Clinical Significance of Transient Asymptomatic Elevations in Aminotransferase (TAEAT) in Oncology.
Journal
American journal of clinical oncology
ISSN: 1537-453X
Titre abrégé: Am J Clin Oncol
Pays: United States
ID NLM: 8207754
Informations de publication
Date de publication:
01 08 2022
01 08 2022
Historique:
pubmed:
19
7
2022
medline:
28
7
2022
entrez:
18
7
2022
Statut:
ppublish
Résumé
Monitoring for liver injury remains an important aspect of drug safety assessment, including for oncotherapeutics. When present, drug-induced liver injury may limit the use or result in the discontinuation of these agents. Drug-induced liver injury can exhibit with a wide spectrum of clinical and biochemical manifestations, ranging from transient asymptomatic elevations in aminotransferases (TAEAT) to acute liver failure. Numerous oncotherapeutics have been associated with TAEAT, with published reports indicating a phenomenon in which patients may be asymptomatic without overt liver injury despite the presence of grade ≥3 aminotransferase elevations. In this review, we discuss the occurrence of TAEAT in the context of oncology clinical trials and clinical practice, as well as the clinical relevance of this phenomenon as an adverse event in response to oncotherapeutics and the related cellular and molecular mechanisms that may underlie its occurrence. We also identify several gaps in knowledge relevant to the diagnosis and the management of TAEAT in patients receiving oncotherapeutics, and identify areas warranting further study to enable the future development of consensus guidelines to support clinical decision-making.
Identifiants
pubmed: 35848749
doi: 10.1097/COC.0000000000000932
pii: 00000421-202208000-00005
pmc: PMC9311471
doi:
Substances chimiques
Aspartate Aminotransferases
EC 2.6.1.1
Alanine Transaminase
EC 2.6.1.2
Types de publication
Journal Article
Review
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
352-365Informations de copyright
Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.
Déclaration de conflit d'intérêts
J.H.L. has no known competing financial interests or personal relationships, that could have appeared to influence the work reported in this paper. S.K.K. and C.D.B. are employed by and own stock in Amgen Inc. A.H.W. has served on advisory boards for Novartis, Janssen, Amgen, Roche, Pfizer, AbbVie, Servier, Celgene-BMS, Macrogenics, Agios, and Gilead; received research funding to his institution from Novartis, AbbVie, Servier, Celgene-BMS, Astra Zeneca, and Amgen; served on the speakers’ bureau for AbbVie, Novartis, and Celgene. M.S. served in a consulting or advisory role for Amgen, Celgene, Gilead Sciences, Janssen, Novartis, Pfizer, and Seattle Genetics; served on the speakers’ bureau for Amgen, Celgene, Gilead Sciences, Janssen, Novartis, and Pfizer; received travel, accommodations, and expenses from Amgen, Celgene, and Gilead Sciences; received research funding from Amgen, Celgene, Gilead Sciences, Miltenyi Biotec, MorphoSys, Novartis, and Seattle Genetics. The other authors declare no conflicts of interest.
Références
Zimmerman HJ. Hepatotoxicity: The Adverse Effects of Drugs and Other Chemicals on the Liver. Philadelphia, PA: Lippincott Williams & Wilkins; 1999.
Björnsson ES. Drug-induced liver injury: an overview over the most critical compounds. Arch Toxicol . 2015;89:327–334.
National Institute of Diabetes and Digestive and Kidney Diseases. LiverTox: clinical and research information on drug-induced liver injury. Available at: https://www.ncbi.nlm.nih.gov/books/NBK548776/ . Accessed January 19, 2021.
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;147:96–108.e4.
Medina-Caliz I, Robles-Diaz M, Garcia-Muñoz B, et al. Definition and risk factors for chronicity following acute idiosyncratic drug-induced liver injury. J Hepatol. 2016;65:532–542.
