Long-term BCR-ABL1 tyrosine kinase inhibitor therapy in chronic myeloid leukemia

Anticancer Research

Volumn 35, Issue 12, 2015, Pages 6355-6364

  Pinilla Ibarz, Javier ^a   Sweet, Kendra ^a   Emole, Josephine ^a   Fradley, Michael ^a,b  

^a H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^b UNIVERSITY OF SOUTH FLORIDA   (United States)

Author keywords

Adherence; Adverse effects; BCR ABL1; Chronic myeloid leukemia; Medication; Review; Therapy management

Indexed keywords

PROTEIN TYROSINE KINASE INHIBITOR; BCR ABL PROTEIN; PROTEIN KINASE INHIBITOR;

CANCER PATIENT; CHRONIC MYELOID LEUKEMIA; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; FOLLOW UP; GENERAL PRACTITIONER; HEALTH CARE NEED; HUMAN; LABORATORY TEST; LONG TERM CARE; ONCOLOGIST; PATIENT CARE; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PLEURA EFFUSION; PRIMARY MEDICAL CARE; PRIORITY JOURNAL; PULMONARY HYPERTENSION; QT PROLONGATION; QTC INTERVAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; GENETICS; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; METABOLISM;

FUSION PROTEINS, BCR-ABL; HUMANS; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; PROTEIN KINASE INHIBITORS;

EID: 84949464077     PISSN: 02507005     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (81)

1. Gleevec [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2015.
2. Johnson JR, Bross P, Cohen M, Rothmann M, Chen G, Zajicek A, Gobburu J, Rahman A, Staten A and Pazdur R: Approval summary: imatinib mesylate capsules for treatment of adult patients with newly diagnosed Philadelphia chromosomepositive chronic myelogenous leukemia in chronic phase. Clin Cancer Res 9: 1972-1979, 2003.
3. O'Brien SG, Guilhot F, Larson RA, Gathmann I, Baccarani M, Cervantes F, Cornelissen JJ, Fischer T, Hochhaus A, Hughes T, Lechner K, Nielsen JL, Rousselot P, Reiffers J, Saglio G, Shepherd J, Simonsson B, Gratwohl A, Goldman JM, Kantarjian H, Taylor K, Verhoef G, Bolton AE, Capdeville R, Druker BJ and IRIS Investigators: Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 348: 994-1004, 2003.
4. Sprycel [package insert]. Princeton, NJ: Bristol-Myers Squibb; 2014.
5. Tasigna [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2015.
6. Bosulif [package insert]. New York, NY: Pfizer; 2013.
7. Iclusig [package insert]. Cambridge, MA: ARIAD Pharmaceuticals; 2014.
8. Huang X, Cortes J and Kantarjian H: Estimations of the increasing prevalence and plateau prevalence of chronic myeloid leukemia in the era of tyrosine kinase inhibitor therapy. Cancer 118: 3123-3127, 2012.
9. NCCN Clinical Practice Guidelines in Oncology. Chronic Myelogenous Leukemia. V1.2015.
10. Larson RA, Hochhaus A, Hughes TP, Clark RE, Etienne G, Kim DW, Flinn IW, Kurokawa M, Moiraghi B, Yu R, Blakesley RE, Gallagher NJ, Saglio G and Kantarjian HM: Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosomepositive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up. Leukemia 26: 2197-2203, 2012.
11. Kantarjian HM, Shah NP, Cortes JE, Baccarani M, Agarwal MB, Undurraga MS, Wang J, Ipina JJ, Kim DW, Ogura M, Pavlovsky C, Junghanss C, Milone JH, Nicolini FE, Robak T, Van Droogenbroeck J, Vellenga E, Bradley-Garelik MB, Zhu C and Hochhaus A: Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood 119: 1123-1129, 2012.
12. Brummendorf TH, Cortes JE, de Souza CA, Guilhot F, Duvillie L, Pavlov D, Gogat K, Countouriotis AM and Gambacorti-Passerini C: Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukaemia: results from the 24-month follow-up of the BELA trial. Br J Haematol 168: 69-81, 2015.
