nach oben

Cancer Chemotherapy and Pharmacology

Erschienen in:

01.10.2020 | Original Article

Assessment of acute kidney injury related to small-molecule protein kinase inhibitors using the FDA adverse event reporting system

verfasst von: Qianqian Fan, Jie Ma, Bo Zhang, Qiuyue Li, Fang Liu, Bin Zhao

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 5/2020

Einloggen, um Zugang zu erhalten

Abstract

Purpose

Small-molecule protein kinase inhibitors (PKIs) have substantially improved clinical outcomes of various diseases. However, some studies suggested these agents might induce acute kidney injury (AKI). This study was designed to comprehensively assess the adverse events of AKI in real-world patients receiving small-molecule PKIs using the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).

Methods

The FAERS data between 2004 and 2019 were extracted to describe the characteristics of AKI cases after the use of small-molecule PKIs approved by the FDA. The reporting odds ratio (ROR) with 95% confidence interval (CI) for AKI was calculated for each small-molecule PKI agent. A disproportionality signal was defined when the lower limit of 95% CI > 1.

Results

Among the 462,020 adverse event reports for small-molecule PKIs, 9970 (2.16%) were identified as AKI cases. The median AKI onset time was 32 (interquartile range 11–124) days after the initiation of small-molecule PKI treatment. A total of 61.38% and 26.04% of AKI cases resulted in hospitalization and death, respectively. Based on RORs, 14 of 52 small-molecule PKIs yielded disproportionality signals for AKI, including six VEGFR inhibitors, three mTOR inhibitors and five small-molecule PKIs with other targets. The agents with the highest AKI RORs were entrectinib (ROR 6.40, 95% CI 2.23, 18.34), sirolimus (ROR 3.76, 95% CI 3.45, 4.09), and cobimetinib (ROR 3.40, 95% CI 2.69, 4.28).

Conclusion

Analysis of the FAERS data helped identify the small-molecule PKIs that were most frequently reported for AKI. Further investigations are needed to confirm these potential risks.

Nur mit Berechtigung zugänglich

Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed 22 Aug 2020

Roskoski R Jr (2020) Properties of FDA-approved small molecule protein kinase inhibitors: a 2020 update. Pharmacol Res 152:104609. https://doi.org/10.1016/j.phrs.2019.104609CrossRef

Porta C, Cosmai L, Gallieni M, Pedrazzoli P, Malberti F (2015) Renal effects of targeted anticancer therapies. Nat Rev Nephrol 11(6):354–370. https://doi.org/10.1038/nrneph.2015.15CrossRef

Goldstein SL (2016) Medication-induced acute kidney injury. Curr Opin Crit Care 22(6):542–545. https://doi.org/10.1097/MCC.0000000000000355CrossRef

Yilmaz M, Lahoti A, O'Brien S, Nogueras-Gonzalez GM, Burger J, Ferrajoli A, Borthakur G, Ravandi F, Pierce S, Jabbour E, Kantarjian H, Cortes JE (2015) Estimated glomerular filtration rate changes in patients with chronic myeloid leukemia treated with tyrosine kinase inhibitors. Cancer 121(21):3894–3904. https://doi.org/10.1002/cncr.29587CrossRefPubMedCentral

Chan JK, Brady W, Monk BJ, Brown J, Shahin MS, Rose PG, Kim JH, Secord AA, Walker JL, Gershenson DM (2018) A phase II evaluation of sunitinib in the treatment of persistent or recurrent clear cell ovarian carcinoma: an NRG Oncology/Gynecologic Oncology Group Study (GOG-254). Gynecol Oncol 150(2):247–252. https://doi.org/10.1016/j.ygyno.2018.05.029CrossRefPubMedCentral

