Cardiac arrhythmias associated with anaplastic lymphoma kinase (ALK) inhibitors: an analysis of the FDA Adverse Event Reporting System (FAERS)

References

• Kwak EL, Bang YJ, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med. 2010 Oct 28;363(18):1693–1703.
   PubMed Web of Science ®Google Scholar
• Wu YL, Lu S, Lu Y, et al. Results of PROFILE 1029, a phase III comparison of first-line crizotinib versus chemotherapy in East Asian patients with ALK-Positive advanced non-small cell lung cancer. J Thorac Oncol. 2018 Oct;13(10):1539–1548.
   PubMed Web of Science ®Google Scholar
• Shaw AT, Kim DW, Nakagawa K, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013 Jun 20;368(25):2385–2394.
   PubMed Web of Science ®Google Scholar
• Du X, Shao Y, Qin HF, et al. ALK-rearrangement in non-small-cell lung cancer (NSCLC). Thorac Cancer. 2018 Apr;9(4):423–430.
   PubMed Web of Science ®Google Scholar
• Peters S, Camidge DR, Shaw AT, et al. Alectinib versus crizotinib in untreated ALK-Positive non-small-cell lung cancer. N Engl J Med. 2017 Aug 31;377(9):829–838.
   PubMed Web of Science ®Google Scholar
• Camidge DR, Kim HR, Ahn MJ, et al. Brigatinib versus Crizotinib in ALK-Positive non-small-cell lung cancer. N Engl J Med. 2018 Nov 22;379(21):2027–2039.
   PubMed Web of Science ®Google Scholar
• Bauer TM, Shaw AT, Johnson ML, et al. Brain penetration of lorlatinib: cumulative incidences of CNS and non-CNS progression with lorlatinib in patients with previously treated ALK-Positive non-small-cell lung cancer. Target Oncol. 2020 Feb;15(1):55–65.
   PubMed Web of Science ®Google Scholar
• Shaw AT, Bauer TM, de Marinis F, et al. First-line lorlatinib or crizotinib in advanced ALK-Positive lung cancer. N Engl J Med. 2020 Nov 19;383(21):2018–2029.
   PubMed Web of Science ®Google Scholar
• Costa RB, Costa RLB, Talamantes SM, et al. Systematic review and meta-analysis of selected toxicities of approved ALK inhibitors in metastatic non-small cell lung cancer. Oncotarget. 2018 Apr 24;9(31):22137–22146.
   PubMedGoogle Scholar
• Kassem L, Shohdy KS, Lasheen S, et al. Safety issues with the ALK inhibitors in the treatment of NSCLC: A systematic review. Crit Rev Oncol Hematol. 2019 Feb;134:56–64.
   PubMed Web of Science ®Google Scholar
• Breadner D, Blanchette P, Shanmuganathan S, et al. Efficacy and safety of ALK inhibitors in ALK-rearranged non-small cell lung cancer: A systematic review and meta-analysis. Lung Cancer. 2020 Jun;144:57–63.
   PubMed Web of Science ®Google Scholar
• Hou H, Sun D, Liu K, et al. The safety and serious adverse events of approved ALK inhibitors in malignancies: a meta-analysis. Cancer Manag Res. 2019;11: 4109–4118. doi: 10.2147/CMAR.S190098
   PubMed Web of Science ®Google Scholar
• Tao Y, Zhou Y, Tang L, et al. Toxicity profile of anaplastic lymphoma kinase tyrosine kinase inhibitors for patients with non-small cell lung cancer: A systematic review and meta-analysis. Invest New Drugs. 2022 Aug;40(4):831–840.
   PubMed Web of Science ®Google Scholar
• Sisi M, Fusaroli M, De Giglio A, et al. Psychiatric adverse reactions to anaplastic lymphoma kinase inhibitors in non-small-cell lung cancer: analysis of spontaneous reports submitted to the FDA adverse event reporting system. Target Oncol. 2022 Jan;17(1):43–51.
   PubMed Web of Science ®Google Scholar
• Zhou Z, Wang C, Ying L, et al. Anaplastic lymphoma kinase tyrosine kinase inhibitor-induced hepatic failure in lung cancer patients: A study of signal mining and analysis of the FDA adverse event reporting system database. J Clin Pharm Ther. 2021 Aug;46(4):1148–1154.
   PubMed Web of Science ®Google Scholar
• Liu B, Yuan M, Sun Y, et al. Incidence and risk of hepatic toxicities associated with anaplastic lymphoma kinase inhibitors in the treatment of non-small-cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2018 Feb 6;9(10):9480–9488.
   PubMedGoogle Scholar
• Wang L, Wang W. Safety and efficacy of anaplastic lymphoma kinase tyrosine kinase inhibitors in non‑small cell lung cancer (Review). Oncol Rep. 2021 Jan;45(1):13–28. doi: 10.3892/or.2020.7851
   PubMed Web of Science ®Google Scholar
• Morcos PN, Bogman K, Hubeaux S, et al. Effect of alectinib on cardiac electrophysiology: results from intensive electrocardiogram monitoring from the pivotal phase II NP28761 and NP28673 studies. Cancer Chemother Pharmacol. 2017 Mar;79(3):559–568.
