Лечение нежелательных явлений, ассоциированных с приемом ленватиниба, у пациентов с радиойодрефрактерным дифференцированным раком щитовидной железы
https://doi.org/10.17650/2222-1468-2019-9-4-49-61
Аннотация
Ключевые слова
Об авторах
M. E. CabanillasСоединённые Штаты Америки
S. Takahashi
Япония
Список литературы
1. Busaidy N.L., Cabanillas M.E. Differentiated thyroid cancer: management of patients with radioiodine nonresponsive disease. J Thyroid Res 2012; 2012: 618985.
2. Pacini F., Ito Y., Luster M. et al. Radioactive iodine-refractory differentiated thyroid cancer: unmet needs and future directions. Expert Rev Endocrinol Metab 2012;7:541–54.
3. Cooper D.S., Doherty G.M., Haugen B.R. et al. Revised American Thyroid Association management guidelines for patients with thyroid nodules and differentiated thyroid cancer. Thyroid 2009;19:1167–214.
4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines® ). Thyroid carcinoma. Version 1; 2018 https://www.nccn.org/professionals/physician_gls/pdf/thyroid.pdf [Accessed October 3, 2018].
5. Durante C., Haddy N., Baudin E. et al. Long-term outcome of 444 patients with distant metastases from papillary and follicular thyroid carcinoma: benefits and limits of radioiodine therapy. J Clin Endocrinol Metab 2006;91:2892–9.
6. Xing M., Haugen B.R., Schlumberger M. Progress in molecular-based management of differentiated thyroid cancer. Lancet 2013;381:1058–69.
7. Gruber J.J., Colevas A.D. Differentiated thyroid cancer: focus on emerging treatments for radioactive iodinerefractory patients. Oncologist 2015;20:113–26.
8. Brose M.S., Nutting C.M., Jarzab B. et al. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet 2014;384:319–28.
9. Worden F. Treatment strategies for radioactive iodine-refractory differentiated thyroid cancer. Ther Adv Med Oncol 2014;6:267–79.
10. Eisai Inc. Lenvima (lenvatinib) [prescribing information]. Eisai Inc., WoodcliffLake, NJ, 2017.
11. Matsui J., Funahashi Y., Uenaka T. et al. Multi-kinase inhibitor E7080 suppresses lymph node and lung metastases of human mammary breast tumor MDA-MB-231 via inhibition of vascular endothelial growth factor-receptor (VEGF-R) 2 and VEGF-R3 kinase. Clin Cancer Res 2008;14:5459–65.
12. Matsui J., Yamamoto Y., Funahashi Y. et al. E7080, a novel inhibitor that targets multiple kinases, has potent antitumor activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. Int J Cancer 2008;122:664–71.
13. Okamoto K., Kodama K., Takase K. et al. Antitumor activities of the targeted multityrosine kinase inhibitor lenvatinib (E7080) against RET gene fusion-driven tumor models. Cancer Lett 2013;340:97–103.
14. Tohyama O., Matsui J., Kodama K. et al. Antitumor activity of lenvatinib(e7080): an angiogenesis inhibitor that targets multiple receptor tyrosine kinases in preclinical human thyroid cancer models. J Thyroid Res 2014;2014:638747.
15. Yamamoto Y., Matsui J., Matsushima T. et al. Lenvatinib, an angiogenesis inhibitor targeting VEGFR/FGFR, shows broad antitumor activity in human tumor xenograft models associated with microvessel density and pericyte coverage. Vasc Cell 2014;6:18.
16. Ikuta K., Yano S., Trung V.T. et al. E7080, a multi-tyrosine kinase inhibitor, suppresses the progression of malignant pleural mesothelioma with different proangiogenic cytokine production profiles. Clin Cancer Res 2009; 15:7229–37.
17. Laursen R., Wehland M., Kopp S. et al. Effects and role of multikinase inhibitors in thyroid cancer. Curr Pharm Des 2016;22:5915–26.
18. Schlumberger M., Tahara M., Wirth L.J. et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med 2015;372:621–30.
19. Cabanillas M.E., Hu M.I., Durand J.B., Busaidy N.L. Challenges associated with tyrosine kinase inhibitor therapy for metastatic thyroid cancer. J Thyroid Res 2011;2011:985780.
20. Brose M.S., Worden F.P., Newbold K.L. et al. Effect of age on the efficacy and safety of lenvatinib in radioiodinefefractory differentiated thyroid cancer in the phase III SELECT trial. J Clin Oncol 2017;35:2692–9.
