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01.06.2009 | Review

QT interval prolongation among patients treated with angiogenesis inhibitors

verfasst von: Stephane Ederhy, Ariel Cohen, Ghislaine Dufaitre, Hassan Izzedine, Christophe Massard, Catherine Meuleman, Benjamin Besse, Emmanuelle Berthelot, Franck Boccara, Jean-Charles Soria

Erschienen in: Targeted Oncology | Ausgabe 2/2009

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Abstract

Among toxicities associated with molecular targeted agents (MTA), cardiovascular toxicities remain largely unknown or underestimated. Their frequency is variable and dependent on the compound. A high incidence of hypertension, symptomatic or asymptomatic left ventricular systolic dysfunction, acute coronary syndrome, arterial and venous thrombosis has been observed in patients receiving MTA. One of the most threatening complications of angiogenic inhibitors (AI) could be QT prolongation with the risk of torsade de pointes (TdP) and sudden death. QT prolongation and torsade de pointes accounted for 29% of cardiac and non-cardiac post-marketing withdrawals. The assessment of the effects of drugs on cardiac repolarization is the subject of recent guidelines and recommendations. Regulatory agencies now require practically every new pharmaceutical compound to undergo a thorough investigation of its propensity to modify cardiac repolarization. To reduce the incidence of QT prolongation and torsade de pointes in patients receiving AI, cancer patients should be closely monitored while receiving AI.

Roodhart JM, Langenberg MH, Witteveen E, Voest EE (2008) The molecular basis of class side effects due to treatment with inhibitors of the VEGF/VEGFR pathway. Curr Clin Pharmacol 3:132–143CrossRefPubMed

Ellis LM, Hicklin DJ (2008) VEGF-targeted therapy: mechanisms of anti-tumour activity. Nat Rev Cancer 8:579–591CrossRefPubMed

Rixe O, Billemont B, Izzedine H (2007) Hypertension as a predictive factor of Sunitinib activity. Ann Oncol 18(6):1117CrossRefPubMed

Force T, Krause DS, Van Etten RA (2007) Molecular mechanisms of cardiotoxicity of tyrosine kinase inhibition. Nat Rev Cancer 7:332–344CrossRefPubMed

Schmidinger M, Zielinski CC, Vogl UM et al (2008) Cardiac toxicity of sunitinib and sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol 26:5204–5212CrossRefPubMed

Hutson TE, Figlin RA, Kuhn JG, Motzer RJ (2008) Targeted therapies for metastatic renal cell carcinoma: an overview of toxicity and dosing strategies. Oncologist 13:1084–1096CrossRefPubMed

Strevel EL, Ing DJ, Siu LL (2007) Molecularly targeted oncology therapeutics and prolongation of the QT interval. J Clin Oncol 25:3362–3371CrossRefPubMed

Hutton DM (2008) The importance of routine QT interval measurement in rhythm interpretation Dynamics 19:29–33

Issa AM, Phillips KA, Van Bebber S et al (2007) Drug withdrawals in the United States: a systematic review of the evidence and analysis of trends. Curr Drug Saf 2:177–185CrossRefPubMed

10.

Vargas HM, Bass AS, Breidenbach A et al (2008) Scientific review and recommendations on preclinical cardiovascular safety Safety pharmacology in focus: new methods developed in the light of the ICH S7B guidance document. J Pharmacol Toxicol Methods 58:72–76CrossRefPubMed

11.

Morita H, Wu J, Zipes DP (2008) The QT syndromes: long and short. Lancet 372:750–763CrossRefPubMed

12.

Schimpf R, Borggrefe M, Wolpert C (2008) Clinical and molecular genetics of the short QT syndrome. Curr Opin Cardiol 23:192–198CrossRefPubMed

13.

Ahmad K, Dorian P, Suppl 4 (2007) Drug-induced QT prolongation and proarrhythmia: an inevitable link? Europace 9:iv16–22CrossRefPubMed

14.

Antzelevitch C, Suppl 4 (2007) Ionic, molecular, and cellular bases of QT-interval prolongation and torsade de pointes. Europace 9:iv4–15CrossRefPubMed

15.

Gupta A, Lawrence AT, Krishnan K et al (2007) Current concepts in the mechanisms and management of drug-induced QT prolongation and torsade de pointes. Am Heart J 153:891CrossRefPubMed

16.

Al-Khatib SM, LaPointe NM, Kramer JM et al (2003) What clinicians should know about the QT interval. JAMA 289:2120–2127CrossRefPubMed

17.