Ferolla P, Brizzi MP, Meyer T, Mansoor W, Mazieres J, Do Cao C, Lena H, Berruti A, Damiano V, Buikhuisen W, Gronbaek H, Lombard-Bohas C, Grohe C, Minotti V, Tiseo M, De Castro J, Reed N, Gislimberti G, Singh N, Stankovic M, Oberg K, Baudin E (2017) Efficacy and safety of long-acting pasireotide or everolimus alone or in combination in patients with advanced carcinoids of the lung and thymus (LUNA): an open-label, multicentre, randomised, phase 2 trial. Lancet Oncol 18(12):1652–1664. https://doi.org/10.1016/S1470-2045(17)30681-2CrossRef

Launay-Vacher V, Zimner-Rapuch S, Poulalhon N, Fraisse T, Garrigue V, Gosselin M, Amet S, Janus N, Deray G (2014) Acute renal failure associated with the new BRAF inhibitor vemurafenib: a case series of 8 patients. Cancer 120(14):2158–2163. https://doi.org/10.1002/cncr.28709CrossRef

Syed U, Wahlberg KJ, Douce DR, Sprague JR (2018) Thrombotic thrombocytopenic purpura associated with pazopanib. Case Rep Hematol 2018:4327904. https://doi.org/10.1155/2018/4327904CrossRefPubMedCentral

10.

Ramachandran P, Morcus R, Tahir M, Onukogu I, Spinowitz B, Wang JC (2018) Alectinib (Alecensa)-induced reversible grade IV nephrotoxicity: a case report and review of the literature. J Med Case Rep 12(1):303. https://doi.org/10.1186/s13256-018-1849-yCrossRefPubMedCentral

11.

Furuto Y, Hashimoto H, Namikawa A, Outi H, Takahashi H, Horiuti H, Honda K, Shibuya Y (2018) Focal segmental glomerulosclerosis lesion associated with inhibition of tyrosine kinases by lenvatinib: a case report. BMC Nephrol 19(1):273. https://doi.org/10.1186/s12882-018-1074-3CrossRefPubMedCentral

12.

Manohar S, Bansal A, Wanchoo R, Sakhiya V, Lucia S, Jhaveri KD (2019) Ibrutinib induced acute tubular injury: a case series and review of the literature. Am J Hematol 94(9):E223–E225. https://doi.org/10.1002/ajh.25546CrossRef

13.

Chawla LS, Bellomo R, Bihorac A, Goldstein SL, Siew ED, Bagshaw SM, Bittleman D, Cruz D, Endre Z, Fitzgerald RL, Forni L, Kane-Gill SL, Hoste E, Koyner J, Liu KD, Macedo E, Mehta R, Murray P, Nadim M, Ostermann M, Palevsky PM, Pannu N, Rosner M, Wald R, Zarbock A, Ronco C, Kellum JA, Acute Disease Quality Initiative W (2017) Acute kidney disease and renal recovery: consensus report of the Acute Disease Quality Initiative (ADQI) 16 Workgroup. Nat Rev Nephrol 13(4):241–257. https://doi.org/10.1038/nrneph.2017.2CrossRefPubMedCentral

14.

Welch HK, Kellum JA, Kane-Gill SL (2018) Drug-associated acute kidney injury identified in the United States food and drug administration adverse event reporting system database. Pharmacotherapy 38(8):785–793. https://doi.org/10.1002/phar.2152CrossRefPubMedCentral

15.

Food and Drug Administration (2018) Data Mining at the Center for Drug Evaluation and Research. https://www.fda.gov/science-research/data-mining/data-mining-center-drug-evaluation-and-research. Accessed 22 Aug 2020

16.

Fukazawa C, Hinomura Y, Kaneko M, Narukawa M (2018) Significance of data mining in routine signal detection: analysis based on the safety signals identified by the FDA. Pharmacoepidemiol Drug Saf 27(12):1402–1408. https://doi.org/10.1002/pds.4672CrossRefPubMedCentral

17.

Harpaz R, DuMouchel W, LePendu P, Bauer-Mehren A, Ryan P, Shah NH (2013) Performance of pharmacovigilance signal-detection algorithms for the FDA adverse event reporting system. Clin Pharmacol Ther 93(6):539–546. https://doi.org/10.1038/clpt.2013.24CrossRefPubMedCentral

18.