Lewis JH. Drug-induced liver injury throughout the drug development life cycle: where we have been, where we are now, and where we are headed. Perspectives of a clinical hepatologist. Pharm Med . 2013;27:165–191.
Aithal GP, Watkins PB, Andrade RJ, et al. Case definition and phenotype standardization in drug-induced liver injury. Clin Pharmacol Ther. 2011;89:806–815.
Kullak-Ublick GA, Andrade RJ, Merz M, et al. Drug-induced liver injury: recent advances in diagnosis and risk assessment. Gut. 2017;66:1154–1164.
Oh RC, Hustead TR, Ali SM, et al. Mildly elevated liver transaminase levels: causes and evaluation. Am Fam Physician. 2017;96:709–715.
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:S57–S62.
US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0; 2017.
Hoofnagle JH, Bjornsson ES. Drug-induced liver injury - types and phenotypes. N Engl J Med. 2019;381:264–273.
Watkins PB, Zimmerman HJ, Knapp MJ, et al. Hepatotoxic effects of tacrine administration in patients with Alzheimer’s disease. JAMA. 1994;271:992–998.
Marx G, Taylor J, Goldstein D. Outpatient treatment with subcutaneous interleukin-2, interferon alpha and fluorouracil in patients with metastatic renal cancer: an Australian experience. Intern Med J. 2005;35:34–38.
King AC, Pappacena JJ, Tallman MS, et al. Blinatumomab administered concurrently with oral tyrosine kinase inhibitor therapy is a well-tolerated consolidation strategy and eradicates measurable residual disease in adults with Philadelphia chromosome positive acute lymphoblastic leukemia. Leuk Res. 2019;79:27–33.
Brahmer JR, Lacchetti C, Schneider BJ, et al. Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2018;36:1714–1768.
Lee WM. Acute liver failure. Semin Respir Crit Care Med. 2012;33:36–45.
US Food and Drug Administration. Guidance for Industry Drug-induced Liver Injury: Premarketing Clinical Evaluation. Silver Spring, MD: US Department of Health and Human Services; 2009.
Temple R. Hy’s law: predicting serious hepatotoxicity. Pharmacoepidemiol Drug Saf. 2006;15:241–243.
Kwo PY, Cohen SM, Lim JK. ACG clinical guideline: evaluation of abnormal liver chemistries. Am J Gastroenterol. 2017;112:18–35.
Chung JY, Longo DM, Watkins PB. A rapid method to estimate hepatocyte loss due to drug-induced liver injury. Clin Pharmacol Ther. 2019;105:746–753.
Stephens C, Robles-Diaz M, Medina-Caliz I, et al. Comprehensive analysis and insights gained from long-term experience of the Spanish DILI Registry. J Hepatol. 2021;75:86–97.
Lewis JH. ‘Hy’s law,’ the ‘Rezulin Rule,’ and other predictors of severe drug-induced hepatotoxicity: puting risk-benefit into perspective. Pharmacoepidemiol Drug Saf. 2006;15:221–229.
Retevmo (selpercatinib). Full Prescribing Information. Indianapolis. IN: Eli Lilly; 2020.
Tabrecta (capmatinib). Full Prescribing Information. East Hanover, NJ: Novartis; 2020.
Tukysa (tucatinib). Full Prescribing Information. Bothell, WA: Seattle Genetics; 2020.
Rozlytrek (entrectinib). Full Prescribing Information. South San Francisco, CA: Genentech; 2019.
Turalio (pexidartinib). Full Prescribing Information. Basking Ridge, NJ: Daiichi Sankyo; 2019.
Polivy (polatuzumab vedotin-piiq). Full Prescribing Information. South San Francisco, CA: Genentech; 2019.
Elzonris (tagraxofusp-erzs). Full Prescribing Information. New York, NY: Stemline Therapeutics; 2018.
Asparlas (calaspargase pegol-mknl). Full Prescribing Information. Boston, MA: Servier Pharmaceuticals; 2018.
