The current role of high-dose imatinib in chronic myeloid leukemia patients, newly diagnosed or resistant to standard dose

Expert Opinion on Pharmacotherapy

Volumn 12, Issue 13, 2011, Pages 2075-2087

  Breccia, Massimo ^a   Alimena, Giuliana ^a  

^a SAPIENZA UNIVERSITY OF ROME   (Italy)

Author keywords

chronic myeloid leukemia; high dose; imatinib; overall survival progression free survival; standard dose

Indexed keywords

ALPHA INTERFERON; BCR ABL PROTEIN; CYTARABINE; DASATINIB; IMATINIB; INTERFERON; NILOTINIB; PEGINTERFERON ALPHA2A; PLASMA PROTEIN;

ABDOMINAL PAIN; ABNORMAL LABORATORY RESULT; ANEMIA; BLEEDING; BLOOD TOXICITY; BONE PAIN; CANCER COMBINATION CHEMOTHERAPY; CANCER RESISTANCE; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CHRONIC MYELOID LEUKEMIA; CONGESTIVE HEART FAILURE; CYTOGENETICS; DIARRHEA; DOSE RESPONSE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ELIMINATION; DRUG ERUPTION; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG URINE LEVEL; DRUG WITHDRAWAL; EDEMA; FATIGUE; FLUID RETENTION; GASTROINTESTINAL SYMPTOM; GASTROINTESTINAL TOXICITY; GENE MUTATION; HUMAN; LEG EDEMA; LEUKEMIA REMISSION; LOW DRUG DOSE; MAXIMUM TOLERATED DOSE; MONOTHERAPY; MUSCLE CRAMP; NAUSEA; NEUROLOGIC DISEASE; NEUTROPENIA; OPTIMAL DRUG DOSE; OVERALL SURVIVAL; PANCYTOPENIA; PATIENT COMPLIANCE; PERIORBITAL EDEMA; PERIPHERAL EDEMA; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHILADELPHIA CHROMOSOME POSITIVE CELL; PLASMA PROTEIN BINDING; PLEURA EFFUSION; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIDE EFFECT; THROMBOCYTOPENIA; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DRUG RESISTANCE, NEOPLASM; HUMANS; LEUKEMIA, MYELOID, CHRONIC-PHASE; PIPERAZINES; PROTEIN KINASE INHIBITORS; PYRIMIDINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 80051517380     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1517/14656566.2011.597741     Document Type: Review

References (64)