21. Haddad R.I., Schlumberger M., Wirth L.J. et al. Incidence and timing of common adverse events in Lenvatinib-treated patients from the SELECT trial and their association with survival outcomes. Endocrine 2017;56:121–8.
22. Brose M.S., Frenette C.T., Keefe S.M., Stein S.M. Management of sorafenibrelated adverse events: a clinician’s perspective. Semin Oncol 2014;41 (suppl 2):S1–S16.
23. Elisei R., Schlumberger M.J., Müller S.P. et al. Cabozantinib in progressive medullary thyroid cancer. J Clin Oncol 2013;31:3639–46.
24. Chrisoulidou A., Mandanas S., Margaritidou E. et al. Treatment compliance and severe adverse events limit the use of tyrosine kinase inhibitors in refractory thyroid cancer. Onco Targets Ther 2015;8:2435–42.
25. Jasim S., Iniguez-Ariza N.M., Hilger C.R. et al. Optimizing lenvatinib therapy in patients with metastatic radioactive iodine-resistant differentiated thyroid cancers. Endocr Pract 2017;23:1254–61.
26. Small H.Y., Montezano A.C., Rios F.J. et al. Hypertension due to an- tiangiogenic cancer therapy with vascular endothelial growth factor inhibitors: understanding and managing a new syndrome. Can J Cardiol 2014;30:534–43.
27. Wasserstrum Y., Kornowski R., Raanani P. et al. Hypertension in cancer patients treated with anti-angiogenic based regimens. Cardiooncology 2015;1:6.
28. Schlumberger M., Jarzab B., Cabanillas M.E. et al. A phase II trial of the multitargeted tyrosine kinase inhibitor lenvatinib(E7080) in advanced medullary thyroid cancer. Clin Cancer Res 2016;22:44–53.
29. Bendtsen M.A.F., Grimm D., Bauer J. et al. Hypertension caused by lenvatinib and everolimus in the treatment of metastatic renal cell carcinoma. Int J Mol Sci 2017;18:E1736. DOI: 10.3390/ijms18081736.
30. Molina A.M., Hutson T.E., Larkin J. et al. A phase 1b clinical trial of the multitargeted tyrosine kinase inhibitor lenvatinib (E7080) in combination with everolimus for treatment of metastatic renal cell carcinoma (RCC). Cancer Chemother Pharmacol 2014;73:181–9.
31. Motzer R.J., Hutson T.E., Glen H. et al. Lenvatinib, everolimus, and the combination in patients with metastatic renal cell carcinoma: a randomised, phase 2, open-label, multicentre trial. Lancet Oncol 2015;16:1473–82.
32. Wirth L.J., Tahara M., Robinson B. et al. Treatment-emergent hypertension and efficacy in the phase 3 Study of (E7080) lenvatinib in differentiated cancer of the thyroid (SELECT). Cancer 2018;124:2365–72.
33. Kiyota N., Schlumberger M., Muro K. et al. Subgroup analysis of Japanese patients in a phase 3 study of lenvatinib in radioiodine-refractory differentiated thyroid cancer. Cancer Sci 2015;106:1714–21.
34. Ancker O.V., Wehland M., Bauer J. et al. The adverse effect of hypertension in the treatment of thyroid cancer with multi-kinase inhibitors. Int J Mol Sci 2017;18:E625. DOI: 10.3390/ijms18030625.
35. Sueta D., Suyama K., Sueta A. et al. Lenvatinib, an oral multi-kinases inhibitor, – associated hypertension: potential role of vascular endothelial dysfunction. Atherosclerosis 2017;260:116–20.
36. Dienstmann R., Braña I., Rodon J., Tabernero J. Toxicity as a biomarker of efficacy of molecular targeted therapies: focus on EGFR and VEGF inhibiting anticancer drugs. Oncologist 2011;16:1729–40.
37. Azizi M., Chedid A., Oudard S. Home blood-pressure monitoring in patients receiving sunitinib. N Engl J Med 2008;358:95–7.
38. Bamias A., Manios E., Karadimou A. et al. The use of 24-h ambulatory blood pressure monitoring (ABPM) during the first cycle of sunitinib improves the diagnostic accuracy and management of hypertension in patients with advanced renal cancer. Eur J Cancer 2011;47:1660–8.
39. Maitland M.L., Bakris G.L., Black H.R. et al. Initial assessment, surveillance, and management of blood pressure in patients receiving vascular endothelial growth factor signaling pathway inhibitors. J Natl Cancer Inst 2010;102:596–604.
40. Takahashi S., Kiyota N., Tahara M. Optimal use of lenvatinib in the treatment of advanced thyroid cancer. Cancers Head Neck 2017;2:7.
