflammatory functions of mature human neutrophils. Blood. 2012;119:4981–4991.
   PubMed Web of Science ®Google Scholar
• Visani G, Breccia M, Montefusco E, et al The incidence of pleural and pericardial effusion is not higher in patients receiving dasatinib at low doses. (Reply). Haematologica. 2011;96:e23–e24.
   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
• Mustjoki S, Ekblom M, Arstila TP, et al. Clonal expansion of T/NK-cells during tyrosine kinase inhibitor dasatinib therapy. Leukemia. 2009;23:1398–1405.
   PubMed Web of Science ®Google Scholar
• Valent J, Schiffer CA. Prevalence of large granular lymphocyte proliferation in chronic myeloid leukemia (CML) patients treated with dasatinib. Blood. 2009;114. abst 1111.
   PubMed Web of Science ®Google Scholar
• Breccia M, Latagliata R, Stagno F, et al. Charlson comorbidity index and adult comorbidity evaluation-27 scores might predict treatment compliance and development of pleural effusions in elderly patients with chronic myeloid leukemia treated with second-line dasatinib. Haematologica. 2011;96:1457–1461.
   PubMed Web of Science ®Google Scholar
• Agarwal R, Gomberg-Matland M. Current therapeutics and practical management strategies for pulmonary arterial hypertension. Am Heart J. 2011;162:201–213.
   PubMed Web of Science ®Google Scholar
• Shah NP, Wallis N, Farber HW, et al. Clinical features of pulmonary arterial hypertension in patients receiving dasatinib. Am J Hematol. 2015;90:1060–1064.
   Google Scholar
• Breccia M, Alimena G. Occurrence and current management of side effects in chronic myeloid leukemia patients treated frontline with tyrosine kinase inhibitors. Leuk Res. 2013;37:713–720.
   PubMed Web of Science ®Google Scholar
• Rasheed W, Flaim B, Seymour JF. Reversible severe pulmonary hypertension secondary to dasatinib in a patient with chronic myeloid leukemia. Leuk Res. 2009;33:861–864.
   PubMed Web of Science ®Google Scholar
• Mattei D, Feola M, Orzan F, et al. Reversible dasatinib-induced pulmonary arterial hypertension and right ventricle failure in a previously allografted CML patient. Bone Marrow Transplant. 2009;43:967–968.
   PubMed Web of Science ®Google Scholar
• Dumitrescu D, Seck C, Ten Freyhaus H, et al. Fully reversible pulmonary arterial hyepertension associated with dasatinib treatment for chronic myeloid leukemia. Eur Respir J. 2011;38:218–220.
   PubMed Web of Science ®Google Scholar
• Hennigs JK, Keller G, Baumann HJ, et al. Multi tyrosine kinase inhibitor dasatinib as novel cause of severe pre-capillary pulmonary hypertension? BMC Pulm Med. 2011;23:11–30.
   Google Scholar
• Orlandi EM, Rocca B, Pazzano AS, et al. Reversible pulmonary arterial hypertension likely related to long-term, low dose dasatinib treatment for chronic myeloid leukemia. Leuk Res. 2012;36:e4–6.
   PubMed Web of Science ®Google Scholar
• Montani D, Bergot E, Gunther S, et al. Pulmonary arterial hypertension in patients treated by dasatinib. Circulation. 2012;125:2128–2137.
   PubMed Web of Science ®Google Scholar
• Gambacorti-Passerini C, Brummendorf TH, Kim DW, et al. Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: minimum 24-month follow-up. Am J Hematol. 2014;89:732–742.
   PubMed Web of Science ®Google Scholar
• Gambacorti-Passerini C, Kantarjian HM, Kim DW, et al. Long-term efficacy and safety of bosutinib in patients with advanced leukemia following resistance/intolerance to imatinib and other tyrosine kinase inhibitors. Am J Hematol. 2015;90:755–768.
   PubMed Web of Science ®Google Scholar
• Gambacorti-Passerini C, Cortes JE, Lipton JH, et al. Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia. Am J Hematol. 2014;89:947–953.
   PubMed Web of Science ®Google Scholar
• Gambacorti-Passerini C, Kantarjian HM, Khoury HJ, et al. Long-term assessment of cardiac toxicity in patients with Ph+ leukemias treated with bosutinib. Haematologica. 2014;99(suppl 1). abstr 903.
   Web of Science ®Google Scholar
• Cortes JE, Kantarjian HM, Khoury HJ, et al. Long-term evaluation of vascular toxicity in patients with Ph+ Leukemias treated with bosutinib. Haematologica. 2014;99(suppl 1). abstr 900.
   Web of Science ®Google Scholar
• Cortes J, Kantarjian H, Shah NP, et al. Ponatinib in refractory Philadelphia chromosome-positive leukemias. New Engl J Med. 2012;367:2075–2088.
   PubMed Web of Science ®Google Scholar
• Cortes JE, Kim DW, Pinilla-Ibarz J, et al. A phase 2 trial of ponatinib in Philadelphia chromosome–positive leukemias. New Engl J Med. 2013;369:1783–1796.
   PubMed Web of Science ®Google Scholar
• Lipton JH, Chuah C, Guerci-Bresler A, et al. Epic: a phase 3 trial of ponatinib compared with imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CP-CML). Blood. 2014;124. abstr 519.
   Google Scholar