13. Chuah C, Guerci-Bresler A, Rosti G, Simpson D, Lustgarten S, Trede N, Rivera VM, Clackson T, Haluska FG, Baccarani M, Cortes JE, Guilhot F, Hochhaus A, Hughes T, Kantarjian H, Shah NP, Talpaz M, Deininger MW and Lipton JH: EPIC: a phase 3 trial of ponatinib vs imatinib in patients (pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CPCML) [abstract]. Haematologica 99: S679, 2014.
14. Rea D, Vellenga E, Junghan C, Baccarani M, Kantarjian H, Lofgren C, Dejardin D and Hochhause A: Six-year follow-up of patients with imatinib-resistant or imatinib-intolerant chronicphase chronic myeloid leukemia receiving dasatinib [abstract 0199]. Haematologica 97(suppl 1): 80, 2012.
15. Giles FJ, le Coutre PD, Pinilla-Ibarz J, Larson RA, Gattermann N, Ottmann OG, Hochhaus A, Radich JP, Saglio G, Hughes TP, Martinelli G, Kim DW, Novick S, Gillis K, Fan X, Cortes J, Baccarani M and Kantarjian HM: 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 27: 107-112, 2013.
16. Gambacorti-Passerini C, Brummendorf TH, Kim DW, Turkina AG, Masszi T, Assouline S, Durrant S, Kantarjian HM, Khoury HJ, Zaritskey A, Shen ZX, Jin J, Vellenga E, Pasquini R, Mathews V, Cervantes F, Besson N, Turnbull K, Leip E, Kelly V and Cortes JE: Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: minimum 24-month follow-up. Am J Hematol 89: 732-742, 2014.
17. Cortes JE, Kim DW, Pinilla-Ibarz J, Le Coutre P, Paquette R, Chuca C, Nicolini FE, Apperlet JF, Khoury HJ, Talpaz M, DiPersio JF, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Muller MC, Gambacorti-Passerini C, Lustgarten S, Rivera VM, Clackson T, Turner CD, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes TP, Shah NP and Kantarjian HM: Longterm follow-up of ponatinib efficacy and safety in the phase 2 PACE trial [abstract 3135]. Blood 124: 3135, 2014.
18. Hughes TP, Larson RA, Kim DW, Issaragrisil S, le Coutre PD, Lobo C, Dubruille V, Kuliczkowski K, Jootar S, Clark RE, Hochhaus A, Saglio G, Kemp C, Deng W, Menssen HD and Kantarjian HM: Efficacy and safety of nilotinib vs imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase: 6-year follow-up of ENESTnd [abstract p228]. Haematologica 100: 61, 2015.
19. Cortes JE, Saglio G, Baccarani M, Kantarjian HM, Mayer J, Boque C, Shah NP, Chuah C, Casanova L, Narayanan G, Bradley-Garelik B, Mano G and Hochhaus A: Final study results of the phase 3 dasatinib versus imatinib in newly diagnosed chronic myeloid leukemia in chronic phase (CMLCP) trial (DASISION, CA180-056) [abstract 152]. Blood 124: 152, 2014.
20. Larson RA, Kim DW, Jootar S, Pasquini R, Clark RE, Lobo C, Goldberg SL, Shibayama H, Hochhaus A, Saglio G, Kantarjian HM, Kemp C, Deng W, Menssen HD and Hughes TP: ENESTnd 5-y update: long-term outcomes of patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) treated with frontline nilotinib (NIL) vs imatinib (IM) [abstract 7073]. J Clin Oncol 32(suppl): 7073, 2014.
21. Silver RT, Woolf SH, Hehlmann R, Appelbaum FR, Anderson J, Bennett C, Goldman JM, Guilhot F, Kantarjian HM, Lichtin AE, Talpaz M and Tura S: An evidence-based analysis of the effect of busulfan, hydroxyurea, interferon, and allogeneic bone marrow transplantation in treating the chronic phase of chronic myeloid leukemia: developed for the American Society of Hematology. Blood 94: 1517-1536, 1999.