Vitrakvi (larotrectinib). Full Prescribing Information. Stamford, CT: Loxo Oncology; 2018.
Copiktra (duvelisib). Full Prescribing Information. Needham, MA: Verastem; 2018.
Mektovi (binimetinib). Full Prescribing Information. Boulder, CO: Array BioPharma; 2018.
Sackstein PE, O’Neil DS, Neugut AI, et al. Epidemiologic trends in neuroendocrine tumors: an examination of incidence rates and survival of specific patient subgroups over the past 20 years. Semin Oncol. 2018;45:249–258.
Libtayo (cemiplimab-rwlc). Full Prescribing Information. Tarrytown, NY: Regeneron Pharmaceuticals; 2018.
Clinton JW, Kiparizoska S, Aggarwal S, et al. Drug-induced liver injury: highlights and controversies in the recent literature. Drug Safety. 2021;44:1125–1149.
Wang E, Song F, Paulus JK, et al. Qualitative and quantitative variations in liver function thresholds among clinical trials in cancer: a need for harmonization. Cancer Chemother Pharmacol. 2019;84:213–216.
Desjardin M, Bonhomme B, Le Bail B, et al. Hepatotoxicities induced by neoadjuvant chemotherapy in colorectal cancer liver metastases: distinguishing the true from the false. Clin Med Insights Oncol. 2019;13:1179554918825450.
De Martin E, Michot JM, Rosmorduc O, et al. Liver toxicity as a limiting factor to the increasing use of immune checkpoint inhibitors. JHEP Rep. 2020;2:100170.
Blenrep (belantamab mafodotin-blmf). Full Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline; 2020.
INQOVI (decitabine and cedazuridine). Full Prescribing Information. Japan: Otsuka Pharmaceutical Co., Ltd.; 2020.
Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf). Full Prescribing Information. South San Francisco, CA: Genentech; 2020.
Tazverik (tazemetostat). Full Prescribing Information. Cambridge, MA: Epizyme; 2020.
Zepzelca (lurbinectedin). Full Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals; 2020.
Qinlock (ripretinib). Full Prescribing Information . Waltham, MA: Deciphera Pharmaceuticals; 2020.
Trodelvy (sacituzumab govitecan-hziy). Full Prescribing Information . Morris Plains, NJ: Immunomedics; 2020.
Pemazyre (pemigatinib). Full Prescribing Information. Wilmington, DE: Incyte; 2020.
Koselugo (selumetinib). Full Prescribing Information. Wilmington, DE: AstraZeneca; 2020.
Ayvakit (avapritinib). Full Prescribing Information. Cambridge, MA: Blueprint Medicines; 2020.
Monjuvi (tafasitamab-cxix). Full Prescribing Information. Boston, MA: Morphosys US; 2020.
Tecartus (brexucabtagene autoleucel). Full Prescribing Information. Santa Monica, CA: Kite Pharma; 2020.
Enhertu (fam-trastuzumab deruxtecan-nxki). Full Prescribing Information. Basking Ridge, NJ: Daiichi Sankyo; 2019.
Brukinsa (zanubrutinib). Full Prescribing Information. San Mateo, CA: BeiGene USA; 2019.
Nubeqa (darolutamide). Full Prescribing Information. Whippany, NJ: Bayer HealthCare Pharmaceuticals; 2019.
Piqray (alpelisib). Full Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals; 2019.
Tibsovo (ivosidenib tablets). Full Prescribing Information. Cambridge, MA: Agios Pharmaceuticals; 2018.
Balversa (erdafitinib). Full Prescribing Information. Horsham, PA: Janssen Products; 2020.
Herceptin Hylecta (trastuzumab and hyaluronidase-oysk). Full Prescribing Information. South San Francisco, CA: Genentech; 2019.
Xospata (gilteritinib). Full Prescribing Information. Northbrook, IL: Astellas Pharma; 2018.
