Ear and Labyrinth Toxicities Induced by Immune Checkpoint Inhibitors: A Disproportionality Analysis from 2014 to 2019

References

• Wrangle JM , VelchetiV , PatelMRet al. ALT-803, an IL-15 superagonist, in combination with nivolumab in patients with metastatic non-small-cell lung cancer: a non-randomised, open-label, Phase Ib trial. Lancet Oncol.19(5), 694–704 (2018).
   PubMed Web of Science ®Google Scholar
• Younes A , SantoroA , ShippMet al. Nivolumab for classical Hodgkin’s lymphoma after failure of both autologous stem-cell transplantation and brentuximab vedotin: a multicentre, multicohort, single-arm Phase II trial. Lancet Oncol.17(9), 1283e94 (2016).
   Web of Science ®Google Scholar
• Balar AV , GalskyMD , RosenbergJEet al. Atezolizumab as first line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, Phase II trial. Lancet389(10064), 67–76 (2017).
   PubMed Web of Science ®Google Scholar
• Nghiem P , BhatiaS , LipsonEJet al. Durable tumor regression and overall survival in patients with advanced merkel cell carcinoma receiving pembrolizumab as first-line therapy. J. Clin. Oncol.37(9), 693–702 (2019).
   PubMed Web of Science ®Google Scholar
• Overman MJ , McDermottR , LeachJLet al. Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, Phase II study. Lancet Oncol.18(9), 1182–1191 (2018).
   Web of Science ®Google Scholar
• Atkins MB , PlimackER , PuzanovIet al. Axitinib in combination with pembrolizumab in patients with advanced renal cell cancer: a non-randomised, open-label, dose-finding, and dose-expansion Phase Ib trial. Lancet Oncol.19(3), 405–415 (2018).
   PubMed Web of Science ®Google Scholar
• D’Angelo SP , MahoneyMR , Van TineBAet al. Nivolumab with or without ipilimumab treatment for metastatic sarcoma (Alliance A091401): two open-label, non-comparative, randomised, Phase II trials. Lancet Oncol.19(3), 416–426 (2018).
   PubMed Web of Science ®Google Scholar
• Varricchi G , GaldieroMR , MercurioV , BonaduceD , MaroneG , TocchettiCG. Pharmacovigilating cardiotoxicity of immune checkpoint inhibitors. Lancet Oncol.19(12), 1545–1546 (2018).
   PubMed Web of Science ®Google Scholar
• Porcu M , DeSilva P , SolinasCet al. Immunotherapy associated pulmonary toxicity: biology behind clinical and radiological features. Cancers11(3), E305 (2019).
   PubMed Web of Science ®Google Scholar
• Berner F , BomzeD , DiemSet al. Association of checkpoint inhibitor-induced toxic effects with shared cancer and tissue antigens in non-small-cell lung cancer. JAMA Oncol.5(7), 1043–1047 (2019).
   PubMed Web of Science ®Google Scholar
• Akturk HK , MichelsAW. Adverse events associated with immune checkpoint inhibitors. JAMA321(12), 1219 (2019).
   PubMedGoogle Scholar
• Noseda R , BertoliR , MüllerL , CeschiA. Haemophagocytic lymphohistiocytosis in patients treated with immune checkpoint inhibitors: analysis of WHO global database of individual case safety reports. J. Immunother. Cancer7(1), 117 (2019).
   PubMed Web of Science ®Google Scholar
• Nader ME , MyersJN , GidleyPW. Sudden hearing loss in a melanoma patient on pembrolizumab: an etiology not to be omitted in the differential diagnosis. J. Immunother. Cancer5, 24 (2017).
   PubMed Web of Science ®Google Scholar
• Zibelman M , PollakN , OlszanskiAJ. Autoimmune inner ear disease in a melanoma patient treated with pembrolizumab. J. Immunother. Cancer4, 8 (2016).
   PubMed Web of Science ®Google Scholar
• Rapisuwon S , IzarB , BatenchukCet al. Exceptional response and multisystem autoimmune-like toxicities associated with the same T cell clone in a patient with uveal melanoma treated with immune checkpoint inhibitors. J. Immunother. Cancer7(1), 61 (2019).
   PubMed Web of Science ®Google Scholar
• Maintenance and Support Services Organization . Support Documentation: MedDRA Version 22.0 English March 2019. (2019). https://www.meddra.org/how-to-use/support-documentation
   Google Scholar
• Van Puijenbroek EP , BateA , LeufkensHG , LindquistM , OrreR , EgbertsAC. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol. Drug Saf.11(1), 3–10 (2002).
   PubMed Web of Science ®Google Scholar
• Bate A , LindquistM , EdwardsIRet al. A Bayesian neural network method for adverse drug reaction signal generation. Eur. J. Clin. Pharmacol.54, 315–321 (1998).
