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Drug Safety Evaluation

A safety evaluation of imatinib mesylate in the treatment of gastrointestinal stromal tumor

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Pages 571-578 | Received 16 Dec 2015, Accepted 05 Feb 2016, Published online: 27 Feb 2016

References

  • Joensuu H, Fletcher C, Dimitrijevic S, et al. Management of malignant gastrointestinal stromal tumours. Lancet Oncol. 2002;3(11):655–664.
  • Miettinen M, Lasota J. Gastrointestinal stromal tumors–definition, clinical, histological, immunohistochemical, and molecular genetic features and differential diagnosis. Virchows Archiv. 2001;438(1):1.
  • Blanke CD, Demetri GD, Von Mehren M, et al.. Long-term results from a randomized phase II trial of standard- versus higher-dose imatinib mesylate for patients with unresectable or metastatic gastrointestinal stromal tumors expressing KIT. J Clin Oncol. 2008;26(4):620–625.
  • Gastrointestinal Stromal Tumor Meta-Analysis Group (MetaGIST). Comparison of two doses of imatinib for the treatment of unresectable or metastatic gastrointestinal stromal tumors: a meta-analysis of 1,640 patients. J Clin Oncol. 2010;28:1247–1253.
  • Call J, Walentas CD, Eickhoff JC et al. Survival of gastrointestinal stromal tumor patients in the imatinib era: life raft group observational registry. BMC Cancer. 2012;12:90.
  • Hirota S, Isozaki K, Moriyama Y. Gain-of-function mutations of c-kit in human gastrointestinal stromal tumors. Science. 1998;279:577–580.
  • Heinrich MC, Corless CL, Duensing A, et al.. PDGFRA activating mutations in gastrointestinal stromal tumors. Science. 2003;299(5607):708–710.
  • 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.
  • Mauro MJ, Druker BJ. STI571: targeting BCR-ABL as therapy for CML. Oncologist. 2001;6:233–238.
  • Kitamura Y, Hirota S, Nishida T. Gastrointestinal stromal tumors (GIST): a model for molecule-based diagnosis and treatment of solid tumors. Cancer Sci. 2003;94(4):315–320.
  • Tuveson DA, Willis NA, Jacks T, et al. STI571 inactivation of the gastrointestinal stromal tumor c-KIT oncoprotein: biological and clinical implications. Oncogene. 2001;20:5054–5058.
  • Weinstein BI, Joe AK. Mechanisms of disease: oncogene addiction—a rationale for molecular targeting in cancer therapy. Nat Clin Pract Oncol. 2006;3:448–457.
  • Siehl J, Thiel E. C-kit, GIST, and imatinib. Recent Results Cancer Res. 2007;176:145–151.
  • Von Mehren M, Widmer N. Correlations between imatinib pharmacokinetics, pharmacodynamics, adherence, and clinical response in advanced metastatic gastrointestinal stromal tumor (GIST): an emerging role for drug blood level testing? Cancer Treat Rev. 2011;37(4):291–299.
  • Peng B, Dutreix C, Mehring G, et al. Absolute bioavailability of imatinib (Glivec) orally versus intravenous infusion. J Clin Pharmacol. 2004;44:158–162.
  • Peng B, Lloyd P, Schran H. Clinical pharmacokinetics of imatinib. Clin Pharmacokinet. 2005;44:879–894.
  • Widmer N, Decosterd LA, Csajka C, et al. Population pharmacokinetics of imatinib and the role of alpha1-acid glycoprotein. Br J Clin Pharmacol. 2006;62:97–112.
  • Rochat B, Fayet A, Widmer N, et al. Imatinib metabolite profiling in parallel to imatinib quantification in plasma of treated patients using liquid chromatography-mass spectrometry. J Mass Spectrom. 2008;43:736–752.
  • Verweij J, Casali PG, Zalcberg J, et al. Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: randomised trial. Lancet. 2004;364(9440):1127–1134.
  • Blanke CD, Rankin C, Demetri GD, et al. Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. J Clin Oncol. 2008;26(4):626.
