Side Effects of ceritinib: A Synthesis of Findings from 19 Studies

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Original Abstract of the Article

Major research findings

Ceritinib is a new, oral, potent and selective second-generation anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with ALK-rearranged non-small cell lung cancer (NSCLC). 8 Ceritinib is active in crizotinib-resistant patients, especially in patients with NSCLC and brain metastasis. 8 Ceritinib is the first report on the use of ALK inhibitors in pediatric patients with ALK-rearranged NSCLC, and it achieved near complete response in an 11-year-old boy. 5 Ceritinib has also been reported to be effective in treating pediatric inflammatory myofibroblastic tumor (IMT). 12

Reason for side effects

Ceritinib is an ALK inhibitor and is used to inhibit the growth of certain cancer cells, such as ALK-rearranged NSCLC and IMT. 5 12 However, ceritinib can affect normal cells as well as cancer cells, which can cause side effects. 2

Common side effects

Diarrhea

Diarrhea is one of the most common side effects of ceritinib. 1 18 86% of patients in the ceritinib group experienced diarrhea. 18

Nausea

Nausea has also been reported as a side effect of ceritinib. 1 80% of patients in the ceritinib group experienced nausea. 18

Vomiting

Vomiting has also been reported as a side effect of ceritinib. 18 60% of patients in the ceritinib group experienced vomiting. 18

Liver function abnormalities

Ceritinib can affect the liver. 18 80% of patients in the ceritinib group experienced elevated ALT and 75% experienced elevated AST. 18

Hyperglycemia

Ceritinib can increase blood sugar levels. 18 49% of patients in the ceritinib group experienced hyperglycemia. 18 A case has been reported of hyperglycemic hyperosmolar state recurring after re-administration of dose-reduced ceritinib. 7

Lipid abnormalities

Ceritinib can affect lipid levels. 18 28% of patients in the ceritinib group experienced elevated lipase. 18

Lung toxicity

ALK inhibitors, including ceritinib, can cause lung toxicity. 14 Lung toxicity from ALK inhibitors can manifest as lung inflammation or interstitial lung disease. 14

Kidney side effects

ALK inhibitors, including ceritinib, can affect the kidneys. 6 Side effects include peripheral edema, rare electrolyte abnormalities, kidney failure, proteinuria, and an increased risk of developing and progressing renal cysts. 6

QT prolongation

Ceritinib can cause QT prolongation. 17 QT prolongation can cause abnormal heart rhythms. 17

Cardiac dysfunction

Ceritinib can cause cardiac dysfunction. 17

Other side effects

Ceritinib can cause a variety of other side effects besides those mentioned above. 18 The frequency of side effects varies depending on the patient. 18

Countermeasures for side effects

Diarrhea

Diarrhea can be treated with dietary changes or medication. 18

Nausea, vomiting

Nausea and vomiting can be treated with antiemetics. 18

Liver function abnormalities

Liver function abnormalities can be treated by stopping or reducing the dose of ceritinib. 18

Hyperglycemia

Hyperglycemia can be treated with dietary changes or insulin therapy. 7

Lung toxicity

Lung toxicity can be treated by stopping or reducing the dose of ceritinib. 14

Kidney side effects

Kidney side effects can be treated by stopping or reducing the dose of ceritinib. 6

QT prolongation

QT prolongation can be treated by regularly monitoring with an electrocardiogram. 13

Cardiac dysfunction

Cardiac dysfunction can be treated by regularly monitoring with cardiac tests. 17

Comparison between studies

Common points of studies

Multiple studies have shown that ceritinib is effective in patients with ALK-rearranged NSCLC. 5 18 Studies have also shown that ceritinib is effective in patients who are resistant to crizotinib. 8 Ceritinib can cause side effects such as diarrhea, nausea, vomiting, and liver function abnormalities. 18

Differences between studies

There may be differences in the efficacy and frequency of side effects of ceritinib between studies. 5 18 8 This is because the study designs and participant characteristics differ. 5 18 8

Points to note regarding application to real life

Ceritinib is a drug used to treat certain cancers, such as ALK-rearranged NSCLC and IMT. 5 12 It is important to take ceritinib as directed by your doctor because it can cause serious side effects. 18 13

Limitations of current research

There is still limited research on ceritinib. 5 18 8 In particular, there is a lack of research on the long-term efficacy and safety in pediatric patients and patients who are resistant to crizotinib. 5 8 Further research is also needed on the interactions of ceritinib with other drugs. 13

Future research directions

Research on the long-term efficacy and safety of ceritinib is needed, especially in pediatric patients and patients who are resistant to crizotinib. 5 8 Further research is also needed on the interactions of ceritinib with other drugs. 13

Conclusion

Ceritinib may be an effective treatment for patients with ALK-rearranged NSCLC. 5 18 However, it is important to take ceritinib as directed by your doctor because it can cause serious side effects. 18 13 Further research on ceritinib is needed. 5 18 8

Literature analysis of 19 papers
Positive Content
14
Neutral Content
2
Negative Content
3
Article Type
0
2
3
6
17
2.