41. James P.A., Oparil S., Carter B.L. et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee(JNC 8). JAMA 2014;311:507–20.
42. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines® ). Cancer-related fatigue. Version 2; 2018. https://www.nccn.org/professionals/physician_gls/PDF/fatigue.pdf [Accessed October 3, 2018].
43. Eisen T., Sternberg C.N., Robert C. et al. Targeted therapies for renal cell carcinoma: review of adverse event management strategies. J Natl Cancer Inst 2012;104:93–113.
44. Berdelou A., Borget I., Godbert Y. et al. Lenvatinib for the treatment of radioiodine-refractory thyroid cancer in real-life practice. Thyroid 2017 DOI: 10.1089/thy.2017.0205.
45. Li J., Gu J. Risk of gastrointestinal events with newly approved(after 2011) vascular endothelial growth factor receptor tyrosine kinase inhibitors in cancer patients: a meta-analysis of randomized controlled trials. Eur J Clin Pharmacol 2017;73:1209–17.
46. Aw D.C., Tan E.H., Chin T.M. et al. Management of epidermal growth factor receptor tyrosine kinase inhibitor-related cutaneous and gastrointestinal toxicities. Asia Pac J Clin Oncol 2018;14:23–31.
47. Cohen R.B., Oudard S. Antiangiogenic therapy for advanced renal cell carcinoma: management of treatment-related toxicities. Invest New Drugs 2012;30:2066–79.
48. Pilotte A.P., Hohos M.B., Polson K.M. et al. Managing stomatitis in patients treated with mammalian target of rapamycin inhibitors. Clin J Oncol Nurs 2011;15:E83–9.
49. Rugo H.S., Seneviratne L., Beck J.T. et al. Prevention of everolimus-related stomatitis in women with hormone receptor-positive, HER2-negative metastatic breast cancer using dexamethasone mouthwash (SWISH): a single-arm, phase 2 trial. Lancet Oncol 2017;18:654–62.
50. Anderson J., Cuellar S. Updates in the use of the mTOR inhibitor everolimus in advanced breast cancer. J Cancer Clin Trials 2016;1:2.
51. Lacouture M.E., Ciccolini K., Kloos R.T., Agulnik M. Overview and management of dermatologic events associated with targeted therapies for medullary thyroid cancer. Thyroid 2014;24:1329–40.
52. Lacouture M.E., Wu S., Robert C. et al. Evolving strategies for the management of hand-foot skin reaction associated with the multitargeted kinase inhibitors sorafenib and sunitinib. Oncologist 2008;13:1001–11.
53. Chen H.X., Cleck J.N. Adverse effects of anticancer agents that target the VEGF pathway. Nat Rev Clin Oncol 2009;6:465–77.
54. Armstrong T.S., Wen P.Y., Gilbert M.R., Schiff D. Management of treatmentassociated toxicites of anti-angiogenic therapy in patients with brain tumors. Neuro Oncol 2012;14:1203–14.
55. Kitamura M., Hayashi T., Suzuki C. et al. Successful recovery from a subclavicular ulcer caused by lenvatinib for thyroid cancer: a case report. World J Surg Oncol 2017;15:24.
56. Verheul H.M., Pinedo H.M. Possible molecular mechanisms involved in the toxicity of angiogenesis inhibition. Nat Rev Cancer 2007;7:475–85.
57. Silberstein J.L., Millard F., Mehrazin R. et al. Feasibility and efficacy of neoadjuvant sunitinib before nephronsparing surgery. BJU Int 2010;106:1270–6.
58. Zhu C., Ma X., Hu Y. et al. Safety and efficacy profile of lenvatinib in cancer therapy: a systematic review and meta-analysis. Oncotarget 2016;7:44545–57.
59. Andrae J., Gallini R., Betsholtz C. Role of platelet-derived growth factors in physiology and medicine. Genes Dev 2008;22:1276–312.
60. Ye J.Y., Chan G.C., Qiao L. et al. Plateletderived growth factor enhances platelet recovery in a murine model of radiationinduced thrombocytopenia and reduces apoptosis in megakaryocytes via its receptors and the PI3-k/Akt path-way. Haematologica 2010;95:1745–53.
61. Kamba T., McDonald D.M. Mechanisms of adverse effects of anti-VEGF therapy for cancer. Br J Cancer 2007; 96:1788–95.
62. Colombo J.R., Wein R.O. Cabozantinib for progressive metastatic medullary thyroid cancer: a review. Ther Clin Risk Manag 2014;10:395–404.