Daurismo (glasdegib). Full Prescribing Information. New York, NY: Pfizer Labs; 2018.
Lorbrena (lorlatinib). Full Prescribing Information. New York, NY: Pfizer Labs; 2018.
Talzenna (talazoparib). Full Prescribing Information. New York, NY: Pfizer Labs; 2018.
Vizimpro (dacomitinib). Full Prescribing Information. New York, NY: Pfizer Labs; 2018.
Azedra (iobenguane I 131). Full Prescribing Information. New York, NY: Progenics Pharmaceuticals; 2018.
Braftovi (encorafenib). Full Prescribing Information. Boulder, CO: Array BioPharma; 2018.
Lumoxiti (moxetumomab pasudotox-tdfk). Full Prescribing Information. Wilmington, DE: AstraZeneca; 2018.
Marshall HT, Djamgoz MBA. Immuno-oncology: emerging targets and combination therapies. Front Oncol. 2018;8:315.
Einsele H, Borghaei H, Orlowski RZ, et al. The BiTE (bispecific T-cell engager) platform: development and future potential of a targeted immuno-oncology therapy across tumor types. Cancer. 2020;126:3192–3201.
Esfahani K, Roudaia L, Buhlaiga N, et al. A review of cancer immunotherapy: from the past, to the present, to the future. Curr Oncol. 2020;27:S87–S97.
Jennings JJ, Mandaliya R, Nakshabandi A, et al. Hepatotoxicity induced by immune checkpoint inhibitors: a comprehensive review including current and alternative management strategies. Expert Opin Drug Metab Toxicol. 2019;15:231–244.
Johncilla M, Misdraji J, Pratt DS, et al. Ipilimumab-associated hepatitis: clinicopathologic characterization in a series of 11 cases. Am J Surg Pathol. 2015;39:1075–1084.
Kim KW, Ramaiya NH, Krajewski KM, et al. Ipilimumab associated hepatitis: imaging and clinicopathologic findings. Invest New Drugs. 2013;31:1071–1077.
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.
O’Day SJ, Maio M, Chiarion-Sileni V, et al. Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study. Ann Oncol. 2010;21:1712–1717.
Padcev (enfortumab vedotin-ejfv). Full Prescribing Information. Bothell, WA: Seattle Genetics; 2019.
Erleada (apalutamide). Full Prescribing Information. Horsham, PA: Janssen Products; 2018.
Xpovio (selinexor). Full Prescribing Information. Newton, MA: Karyopharm Therapeutics; 2019.
Darzalex (daratumumab). Full Prescribing Information. Horsham, PA: Janssen Biotech; 2016.
Sarclisa (isatuximab-irfc). Full Prescribing Information. Bridgewater, NJ: Sanofi-Aventis US; 2020.
Poteligeo (mogamulizumab-kpkc). Full Prescribing Information. Bedminster, NJ: Kyowa Kirin; 2018.
LoRusso PM, Boerner SA, Seymour L. An overview of the optimal planning, design, and conduct of phase I studies of new therapeutics. Clin Cancer Res. 2010;16:1710–1718.
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;49:702–713.
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;51:90–109.
Kim C, Zhu S, Kouros-Mehr H, et al. Incidence of elevated aminotransferase with or without bilirubin elevation during treatment with immune checkpoint inhibitors: a retrospective study of patients from community oncology clinics in the United States. Cureus. 2022;14:e24053.
Soni S, Abdel-Azim H, McManus M, et al. Phase I study of clofarabine and 2-Gy total body irradiation as a nonmyeloablative preparative regimen for hematopoietic stem cell transplantation in pediatric patients with hematologic malignancies: a therapeutic advances in childhood leukemia consortium study. Biol Blood Marrow Transplant. 2017;23:1134–1141.
