Emerging safety issues with imatinib and other Abl tyrosine kinase inhibitors

Clinical Lymphoma and Myeloma

Volumn 7, Issue SUPPL. 3, 2007, Pages

  Atallah, Ehab ^a   Kantarjian, Hagop ^a   Cortes, Jorge ^a  

^a UNIVERSITY OF TEXAS   (United States)

Author keywords

Chronic myeloid leukemia; Gastrointestinal stromal tumors; Side effects

Indexed keywords

CARBAMAZEPINE; CLARITHROMYCIN; CYCLOSPORIN; DASATINIB; DILTIAZEM; ERYTHROMYCIN; IMATINIB; ITRACONAZOLE; KETOCONAZOLE; NILOTINIB; PARACETAMOL; PHENOBARBITAL; PHENYTOIN; PIMOZIDE; PREDNISONE; RIFAMPICIN; STEROID; VERAPAMIL; WARFARIN; ABELSON KINASE; PIPERAZINE DERIVATIVE; PROTEIN KINASE INHIBITOR; PYRIMIDINE DERIVATIVE;

ACUTE FEBRILE NEUTROPHILIC DERMATOSIS; ACUTE LYMPHOCYTIC LEUKEMIA; BONE MARROW APLASIA; BONE METABOLISM; CATARACT; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; DERMATITIS; DIABETES MELLITUS; DIARRHEA; DISEASE COURSE; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; ERYTHEMA MULTIFORME; FATIGUE; FERTILITY; FLUID RETENTION; FOLLOW UP; GASTROINTESTINAL STROMAL TUMOR; GRAPE JUICE; GYNECOMASTIA; HUMAN; HYPEREOSINOPHILIC SYNDROME; HYPERICUM PERFORATUM; HYPOPHOSPHATEMIA; HYPOPIGMENTATION; HYPOTHYROIDISM; INTERSTITIAL LUNG DISEASE; LIVER FAILURE; LIVER NECROSIS; LIVER TOXICITY; MUSCLE CRAMP; NONHUMAN; PANNICULITIS; PERIORBITAL EDEMA; PHILADELPHIA CHROMOSOME POSITIVE CELL; PITYRIASIS; PREGNANCY; PULMONARY HYPERTENSION; PUSTULOSIS; RASH; RETINA MACULA CYSTOID EDEMA; REVIEW; SIDE EFFECT; SPLEEN RUPTURE; STEVENS JOHNSON SYNDROME; TREATMENT OUTCOME; TUMOR; DRUG ANTAGONISM; ENZYMOLOGY; FOOD AND DRUG ADMINISTRATION; NEOPLASM; TIME; UNITED STATES;

CLINICAL TRIALS; FOLLOW-UP STUDIES; HUMANS; NEOPLASMS; PIPERAZINES; PROTEIN KINASE INHIBITORS; PROTO-ONCOGENE PROTEINS C-ABL; PYRIMIDINES; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 34249653546     PISSN: 15579190     EISSN: None     Source Type: Journal    
DOI: 10.3816/CLM.2007.s.010     Document Type: Article

References (86)

