Toxicity spectrum of immunotherapy in advanced lung cancer: A safety analysis from clinical trials and a pharmacovigilance system

Yan, Yi–Dan; Zhao, Ying; Zhang, Chi; Fu, Jie; Su, Ying-Jie; Cui, Xiangli; Ma, Er-Li; Liu, Bing-Long; Z, Gu; Lin, Hou‐Wen

doi:10.1016/j.eclinm.2022.101535

Cited by 35 publications

(9 citation statements)

References 39 publications

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“…In addition, there is an urgent need to distinguish from responders and non-responders to immunotherapy. A wealth of studies demonstrated that the efficiency of immunologic therapy always depends on the adequate expression of immune checkpoints in the tumor tissues (44,45). In this study, the expression level of common checkpoints upregulated in the high-risk group indicating that patients in the high-risk group were more likely to gain benefits from immunotherapy.…”

Section: Discussionmentioning

confidence: 57%

A novel signature of combing cuproptosis- with ferroptosis-related genes for prediction of prognosis, immunologic therapy responses and drug sensitivity in hepatocellular carcinoma

Zhao

Zhang

2022

Front. Oncol.

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BackgroundOur study aimed to construct a novel signature (CRFs) of combing cuproptosis-related genes with ferroptosis-related genes for the prediction of the prognosis, responses of immunological therapy, and drug sensitivity of hepatocellular carcinoma (HCC) patients.MethodsThe RNA sequencing and corresponding clinical data of patients with HCC were downloaded from The Cancer Genome Atlas (TCGA), International Cancer Genome Consortium (ICGC), GSE76427, GSE144269, GSE140580, Cancer Cell Line Encyclopedia (CCLE), and IMvigor210 cohorts. CRFs was constructed using the least absolute shrinkage and selection operator (LASSO) algorithm. The analyses involved in the prognosis, response to immunologic therapy, efficacy of transcatheter arterial chemoembolization (TACE) therapy, and drug sensitivity were performed. Furthermore, the molecular function, somatic mutation, and stemness analyses were further performed between the low- and high-risk groups, respectively. In this study, the statistical analyses were performed by using the diverse packages of R 4.1.3 software and Cytoscape 3.8.0.ResultsCRFs included seven genes (G6PD, NRAS, RRM2, SQSTM1, SRXN1, TXNRD1, and ZFP69B). Multivariate Cox regression analyses demonstrated that CRFs were an independent risk factor for prognosis. In addition, these patients in the high-risk group presented with worse prognoses and a significant state of immunosuppression. Moreover, patients in the high-risk group might achieve greater outcomes after receiving immunologic therapy, while patients in the low-risk group are sensitive to TACE. Furthermore, we discovered that patients in the high-risk group may benefit from the administration of sunitinib. In addition, enhanced mRANsi and tumor mutation burden (TMB) yielded in the high-risk group. Additionally, the functions enriched in the low-risk group differed from those in the other group.ConclusionIn summary, CRFs may be regarded not only as a novel biomarker of worse prognosis, but also as an excellent predictor of immunotherapy response, efficacy of TACE and drug sensitivity in HCC, which is worthy of clinical promotion.

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Section: Discussionmentioning

confidence: 57%

A novel signature of combing cuproptosis- with ferroptosis-related genes for prediction of prognosis, immunologic therapy responses and drug sensitivity in hepatocellular carcinoma

Zhao

Zhang

2022

Front. Oncol.

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“…However, overactivation of T lymphocytes can occur systemically and may lead to not only an anti-tumor immune response but also autoimmunity, resulting in various irAEs ( 5 ). A study focused on toxicity spectrum of immunotherapy in advanced lung cancer found that chemotherapy combined with both PD-L1 and CTLA-4 antibody was associated with the highest risk of grade 1–5 irAEs compared with ICI monotherapy and chemotherapy alone ( 6 ). Unlike other irAEs, neurological complications caused by ICIs are rare ( 7 ) and often occur in melanoma patients ( 8 ).…”

Section: Discussionmentioning

confidence: 99%

Case Report: ICIs-induced Guillain–Barré syndrome recovered from mycophenolate mofetil

et al. 2023

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The emergence of immune checkpoint inhibitors (ICIs) has significantly prolonged the survival time of cancer patients. However, it may also lead to various immune-related adverse events (irAEs), including Guillain–Barré syndrome (GBS), a rare type of irAE. Most GBS patients can recover spontaneously due to the self-limited nature of the disease, but severe cases can result in respiratory failure or even death. Here we report a rare case of GBS occurring in a 58-year-old male patient with non-small cell lung cancer (NSCLC) who developed muscle weakness and numbness of the extremities during chemotherapy combined with KN046, a PD-L1/CTLA-4 bispecific antibody. Despite receiving methylprednisolone and γ-globulin, the patient’s symptoms did not improve. However, there was significant improvement after treatment with mycophenolate mofetil (MM) capsules, which is not a routine regimen for GBS. To the best of our knowledge, this is the first reported case of ICIs-induced GBS that responded well to mycophenolate mofetil instead of methylprednisolone or γ-globulin. Thus, it provides a new treatment option for patients with ICIs-induced GBS.

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“…Because many items were not required fields in the database, we considered the effect of unexploitable data and calculated the available data, such as sex, age, weight, indications, cumulative dose, outcomes, combination medication and reporting countries, etc. Disproportionality analyses, including reporting odds ratio (ROR), proportional reporting ratio (PRR), the information component (IC) and the empirical bayes geometric mean (EBGM), are used to identify drug-associated AEs (signals) that are reported more frequently than expected by estimating proportion of specific AEs occurrence between a specific drug and all other drugs [ 16 , 17 ]. We performed the disproportionality analyses at both PT and SOC levels to explore the correlation of sotorasib at different hierarchies.…”

Section: Methodsmentioning

confidence: 99%

Post-marketing safety concerns of sotorasib: A disproportionality analysis based on FDA adverse event reporting system

Ding,

Su,

Shu

et al. 2024

Heliyon

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Toxicity spectrum of immunotherapy in advanced lung cancer: A safety analysis from clinical trials and a pharmacovigilance system

Cited by 35 publications

References 39 publications

A novel signature of combing cuproptosis- with ferroptosis-related genes for prediction of prognosis, immunologic therapy responses and drug sensitivity in hepatocellular carcinoma

A novel signature of combing cuproptosis- with ferroptosis-related genes for prediction of prognosis, immunologic therapy responses and drug sensitivity in hepatocellular carcinoma

Case Report: ICIs-induced Guillain–Barré syndrome recovered from mycophenolate mofetil

Post-marketing safety concerns of sotorasib: A disproportionality analysis based on FDA adverse event reporting system

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