22. Erba HP: Molecular monitoring to improve outcomes in patients with chronic myeloid leukemia in chronic phase: importance of achieving treatment-free remission. Am J Hematol 90: 242-249, 2015.
23. Breccia M and Alimena G: Discontinuation of tyrosine kinase inhibitors and new approaches to target leukemic stem cells: treatment-free remission as a new goal in chronic myeloid leukemia. Cancer Lett 347: 22-28, 2014.
24. Mahon FX and Etienne G: Deep molecular response in chronic myeloid leukemia: the new goal of therapy? Clin Cancer Res 20: 310-322, 2014.
25. Ross DM and Hughes TP: How I determine if and when to recommend stopping tyrosine kinase inhibitor treatment for chronic myeloid leukaemia. Br J Haematol 166: 3-11, 2014.
26. Baccarani M, Deininger MW, Rosti G, Hochhaus A, Soverini S, Apperley JF, Cervantes F, Clark RE, Cortes JE, Guilhot F, Hjorth-Hansen H, Hughes TP, Kantarjian HM, Kim DW, Larson RA, Lipton JH, Mahon FX, Martinelli G, Mayer J, Muller MC, Niederwieser D, Pane F, Radich JP, Rousselot P, Saglio G, Saussele S, Schiffer C, Silver R, Simonsson B, Steegmann JL, Goldman JM and Hehlmann R: European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood 122: 872-884, 2013.
27. Jabbour EJ, Kantarjian H, Eliasson L, Cornelison AM and Marin D: Patient adherence to tyrosine kinase inhibitor therapy in chronic myeloid leukemia. Am J Hematol 87: 687-691, 2012.
28. Pinilla-Ibarz J, Cortes J and Mauro MJ: Intolerance to tyrosine kinase inhibitors in chronic myeloid leukemia: definitions and clinical implications. Cancer 117: 688-697, 2011.
29. Efficace F, Baccarani M, Breccia M, Cottone F, Alimena G, Deliliers GL, Barate C, Specchia G, Di Lorenzo R, Luciano L, Turri D, Martino B, Stagno F, Dabusti M, Bergamaschi M, Leoni P, Simula MP, Levato L, Fava C, Veneri D, Sica S, Rambaldi A, Rosti G, Vignetti M and Mandelli F: Chronic fatigue is the most important factor limiting health-related quality of life of chronic myeloid leukemia patients treated with imatinib. Leukemia 27: 1511-1519, 2013.
30. Phillips KM, Pinilla-Ibarz J, Sotomayor E, Lee MR, Jim HS, Small BJ, Sokol L, Lancet J, Tinsley S, Sweet K, Komrokji R and Jacobsen PB: Quality of life outcomes in patients with chronic myeloid leukemia treated with tyrosine kinase inhibitors: a controlled comparison. Support Care Cancer 21: 1097-1103, 2013.
31. Efficace F, Rosti G, Cottone F, Breccia M, Castagnetti F, Iurlo A, Mandelli F and Baccarani M: Profiling chronic myeloid leukemia patients reporting intentional and unintentional nonadherence to lifelong therapy with tyrosine kinase inhibitors. Leuk Res 38: 294-298, 2014.
32. Cella D, Jensen SE, Webstrer K, Hongyan D, Lai JS, Rosen S, Tallman MS and Yount S: Measuring health-related quality of life in leukemia: the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionnaire. Value Health 15: 1051-1058, 2012.
33. Williams LA, Gonzalez AGG, Ault P, Mendoza TR, Sailors ML, Williams JL, Huang F, Nazha A, Kantarjian HM, Cleeland CS and Cortes JE: Measuring the symptom burden associated with the treatment of chronic myeloid leukemia. Blood 122: 641-647, 2013.
34. Efficace F, Baccarani M, Breccia M, Saussele S, Abel G, Caocci G, Guilhot F, Cocks K, Naeem A, Sprangers M, Oerlemans S, Chie W, Castagnetti F, Bombaci F, Sharf G, Cardoni A, Noens L, Pallua S, Salvucci M, Nicolatou-Galitis O, Rosti G and Mandelli F: International development of an EORTC questionnaire for assessing health-related quality of life in chronic myeloid leukemia patients: the EORTC QLQ-CML24. Qual Life Res 23: 825-836, 2014.