Viskin S, Rosovski U, Sands AJ, Chen E et al (2005) Inaccurate electrocardiographic interpretation of long QT: the majority of physicians cannot recognize a long QT when they see one. Heart Rhythm 2:569–574CrossRefPubMed

18.

Soria JC, Dieras V, Girre V et al (2007) QTc monitoring during a phase I study: experience with SR271425. Am J Clin Oncol 30:106–112CrossRefPubMed

19.

Rubel P, Hamidi S, Behlouli H et al (1996) Are serial Holter QT, late potential, and wavelet measurement clinically useful? J Electrocardiol 29 Suppl:52–61

20.

Charbit B, Samain E, Merckx P et al (2006) QT interval measurement: evaluation of automatic QTc measurement and new simple method to calculate and interpret corrected QT interval. Anesthesiology 104:255–260CrossRefPubMed

21.

Yarnoz MJ, Curtis AB (2008) More reasons why men and women are not the same (gender differences in electrophysiology and arrhythmias). Am J Cardiol 101:1291–1296CrossRefPubMed

22.

Davey P (2002) How to correct the QT interval for the effects of heart rate in clinical studies. J Pharmacol Toxicol Methods 48:3–9CrossRefPubMed

23.

Goldenberg I, Moss AJ (2008) Long QT syndrome. J Am Coll Cardiol 51:2291–2300CrossRefPubMed

24.

Zeltser D, Justo D, Halkin A et al (2003) Torsade de pointes due to noncardiac drugs: most patients have easily identifiable risk factors. Medicine 82:282–290CrossRefPubMed

25.

Meinardi MT, van Veldhuisen DJ, Gietema JA et al (2001) Prospective evaluation of early cardiac damage induced by epirubicin-containing adjuvant chemotherapy and locoregional radiotherapy in breast cancer patients. J Clin Oncol 19:2746–2753PubMed

26.

Varterasian M, Meyer M, Fingert H et al (2003) Baseline heart rate-corrected QT and eligibility for clinical trials in oncology. J Clin Oncol 21:3378–3379CrossRefPubMed

27.

Trotti A, Colevas AD, Setser A et al (2003) CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol 13:176–181CrossRefPubMed

28.

Mann BS, Johnson JR et al (2007) FDA approval summary: vorinostat for treatment of advanced primary cutaneous T-cell lymphoma. The Oncologist 12(10):1247–1252CrossRefPubMed

29.

Gu W, Roeder RG (1997) Activation of p53 sequence-specific DNA binding by acetylation of the p53 C-terminal domain 90:595–606

30.

Piekarz RL, Robey R, Sandor V, Bakke S et al (2001) Inhibitor of histone deacetylation, depsipeptide (FR901228), in the treatment of peripheral and cutaneous T-cell lymphoma: a case report. Blood 98:2865–2868CrossRefPubMed

31.

Shah MH, Binkley P, Chan K, Xiao J et al (2006) Cardiotoxicity of histone deacetylase inhibitor depsipeptide in patients with metastatic neuroendocrine tumors. Clin Cancer Res 12:3997–4003CrossRefPubMed

32.

Piekarz RL, Frye AR, Wright JJ, Steinberg SM et al (2006) Cardiac studies in patients treated with depsipeptide, FK228, in a phase II trial for T-cell lymphoma. Clin Cancer Res 12:3762–3773CrossRefPubMed

33.

Oh Y, Herbst RS, Burris H, Cleverly A et al (2008) Enzastaurin, an oral serine/threonine kinase inhibitor, as second- or third-line therapy of non-small-cell lung cancer. J Clin Oncol 26:1135–1141CrossRefPubMed

34.

Carducci MA, Musib L, Kies MS et al (2006) Phase I dose escalation and pharmacokinetic study of enzastaurin, an oral protein kinase C beta inhibitor, in patients with advanced cancer. J Clin Oncol 24:4092–4099CrossRefPubMed

35.

Rademaker-Lakhai JM, Beerepoot LV, Mehra N et al (2007) Phase I pharmacokinetic and pharmacodynamic study of the oral protein kinase C beta-inhibitor enzastaurin in combination with gemcitabine and cisplatin in patients with advanced cancer. Clin Cancer Res 13:4474–4781CrossRefPubMed

36.

Motzer RJ, Rini BI, Bukowski RM, Curti BD et al (2006) Sunitinib in patients with metastatic renal cell carcinoma. JAMA 295:2516–2524CrossRefPubMed

37.

Goodman VL, Rock EP, Dagher R, Ramchandani RP et al (2007) Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma. Clin Cancer Res 13(5):1367–1373CrossRefPubMed

38.