   PubMed Web of Science ®Google Scholar
• Gemma A, Kusumoto M, Kurihara Y, et al. Interstitial lung disease onset and its risk factors in Japanese patients with ALK-Positive NSCLC after treatment with crizotinib. J Thorac Oncol. 2019 Apr;14(4):672–682.
   PubMed Web of Science ®Google Scholar
• Camidge DR, Kim HR, Ahn MJ, et al. Brigatinib versus crizotinib in advanced ALK inhibitor-naive ALK-Positive non-small cell lung cancer: second interim analysis of the phase III ALTA-1L trial. J Clin Oncol. 2020 Nov 1;38(31):3592–3603.
   PubMed Web of Science ®Google Scholar
• Solomon BJ, Besse B, Bauer TM, et al. Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet Oncol. 2018 Dec;19(12):1654–1667.
   PubMed Web of Science ®Google Scholar
• Cho BC, Obermannova R, Bearz A, et al. Efficacy and safety of ceritinib (450 mg/d or 600 mg/d) with Food versus 750-mg/d fasted in patients with ALK Receptor Tyrosine Kinase (ALK)-Positive NSCLC: primary efficacy results from the ASCEND-8 study. J Thorac Oncol. 2019 Jul;14(7):1255–1265.
   PubMed Web of Science ®Google Scholar
• Cirne F, Zhou S, Kappel C, et al. ALK inhibitor-induced bradycardia: A systematic-review and meta-analysis. Lung Cancer. 2021 Nov;161:9–17.
   PubMed Web of Science ®Google Scholar
• Bate A, Evans SJ. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf. 2009 Jun;18(6):427–436. doi: 10.1002/pds.1742
   PubMed Web of Science ®Google Scholar
• Bate A, Lindquist M, Edwards IR, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol. 1998 Jun;54(4):315–321.
   PubMed Web of Science ®Google Scholar
• Bove C, Baldock RA, Champigneulle O, et al. Fluoroquinolones: old drugs, putative new toxicities. Expert Opin Drug Saf. 2022;21(11):1365–1378. doi: 10.1080/14740338.2022.2147924
   PubMed Web of Science ®Google Scholar
• Solomon BJ, Mok T, Kim DW, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014 Dec 4;371(23):2167–2177.
   PubMed Web of Science ®Google Scholar
• Camidge DR, Kim HR, Ahn MJ, et al. Brigatinib versus Crizotinib in ALK Inhibitor-Naive advanced ALK-Positive NSCLC: final results of phase 3 ALTA-1L trial. J Thorac Oncol. 2021 Dec;16(12):2091–2108.
   PubMed Web of Science ®Google Scholar
• Fukuizumi A, Miyanaga A, Seike M, et al. Effective Crizotinib schedule for an elderly patient with ALK rearranged non-small-cell lung cancer: a case report. BMC Res Notes. 2015 Apr 23;8(1):165.
   PubMedGoogle Scholar
• Bauer TM, Felip E, Solomon BJ, et al. Clinical management of adverse events associated with lorlatinib. Oncology. 2019 Aug;24(8):1103–1110.
   Google Scholar
• Gaillard CM, Chumbi-Flores W, Gaillot-Durand L, et al. Diffuse infiltrative lung disease, pericarditis, pleural effusion and ceritinib hypersensitivity. Rev Mal Respir. 2019 Sep;36(7):902–905.
   PubMed Web of Science ®Google Scholar
• Zhang Z, Huang TQ, Nepliouev I, et al. Crizotinib inhibits hyperpolarization-activated cyclic nucleotide-gated channel 4 activity. Cardiooncology. 2017;3(1):3. doi: 10.1186/s40959-017-0020-z
   PubMedGoogle Scholar
• Soo RA, Kawaguchi T, Loh M, et al. Differences in outcome and toxicity between Asian and caucasian patients with lung cancer treated with systemic therapy. Future Oncol. 2012 Apr;8(4):451–462.
   PubMed Web of Science ®Google Scholar
• Liu Y, Chen C, Rong C, et al. Anaplastic lymphoma kinase tyrosine kinase inhibitor-associated cardiotoxicity: a recent five-year pharmacovigilance study. Front Pharmacol. 2022;13:858279. doi: 10.3389/fphar.2022.858279
   PubMed Web of Science ®Google Scholar
• Ma Z, Pei J, Zhang Y, et al. Interstitial pneumonitis associated with EGFR/ALK tyrosine kinase inhibitors used in non-small cell lung cancer: an observational, retrospective, pharmacovigilance study. Expert Opin Drug Saf. 2022 Aug;5:1–6.
   Google Scholar