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Original Research

Liver toxicity in oncology trials and beyond: a simplified concept for management of hepatocellular drug-induced liver injury in patients with abnormal baseline liver tests

ORCID Icon, , , , &
Pages 527-537 | Received 27 Sep 2023, Accepted 26 Jan 2024, Published online: 04 Apr 2024

References

  • Fontana RJ, Hayashi PH, Gu J, et al. Idiosyncratic drug-induced liver injury is associated with substantial morbidity and mortality within 6 months from onset. Gastroenterology. 2014;147(1):96–108 e4. doi: 10.1053/j.gastro.2014.03.045
  • Larrey D, Pageaux GP. Drug-induced acute liver failure. Eur J Gastroenterol Hepatol. 2005;17(2):141–143. doi: 10.1097/00042737-200502000-00002
  • Lee WM. Drug-induced hepatotoxicity. N Engl J Med. 2003;349(5):474–485. doi: 10.1056/NEJMra021844
  • Lee WM. Drug-induced acute liver failure. Clin Liver Dis. 2013;17(4):575–586. viii. doi: 10.1016/j.cld.2013.07.001.
  • U.S. Department of health and human services, FDA, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance For Industry. Drug-Induced Liver Injury: Premarketing Clinical Evaluation. 2009 [cited 2022 Jan 20]. Available from: https://www.fda.gov/media/116737/download
  • Dhanasekaran R, Kwo PY. The liver in oncology. Clin Liver Dis. 2017;21(4):697–707. doi: 10.1016/j.cld.2017.06.003
  • Vincenzi B, Armento G, Spalato Ceruso M, et al. Drug-induced hepatotoxicity in cancer patients - implication for treatment. Expert Opin Drug Saf. 2016;15(9):1219–1238. doi: 10.1080/14740338.2016.1194824
  • Allison KH, Fligner CL, Parks WT. Radiographically occult, diffuse intrasinusoidal hepatic metastases from primary breast carcinomas: a clinicopathologic study of 3 autopsy cases. Arch Pathol Lab Med. 2004;128(12):1418–1423. doi: 10.5858/2004-128-1418-RODIHM
  • Diamond JR, Finlayson CA, Borges VF. Hepatic complications of breast cancer. Lancet Oncol. 2009;10(6):615–621. doi: 10.1016/S1470-2045(09)70029-4
  • Hampel PJ, Chaffee KG, King RL, et al. Liver dysfunction in chronic lymphocytic leukemia: prevalence, outcomes, and pathological findings. Am J Hematol. 2017;92(12):1362–1369. doi: 10.1002/ajh.24915
  • Kullak-Ublick GA, Merz M, Griffel L, et al. Liver safety assessment in special populations (hepatitis B, C, and oncology trials). Drug Saf. 2014;37 Suppl 1(S1):S57–S62. doi: 10.1007/s40264-014-0186-3
  • Lee KW, Chan SL. Hepatotoxicity of targeted therapy for cancer. Expert Opin Drug Metab Toxicol. 2016;12(7):789–802. doi: 10.1080/17425255.2016.1190831
  • Lopez JB, Balasegaram M, Thambyrajah V, et al. The value of liver function tests in hepatocellular carcinoma. Malays J Pathol. 1996;18(2):95–99.
  • Meunier L, Larrey D. Chemotherapy-associated steatohepatitis. Ann Hepatol. 2020;19(6):597–601. doi: 10.1016/j.aohep.2019.11.012
  • Prowell TM, Theoret MR, Pazdur R. Seamless oncology-drug development. N Engl J Med. 2016;374(21):2001–2003. doi: 10.1056/NEJMp1603747
  • Shantakumar S, Landis S, Lawton A, et al. Prevalence and incidence of liver enzyme elevations in a pooled oncology clinical trial cohort. Regul Toxicol Pharmacol. 2016;77:257–262. doi: 10.1016/j.yrtph.2016.03.019
  • Ulcickas Yood M, Bortolini M, Casso D, et al. Incidence of liver injury among cancer patients receiving chemotherapy in an integrated health system. Pharmacoepidemiol Drug Saf. 2015;24(4):427–434. doi: 10.1002/pds.3757
  • Regev A, Avigan MI, Kiazand A, et al. Best practices for detection, assessment and management of suspected immune-mediated liver injury caused by immune checkpoint inhibitors during drug development. J Autoimmun. 2020;114:102514. doi: 10.1016/j.jaut.2020.102514