Mannavola D, Coco P, Vannucchi G, Bertuelli R et al (2007) A novel tyrosine-kinase selective inhibitor, sunitinib, induces transient hypothyroidism by blocking iodine uptake. J Clin Endocrinol Metab 92(9):3531–3534CrossRefPubMed

39.

Chu TF, Rupnick MA, Kerkela R et al (2007) Cardiotoxicity associated with tyrosine kinase inhibitor sunitinib. Lancet 370(9604):2011–2019CrossRefPubMed

40.

US Food and Drug Administration (FDA) (2006) Dasatinib (BMS-35825) Oncologic Drug Advisory Committee Briefing Document NDA 21–96. Washington, DC, FDA, pp 52

41.

Herbst RS, Heymach JV, O’Reilly MS et al (2007) Vandetanib (ZD6474): an orally available receptor tyrosine kinase inhibitor that selectively targets pathways critical for tumor growth and angiogenesis. Expert Opin Investig Drugs 16:239–249CrossRefPubMed

42.

Miller KD, Manuel Trigo J, Wheeler C et al (2005) Multicenter phase II trial of ZD6474, a vascular endothelial growth factor receptor-2 and epidermal growth factor receptor tyrosine kinase inhibitor, in patients with previously treated metastastic breast cancer. Clin Cancer Res 11:3369–3376CrossRefPubMed

43.

Tamura T, Minami H, Yamada Y et al (2006) A phase I dose-escalation study of ZD6474 in Japanese patients with solid malignant tumors. J Thorac Oncol 1(9):1002–1009CrossRefPubMed

44.

Holden SN, Eckhardt SG, Basser R et al (2005) Clinical evaluation of ZD6474, an orally active inhibitor of VEGF and EGF receptor signaling, in patients with solid, malignant tumors. Ann Oncol 16:1391–1397CrossRefPubMed

45.

Heymach JV, Johnson BE, Prager D et al (2007) Randomized, placebo-controlled phase II study of vandetanib plus docetaxel in previously treated non small-cell lung cancer. J Clin Oncol 25(27):4270–4277CrossRefPubMed

46.

Kovacs MJ, Reece DE, Marcellus D et al (2006) A phase II study of ZD6474 (Zactima, a selective inhibitor of VEGFR and EGFR tyrosine kinase in patients with relapsed multiple myeloma—NCIC CTG IND.145. Invest New Drugs 24(6):529–535PubMed

47.

Miller KD, Trigo JM, Wheeler C et al (2005) A multicenter phase II trial of ZD6474, a vascular endothelial growth factor receptor-2 and epidermal growth factor receptor tyrosine kinase inhibitor, in patients with previously treated metastatic breast cancer. Clin Cancer Res 11(9):3369–3376CrossRefPubMed

48.

Kiura K, Nakagawa K, Shinkai T et al (2008) A randomized, double-blind, phase IIa dose-finding study of Vandetanib (ZD6474) in Japanese patients with non-small cell lung cancer. J Thorac Oncol 3(4):386–393CrossRefPubMed

49.

Hazarika M, Jiang X, Liu Q et al (2008) Tasigna for chronic and accelerated phase Philadelphia chromosome—positive chronic myelogenous leukemia resistant to or intolerant of imatinib. Clin Cancer Res 14(17):5325–5331CrossRefPubMed

50.

Tam CS, Kantarjian H, Garcia-Manero G et al (2008) Failure to achieve a major cytogenetic response by 12 months defines inadequate response in patients receiving nilotinib or dasatinib as second or subsequent line therapy for chronic myeloid leukemia. Blood 112(3):516–518CrossRefPubMed

51.

Zeltser D, Justo D, Halkin A et al (2003) Torsade de pointes due to noncardiac drugs: most patients have easily identifiable risk factors. Medicine (Baltimore) 82:282–290CrossRef

Titel: QT interval prolongation among patients treated with angiogenesis inhibitors
verfasst von: Stephane Ederhy
Ariel Cohen
Ghislaine Dufaitre
Hassan Izzedine
Christophe Massard
Catherine Meuleman
Benjamin Besse
Emmanuelle Berthelot
Franck Boccara
Jean-Charles Soria
Publikationsdatum: 01.06.2009
Verlag: Springer-Verlag
Erschienen in: Targeted Oncology / Ausgabe 2/2009
Print ISSN: 1776-2596
Elektronische ISSN: 1776-260X
DOI: https://doi.org/10.1007/s11523-009-0111-3

Springer Medizin

QT interval prolongation among patients treated with angiogenesis inhibitors

Abstract

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Springer Medizin

Abstract

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