The real-world safety of atezolizumab as second-line or later treatment in Japanese patients with non-small-cell lung cancer: a post-marketing surveillance study

Ohe, Yuichiro; Yamazaki, Naoya; Yamamoto, Nobuyuki; Murakami, Haruyasu; Yoh, Kiyotaka; Kitano, Shigehisa; Hashimoto, Hideyuki; Murayama, Ayako; Nakane, Sayuri; Gemma, Akihiko

doi:10.1093/jjco/hyac024

Cited by 4 publications

(1 citation statement)

References 24 publications

(28 reference statements)

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“…46/47 studies that performed univariate analysis used p=0.05 as significance threshold, one implied a threshold of p=0.001 ( 59 ). None, except one study, applied multiple testing correction ( 24 ).…”

Section: Resultsmentioning

confidence: 99%

Common methodological pitfalls in ICI pneumonitis risk prediction studies

Chen,

Welsh,

Pillay

et al. 2023

Front. Immunol.

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BackgroundPneumonitis is one of the most common adverse events induced by the use of immune checkpoint inhibitors (ICI), accounting for a 20% of all ICI-associated deaths. Despite numerous efforts to identify risk factors and develop predictive models, there is no clinically deployed risk prediction model for patient risk stratification or for guiding subsequent monitoring. We believe this is due to systemic suboptimal approaches in study designs and methodologies in the literature. The nature and prevalence of different methodological approaches has not been thoroughly examined in prior systematic reviews.MethodsThe PubMed, medRxiv and bioRxiv databases were used to identify studies that aimed at risk factor discovery and/or risk prediction model development for ICI-induced pneumonitis (ICI pneumonitis). Studies were then analysed to identify common methodological pitfalls and their contribution to the risk of bias, assessed using the QUIPS and PROBAST tools.ResultsThere were 51 manuscripts eligible for the review, with Japan-based studies over-represented, being nearly half (24/51) of all papers considered. Only 2/51 studies had a low risk of bias overall. Common bias-inducing practices included unclear diagnostic method or potential misdiagnosis, lack of multiple testing correction, the use of univariate analysis for selecting features for multivariable analysis, discretization of continuous variables, and inappropriate handling of missing values. Results from the risk model development studies were also likely to have been overoptimistic due to lack of holdout sets.ConclusionsStudies with low risk of bias in their methodology are lacking in the existing literature. High-quality risk factor identification and risk model development studies are urgently required by the community to give the best chance of them progressing into a clinically deployable risk prediction model. Recommendations and alternative approaches for reducing the risk of bias were also discussed to guide future studies.

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Section: Resultsmentioning

confidence: 99%

Common methodological pitfalls in ICI pneumonitis risk prediction studies

Chen,

Welsh,

Pillay

et al. 2023

Front. Immunol.

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Atezolizumab

2022

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Are Immune Checkpoint Inhibitors Safe and Effective in Lung Cancer Patients with Pre-Existing Interstitial Lung Disease?

Zhu,

Gao,

et al. 2024

Immunotherapy

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Aim: This study aims to clarify the efficacy and adverse effects of immune checkpoint inhibitors (ICIs) in the lung cancer patients with a history of interstitial lung disease (ILD). Methods: From the inception of the database to 4 April 2023, we systematically searched the four databases. Results: The objective remission rate, disease control rate, incidence of immune-associated pneumonitis (ICIP) in the combined ILD group were significantly higher than those in the non-combined ILD group. There were no significant differences between the two groups in progression-free survival, overall survival, renal insufficiency, thyroid dysfunction and gastrointestinal toxicity. Conclusion: Generally, a pre-existing ILD history can increase the efficacy and incidence of ICIs' adverse reactions. Therefore, ICIs should be administered with caution.

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The real-world safety of atezolizumab as second-line or later treatment in Japanese patients with non-small-cell lung cancer: a post-marketing surveillance study

Cited by 4 publications

References 24 publications

Common methodological pitfalls in ICI pneumonitis risk prediction studies

Common methodological pitfalls in ICI pneumonitis risk prediction studies

Atezolizumab

Are Immune Checkpoint Inhibitors Safe and Effective in Lung Cancer Patients with Pre-Existing Interstitial Lung Disease?

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