35. Quintas-Cardama A, Kantarjian H, O'Brien S, Borthakur G, Bruzzi J, Munden R and Cortes J: Pleural effusion in patients with chronic myelogenous leukemia treated with dasatinib after imatinib failure. J Clin Oncol 25: 3908-3914, 2007.
36. Shah NP, Kantarjian H, Kim DW, Hochhaus A, Saglio G, Guilhot F, Schiffer CA, Steegmann JL, Mohamed H, Dejardin D, Healey DI and Cortes JE: Six-year (yr) follow-up of patients (pts) with imatinib-resistant or-intolerant chronic-phase chronic myeloid leukemia (CML-CP) receiving dasatinib [abstract 6506]. J Clin Oncol 30(suppl): 6506, 2012.
37. Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, Moiraghi B, Shen Z, Mayer J, Pasquini R, Nakamae H, Huguet F, Boque C, Chuah C, Bleickardt E, Bradley-Garelik MB, Zhu C, Szatrowski T, Shapiro D and Baccarani M: Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 362: 2260-2270, 2010.
38. Cortes JE, Kantarjian HM, Brummendorf TH, Kim DW, Turkina AG, Shen ZX, Pasquini R, Khoury HJ, Arkin S, Volkert A, Besson N, Abbas R, Wang J, Leip E and Gambacorti-Passerini C: Safety and efficacy of bosutinib (SKI-606) in chronic phase Philadelphia chromosome-positive chronic myeloid leukemia patients with resistance or intolerance to imatinib. Blood 118: 4567-4576, 2011.
39. Irvine E and Williams C: Treatment-, patient-, and diseaserelated factors and the emergence of adverse events with tyrosine kinase inhibitors for the treatment of chronic myeloid leukemia. Pharmacotherapy 33: 868-881, 2013.
40. Dumitrescu D, Seck C, Ten Freyhaus H, Gerhardt F, Erdmann E and Rosenkranz S: Fully reversible pulmonary arterial hypertension associated with dasatinib treatment for chronic myeloid leukaemia. Eur Respir J 38: 218-220, 2011.
41. Mattei D, Feola M, Orzan F, Mordini N, Rapezzi D and Gallamini A: Reversible dasatinib-induced pulmonary arterial hypertension and right ventricle failure in a previously allografted CML patient. Bone Marrow Transplant 43: 967-968, 2009.
42. Montani D, Bergot E, Gunther S, Savale L, Bergeron A, Bourdin A, Bouvaist H, Canuet M, Pison C, Macro M, Poubeau P, Girerd B, Natali D, Guignabert C, Perros F, O'Callaghan DS, Jais X, Tubert-Bitter P, Zalcman G, Sitbon O, Simonneau G and Humbert M: Pulmonary arterial hypertension in patients treated by dasatinib. Circulation 125: 2128-2137, 2012.
43. Orlandi EM, Rocca B, Pazzano AS and Ghio S: Reversible pulmonary arterial hypertension likely related to long-term, lowdose dasatinib treatment for chronic myeloid leukaemia. Leuk Res 36: e4-e6, 2012.
44. Rasheed W, Flaim B and Seymour JF: Reversible severe pulmonary hypertension secondary to dasatinib in a patient with chronic myeloid leukemia. Leuk Res 33: 861-864, 2009.
45. Sano M, Saotome M, Urushida T, Katoh H, Satoh H, Ohnishi K and Hayashi H: Pulmonary arterial hypertension caused by treatment with dasatinib for chronic myeloid leukemia-critical alert-. Intern Med 51: 2337-2340, 2012.