Mathiesen UL, Franzen LE, Fryden A, et al. The clinical significance of slightly to moderately increased liver transaminase values in asymptomatic patients. Scand J Gastroenterol. 1999;34:85–91.
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;151:1046–1051.
Adamson PC, Zimm S, Ragab AH, et al. A phase II trial of continuous-infusion 6-mercaptopurine for childhood solid tumors. Cancer Chemother Pharmacol. 1990;26:343–344.
Aviles A, Herrera J, Ramos E, et al. Hepatic injury during doxorubicin therapy. Arch Pathol Lab Med. 1984;108:912–913.
Paciucci PA, Sklarin NT. Mitoxantrone and hepatic toxicity. Ann Intern Med. 1986;105:805–806.
Pollera CF, Ameglio F, Nardi M, et al. Cisplatin-induced hepatic toxicity. J Clin Oncol. 1987;5:318–319.
Le Tourneau C, Lee JJ, Siu LL. Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009;101:708–20.
Shah RR, Morganroth J, Shah DR. Hepatotoxicity of tyrosine kinase inhibitors: clinical and regulatory perspectives. Drug Saf. 2013;36:491–503.
Regev A, Seeff LB, Merz M, et al. Causality assessment for suspected DILI during clinical phases of drug development. Drug Saf. 2014;37:S47–S56.
Danan G, Teschke R. Roussel Uclaf Causality Assessment Method for drug-induced liver injury: present and future. Front Pharmacol. 2019;10:853.
Chalasani N, Bonkovsky HL, Fontana R, et al. Features and outcomes of 899 patients with drug-induced liver injury: the DILIN prospective study. Gastroenterology. 2015;148:1340–1352.e7.
Schreve RH, Terpstra OT, Ausema L, et al. Detection of liver metastases. A prospective study comparing liver enzymes, scintigraphy, ultrasonography and computed tomography. Br J Surg. 1984;71:947–949.
Bonfanti G, Bombelli L, Bozzetti F, et al. The role of CEA and liver function tests in the detection of hepatic metastases from colo-rectal cancer. HPB Surg . 1990;3:29–36.
Kamath PS. Clinical approach to the patient with abnormal liver test results. Mayo Clin Proc. 1996;71:1089–1094.
Barlow A, Prusak ES, Barlow B, et al. Interventions to reduce polypharmacy and optimize medication use in older adults with cancer. J Geriatr Oncol. 2021;12:863–871.
Qato DM, Alexander GC, Conti RM, et al. Use of prescription and over-the-counter medications and dietary supplements among older adults in the United States. JAMA. 2008;300:2867–2878.
Benitez LL, Carver PL. Adverse effects associated with long-term administration of azole antifungal agents. Drugs. 2019;79:833–853.
Van Laethem JL, De Broux S, Eisendrath P, et al. Clinical impact of biliary drainage and jaundice resolution in patients with obstructive metastases at the hilum. Am J Gastroenterol. 2003;98:1271–1277.
Segal I, Rassekh SR, Bond MC, et al. Abnormal liver transaminases and conjugated hyperbilirubinemia at presentation of acute lymphoblastic leukemia. Pediatr Blood Cancer. 2010;55:434–439.
Lu TX, Wu S, Cai DY, et al. Prognostic significance of serum aspartic transaminase in diffuse large B-cell lymphoma. BMC Cancer. 2019;19:553.
Singh MM, Pockros PJ. Hematologic and oncologic diseases and the liver. Clin Liver Dis. 2011;15:69–87.
Lewis JH, Cottu PH, Lehr M, et al. Onapristone extended release: safety evaluation from phase I-II studies with an emphasis on hepatotoxicity. Drug Saf. 2020;43:1045–1055.
Cao R, Wang LP. Serological diagnosis of liver metastasis in patients with breast cancer. Cancer Biol Med. 2012;9:57–62.
Wu XZ, Ma F, Wang XL. Serological diagnostic factors for liver metastasis in patients with colorectal cancer. World J Gastroenterol. 2010;16:4084–4088.