  • Council for international organizations of medical sciences (CIOMS), CIOMS working group on drug-induced liver injury (DILI): consensus report. Geneva; 2020 [cited 2022 Jun 28]. Available from: https://cioms.ch/publications/product/drug-induced-liver-injury/
  • Ricart AD. Drug-induced liver injury in oncology. Ann Oncol. 2017;28(8):2013–2020. doi: 10.1093/annonc/mdx158
  • Kaplowitz N. Drug-induced liver injury. Clin Infect Dis. 2004;38 Suppl 2(Supplement_2):S44–8. doi: 10.1086/381446
  • Aithal GP, Watkins PB, Andrade RJ, et al. Case definition and phenotype standardization in drug-induced liver injury. Clin Pharmacol Ther. 2011;89(6):806–815. doi: 10.1038/clpt.2011.58
  • Green RM, Flamm S. AGA technical review on the evaluation of liver chemistry tests. Gastroenterology. 2002;123(4):1367–1384. doi: 10.1053/gast.2002.36061
  • National Cancer Institute, Division of Cancer Treatment and Diagnosis. Common terminology criteria for adverse events (CTCAE). [cited 2022 Jul 12]. Available from: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm
  • Chalasani N, Regev A. Drug-induced liver injury in patients with preexisting chronic liver disease in drug development: how to identify and manage? Gastroenterology. 2016;151(6):1046–1051. doi: 10.1053/j.gastro.2016.10.010
  • Regev A, Palmer M, Avigan MI, et al. Consensus: guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury during clinical trials in patients with nonalcoholic steatohepatitis. Aliment Pharmacol Ther. 2019;49(6):702–713. doi: 10.1111/apt.15153
  • Palmer M, Regev A, Lindor K, et al. Consensus guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury occurring during clinical trials in adults with chronic cholestatic liver disease. Aliment Pharmacol Ther. 2020;51(1):90–109. doi: 10.1111/apt.15579
  • Treem WR, Palmer M, Lonjon-Domanec I et al. Consensus guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury during clinical trials in adults with chronic viral hepatitis and adults with cirrhosis secondary to hepatitis B, C and Nonalcoholic Steatohepatitis. Drug Saf. 2020;44:133–165
  • Benes M. A possible use of the cubit rod in ancient Egypt to measure and draw lengths based on fractions. J Math Sci Adv Appl. 2021;67(1):85–93. doi: 10.18642/jmsaa_7100122234
  • Dilling FS, Stricker I. Comparison: light rays and the intercept theorem in mathematics and physics education, In: Dilling FK, editor. Comparison of Mathematics and Physics Education II. MINTUS – Beiträge zur mathematisch-naturwissenschaftlichen Bildung. Wiesbaden:Springer Spektrum; 2022. p. 307–329.
  • Zhou B, Sun C, Ahn D, et al. A novel passive tracking scheme exploiting geometric and intercept theorems. Sens (Basel). 2018;18(3). doi: 10.3390/s18030895
  • French D. The intercept theorem. In: French D, editor. Teaching and learning geometry. London (NY):Continuum International Publishing Group; 2004. p. 84–87.
  • Seitz HK, Bataller R, Cortez-Pinto H, et al. Alcoholic liver disease. Nat Rev Dis Primers. 2018;4(1):16. doi: 10.1038/s41572-018-0014-7
  • Liu R, Pan X, Whitington PF. Increased hepatic expression is a major determinant of serum alanine aminotransferase elevation in mice with nonalcoholic steatohepatitis. Liver Int. 2009;29(3):337–343. doi: 10.1111/j.1478-3231.2008.01862.x
  • Qian K, Zhong S, Xie K, et al. Hepatic ALT isoenzymes are elevated in gluconeogenic conditions including diabetes and suppressed by insulin at the protein level. Diabetes Metab Res Rev. 2015;31(6):562–571. doi: 10.1002/dmrr.2655

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