MedDRA MSSO (2019) Introductory Guide for Standardised MedDRA Queries (SMQs) Version 21.0. https://www.meddra.org/sites/default/files/guidance/file/000356_smq_intguide_22_1.pdf. Accessed 22 Aug 2020

19.

Food and Drug Administration (2020) FDA Adverse Event Reporting System (FAERS) Quarterly Data Extract Files. https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html. Accessed 22 Aug 2020

20.

Kidney disease: improving global outcomes (KDIGO) Acute Kidney Injury Work Group (2012) KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney Int Suppl 2(1):1–138. https://www.sciencedirect.com/journal/kidney-international-supplements/vol/2/issue/1. Accessed 22 Aug 2020

21.

Food and Drug Administration (2016) What is a serious adverse event? https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event. Accessed 22 Aug 2020

22.

Zink RC (2016) Disproportionality analysis and its application to spontaneously reported adverse events in pharmacovigilance. https://www.jmp.com/content/dam/jmp/documents/en/white-papers/disproportionality-105686.pdf. Accessed 22 Aug 2020

23.

Chen Y, Guo JJ, Steinbuch M, Lin X, Buncher CR, Patel NC (2008) Comparison of sensitivity and timing of early signal detection of four frequently used signal detection methods. Pharmaceutical Medicine 22(6):359–365CrossRef

24.

Poluzzi E, Raschi E, Piccinni C, Ponti FD (2012) Data mining techniques in pharmacovigilance: analysis of the publicly accessible FDA Adverse Event Reporting System (AERS). Data Mining Applications in Engineering and Medicine. https://api.intechopen.com/chapter/pdf-preview/38579. Accessed 22 Aug 2020

25.

Wang ML, Rule S, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, Barrientos JC, Chmielowska E, Radford J, Stilgenbauer S, Dreyling M, Jedrzejczak WW, Johnson P, Spurgeon SE, Li L, Zhang L, Newberry K, Ou Z, Cheng N, Fang B, McGreivy J, Clow F, Buggy JJ, Chang BY, Beaupre DM, Kunkel LA, Blum KA (2013) Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med 369(6):507–516. https://doi.org/10.1056/NEJMoa1306220CrossRefPubMedCentral

26.

Wahab IA, Pratt NL, Kalisch LM, Roughead EE (2013) The detection of adverse events in randomized clinical trials: can we really say new medicines are safe? Curr Drug Saf 8(2):104–113. https://doi.org/10.2174/15748863113089990030CrossRef

27.

Loke YK, Price D, Derry S, Aronson JK (2006) Case reports of suspected adverse drug reactions—systematic literature survey of follow-up. BMJ 332(7537):335–339. https://doi.org/10.1136/bmj.38701.399942.63CrossRefPubMedCentral

28.

Boddu R, Fan C, Rangarajan S, Sunil B, Bolisetty S, Curtis LM (2017) Unique sex- and age-dependent effects in protective pathways in acute kidney injury. Am J Physiol Renal Physiol 313(3):F740–F755. https://doi.org/10.1152/ajprenal.00049.2017CrossRefPubMedCentral

29.

Neugarten J, Golestaneh L, Kolhe NV (2018) Sex differences in acute kidney injury requiring dialysis. BMC Nephrol 19(1):131. https://doi.org/10.1186/s12882-018-0937-yCrossRefPubMedCentral

30.

Anderson S, Eldadah B, Halter JB, Hazzard WR, Himmelfarb J, Horne FM, Kimmel PL, Molitoris BA, Murthy M, O'Hare AM, Schmader KE, High KP (2011) Acute kidney injury in older adults. J Am Soc Nephrol 22(1):28–38. https://doi.org/10.1681/ASN.2010090934CrossRef

31.