Cotogno PM, Ranasinghe LK, Ledet EM, et al. Laboratory-based biomarkers and liver metastases in metastatic castration-resistant prostate cancer. Oncologist. 2018;23:791–797.
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.
Mondaca SP, Liu D, Flynn JR, et al. Clinical implications of drug-induced liver injury in early-phase oncology clinical trials. Cancer. 2020;126:4967–4974.
McGill MR. The past and present of serum aminotransferases and the future of liver injury biomarkers. EXCLI Journal. 2016;15:817–828.
Kebenko M, Goebeler ME, Wolf M, et al. A multicenter phase 1 study of solitomab (MT110, AMG 110), a bispecific EpCAM/CD3 T-cell engager (BiTE(R)) antibody construct, in patients with refractory solid tumors. Oncoimmunology. 2018;7:e1450710.
Dara L, Liu ZX, Kaplowitz N. Mechanisms of adaptation and progression in idiosyncratic drug induced liver injury, clinical implications. Liver Int. 2016;36:158–165.
Jee A, Sernoskie SC, Uetrecht J. Idiosyncratic drug-induced liver injury: mechanistic and clinical challenges. Int J Mol Sci. 2021;22:2954.
Gerber MA, Thung SN. Histology of the liver. Am J Surg Pathol. 1987;11:709–722.
Schiff ER, Maddrey WC, Reddy KR. Schiff’s Diseases of the Liver. Chichester, West Sussex, UK: John Wiley & Sons; 2017.
Racanelli V, Rehermann B. The liver as an immunological organ. Hepatology. 2006;43:S54–S62.
Park S, Murray D, John B, et al. Biology and significance of T-cell apoptosis in the liver. Immunol Cell Biol. 2002;80:74–83.
Russell JQ, Morrissette GJ, Weidner M, et al. Liver damage preferentially results from CD8(+) T cells triggered by high affinity peptide antigens. J Exp Med. 1998;188:1147–1157.
Bowen DG, Warren A, Davis T, et al. Cytokine-dependent bystander hepatitis due to intrahepatic murine CD8 T-cell activation by bone marrow-derived cells. Gastroenterology. 2002;123:1252–1264.
Dunn C, Brunetto M, Reynolds G, et al. Cytokines induced during chronic hepatitis B virus infection promote a pathway for NK cell-mediated liver damage. J Exp Med. 2007;204:667–680.
Zhang Z, Zhang S, Zou Z, et al. Hypercytolytic activity of hepatic natural killer cells correlates with liver injury in chronic hepatitis B patients. Hepatology. 2011;53:73–85.
Oliviero B, Varchetta S, Paudice E, et al. Natural killer cell functional dichotomy in chronic hepatitis B and chronic hepatitis C virus infections. Gastroenterology. 2009;137:1151–1160.
Winwood PJ, Arthur MJ. Kupffer cells: their activation and role in animal models of liver injury and human liver disease. Semin Liver Dis. 1993;13:50–59.
Hogue MJ. The effect of hypotonic and hypertonic solutions on fibroblasts of the embryonic chick heart in vitro. J Exp Med. 1919;30:617–648.
Jansen C, Tobita C, Umemoto EU, et al. Calcium-dependent, non-apoptotic, large plasma membrane bleb formation in physiologically stimulated mast cells and basophils. J Extracell Vesicles. 2019;8:1578589.
Gores GJ, Herman B, Lemasters JJ. Plasma membrane bleb formation and rupture: a common feature of hepatocellular injury. Hepatology. 1990;11:690–698.
Aboelsoud MM, Javaid AI, Al-Qadi MO, et al. Hypoxic hepatitis—its biochemical profile, causes and risk factors of mortality in critically-ill patients: a cohort study of 565 patients. J Crit Care. 2017;41:9–15.