1. Goldman JM, Melo JV. Chronic myeloid leukemia - advances in biology and new approaches to treatment. N Engl J Med 2003;349:1451-64 (Pubitemid 37211061)
2. Hantschel O, Superti-Furga G. Regulation of the c-Abl and Bcr-Abl tyrosine kinases. Nat Rev Mol Cell Biol 2004;5:33-44 (Pubitemid 38089839)
3. Hehlmann R, Hochhaus A, Baccarani M; European LeukemiaNet. Chronic myeloid leukaemia. Lancet 2007;370:342-50 (Pubitemid 47094995)
4. Quintas-Cardama A, Cortes J. Molecular biology of bcr-abl1 positive chronic myeloid leukaemia. Blood 2009;113:1619-30
5. 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;114:1126
6. de Lavallade H, Apperley JF, Khorashad JS, et al. Imatinib for newly diagnosed patients with chronic myeloid leukemia: Incidence of sustained responses in an intention-to-treat analysis. J Clin Oncol 2008;26:3358-63
7. Cortes J, Hochhaus A, Hughes T, et al. Front-line and salvage therapies with tyrosine kinase inhibitors and other treatments in chronic myeloid leukemia. J Clin Oncol 2011;29:524-31
8. Apperley JF. Part I: Mechanisms of resistance to imatinib in chronic myeloid leukaemia. Lancet Oncol 2007;8:1018-29 (Pubitemid 47629897)
9. Milojkovic D, Apperley JF. Mechanisms of resistance to imatinib and second-generation tyrosine inhibitors in chronic myeloid leukaemia. Clin Cancer Res 2009;15:7519-27
10. Branford S, Rudzki Z, Walsh S, et al. Detection of BCR-ABL mutations in patients with CML treated with imatinib is virtually always accompanied by clinical resistance and mutations in the ATP phosphate-binding loop (p-loop) are associated with a poor prognosis. Blood 2003;102:276-83 (Pubitemid 36759665)
11. Bixby D, Talpaz M. Seeking the causes and solutions to imatinib-resistance in chronic myeloid leukemia. Leukemia 2011;25:7-22
12. Weisberg E, Griffin JD. Mechanism of resistance to the ABL tyrosine kinase inhibitor STI571 in BCR/ABL-transformed hematopoietic cell lines. Blood 2000;95:3498-505 (Pubitemid 30428483)
13. le Coutre P, Tassi E, Varella-Garcia M, et al. Induction of resistance to the Abelson inhibitor STI571 in human leukemic cells through gene amplification. Blood 2000;95:1758-66 (Pubitemid 30120840)
14. Gorre ME, Mohammed M, Ellwood K, et al. Clinical resistance to STI-571 cancer therapy caused by BCR-ABL gene mutation or amplification. Science 2001;293:876-80 (Pubitemid 32743979)
15. Savona M, Talpaz M. Getting to the stem of chronic myeloid leukemia. Nat Rev Cancer 2008;8:341-50 (Pubitemid 351589698)
16. Stanglmaier M, Warmuth M, Kleinlein I, et al. The interaction of the Bcr-Abl tyrosine kinase with the Src kinase Hck is mediated by multiple binding domains. Leukemia 2003;17:283-9 (Pubitemid 36266903)
17. Sattler M, Mohi MG, Pride YB, et al. Critical role for Gab2 in transformation by BCR/ABL. Cancer Cell 2002;1:479-92 (Pubitemid 41039128)
18. Chai SK, Nichols GL, Rothman P. Constitutive activation of JAKs and STATs in BCR-ABL-expressing cell lines and peripheral blood cells derived from leukemic patients. J Immunol 1997;159:4720-8 (Pubitemid 127471006)
19. Jabbour E, Kantarjian H, Jones D, et al. Frequency and clinical significance of BCR-ABL mutations in patients with chronic myeloid leukaemia treated with imatinib mesylate. Leukemia 2006;20:1767-73 (Pubitemid 44574988)
20. Soverini S, Colarossi S, Gnani A, et al. Contribution of ABL kinase domain mutations to imatinib resistance in different subsets of Philadelphia-positive patients: By the GIMEMA Working Party on Chronic Myeloid Leukemia. Clin Cancer Res 2006;12:7374-9 (Pubitemid 46095411)
21. Peng B, Hayes M, Resta D, et al. Pharmacokinetics and pharmacodynamics of imatinib in a phase I trial with chronic myeloid leukemia patients. J Clin Oncol 2004;22:935-42 (Pubitemid 41103606)
22. Peng B, Lloyd P, Schran H. Clinical pharmacokinetics of imatinib. Clin Pharmacokinet 2005;44:879-94 (Pubitemid 41252840)
23. Kantarjian H, Talpaz M, O'Brien S, et al. Survival benefit with imatinib mesylate versus interpheron-alpha-based regimens in newly diagnosed chronic phase chronic myelogenous leukemia. Blood 2006;108:1835-40 (Pubitemid 44394991)