63. Walraven M., Witteveen P.O., Lolkema M.P. et al. Antiangiogenic tyrosine kinase inhibition related gastrointestinal perforations: a case report and literature review. Angiogenesis 2011;14:135–41.
64. Stone R.L., Sood A.K., Coleman R.L. Collateral damage: toxic effects of targeted antiangiogenic therapies in ovarian cancer. Lancet Oncol 2010;11:465–75.
65. Qi W.X., Sun Y.J., Tang L.N. et al. Risk of gastrointestinal perforation in cancer patients treated with vascular endothelial growth factor receptor tyrosine kinase inhibitors: a systematic review and metaanalysis. Crit Rev Oncol Hematol 2014;89:394–403.
66. Spigel D.R., Hainsworth J.D., Yardley D.A. et al. Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol 2010;28:43–8.
67. Blevins D.P., Dadu R., Hu M. et al. Aerodigestive fistula formation as a rare side effect of antiangiogenic tyrosine kinase inhibitor therapy for thyroid cancer. Thyroid 2014;24:918–22.
68. Stott V.L., Hurrell M.A., Anderson T.J. Reversible posterior leukoencephalopathy syndrome: a misnomer reviewed. Intern Med J 2005;35:83–90.
69. Allen J.A., Adlakha A., Bergethon P.R. Reversible posterior leukoencephalopathy syndrome after bevacizumab/FOLFIRI regimen for metastatic colon cancer. Arch Neurol 2006;63:1475–8.
70. Seet R.C., Rabinstein A.A. Clinical features and outcomes of posterior reversible encephalopathy syndrome following bevacizumab treatment. QJM 2012;105:69–75.
71. Fugate J.E., Claassen D.O., Cloft H.J. et al. Posterior reversible encephalopathy syndrome: associated clinical and radiologic findings. Mayo Clin Proc 2010;85:427–32.
72. Tlemsani C., Mir O. Boudou-Rouquette P. et al. Posterior reversible encephalopathy syndrome induced by anti-VEGF agents. Target Oncol 2011;6:253–8.
73. Hobson E.V., Craven I., Blank S.C. Posterior reversible encephalopathy syndrome: a truly treatable neurologic illness. Perit Dial Int 2012;32:590–4.
74. Datar S., Singh T., Rabinstein A.A. et al. Long-term risk of seizures and epilepsy in patients with posterior reversible encephalopathy syndrome. Epilepsia 2015;56:564–8.
75. Ay H., Buonanno F.S., Schaefer P.W. et al. Posterior leukoencephalopathy without severe hypertension: utility of diffusionweighted MRI. Neurology 1998;51:1369–76.
76. Orphanos G.S., Ioannidis G.N., Ardavanis A.G. Cardiotoxicity induced by tyrosine kinase inhibitors. Acta Oncol 2009;48:964–70.
77. Tocchetti C.G., Gallucci G., Coppola C. et al. The emerging issue of cardiac dysfunction induced by antineoplastic angiogenesis inhibitors. Eur J Heart Fail 2013;15:482–9.
78. Van Marcke C., Ledoux B., Petit B., Seront E. Rapid and fatal acute heart failure induced by pazopanib. BMJ Case Rep 2015;2015. pii: bcr2015211522. DOI: 10.1136/bcr-2015-211522.
79. Lenihan D.J., Kowey P.R. Overview and management of cardiac adverse events associated with tyrosine kinase inhibitors. Oncologist 2013;18:900–8.
80. Mouhayar E., Durand J.B., Cortes J. Cardiovascular toxicity of tyrosine kinase inhibitors. Expert Opin Drug Saf 2013;12:687–96.
81. Resteghini C., Cavalieri S., Galbiati D. et al. Management of tyrosine kinase inhibitors (TKI) side effects in differentiated and medullary thyroid cancer patients. Best Pract Res Clin Endocrinol Metab 2017;31:349–61.
82. Common Terminology Criteria for Adverse Events v3.0(CTCAE). https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf [Accessed October 3, 2018].
Рецензия
Для цитирования:
Cabanillas M.E., Takahashi S. Лечение нежелательных явлений, ассоциированных с приемом ленватиниба, у пациентов с радиойодрефрактерным дифференцированным раком щитовидной железы. Опухоли головы и шеи. 2019;9(4):49-61. https://doi.org/10.17650/2222-1468-2019-9-4-49-61
For citation:
Cabanillas M.E., Takahashi S. Managing the adverse events associated with lenvatinib therapy in radioiodine-refractory differentiated thyroid cancer. Head and Neck Tumors (HNT). 2019;9(4):49-61. (In Russ.) https://doi.org/10.17650/2222-1468-2019-9-4-49-61