Birrer R, Takuda Y, Takara T. Hypoxic hepatopathy: pathophysiology and prognosis. Intern Med. 2007;46:1063–1070.
Shimabukuro-Vornhagen A, Godel P, Subklewe M, et al. Cytokine release syndrome. J Immunother Cancer. 2018;6:56.
Winkler U, Jensen M, Manzke O, et al. Cytokine-release syndrome in patients with B-cell chronic lymphocytic leukemia and high lymphocyte counts after treatment with an anti-CD20 monoclonal antibody (rituximab, IDEC-C2B8). Blood. 1999;94:2217–2224.
Freeman CL, Morschhauser F, Sehn L, et al. Cytokine release in patients with CLL treated with obinutuzumab and possible relationship with infusion-related reactions. Blood. 2015;126:2646–2649.
Silver J, Garcia-Neuer M, Lynch DM, et al. Endophenotyping oxaliplatin hypersensitivity: personalizing desensitization to the atypical platin. J Allergy Clin Immunol Pract. 2020;8:1668–1680.e2.
Nakamura N, Kanemura N, Shibata Y, et al. Lenalidomide-induced cytokine release syndrome in a patient with multiple myeloma. Leuk Lymphoma. 2014;55:1691–1693.
Badar T, Szabo A, Advani A, et al. Real-world outcomes of adult B-cell acute lymphocytic leukemia patients treated with blinatumomab. Blood Adv. 2020;4:2308–2316.
Brudno JN, Kochenderfer JN. Toxicities of chimeric antigen receptor T cells: recognition and management. Blood. 2016;127:3321–3330.
Weemhoff JL, Woolbright BL, Jenkins RE, et al. Plasma biomarkers to study mechanisms of liver injury in patients with hypoxic hepatitis. Liver Int. 2017;37:377–384.
Edgar AD, Tomkiewicz C, Costet P, et al. Fenofibrate modifies transaminase gene expression via a peroxisome proliferator activated receptor alpha-dependent pathway. Toxicol Lett. 1998;98:13–23.
Thulin P, Rafter I, Stockling K, et al. PPARalpha regulates the hepatotoxic biomarker alanine aminotransferase (ALT1) gene expression in human hepatocytes. Toxicol Appl Pharmacol. 2008;231:1–9.
Kantarjian H, Stein A, Gokbuget N, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017;376:836–847.
Josekutty J, Iqbal J, Iwawaki T, et al. Microsomal triglyceride transfer protein inhibition induces endoplasmic reticulum stress and increases gene transcription via Ire1alpha/cJun to enhance plasma ALT/AST. J Biol Chem. 2013;288:14372–14383.
Thulin P, Bamberg K, Buler M, et al. The peroxisome proliferator-activated receptor alpha agonist, AZD4619, induces alanine aminotransferase-1 gene and protein expression in human, but not in rat hepatocytes: correlation with serum ALT levels. Int J Mol Med. 2016;38:961–968.
Lewis JH, Jadoul M, Block GA, et al. Effects of bardoxolone methyl on hepatic enzymes in patients with type 2 diabetes mellitus and stage 4 CKD. Clin Transl Sci. 2021;14:299–309.
Ecker DM, Jones SD, Levine HL. The therapeutic monoclonal antibody market. MAbs. 2015;7:9–14.
Bakema JE, van Egmond M. Fc receptor-dependent mechanisms of monoclonal antibody therapy of cancer. Curr Top Microbiol Immunol. 2014;382:373–392.
Muro H, Shirasawa H, Maeda M, et al. Fc receptors of liver sinusoidal endothelium in normal rats and humans. A histologic study with soluble immune complexes. Gastroenterology. 1987;93:1078–1085.
Perussia B. Fc receptors on natural killer cells. Curr Top Microbiol Immunol. 1998;230:63–88.