46. Anonymous: Dasatinib: pulmonary arterial hypertension. French data. Prescrire Int 20: 241, 2011.
47. McLaughlin VV, Archer SL, Badersch DB, Barst RJ, Farber HW, Lindner JR, Mathier MA, McGoon MD, Park MH, Rosenson RS, Rubin LJ, Tapson VF, Varga J, Harrington RA, Anderson JL, Bates ER, Bridges CR, Eisenberb MJ, Ferrari VA, Grines CL, Hlatky MA, Jacobs AK, Kaul S, Lichtenberg RC, Lindner JR, Moliterno DJ, Mukherjee D, Pohost GM, Rosenson RS, Schofield RS, Shubrooks SJ, Stein JH, Tracy CM, Witz HH, Wesley DJ and ACCF/AHA: ACCF/AHA 2009 expert consensus document on pulmonary hypertension: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association: developed in collarboration with the American College of Chest Physicians, American Thoracic Society, Inc., and the Pulmonary Hypertension Association. Circulation 119: 2250-2294, 2009.
48. Aichberger KJ, Herndlhofer S, Schernthaner GH, Schillinger M, Mitterbauer-Hohendanner G, Sillaber C and Valent P: Progressive peripheral arterial occlusive disease and other vascular events during nilotinib therapy in CML. Am J Hematol 86: 533-539, 2011.
49. Hadzijusufovic E, Herndlhofer S, Aichberger KJ, Ghanim V, Suppan V, Cerny-Reiterer S, Sperr WR and Valent P: Nilotinib exerts direct efects on vascular endothelial cells and may act as a co-trigger of atherosclerosis in patients with Ph+ CML [abstract 2753]. Blood 118: 2753, 2011.
50. Kim TD, Rea D, Schwarz M, Grille P, Nicolini FE, Rosti G, Levato L, Giles FJ, Dombret H, Mirault T, Labussiere H, Lindhorst R, Haverkamp W, Buschmann I, Dorken B and le Coutre PD: Peripheral artery occlusive disease in chronic phase chronic myeloid leukemia patients treated with nilotinib or Imatinib. Leukemia 27: 1316-1321, 2013.
51. le Coutre P, Rea D, Abruzzese E, Dombret H, Trawinska MM, Herndlhofer S, Dorken B and Valent P: Severe peripheral arterial disease during nilotinib therapy. J Natl Cancer Inst 103: 1347-1348, 2011.
52. Levato L, Cantaffa R, Kropp MG, Magro D, Piro E and Molica S: Progressive peripheral arterial occlusive disease and other vascular events during nilotinib therapy in chronic myeloid leukemia: a single institution study. Eur J Haematol 90: 531-532, 2013.
53. Quintas-Cardama A, Kantarjian H and Cortes J: Nilotinibassociated vascular events. Clin Lymphoma Myeloma Leuk 12: 337-340, 2012.
54. Tefferi A and Letendre L: Nilotinib treatment-associated peripheral artery disease and sudden death: yet another reason to stick to imatinib as front-line therapy for chronic myelogenous leukemia. Am J Hematol 86: 610-611, 2011.
55. Giles FJ, Mauro MJ, Hong F, Ortmann CE, McNeill C, Woodman RC, Hochhaus A, le Coutre PD and Saglio G: 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 27: 1310-1315, 2013.
56. le Coutre PD, Hughes TP, Mahon FX, Kim DW, Steegmann JL, Shah NP, Wallis N and Cortes JE: Peripheral arterial occlusive disease (PAOD) in patients (Pts) receiving dasatinib: experience across multiple clinical trials [abstract 1489]. Blood 122: 1489, 2013.
57. Cortes JE, Kantarjian H, Khoury HJ, Brummendorf TH, Conlan MG, Wang K, Fly KD, Shapiro M, Lipton JH, Durand JB and Gambacorti-Passerini C: Long-term evaluation of vascular toxicity in patients with Ph+ leukemias treated with bosutinib [abstract P900]. Haematologica 99: 336, 2014.
58. US Food and Drug Administration (FDA): Information on drugs: Iclusig (ponatinib). Available at: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm373072.htm. Accessed August 6, 2015.
59. Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre PD, Paquette R, Chuah C, Nicolini FE, Apperley JF, Khoury HJ, Talpaz M, DiPersio JF, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Muller MC, Gambacorti-Passerini C, Lustgarten S, Rivera VM, Clackson T, Turner CD, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes TP, Goldman JM, Shah NP and Kantarjian HM: Ponatinib in patients (pts) with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) resistant or intolerant to dasatinib or nilotinib, or with the T315I BCR-ABL mutation: 2-year follow-up of the PACE trial [abstract 650]. Blood 122: 650, 2013.