Cerda J, Mohan S, Garcia-Garcia G, Jha V, Samavedam S, Gowrishankar S, Bagga A, Chakravarthi R, Mehta R (2017) Acute kidney injury recognition in low- and middle-income countries. Kidney Int Rep 2(4):530–543. https://doi.org/10.1016/j.ekir.2017.04.009CrossRefPubMedCentral

32.

Lunyera J, Kilonzo K, Lewington A, Yeates K, Finkelstein FO (2016) Acute kidney injury in low-resource settings: barriers to diagnosis, awareness, and treatment and strategies to overcome these barriers. Am J Kidney Dis 67(6):834–840. https://doi.org/10.1053/j.ajkd.2015.12.018CrossRef

33.

Hoste EAJ, Kellum JA, Selby NM, Zarbock A, Palevsky PM, Bagshaw SM, Goldstein SL, Cerda J, Chawla LS (2018) Global epidemiology and outcomes of acute kidney injury. Nat Rev Nephrol 14(10):607–625. https://doi.org/10.1038/s41581-018-0052-0CrossRef

34.

Izzedine H, Escudier B, Lhomme C, Pautier P, Rouvier P, Gueutin V, Baumelou A, Derosa L, Bahleda R, Hollebecque A, Sahali D, Soria JC (2014) Kidney diseases associated with anti-vascular endothelial growth factor (VEGF): an 8-year observational study at a single center. Medicine (Baltimore) 93(24):333–339. https://doi.org/10.1097/MD.0000000000000207CrossRef

35.

Winn SK, Ellis S, Savage P, Sampson S, Marsh JE (2009) Biopsy-proven acute interstitial nephritis associated with the tyrosine kinase inhibitor sunitinib: a class effect? Nephrol Dial Transplant 24(2):673–675. https://doi.org/10.1093/ndt/gfn625CrossRef

36.

Iwasaki K, Obara W, Fujioka T (2012) Case of complete response to everolimus for metastatic renal cell carcinoma. Int J Urol 19(9):891–892. https://doi.org/10.1111/j.1442-2042.2012.03039.xCrossRefPubMedCentral

37.

Ismail I, Nigam S, Parnham A, Srinivasa V (2017) Anti-glomerular basement membrane glomerulonephritis following nintedanib for idiopathic pulmonary fibrosis: a case report. J Med Case Rep 11(1):214. https://doi.org/10.1186/s13256-017-1384-2CrossRefPubMedCentral

38.

den Deurwaarder ES, Desar IM, Steenbergen EJ, Mulders PF, Wetzels JF, van Herpen CM (2012) Kidney injury during VEGF inhibitor therapy. Neth J Med 70(6):267–271

39.

Dowling RJ, Topisirovic I, Fonseca BD, Sonenberg N (2010) Dissecting the role of mTOR: lessons from mTOR inhibitors. Biochim Biophys Acta 1804(3):433–439. https://doi.org/10.1016/j.bbapap.2009.12.001CrossRefPubMedCentral

40.

Paluri RK, Sonpavde G, Morgan C, Rojymon J, Mar AH, Gangaraju R (2019) Renal toxicity with mammalian target of rapamycin inhibitors: a meta-analysis of randomized clinical trials. Oncol Rev 13(2):455. https://doi.org/10.4081/oncol.2019.455CrossRefPubMedCentral

41.

Ha SH, Park JH, Jang HR, Huh W, Lim HY, Kim YG, Kim DJ, Oh HY, Lee JE (2014) Increased risk of everolimus-associated acute kidney injury in cancer patients with impaired kidney function. BMC Cancer 14:906. https://doi.org/10.1186/1471-2407-14-906CrossRefPubMedCentral

42.

Izzedine H, Escudier B, Rouvier P, Gueutin V, Varga A, Bahleda R, Soria JC (2013) Acute tubular necrosis associated with mTOR inhibitor therapy: a real entity biopsy-proven. Ann Oncol 24(9):2421–2425. https://doi.org/10.1093/annonc/mdt233CrossRef

43.