Vogelpoel LT, Baeten DL, de Jong EC, et al. Control of cytokine production by human fc gamma receptors: implications for pathogen defense and autoimmunity. Front Immunol. 2015;6:79.
Galasso PJ, Litin SC, O’Brien JF. The macroenzymes: a clinical review. Mayo Clin Proc. 1993;68:349–354.
Lee M, Vajro P, Keeffe EB. Isolated aspartate aminotransferase elevation: think macro-AST. Dig Dis Sci. 2011;56:311–13.
Ono S, Kurata C, Nishimura N, et al. Importance of laboratory detection of macro-aspartate aminotransferase. Int J Gen Med. 2019;12:433–436.
Parks D, Lin X, Painter JL, et al. A proposed modification to Hy’s law and Edish criteria in oncology clinical trials using aggregated historical data. Pharmacoepidemiol Drug Saf. 2013;22:571–578.
Dufour DR, Lott JA, Nolte FS, et al. Diagnosis and monitoring of hepatic injury. I. Performance characteristics of laboratory tests. Clin Chem. 2000;46:2027–2049.
van der Lely AJ, Biller BM, Brue T, et al. Long-term safety of pegvisomant in patients with acromegaly: comprehensive review of 1288 subjects in ACROSTUDY. J Clin Endocrinol Metab. 2012;97:1589–1597.
Freda PU, Gordon MB, Kelepouris N, et al. Long-term treatment with pegvisomant as monotherapy in patients with acromegaly: experience from ACROSTUDY. Endocr Pract. 2015;21:264–274.
Costa-Moreira P, Gaspar R, Pereira P, et al. Role of liver biopsy in the era of clinical prediction scores for “drug-induced liver injury” (DILI): experience of a tertiary referral hospital. Virchows Arch. 2020;477:517–525.
European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Drug-induced liver injury. J Hepatol. 2019;70:1222–1261.
Ettel MG, Appelman HD. Approach to the liver biopsy in the patient with chronic low-level aminotransferase elevations. Arch Pathol Lab Med. 2018;142:1186–1190.
Roth SE, Avigan MI, Bourdet D, et al. Next-generation DILI biomarkers: prioritization of biomarkers for qualification and best practices for biospecimen collection in drug development. Clin Pharmacol Ther. 2020;107:333–346.
Hunt CM, Papay JI, Stanulovic V, et al. Drug rechallenge following drug-induced liver injury. Hepatology. 2017;66:646–654.
Watanabe H, Kubo T, Ninomiya K, et al. The effect and safety of immune checkpoint inhibitor rechallenge in non-small cell lung cancer. Jpn J Clin Oncol. 2019;49:762–765.
Kitagawa S, Hakozaki T, Kitadai R, et al. Switching administration of anti-PD-1 and anti-PD-L1 antibodies as immune checkpoint inhibitor rechallenge in individuals with advanced non-small cell lung cancer: case series and literature review. Thorac Cancer. 2020;11:1927–1933.
Gobbini E, Charles J, Toffart AC, et al. Current opinions in immune checkpoint inhibitors rechallenge in solid cancers. Crit Rev Oncol Hematol. 2019;144:102816.
Dolladille C, Ederhy S, Sassier M, et al. Immune checkpoint inhibitor rechallenge after immune-related adverse events in patients with cancer. JAMA Oncol. 2020;6:865–871.
Miller ED, Abu-Sbeih H, Styskel B, et al. Clinical characteristics and adverse impact of hepatotoxicity due to immune checkpoint inhibitors. Am J Gastroenterol. 2020;115:251–261.
Patrinely JR Jr, McGuigan B, Chandra S, et al. A multicenter characterization of hepatitis associated with immune checkpoint inhibitors. Oncoimmunology. 2021;10:1875639.
Li M, Sack JS, Rahma OE, et al. Outcomes after resumption of immune checkpoint inhibitor therapy after high-grade immune-mediated hepatitis. Cancer. 2020;126:5088–5097.