1. Kantarjian HM, Talpaz M, O'Brien S, et al. Survival benefit with imatinib mesylate versus interferon-alpha-based regimens in newly diagnosed chronic-phase chronic myelogenous leukemia. Blood 2006; 108:1835-1840.
2. Roy L, Guilhot J, Krahnke T, et al. Survival advantage from imatinib compared with the combination interferon-alpha plus cytarabine in chronic-phase chronic myelogenous leukemia: historical comparison between two phase 3 trials. Blood 2006; 108:1478-1484.
3. Demetri GD, von Mehren M, Blanke CD, et al. Efficacy and safety of imatinib mesylate in advanced gastrointestinal stromal tumors. N Engl J Med 2002; 347:472-480.
4. Thomas DA, Faderl S, Cortes J, et al. Treatment of Philadelphia chromosome-positive acute lymphocytic leukemia with hyper-CVAD and imatinib mesylate. Blood 2004; 103:4396-4407.
5. Cortes J, Ault P, Koller C, et al. Efficacy of imatinib mesylate in the treatment of idiopathic hypereosinophilic syndrome. Blood 2003; 101:4714-4716.
6. Cohen MH, Williams G, Johnson JR, et al. Approval summary for imatinib mesylate capsules in the treatment of chronic myelogenous leukemia. Clin Cancer Res 2002; 8:935-942.
7. Cohen MH, Johnson JR, Pazdur R. U.S. Food and Drug Administration drug approval summary: conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval. Clin Cancer Res 2005; 11:12-19.
8. Kerkela R, Grazette L, Yacobi R, et al. Cardiotoxicity of the cancer therapeutic agent imatinib mesylate. Nat Med 2006; 12:908-916.
9. Lloyd-Jones DM, Larson MG, Leip EP, et al. Lifetime risk for developing congestive heart failure: the Framingham heart study. Circulation 2002; 106:3068-3072.
10. Schellings MW, Baumann M, van Leeuwen RE, et al. Imatinib attenuates end-organ damage in hypertensive homozygous TGR(mRen2)27 rats. Hypertension 2006; 47:467-474.
11. Berman E, Nicolaides M, Maki RG, et al. Altered bone and mineral metabolism in patients receiving imatinib mesylate. N Engl J Med 2006; 354:2006-2013.
12. Joensuu H, Reichardt P. Imatinib and altered bone and mineral metabolism. N Engl J Med 2006; 355:628-629.
13. Owen S, Hatfield A, Letvak L. Imatinib and altered bone and mineral metabolism. N Engl J Med 2006; 355:627-629.
14. Heuchel R, Berg A, Tallquist M, et al. Platelet-derived growth factor beta receptor fegulates interstitial fluid homeostasis through phosphatidylinositol-3′ kinase signaling. Proc Natl Acad Sci U S A 1999; 96:11410-11415.
15. Jayson GC, Parker GJM, Mullamitha S, et al. Blockade of platelet-derived growth factor receptor-Beta by CDP860, a humanized, PEGylated di-Fab', leads to fluid accumulation and is associated with increased tumor vascularized volume. J Clin Oncol 2005; 23:973-981.
16. Ebnoether M, Stentoft J, Ford J, et al. Cerebral oedema as a possible complication of treatment with imatinib. Lancet 2002; 359:1751-1752.
17. Moore JC, Dennehey CF, Anavim A, et al. Multiple joint effusions associated with high-dose imatinib therapy in a patient with chronic myelogenous leukaemia. Eur J Haematol 2006; 76:444-446.
18. Breccia M, D'Elia GM, D'Andrea M, et al. Pleural-pericardic effusion as uncommon complication in CML patients treated with Imatinib. Eur J Haematol 2005; 74:89-90.
19. Ramar K, Potti A, Mehdi SA. Uncommon syndromes and treatment manifestations of malignancy: case 4. Periorbital edema and imatinib mesylate therapy for chronic myelogenous leukemia. J Clin Oncol 2003; 21:172-173.
20. Kathula SK, Chu SC, Tang JL, et al. Dasatinib in chronic myelogenous leukemia. N Engl J Med 2006; 355:1062-1064.