24. Schmidli H, Peng B, Riviere GJ, et al; IRIS study group. Population pharmacokinetics of imatinib mesylate in patients with chronic phase chronic myeloid leukemia; results of a phase III study. Br J Clin Pharmacol 2005;60:35-44 (Pubitemid 40942779)
25. Willis SG, Lange T, Demehri S, et al. High-sensitivity detection of BCR-ABL kinase domain mutations in imatinib-naive patients: Correlation with clonal cytogenetic evolution but not response to therapy. Blood 2005;106:2128-37 (Pubitemid 41291730)
26. O'Hare T, Eide CA, Deininger MWN. Bcr-Abl kinase domain mutations, drug resistance, and the road to a cure for chronic myeloid leukemia. Blood 2007;110:2242-9 (Pubitemid 47523141)
27. Aoki E, Kantarjian H, O'Brien SG, et al. High-dose imatinib provides better responses in patients with untreated early chronic phase CML. Blood 2006;108:608a
28. White DL, Saunders VA, Dang P, et al. OCT-1-mediated influx is a key determinant of the intracellular uptake of imatinib but not nilotinib (AMN107): Reduced OCT-1 activity is the casue of low in vitro sensitivity to imatinib. Blood 2006;108:697-704 (Pubitemid 44061372)
29. Crossman L, Druker BJ. Deininger M. hOCT1 and resistance to imatinib. Blood 2005;106:1133-4
30. Kantarjian HM, Talpaz M, O'Brien S, et al. Dose escalation of imatinib mesylate can overcome resistance to standard-dose therapy in patients with chronic myelogenous leukemia. Blood 2003;101:473-5 (Pubitemid 36077567)
31. Marin D, Goldman JM, Olavarria E, et al. Transient benefit only from increasing the imatinib dose in CML patients who do not achieve complete cytogenetic remissions on conventional doses. Blood 2003;102:2702-3
32. Zonder JA, Pemberton P, Brandt H, et al. The effect of dose increase of imatinib mesylate in patients with chronic or accelerated phase chronic myelogenous leukemia with inadequate hematologic or cytogenetic response to initial treatment. Clin Cancer Res 2003;9:2092-7 (Pubitemid 36687630)
33. Kantarjian HM, Larson RA, Guilhot F, et al; International Randomized Study of Interferon and STI571 (IRIS) investigators. Efficacy of imatinib dose escalation in patients with chronic myeloid leukemia in chronic phase. Cancer 2009;115:551-60
34. 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;113:2154-60
35. Rea D, Etienne G, Corm S, et al. Imatinib dose escalation for chronic phase-chronic myelogenous leukemia patients in primary suboptimal response to imatinib 400 mg daily standard therapy. Leukemia 2009;23:1193-6
36. Breccia M, Stagno F, Vigneri P, et al. Imatinib dose escalation in 74 failure or suboptimal response chronic myeloid leukemia patients at 3-year follow up. Am J Hematol 2010;85:375-7
37. Petzer AL, Wolf D, Fong D, et al. High-dose imatinib improbe cytogenetic and molecular remissions in patients pre-treated Philadelphia positive, BCR-ABL positive chronic phase chronic myeloid leukemia: First results from the randomized CELSG phase III CML 11 'ISTAHIT' study. Haematologica 2010;95:908-13
38. Cervantes F, Lopez-Garrido P, Montero MI, et al. Early intervention during imatinib therapy in patients with newly diagnosed chronic-phase chronic myeloid leukemia: A study of the Spanish PETHEMA group. Haematologica 2010;95:1317-24
39. Hochhaus A, La Rosee P. Imatinib therapy in chronic myelogenous leukemia: Strategies to avoid and overcome resistance. Leukemia 2004;18:1321-31 (Pubitemid 39136739)
40. Cortes J, Giles F, O'Brien S, et al. Result of high-dose imatinib mesylate in patients with Philadelphia chromosome-positive chronic myeloid leukemia after failure of interferon-alpha. Blood 2003;102:83-6 (Pubitemid 36759639)
41. Kantarjian HM, Talpaz M, O'Brien S, et al. High-dose imatinib mesylate therapy in newly diagnosed Philadelphia chromosome-positive chronic phase chronic myeloid leukemia. Blood 2004;103:2873-8
42. Castagnetti F, Palandri F, Amabile M, et al. Results of high-dose imatinib mesylate in intermediate Sokal risk chronic myeloid leukemia patients in early chronic phase: A phase 2 trial of the GIMEMA CML Working Party. Blood 2009;113:3428-34
43. Hughes TP, Branford S, White DL, et al; Australasian Leukemia and Lymphoma Group. Impact of early dose intensity on cytogenetic and molecular responses in chronic-phase CML patients receiving 600 mg/day of imatinib as initial therapy. Blood 2008;112:3965-73