  • Dematteo RP, Ballman KV, Antonescu CR, et al. Adjuvant imatinib mesylate after resection of localised, primary gastrointestinal stromal tumour: a randomised, double-blind, placebo-controlled trial. Lancet. 2009;373(9669):1097.
  • Yoo C, Ryu M-H, Kang BW, et al. Cross-sectional study of imatinib plasma trough levels in patients with advanced gastrointestinal stromal tumors: impact of gastrointestinal resection on exposure to imatinib. J Clin Oncol. 2010;28(9):1554–1559.
  • Demetri GD, Wang Y, Wehrle E, et al. Imatinib plasma levels are correlated with clinical benefit in patients with unresectable/metastatic gastrointestinal stromal tumors. J Clin Oncol. 2009;27(19):3141–3147.
  • Eisenhauera EA, Therasseb P, Bogaertsc J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–247.
  • DeMatteo RP, Lewis JJ, Leung D, et al. Two hundred gastrointestinal stromal tumors: recurrence patterns and prognostic factors for survival. Ann Surg. 2000;231:51–58.
  • Trent JC, Beach J, Burgess MA, et al. A two-arm phase II study of temozolomide in patients with advanced gastrointestinal stromal tumors and other soft tissue sarcomas. Cancer. 2003;98:2693–2699.
  • Joensuu H, Eriksson M, Sundby HK, et al.. One vs three years of adjuvant imatinib for operable gastrointestinal stromal tumor: a randomized trial. Jama. 2012;307(12):1265–1272.
  • Casali PG, Cesne AL, Velasco AP et al. Time to definitive failure to the first tyrosine kinase inhibitor in localized GI stromal tumors treated with imatinib as an adjuvant: a European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Intergroup Randomized Trial in collaboration with the Australasian Gastro-Intestinal Trials Group, UNICANCER, French Sarcoma Group, Italian Sarcoma Group, and Spanish Group for Research on Sarcomas. JCO.2015.62.4304. Epub ahead of print.
  • Joensuu H, Trent JC, Reichardt P. Practical management of tyrosine kinase inhibitor-associated side effects in GIST. Cancer Treat Rev. 2011;37:75–88.
  • Verweij J, van Oosterom A, Blay JY, et al. Imatinib mesylate (STI-571 Glivec, Gleevec) is an active agent for gastrointestinal stromal tumours, but does not yield responses in other soft-tissue sarcomas that are unselected for a molecular target. Results from an EORTC Soft Tissue and Bone Sarcoma Group phase II study. Eur J Cancer. 2003;39(14):2006.
  • Guilhot F. Indications for imatinib mesylate therapy and clinical management. Oncologist. 2004;9(3):271–281.
  • Thanopoulou E, Judson I. The safety profile of imatinib in CML and GIST: long-term considerations. Arch Toxicol. 2012;86:1–12.
  • Kim KW, Shinagare AB, Krajewski KM, et al. Fluid retention associated with imatinib treatment in patients with gastrointestinal stromal tumor: quantitative radiologic assessment and implications for management. Korean J Radiol. 2015;16(2):304–313. doi:10.3348/kjr.2015.16.2.304.
  • Heuchel R, Berg A, Tallquist M, et al. Platelet-derived growth factor beta receptor regulates interstitial fluid homeostasis through phosphatidylinositol-3’ kinase signaling. Proc Natl Acad Sci USA. 1999;96(20):11410–11415.
  • Pietras K, Ostman A, Sjöquist M, et al. Inhibition of platelet-derived growth factor receptors reduces interstitial hypertension and increases transcapillary transport in tumors. Cancer Res. 2001;61(7):2929–2934.
  • 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(17715389):3540–3546.
  • Trent JC, Patel SS, Zhang J, et al. Rare incidence of congestive heart failure in gastrointestinal stromal tumor and other sarcoma patients receiving imatinib mesylate. Cancer. 2010;116(1):184–192.