21. Talpaz M, Shah NP, Kantarjian H, et al. Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias. N Engl J Med 2006; 354:2531-2541.
22. Hensley ML, Ford JM. Imatinib treatment: specific issues related to safety, fertility, and pregnancy. Semin Hematol 2003; 40:21-25.
23. Ault P, Kantarjian H, O'Brien S, et al. Pregnancy among patients with chronic myeloid leukemia treated with imatinib. J Clin Oncol 2006; 24:1204-1208.
24. AlKindi S, Dennison D, Pathare A. Imatinib in pregnancy. Eur J Haematol 2005; 74:535-537.
25. Prabhash K, Sastry PS, Biswas G, et al. Pregnancy outcome of two patients treated with imatinib. Ann Oncol 2005; 16:1983-1984.
26. Heartin E, Walkinshaw S, Clark RE. Successful outcome of pregnancy in chronic myeloid leukaemia treated with imatinib. Leuk Lymphoma 2004; 45:1307-1308.
27. Choudhary DR, Mishra P, Kumar R, et al. Pregnancy on imatinib: fatal outcome with meningocele. Ann Oncol 2006; 17:178-179.
28. Ali R, Ozkalemkas F, Ozcelik T, et al. Imatinib and pregnancy. J Clin Oncol 2006; 24:3812-3813.
29. Seshadri T, Seymour JF, McArthur GA. Oligospermia in a patient receiving imatinib therapy for the hypereosinophilic syndrome. N Engl J Med 2004; 351:2134-2135.
30. Valeyrie L, Bastuji-Garin S, Revuz J, et al. Adverse cutaneous reactions to imatinib (STI571) in Philadelphia chromosome-positive leukemias: a prospective study of 54 patients. J Am Acad Dermatol 2003; 48:201-206.
31. Tsao AS, Kantarjian H, Cortes J, et al. Imatinib mesylate causes hypopigmentation in the skin. Cancer 2003; 98:2483-2487.
32. Ayirookuzhi SJ, Ma L, Ramshesh P, et al. Imatinib-induced sweet syndrome in a patient with chronic myeloid leukemia. Arch Dermatol 2005; 141:368-370.
33. Brazzelli V, Prestinari F, Roveda E, et al. Pityriasis rosea-like eruption during treatment with imatinib mesylate: description of 3 cases. J Am Acad Dermatol 2005; 53:S240-S243.
34. Lim D, Muir J. Imatinib for chronic myeloid leukaemia: a NICE mess. Lancet 2001; 358:1903.
35. Sanchez-Gonzalez B, Pascual-Ramirez JC, Fernandez-Abellan P, et al. Severe skin reaction to imatinib in a case of Philadelphia-positive acute lymphoblastic leukemia. Blood 2003; 101:2446.
36. Brouard MC, Prins C, Mach-Pascual S, et al. Acute generalized exanthematous pustulosis associated with STI571 in a patient with chronic myeloid leukemia. Dermatology 2001; 203:57-59.
37. Schwarz M, Kreuzer KA, Baskaynak G, et al. Imatinib-induced acute generalized exanthematous pustulosis (AGEP) in two patients with chronic myeloid leukemia. Eur J Haematol 2002; 69:254-256.
38. Hsiao LT, Chung HM, Lin JT, et al. Stevens-Johnson syndrome after treatment with STI571: a case report. Br J Haematol 2002; 117:620-622.
39. Rule SA, O'Brien SG, Crossman LC. Managing cutaneous reactions to imatinib therapy. Blood 2002; 100:3434.
40. Breccia M, Carmosino I, Russo E, et al. Early and tardive skin adverse events in chronic myeloid leukaemia patients treated with imatinib. Eur J Haematol 2005; 74:121-123.
41. Brouard M, Saurat JH. Cutaneous reactions to STI571. N Engl J Med 2001; 345:618-619.
42. Park MA, Volcheck GW, Guarderas JC. Successful progressive challenge after a cutaneous reaction to imatinib mesylate (Gleevec): a case report and review of the literature. Allergy Asthma Proc 2004; 25:345-347.
43. Assouline S, Laneuville P, Gambacorti-Passerini C. Panniculitis during dasatinib therapy for imatinib-resistant chronic myelogenous leukemia. N Engl J Med 2006; 354:2623-2624.
44. Gschwind HP, Pfaar U, Waldmeier F, et al. Metabolism and disposition of imatinib mesylate in healthy volunteers. Drug Metab Dispos 2005; 33:1503-1512.