Teuma C, Pelletier S, Amini-Adl M, Perier-Muzet M, Maucort-Boulch D, Thomas L, Laville M, Fouque D, Dalle S (2017) Adjunction of a MEK inhibitor to Vemurafenib in the treatment of metastatic melanoma results in a 60% reduction of acute kidney injury. Cancer Chemother Pharmacol 79(5):1043–1049. https://doi.org/10.1007/s00280-017-3300-2CrossRef

44.

Cosmai L, Gallieni M, Porta C (2015) Renal toxicity of anticancer agents targeting HER2 and EGFR. J Nephrol 28(6):647–657. https://doi.org/10.1007/s40620-015-0226-9CrossRef

45.

Teuma C, Perier-Muzet M, Pelletier S, Nouvier M, Amini-Adl M, Dijoud F, Duru G, Thomas L, Fouque D, Laville M, Dalle S (2016) New insights into renal toxicity of the B-RAF inhibitor, vemurafenib, in patients with metastatic melanoma. Cancer Chemother Pharmacol 78(2):419–426. https://doi.org/10.1007/s00280-016-3086-7CrossRef

46.

Gastaud L, Ambrosetti D, Otto J, Marquette CH, Coutts M, Hofman P, Esnault V, Favre G (2013) Acute kidney injury following crizotinib administration for non-small-cell lung carcinoma. Lung Cancer 82(2):362–364. https://doi.org/10.1016/j.lungcan.2013.08.007CrossRef

Titel: Assessment of acute kidney injury related to small-molecule protein kinase inhibitors using the FDA adverse event reporting system
verfasst von: Qianqian Fan
Jie Ma
Bo Zhang
Qiuyue Li
Fang Liu
Bin Zhao
Publikationsdatum: 01.10.2020
Verlag: Springer Berlin Heidelberg
Erschienen in: Cancer Chemotherapy and Pharmacology / Ausgabe 5/2020
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-020-04151-8

Springer Medizin

Assessment of acute kidney injury related to small-molecule protein kinase inhibitors using the FDA adverse event reporting system

Abstract

Purpose

Methods

Results

Conclusion

Neu im Fachgebiet Onkologie

Adjuvante Immuntherapie verlängert Leben bei RCC

Alectinib verbessert krankheitsfreies Überleben bei ALK-positivem NSCLC

Bei Senioren mit Prostatakarzinom auf Anämie achten!

ICI-Therapie in der Schwangerschaft wird gut toleriert

Update Onkologie

Springer Medizin

Abstract

Purpose

Methods

Results

Conclusion

Bitte loggen Sie sich ein, um Zugang zu diesem Inhalt zu erhalten

Weitere Artikel der Ausgabe 5/2020

A placebo-controlled, double-blind, randomized study of recombinant thrombomodulin (ART-123) to prevent oxaliplatin-induced peripheral neuropathy

Beta-adrenergic blocker inhibits oral carcinogenesis and reduces tumor invasion

A preliminary assessment of oral monepantel’s tolerability and pharmacokinetics in individuals with treatment-refractory solid tumors

Population pharmacokinetic analysis of phase 1 bemarituzumab data to support phase 2 gastroesophageal adenocarcinoma FIGHT trial

Combination efficacy of pertuzumab and trastuzumab for trastuzumab emtansine-resistant cells exhibiting attenuated lysosomal trafficking or efflux pumps upregulation

Physiologically based pharmacokinetic modeling and simulation to predict drug–drug interactions of ivosidenib with CYP3A perpetrators in patients with acute myeloid leukemia

Neu im Fachgebiet Onkologie

Adjuvante Immuntherapie verlängert Leben bei RCC

Alectinib verbessert krankheitsfreies Überleben bei ALK-positivem NSCLC

Bei Senioren mit Prostatakarzinom auf Anämie achten!

ICI-Therapie in der Schwangerschaft wird gut toleriert

Update Onkologie