60. Khoury HJ, Cortes JE, Kim DW, Pinilla-Ibarz J, Le Coutre PD, Paquette R, Chuah C, Nicolini FE, Apperley J, Talpaz M, DiPersio JF, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Muller MC, Gambacorti-Passerini C, Lustgarten S, Yanase K and Kantarjian HM: Analysis of the cardiovascular risk profile of Ph+ leukemia patients treated with ponatinib [abstract 7048]. J Clin Oncol 31: 7048, 2013.
61. le Coutre PD, Kim DW, Pinilla-Ibarz J, Paquette R, Chuah C, Nicolini FE, Apperley JF, Khoury HJ, Talpaz M, Dipersio JF, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Muller MC, Gambacorti-Passerini C, Lustgarten S, Yanase K, Turner CD, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes TP, Goldman JM, Shah NP, Kantarjian HM and Cortes JE: Ponatinib in heavily pretreated patients with chronic phase chronic myeloid leukemia (CP-CML): management of adverse events (AEs) [abstract 1496]. Blood 122: 1496, 2013.
62. Valent P, Hadzijusufovic E, Schernthaner GH, Wolf D, Rea D and le Coutre PD: Vascular safety issues in CML patients treated with BCR/ABL1 kinase inhibitors. Blood 125: 901-906, 2015.
63. Goff DC, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, Robinson JG, Schwartz JS, Shero ST, Smith SC, Sorlie P, Stone NJ, Wilson PW, Jordan HS, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SCJ, Tomaselli GF and American College of Cardiology/American Heart Association Task Force on Practice Guidelines: 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 129: S49-S73, 2014.
64. Smith SCJ, Benjamin EJ, Bonow RO, Braun LT, Creager MA, Franklin BA, Gibbons RJ, Grundy SM, Hiratzka LF, Jones DW, Lloyd-Jones DM, Minissian M, Mosca L, Pterson ED, Sacco RL, Spertus J, Stein JH, Taubert KA and World Heart Federation and the Preventitive Cardiovascular Nurses Association: AHA/ACCF secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update: a guideline from the American Heart Association and America College of Cardiology Foundation. Ciculation 124: 2458-2473, 2011.
65. Stone NJ, Robinson J, Lichtenstein AH, Merz CNB, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC, Watson K and Wilson PWF: 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 129: S1-S45, 2014.
66. Eckel RH, Jakicic JM, Ard JD, Hubbard VS, de Jesus JM, Lee IM, Lichtenstein AH, Loria CM, Millen BE, Miller NH, Nonas CA, Sacks FM, Smith SC, Svetkey LP, Wadden TW and Yanovski SZ: 2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 129: S76-S99, 2014.
67. Fradley MG and Moslehi J: QT prolongation and oncology drug development. Card Electrophysiol Clin 7: 341-355, 2015.
68. Cortes JE, Kim DW, Kantarjian HM, Brummendorf TH, Dyagil I, Griskevicius L, Malhotra H, Powell C, Gogat K, Countouriotis AM and Gambacorti-Passerini C: Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: results from the BELA trial. J Clin Oncol 30: 3486-3492, 2012.
69. Kantarjian HM, Giles FJ, Bhalla KN, Pinilla-Ibarz JA, Larson RA, Gattermann N, Ottmann OG, Hochhaus A, Radich JP, Saglio G, Hughes TP, Martinelli G, Kim DW, Shou Y, Gallagher NJ, Blakesley R, Baccarani M, Cortes J and le Coutre PD: Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase after imatinib resistance or intolerance: 24-month follow-up results. Blood 117: 1141-1145, 2011.