  • 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(14):1031–1037.
  • Fraunfelder FW, Solomon J, Druker BJ, et al. Ocular side-effects associated with imatinib mesylate (Gleevec). J Ocul Pharmacol Ther. 2003;19(4):371–375.
  • McClelland CM, Harocopos GJ, Custer PL. Periorbital edema secondary to imatinib mesylate. Clin Ophthalmol (Auckland, NZ). 2010;4:427–431.
  • Radaelli F, Vener C, Ripamonti F, et al. Conjunctival hemorrhagic events associated with imatinib mesylate. Int J Hematol. 2007;86(5):390–393.
  • Deininger MW, O’Brien SG, Ford JM, et al. Practical management of patients with chronic myeloid leukemia receiving imatinib. J Clin Oncol. 2003;21(8):1637–1647.
  • 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(2):201–206.
  • Lammie A, Drojnak M, Gerald W, et al. Expression of c-kit and kit ligands proteins in normal human tissues. J Histochem Cytochem. 1994;42:1417–1425.
  • Rule SA, O’Brien SG, Crossman LC. Managing cutaneous reactions to imatinib therapy. Blood. 2002;100:3434–3435.
  • 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.
  • Vidal D, Puig L, Sureda A, et al. STI571-induced Stevens-Johnson syndrome. Br J Haematol. 2002;119:274–275.
  • Scheinfeld N. Imatinib mesylate and dermatology part 2: a review of the cutaneous side eVects of imatinib mesylate. J Drugs Dermatol. 5;3:228–231.
  • Bauer S, Hagen V, Pielken HJ, et al. Imatinib mesylate therapy in patients with gastrointestinal stromal tumors and impaired liver function. Anticancer Drugs. 2002;13:847–849.
  • Ohyashiki K, Kuriyama Y, Nakajima A, et al. Imatinib mesylate-induced hepato-toxicity in chronic myeloid leukemia demonstrated focal necrosis resembling acute viral hepatitis. Leukemia. 2002;16:2160–2161.
  • Lin NU, Sarantopoulos S, Stone JR, et al. Fatal hepatic necrosis following imatinib mesylate therapy. Blood. 2003;102:3455–3456.
  • James C, Trouette H, Marit G, et al. Histological features of acute hepatitis after imatinib mesylate treatment. Leukemia. 2003;17:978–979.
  • Talpaz M, Silver RT, Druker BJ, et al. Imatinib induces durable hematologic and cytogenetic responses in patients with accelerated phase chronic myeloid leukemia: results of a phase 2 study. Blood. 2002;99:1928–1937.
  • 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.
  • Ferrero D, Pogliani EM, Rege-Cambrin G, et al. Corticosteroids can reverse severe imatinib-induced hepatotoxicity. Haematologica. 2006;91(6 Suppl):79–80.
  • Zonder JA, Schiffer CA. Update on practical aspects of the treatment of chronic myeloid leukemia with imatinib mesylate. Curr Hematol Malig Rep. 2006;1:141–151.
  • Van Oosterom AT, Judson I, Verweij J, et al. Safety and efficacy of imatinib (STI571) in metastatic gastrointestinal stromal tumours: a phase I study. Lancet. 2001;358:1421–1423.
  • Spivak JL. Cancer-related anemia: its causes and characteristics. Semin Oncol. 1994;21(2 Suppl 3):3–8.
  • Schallier D1, Trullemans F, Fontaine C, et al. Tyrosine kinase inhibitor-induced macrocytosis. Anticancer Res. 2009;29(12):5225–5228.
  • Aliberti S, Grignani G, Allione P, et al. Erythrocyte macrocytosis is a rather common apparently uneventful yet unexplained finding in GIST imatinib(I) chronic therapy. Proc ASCO. 2005;827S:9045.
  • Demetri GD, Reichardt P, Kang YK, et al. Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicenter, randomized, placebo-controlled, phase 3 trial. Lancet. 2013;381:295–302.
  • Motzer RJ1, Hutson TE, Tomczak P, et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009;27(22):3584–3590.

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