Increased Hepatotoxicity Associated with Sequential Immune Checkpoint Inhibitor and Crizotinib Therapy in Patients with Non–Small Cell Lung Cancer

Lin, Jessica J.; Chin, Emily; Yeap, Beow Y.; Ferris, Lorin A.; Kamesan, Vashine; Lennes, Inga T.; Sequist, Lecia V.; Heist, Rebecca S.; Mino-Kenudson, Mari; Gainor, Justin F.; Shaw, Alice T.

doi:10.1016/j.jtho.2018.09.001

Cited by 140Lung Cancer Treatments and MutationsCancer Immunotherapy and BiomarkersDrug-Induced Hepatotoxicity and Protection

Increased Hepatotoxicity Associated with Sequential Immune Checkpoint Inhibitor and Crizotinib Therapy in Patients with Non–Small Cell Lung Cancer

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Lin, Jessica J., Chin, Emily, Yeap, Beow Y., Ferris, Lorin A., Kamesan, Vashine, Lennes, Inga T., Sequist, Lecia V., Heist, Rebecca S. +3 more·2019·Journal of Thoracic Oncology

DOI 10.1016/j.jtho.2018.09.001PMC PMC6309637

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Abstract

Introduction Immune checkpoint inhibitors (ICIs) are standard therapies in advanced NSCLC. Although genotype-directed tyrosine kinase inhibitors represent the standard of care for subsets of oncogene-driven NSCLC, patients may receive ICIs during their disease course. The impact of sequential ICI and tyrosine kinase inhibitor therapy on the risk of hepatotoxicity has not been described.Methods Patients with advanced ALK receptor tyrosine kinase (ALK)-driven, ROS1-driven, or MET proto-oncogene, receptor tyrosine kinase (MET)-driven NSCLC treated with crizotinib, with or without preceding ICI therapy, were identified. The cumulative incidences of crizotinib-associated grade 3 or higher increases in transaminase level (per the Common Terminology Criteria for Adverse Events, version 4.0) were compared.Results We identified 453 patients who had NSCLC with an oncogenic alteration in ALK receptor tyrosine kinase gene (ALK), ROS1, or MET proto-oncogene, receptor tyrosine kinase gene (MET) and were treated with crizotinib (11 with and 442 without prior ICI therapy). Among the 11 patients treated with an ICI followed by crizotinib, five (cumulative incidence 45.5% [95% confidence interval (CI): 14.9-72.2]) experienced development of a grade 3 or 4 increase in alanine transaminase level and four (cumulative incidence 36.4% [95% CI: 10.0-64.2]) experienced development of a grade 3 or 4 increase in aspartate transaminase level. In comparison, among the 442 patients who received crizotinib only, a grade 3 or 4 increase in alanine transaminase level occurred in 34 patients (cumulative incidence 8.1% [95% CI: 5.7-11.0, p < 0.0001]) and a grade 3 or 4 increase in aspartate transaminase level occurred in 14 (cumulative incidence 3.4% [95% CI: 1.9-5.5, p < 0.0001]). There were no grade 5 transaminitis events. All cases of hepatotoxicity after sequential ICI and crizotinib use were reversible and nonfatal, and no case met the Hy's law criteria.Conclusions Sequential ICI and crizotinib treatment is associated with a significantly increased risk of hepatotoxicity. Careful consideration and monitoring for hepatotoxicity may be warranted in patients treated with crizotinib after ICI therapy.

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The timing and sequence of combination therapy also influence treatment toxicity.
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Authors: Lin, J. J., Chin, E., Yeap, B. Y., Ferris, L. A., Kamesan, V., Lennes, I. T., Sequist, L. V., Heist, R. S., Mino-Kenudson, M., Gainor, J. F., & Shaw, A. T.
Affiliations: Massachusetts General Hospital (US)
Corresponding author: Shaw, Alice T.
ORCID: Lin, Jessica J.
Chin, Emily
Yeap, Beow Y.
Lennes, Inga T.
Sequist, Lecia V.
Heist, Rebecca S.
Mino-Kenudson, Mari
Gainor, Justin F.
Shaw, Alice T.
Venue: Journal of Thoracic Oncology
Publisher: Elsevier BV
Published: 2019-01
Volume: 14
Issue: 1
Pages: 135-140
ISSN: 1556-0864 (ISSN-L)
DOI: 10.1016/j.jtho.2018.09.001
PMC: PMC6309637
OpenAlex: W2890230728
Cited by: 140
References: 15
Citations by year: 2026: 12 · 2025: 18 · 2024: 24 · 2023: 24 · 2022: 16 · 2021: 15 · 2020: 24 · 2019: 5 · 2018: 2
FWCI: 8.66
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 365 d)
Locations: Journal of Thoracic Oncology (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: Massachusetts General Hospital
National Cancer Institute (R01CA164273)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
Keywords: immune checkpoint inhibitors, crizotinib, non-small cell lung cancer, anaplastic lymphoma kinase, ROS1, MET, tyrosine kinase inhibitors, sequential therapy, drug-drug interactions, transaminase elevation, liver injury, adverse drug reactions, immune-related adverse events, immune-related pneumonitis, immune-related colitis
MeSH terms: Crizotinib, Proto-Oncogene Mas, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Protein Kinase Inhibitors

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Increased Hepatotoxicity Associated with Sequential Immune Checkpoint Inhibitor and Crizotinib Therapy in Patients with Non–Small Cell Lung Cancer

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