44. White DL, Saunders VA, Dang P, et al. Most CML patients who have a suboptimal response to imatinib have low OCT-1 activity: Higher doses of imatinib may overcome the negative impact of low OCT-1 activity. Blood 2007;110:4064-72 (Pubitemid 350248463)
45. Baccarani M, Rosti G, Castagnetti F, et al. Comparison of imatinib 400 mg and 800 mg daily in the front-line treatment of high-risk, Philadelphia- positive chronic myeloid leukemia: A European LeukemiaNet study. Blood 2009;113:4497-504
46. Cortes JE, Baccarani M, Guilhot F, et al. Phase III, randomized, open-label study of daily imatinib mesylate 400 mg versus 800 mg in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase using molecular end points: Tyrosine kinase inhibitor optimization and selectivity study. J Clin Oncol 2010;28:424-30
47. Marin D, Bazeos A, Mahon FX, et al. Adherence is the critical factor for achieving molecular responses in patients with chronic myeloid leukaemia who achieve complete cytogenetic responses on imatinib. J Clin Oncol 2010;28:2381-8
48. Ibrahim AR, Eliasson L, Apperley JF, et al. Poor adherence is the main reason for loss of CCyR and imatinib failure for chronic myeloid leukaemia patients on long-term therapy. Blood 2011;117:3733-6
49. Hehlmann R, Lauseker M, Jung-Munkwitz S, et al. Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-alpha in newly diagnosed chronic myeloid leukemia. J Clin Oncol 2011;29:1634-42
50. Preudhomme C, Guilhot J, Nicolini FE, et al; SPIRIT Investigators; France Intergroupe des Leucemies Myeloides Chroniques (Fi-LMC). Imatinib plus peginterferon alfa-2a in chronic myeloid leukemia. N Engl J Med 2010;363:2511-21
51. Kantarjian H, Pasquini R, Levy V, et al. Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukaemia resistant to imatinib at a dose of 400 to 600 mg milligrams daily: Two-year follow-up of a randomized phase 2 study (START-R). Cancer 2009;15:4136-47
52. Manley PW, Bretenstein W, Bruggen J, et al. Urea derivatives of STI571 as inhibitors of Bcr-Abl and PDGFR kinases. Bioorg Med Chem Lett 2004;14:5793-7 (Pubitemid 39421520)
53. Manley PW, Cowan-Jacob SW, Mestan J. Advances in the structural biology, design and clinical development of Bcr-Abl kinase inhibitors for the treatment of chronic myeloid leukaemia. Biochim Biophys Acta 2005;1754:3-13 (Pubitemid 41797682)
54. Bradeen HA, Eide CA, O'Hare T, et al. Comparison of imatinib mesylate, dasatinib (BMS-354825), and nilotinib (AMN107) in an N-ethyl-N-nitrosourea (ENU)-based mutagenesis screen: High efficacy of drug combinations. Blood 2006;108:2332-8 (Pubitemid 44497517)
55. Saglio G, Kim DW, Issaragrisil S, et al. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med 2010;362:2251-6
56. Hughes TP, Hochhaus A, Saglio G, et al. ENESTnd update: Continued superiority of nilotinib versus imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP). Blood 2010;116:207
57. Keam SJ. Dasatinib: In chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. BioDrugs 2008;22:59-69 (Pubitemid 351158536)
58. Jabbour E, Cortes J, Kantarjian H. Dasatinib for the treatment of Philadelphia chromosome-positive leukemias. Expert Opin Investig Drugs 2007;16:679-87 (Pubitemid 46723272)
59. Steinberg M. Dasatinib: A tyrosine kinase inhibitor for the treatment of chronic myelogenous leukaemia and Philadelphia chromosome positive acute lymphoblastic leukaemia. Clin Ther 2007;29:2289-308
60. Kantarjian H, Shah NP, Hochhaus A, et al. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 2010;362:2260-70
61. Shah NP, Kantarjian HM, Hochhaus A, et al. Dasatinib versus imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) in the DASISION trial: 18-month follow-up. Blood 2010;116:206
62. Radich JP, Kopecky KJ, Kamel-Reid S, et al. A randomized phase II trial of dasatinib 100 mg vs imatinib 400 mg in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): The S0325 Intergroup trial. Blood 2010;116:6
63. Baccarani M, Cortes J, Pane F, et al. Chronic myeloid leukemia: An update of concepts and management recommendations of European LeukemiaNet. J Clin Oncol 2009;27:6041-51
64. Druker BJ, Talpaz M, Resta DJ, et al. Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. N Engl J Med 2001;344:1031-7 (Pubitemid 32267972)