70. Saglio G, Kim DW, Issaragrisil S, le Coutre P, Etienne G, Lobo C, Pasquini R, Clark RE, Hochhaus A, Hughes TP, Gallagher N, Hoenekopp A, Dong M, Haque A, Larson RA, Kantarjian HM and the ENESTnd Investigators: Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med 362: 2251-2259, 2010
71. Gambacorti-Passerini C, Cortes JE, Lipton JH, Dmoszynska A, Wong RS, Rossiev V, Pavlov D, Gogat Marchant K, Duvillie L, Khattry N, Kantarjian HM and Brummendorf TH: Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia. Am J Hematol 89: 947-953, 2014.
72. Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre P, Paquette R, Chuah C, Nicolini FE, Apperley JF, Khoury HJ, Talpaz M, DiPersio J, DeAngelo DJ, Abruzzese E, Rea D, Baccarani M, Muller MC, Gambacorti-Passerini C, Wong S, Lustgarten S, Rivera VM, Clackson T, Turner CD, Haluska FG, Guilhot F, Deininger MW, Hochhaus A, Hughes T, Goldman JM, Shah NP, Kantarjian H and PACE Investigators: A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med 369: 1783-1796, 2013.
73. Saglio G, Larson RA, Hughes TP, Issaragrisil S, Turkina AG, Marin D, Zanichelli M, Shibayama H, Kalaycio ME, Rigal-Huguet F, Gallagher NJ, Kayath M, Zheng M, Kantarjian H and Hochhaus A: Efficacy and safety of nilotinib in chronic phase (CP) chronic myeloid leukemia (CML) patients (pts) with type 2 diabetes in the ENESTnd trial [abstract 3430]. Blood 116: 3430, 2010.
74. Breccia M, Loglisci G, Salaroli A, Serrao A and Alimena G: Nilotinib-mediated increase in fasting glucose level is reversible, does not convert to type 2 diabetes and is likely correlated with increased body mass index. Leuk Res 36: e66-e67, 2012.
75. Berman E, Nicolaides M, Maki RG, Fleisher M, Chanel S, Scheu K, Wilson BA, Heller G and Sauter NP: Altered bone and mineral metabolism in patients receiving imatinib mesylate. N Engl J Med 354: 2006-2013, 2006.
76. Berman E, Girotra M, Cheng C, Chanel S, Maki R, Shelat M, Strauss HW, Fleisher M, Heller G and Farooki A: Effect of long term imatinib on bone in adults with chronic myelogenous leukemia and gastrointestinal stromal tumors. Leuk Res 37: 790-794, 2013.
77. Palandri F, Castagnetti F, Soverini S, Poerio A, Gugliotta G, Luatti S, Amabile M, Martinelli G, Rosti G and Baccarani M: Pancreatic enzymes elevation in chronic myeloid leukemia patients treated with nilotinib after imatinib failure. Haematologica 94: 1758-1761, 2009.
78. Teo YL, Ho HK and Chan A: Risk of tyrosine kinase inhibitorsinduced hepatoxicity in cancer patients: a meta-analysis. Cancer Treat Rev 39: 199-206, 2013.
79. O'Brien SG, Guilhot F, Goldman JM, Hochhaus A, Hughes T, Radich JP, Rudoltz M, Filian J, Gathmann I, Druker BJ and Larson RA: 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 (CML-CP) treated with imatinib (IM) [abstract 186]. Blood 112: 76, 2008.
80. Deininger M, O'Brien SG, Guilhot F, Goldman JM, Hochhaus A, Hughes TP, Radich JP, Hatfield AK, Mone M, Filian J, Reynolds J, Gathmann I, Larson RA and Druker BJ: 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 [abstract 1126]. Blood 114: 1126, 2009.
81. Rosti G, Gugliotta G, Castagnetti F, Breccia M, Levato L, Rege-Cambrin G, Capucci A, Tiribelli M, Zaccaria A, Bocchia M, Stagno F, Cavazzini F, Specchia G, Martino B, Cedrone M, Intermesoli T, Palandri F, Soverini S, Bochicchio MT, Testoni N, Alimena G, Pane F, Saglio G, Martinelli G and Baccarani M: Five-year results of nilotinib 400 mg BID in early chronic phase chronic myeloid leukemia (CML): high rate of deep molecular response-update of the GIMEMA CML WP Trial CML0307 [abstract 3784]. Blood 120: 3784, 2012.