45. Wilkinson GR. Drug metabolism and variability among patients in drug response. N Engl J Med 2005; 352:2211-2221.
46. Gardner ER, Burger H, van Schaik RH, et al. Association of enzyme and transporter genotypes with the pharmacokinetics of imatinib. Clin Pharmacol Ther 2006; 80:192-201.
47. Beumer JH, Natale JJ, Lagattuta TF, et al. Disposition of imatinib and its metabolite CGP74588 in a patient with chronic myelogenous leukemia and short-bowel syndrome. Pharmacotherapy 2006; 26:903-907.
48. 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; 22:935-942.
49. Bolton AE, Peng B, Hubert M, et al. Effect of rifampicin on the pharmacokinetics of imatinib mesylate (Gleevec, STI571) in healthy subjects. Cancer Chemother Pharmacol 2004; 53:102-106.
50. Frye RF, Fitzgerald SM, Lagattuta TF, et al. Effect of St John's wort on imatinib mesylate pharmacokinetics. Clin Pharmacol Ther 2004; 76:323-329.
51. Dutreix C, Peng B, Mehring G, et al. Pharmacokinetic interaction between ketoconazole and imatinib mesylate (Glivec) in healthy subjects. Cancer Chemother Pharmacol 2004; 54:290-294.
52. Gambillara E, Laffitte E, Widmer N, et al. Severe pustular eruption associated with imatinib and voriconazole in a patient with chronic myeloid leukemia. Dermatology 2005; 211:363-365.
53. Larson RA, Druker BJ, Guilhot F, et al. Correlation of pharmacokinetic data with cytogenetic and molecular response in newly diagnosed patients with chronic myeloid leukemia in chronic phase (CML-CP) treated with imatinib - and analysis of IRIS study data. Blood 2006; 108:131a (Abstract #429).
54. Picard S, Titier K, Etienne G, et al. Trough plasma imatinib concentrations are associated with both cytogenetic and molecular responses to standard dose imatinib in chronic myeloid leukemia. Blood 2006; 108:607a (Abstract #2141).
55. Feng W, Henk H, Thomas S, et al. Compliance and persistency with imatinib. J Clin Oncol 2006; 24 (18 suppl):310s (Abstract #6038).
56. Schermuly RT, Dony E, Ghofrani HA, et al. Reversal of experimental pulmonary hypertension by PDGF inhibition. J Clin Lnvest 2005; 115:2811-2821.
57. Ghofrani HA, Seeger W, Grimminger F. Imatinib for the treatment of pulmonary arterial hypertension. N Engl J Med 2005; 353:1412-1413.
58. Bergeron A, Bergot E, Vilela G, et al. Hypersensitivity pneumonitis related to imatinib mesylate. J Clin Oncol 2002; 20:4271-4272.
59. Isshiki I, Yamaguchi K, Okamoto S. Interstitial pneumonitis during imatinib therapy. Br J Haematol 2004; 125:420.
60. Rajda J, Phatak PD. Reversible drug-induced interstitial pneumonitis following imatinib mesylate therapy. Am J Hematol 2005; 79:80-81.
61. Wagner U, Staats P, Moll R, et al. Imatinib-associated pulmonary alveolar proteinosis. Am J Med 2003; 115:674.
62. Ma CX, Hobday TJ, Jett JR. Imatinib mesylate-induced interstitial pneumonitis. Mayo Clin Proc 2003; 78:1578-1579.
63. Grimison P, Goldstein D, Schneeweiss J, et al. Corticosteroid-responsive interstitial pneumonitis related to imantinib mesylate with successful rechallenge, and potential causative mechanisms. Intern Med J 2005; 35:136-137.
64. Yokoyama T, Miyazawa K, Kurakawa E, et al. Interstitial pneumonia induced by imatinib mesylate: pathologic study demonstrates alveolar destruction and fibrosis with eosinophilic infiltration. Leukemia 2004; 18:645-646.
65. Rosado MF, Donna E, Ahn YS. Challenging problems in advanced malignancy: case 3. imatinib mesylate-induced interstitial pneumonitis. J Clin Oncol 2003; 21:3171-3173.