The small-molecule kinase inhibitor ceritinib, unlike imatinib, causes a significant disturbance of lipid membrane integrity: A combined experimental and MD study.

Author: FischerMarkus, LuckMeike, WerleMax, VogelAlexander, BashawatMohammad, LudwigKai, ScheidtHolger A, MüllerPeter

Cancer treatment
Apoptosis
Cell lysis

This study investigated the interaction of ceritinib and imatinib, protein kinase inhibitors, with lipid membranes. Ceritinib was found to interact more strongly with membranes, potentially impacting its safety and efficacy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

3.

Dose Optimization in Oncology Drug Development: The Emerging Role of Pharmacogenomics, Pharmacokinetics, and Pharmacodynamics.

Author: PapachristosApostolos, PatelJai, VasileiouMaria, PatrinosGeorge P

Dose optimization

This review discusses the challenges of dose optimization in oncology, particularly with targeted therapies. The role of pharmacological tools like pharmacogenomics and pharmacodynamics in supporting dose optimization is explored.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

4.

Expert consensus of management of adverse drug reactions with anaplastic lymphoma kinase tyrosine kinase inhibitors.

Author: ZhouF, YangY, ZhangL, ChengY, HanB, LuY, WangC, WangZ, YangN, FanY, WangL, MaZ, YaoY, ZhaoJ, DongX, ZhuB, ZhouC

ALK inhibition
Improved survival for NSCLC patients
Adverse drug reactions

ALK rearrangements are found in about 3%-6% of patients with advanced non-small-cell lung cancer. ALK tyrosine kinase inhibitors (ALK-TKIs) are effective in treating these patients but can cause a range of side effects. This article summarizes the incidence, diagnosis, and treatment of adverse drug reactions (ADRs) caused by ALK-TKIs in China.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

6.

Anaplastic lymphoma kinase inhibitors and their effect on the kidney.

Author: BonillaMarco, JhaveriKenar D, IzzedineHassan

NSCLC treatment
Kidney failure
Peripheral edema
Renal cysts

This review provides an update on the kidney-related side effects of ALK inhibitors, such as crizotinib, ceritinib, and alectinib, used for treating non-small-cell lung cancer (NSCLC) patients with ALK gene rearrangement. Treatment with ALK inhibitors may lead to peripheral edema, electrolyte disorders, kidney failure, proteinuria, and an increased risk of renal cysts.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

8.

Efficacy and safety of ceritinib in anaplastic lymphoma kinase-rearranged non-small cell lung cancer: A systematic review and meta-analysis.

Author: TianWei, ZhangPing, YuanYuan, DengXiao-Hui, YueRui, GeXiao-Zhu

ALK-rearranged NSCLC treatment
Side effects

Ceritinib, a second-generation ALK inhibitor, is effective in crizotinib-resistant patients with ALK-rearranged NSCLC, especially those with brain metastasis. However, it is associated with side effects that must be carefully monitored.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

9.

Clinical characteristics and risk factors of drug-induced lung injury by ALK tyrosine kinase inhibitors: A single center retrospective analysis.

Author: KoshikawaKen, TeradaJiro, AbeMitsuhiro, IwasawaShunichiro, SakayoriMasashi, YoshiokaKeiichiro, HirasawaYasutaka, KasaiHajime, KawasakiYohei, TsushimaKenji, TatsumiKoichiro

ALK-TKI treatment
DILI risk

ALK-TKIs are effective treatment for lung cancer with ALK gene rearrangement. However, drug-induced lung injury (DILI) is a serious side effect. This study investigated clinical features and risk factors for DILI caused by ALK-TKIs in clinical practice.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

Ceritinib-Induced Regression of an Insulin-Like Growth Factor-Driven Neuroepithelial Brain Tumor.