   PubMed Web of Science ®Google Scholar
• Noren GN , HopstadiusJ , BateA. Shrinkage observed-to-expected ratios for robust and transparent large-scale pattern discovery. Stat. Methods Med. Res.22, 57–69 (2013).
   PubMed Web of Science ®Google Scholar
• Zhai Y , YeX , HuFet al. Endocrine toxicity of immune checkpoint inhibitors: a real-world study leveraging US Food and Drug Administration adverse events reporting system. J. Immunother. Cancer7(1), 286 (2019).
   PubMed Web of Science ®Google Scholar
• Raschi E , MazzarellaA , AntonazzoICet al. Toxicities with immune checkpoint inhibitors: emerging priorities from disproportionality analysis of the FDA adverse event reporting system. Target Oncol.14(2), 205–221 (2019).
   PubMed Web of Science ®Google Scholar
• Ji HH , TangXW , DongZ , SongL , JiaYT. Adverse event profiles of anti-CTLA-4 and anti-PD-1 monoclonal antibodies alone or in combination: analysis of spontaneous reports submitted to FAERS. Clin. Drug Investig.39(3), 319–330 (2019).
   PubMed Web of Science ®Google Scholar
• Wang DY , SalemJE , CohenJVet al. Fatal toxic effects associated with immune checkpoint inhibitors: a systematic review and meta-analysis. JAMA Oncol.4(12), 1721–1728 (2018).
   PubMed Web of Science ®Google Scholar
• Salem JE , ManouchehriA , MoeyMet al. Cardiovascular toxicities associated with immune checkpoint inhibitors: an observational, retrospective, pharmacovigilance study. Lancet Oncol.19(12), 1579–1589 (2018).
   PubMed Web of Science ®Google Scholar
• Johnson DB , ManouchehriA , HaughAMet al. Neurologic toxicity associated with immune checkpoint inhibitors: a pharmacovigilance study. J. Immunother. Cancer7(1), 134 (2019).
   PubMed Web of Science ®Google Scholar
• Vitaliani R , SpinazziM , DelMistro AR , ManaraR , TavolatoB , BonifatiDM. Subacute onset of deafness and vertigo in a patient with leptomeningeal metastasis from ovarian cancer. Neurol. Sci.30(1), 65–67 (2009).
   PubMed Web of Science ®Google Scholar
• Kim CH , ShinJE , KimHJ , LeeKY. Bilateral internal auditory canal metastasis of non-small-cell lung cancer. Cancer Res. Treat.47(1), 110–114 (2015).
   PubMed Web of Science ®Google Scholar
• Geukes Foppen MH , BrandsmaD , BlankCU , van ThienenJV , HaanenJB , BoogerdW. Targeted treatment and immunotherapy in leptomeningeal metastases from melanoma. Ann. Oncol.27(6), 1138–1142 (2016).
   PubMed Web of Science ®Google Scholar
• Rotte A . Combination of CTLA-4 and PD-1 blockers for treatment of cancer. J. Exp. Clin. Cancer Res.38(1), 255 (2019).
   PubMed Web of Science ®Google Scholar
• Wang X , GuoG , GuanH , YuY , LuJ , YuJ. Challenges and potential of PD-1/PD-L1 checkpoint blockade immunotherapy for glioblastoma. J. Exp. Clin. Cancer Res.38(1), 87 (2019).
   PubMed Web of Science ®Google Scholar
• Looi CK , ChungFF , LeongCO , WongSF , RosliR , MaiCW. Therapeutic challenges and current immunomodulatory strategies in targeting the immunosuppressive pancreatic tumor microenvironment. J. Exp. Clin. Cancer Res.38(1), 162 (2019).
   PubMed Web of Science ®Google Scholar
• Öztürk M , IlaK , DüzgölC , AkanselG , AlmaçA. Bilateral sudden sensorineural hearing loss caused by leptomeningealcarcinomatosis: case report and review. Kulak Burun Bogaz Ihtis. Derg.24(5), 287–291 (2014).
   PubMedGoogle Scholar
• Liese JG , SilfverdalSA , GiaquintoCet al. Incidence and clinical presentation of acute otitis media in children aged <6 years in European medical practices. Epidemiol. Infect.142(8), 1778–1788 (2014).
   PubMed Web of Science ®Google Scholar
• Grossman Z , ZehaviY , LeibovitzEet al. Severe acute mastoiditis admission is not related to delayed antibiotic treatment for antecedent acute otitis media. Pediatr. Infect. Dis. J.35(2), 162–165 (2016).
   PubMed Web of Science ®Google Scholar
• Kim CH , YangYS , ImD , ShinJE. Nystagmus in patients with unilateral acute otitis media complicated by serous labyrinthitis. Acta Otolaryngol.136(6), 559–563 (2016).
   PubMed Web of Science ®Google Scholar
• Atkinson H , WallisS , CoatesworthAP. Acute otitis media. Postgrad. Med.127(4), 386–390 (2015).
   PubMed Web of Science ®Google Scholar