66. Lin JT, Yeh KT, Fang HY, et al. Fulminant, but reversible interstitial pneumonitis associated with imatinib mesylate. Leuk Lymphoma 2006; 47:1693-1695.
67. Ohnishi K, Sakai F, Kudoh S, et al. Twenty-seven cases of drug-induced interstitial lung disease associated with imatinib mesylate. Leukemia 2006; 20:1162-1164.
68. Cross TJ, Bagot C, Portmann B, et al. Imatinib mesylate as a cause of acute liver failure. Am J Hematol 2006; 81:189-192.
69. Lin NU, Sarantopoulos S, Stone JR, et al. Fatal hepatic necrosis following imatinib mesylate therapy. Blood 2003; 102:3455-3456.
70. Ferrero D, Pogliani EM, Rege-Cambrin G, et al. Corticosteroids can reverse severe imatinib-induced hepatotoxicity. Haematologica 2006; 91:ECR27.
71. Gambacorti-Passerini C, Tornaghi L, Cavagnini F, et al. Gynaecomastia in men with chronic myeloid leukaemia after imatinib. Lancet 2003; 361:1954-1956.
72. Veneri D, Franchini M, Bonora E. Imatinib and regression of type 2 diabetes. N Engl J Med 2005; 352:1049-1050.
73. Breccia M, Muscaritoli M, Aversa Z, et al. Imatinib mesylate may improve fasting blood glucose in diabetic Ph+ chronic myelogenous leukemia patients responsive to treatment. J Clin Oncol 2004; 22:4653-4655.
74. Hamberg P, de Jong FA, Boonstra JG, et al. Non-islet-cell tumor induced hypoglycemia in patients with advanced gastrointestinal stromal tumor possibly worsened by imatinib. J Clin Oncol 2006; 24:e30-e31.
75. de Groot JW, Zonnenberg BA, Plukker JT, et al. Imatinib induces hypothyroidism in patients receiving levothyroxine. Clin Pharmacol Ther 2005; 78:433-438.
76. Chng WJ, Tan LH. Late-onset marrow aplasia due to imatinib in newly diagnosed chronic phase chronic myeloid leukaemia. Leuk Res 2005; 29:719-720.
77. Lokeshwar N, Kumar L, Kumari M. Severe bone marrow aplasia following imatinib mesylate in a patient with chronic myelogenous leukemia. Leuk Lymphoma 2005; 46:781-784.
78. Srinivas U, Pillai LS, Kumar R, et al. Bone marrow aplasia-a rare complication of imatinib therapy in CML patients. Am J Hematol 2006. [Epub ahead of print].
79. Medina J, Kantarjian H, Talpaz M, et al. Chromosomal abnormalities in Philadelphia chromosome-negative metaphases appearing during imatinib mesylate therapy in patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase. Cancer 2003; 98:1905-1911.
80. Quintas-Cardama A, Kantarjian H, Jones D, et al. Dasatinib (BMS-354825) is active in Philadelphia chromosome-positive chronic myelogenous leukemia after imatinib and nilotinib (AMN107) therapy failure. Blood 2006; 109:497-499.
81. Kovitz C, Kantarjian H, Garcia-Manero G, et al. Myelodysplastic syndromes and acute leukemia developing after imatinib mesylate therapy for chronic myeloid leukemia. Blood 2006; 108:2811-2813.
82. Roy L, Guilhot J, Martineau G, et al. Unexpected occurrence of second malignancies in patients treated with interferon followed by imatinib mesylate for chronic myelogenous leukemia. Leukemia 2005; 19:1689-1692.
83. Pilot PR, Sablinska K, Owen S, et al. Epidemiological analysis of second primary malignancies in more than 9500 patients treated with imatinib. Leukemia 2005; 20:148.
84. Elliott MA, Mesa RA, Tefferi A, et al. Adverse events after imatinib mesylate therapy. N Engl J Med 2002; 346:712-713.
85. Kusumi E, Arakawa A, Kami M, et al. Visual disturbance due to retinal edema as a complication of imatinib. Leukemia 2004; 18:1138-1139.
86. Masood I, Negi A, Dua HS. Imatinib as a cause of cystoid macular edema following uneventful phacoemulsification surgery. J Cataract Refract Surg 2005; 31:2427-2428.