Author: RussoAlexandra, ParetClaudia, AltFrancesca, BurhenneJürgen, FresnaisMargaux, WagnerWolfgang, GlaserMartin, BenderHannah, HuprichSabrina, HarterPatrick N, FilipskiKatharina, LehmannNadine, BackesNora, RothLea, SeidmannLarissa, SommerClemens, BrockmannMarc A, PietschTorsten, NeuMarie A, WingerterArthur, FaberJörg

Treat brain tumors
Side effects

This study investigated the use of ceritinib, an off-target inhibitor of IGF1R and INSR, in a pediatric patient with an unclassified brain tumor and a *NOTCH1* germline mutation. Ceritinib showed promising results in inhibiting tumor proliferation and may be a promising drug for the treatment of IGF-driven brain tumors.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

11.

The incidence of ALK inhibitor-related pneumonitis in advanced non-small-cell lung cancer patients: A systematic review and meta-analysis.

Author: SuhChong Hyun, KimKyung Won, PyoJunhee, HatabuHiroto, NishinoMizuki

Pneumonitis

This study evaluated the incidence of pneumonitis in clinical trials of anaplastic lymphoma kinase (ALK) inhibitors in patients with advanced non-small cell lung cancer (NSCLC). The study compared the incidence among different cohorts to identify potential predisposing factors for ALK inhibitor-related pneumonitis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

12.

ALK inhibition in two emblematic cases of pediatric inflammatory myofibroblastic tumor: Efficacy and side effects.

Author: BrivioErica, ZwaanC Michel

ALK inhibitor therapy
Treatment of IMT

This report describes two cases of pediatric patients with inflammatory myofibroblastic tumor (IMT) who were treated with the second-generation ALK inhibitor ceritinib. The report highlights the potential role of ALK inhibitors in treating IMT, particularly when standard surgical treatment is not feasible.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

13.

Current perspective: Osimertinib-induced QT prolongation: new drugs with new side-effects need careful patient monitoring.

Author: SchieferMart, HendriksLizza E L, DinhTrang, LaljiUlrich, DingemansAnne-Marie C

NSCLC treatment
Disease flare
QT prolongation

Osimertinib, a third-generation epidermal growth factor receptor (EGFR)-TKI, can cause QT prolongation. Discontinuation of osimertinib can lead to a symptomatic disease flare, presenting a difficult ethical dilemma for physicians.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

14.

Lung Toxicity in Non-Small-Cell Lung Cancer Patients Exposed to ALK Inhibitors: Report of a Peculiar Case and Systematic Review of the Literature.

Author: PellegrinoBenedetta, FacchinettiFrancesco, BordiPaola, SilvaMario, GnettiLetizia, TiseoMarcello

Lung toxicity

Lung toxicity is a potential fatal side effect of tyrosine kinase inhibitors (TKIs) used to treat non-small-cell lung cancer (NSCLC). This systematic review assessed the epidemiologic magnitude and clinical significance of lung toxicity in NSCLC patients treated with ALK-TKIs. Lung toxicity was reported in 2.1% of patients, with brigatinib associated with the highest frequency (7%).

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

16.

Post-crizotinib management of effective ceritinib therapy in a patient with ALK-positive non-small cell lung cancer.

Author: WonBrian, MambetsarievIsa, SalgiaRavi

Efficacious
Well tolerated

Ceritinib 450 mg/day taken with food was effective and well tolerated in a patient with ALK-positive lung adenocarcinoma who had previously discontinued crizotinib due to disease progression and gastrointestinal intolerance.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

18.

FDA approval: ceritinib for the treatment of metastatic anaplastic lymphoma kinase-positive non-small cell lung cancer.

Author: KhozinSean, BlumenthalGideon M, ZhangLijun, TangShenghui, BrowerMargaret, FoxEmily, HelmsWhitney, LeongRuby, SongPengfei, PanYuzhuo, LiuQi, ZhaoPing, ZhaoHong, LuDonghao, TangZhe, Al HakimAli, BoydKaren, KeeganPatricia, JusticeRobert, PazdurRichard

ALK-Positive NSCLC Treatment
Diarrhea
Liver Toxicity
Nausea

Ceritinib is a drug used to treat anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC). This article describes the FDA approval of ceritinib for the treatment of ALK-positive NSCLC. Ceritinib was found to be effective in treating this type of cancer, with an objective response rate of 44%.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.

Language : English

19.

The next-generation ALK inhibitors.

Author: PallGeorg

ALK-rearranged lung adenocarcinoma

This review discusses the mechanisms of crizotinib resistance in ALK-rearranged lung adenocarcinomas and the development of second-generation ALK inhibitors. Crizotinib is a standard first-line treatment for this type of cancer, but resistance often develops. The review provides an overview of the preclinical background and clinical development of these second-generation inhibitors, which are aimed at overcoming crizotinib resistance.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

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