Nivolumab-induced interstitial lung disease analysis of two phase II studies patients with recurrent or advanced non-small-cell lung cancer

Kato, Terufumi; Masuda, Noriyuki; Nakanishi, Yoichi; Takahashi, Masashi; Hida, Toyoaki; Sakai, Hiroshi; Atagi, Shinji; Fujita, Shiro; Tanaka, Hiroshi; Takeda, Koji; Satouchi, Miyako; Namba, Yoshinobu; Tamura, Tomohide

doi:10.1016/j.lungcan.2016.12.016

Cited by 94 publications

(127 citation statements)

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“…The synergistic effect of osimertinib and nivolumab may contribute to the high incidence of ILD. Recently, Kato et al reported that nivolumab‐induced ILD was observed in 7.2% of patients, with radiological imaging showing a pattern of organized pneumonia or nonspecific interstitial pneumonia without traction bronchiectasis . The radiological findings of ILD in our study also revealed a pattern of organized pneumonia.…”

Section: Discussionsupporting

confidence: 76%

Different incidence of interstitial lung disease according to different kinds of EGFR‐tyrosine kinase inhibitors administered immediately before and/or after anti‐PD‐1 antibodies in lung cancer

et al. 2019

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Background The aim of our study was to retrospectively assess the incidence of interstitial lung disease (ILD) related to EGFR‐tyrosine kinase inhibitor (TKI) treatment immediately before and/or after the administration of a PD‐1 antibody. Methods We analyzed the data of 26 patients who underwent treatment with EGFR‐TKIs immediately before and/or after the administration of an anti‐PD‐1 antibody. Results Four out of the 26 patients developed ILD during EGFR‐TKI treatment: three patients during the administration of osimertinib immediately after, and one during afatinib immediately before treatment with an anti‐PD‐1 antibody. Three of 12 patients who underwent EGFR‐TKI therapy immediately after anti‐PD‐1 antibody treatment experienced osimertinib‐induced ILD. ILD was not observed in the five patients administered an anti‐PD‐1 antibody followed by first or second‐generation EGFR‐TKIs. Conclusion ILD was observed in the treatment sequence of an anti‐PD‐1 antibody followed by osimertinib, but not with first or second‐generation EGFR‐TKIs.

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Section: Discussionsupporting

confidence: 76%

Different incidence of interstitial lung disease according to different kinds of EGFR‐tyrosine kinase inhibitors administered immediately before and/or after anti‐PD‐1 antibodies in lung cancer

et al. 2019

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“…Kato et al . reported seven of eight patients had a pattern of OP or nonspecific interstitial pneumonia . Naidoo et al .…”

Section: Discussionmentioning

confidence: 93%

Immune checkpoint inhibitor‐associated interstitial lung diseases correlate with better prognosis in patients with advanced non‐small‐cell lung cancer

et al. 2020

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Background Interstitial lung disease (ILD) induced by immune checkpoint inhibitors (ICIs) is a potentially life‐threatening adverse event. The purpose of this study was to evaluate whether the development of immune‐related adverse events (irAEs), especially ILD, was associated with treatment efficacy and to research the features and risk factors of ILD in advanced non‐small cell lung cancer (NSCLC). Methods Between December 2015 and November 2018, 130 advanced NSCLC patients were treated with nivolumab, pembrolizumab or atezolizumab. The patients were categorized into two groups (irAEs group or non‐irAEs group). Subsequently, we divided the irAEs group into two groups based on the incidence of ILD (ILD group and irAEs‐non‐ILD group). Treatment efficacy and the characteristics of ILD were evaluated. Results A total of 39 (30%) patients developed irAEs. ILD was observed in 16 (12%) patients. Patients with ILD had a higher objective response rate (ORR) compared with irAEs‐non‐ILD patients and non‐irAEs patients (63%, 43% and 22%, respectively). Median progression‐free survival (mPFS) was 15.9 months in ILD patients, 5.4 months in irAEs‐non‐ILD patients and 3.3 months in non‐irAEs patients (log‐rank test, P = 0.033). Pre‐existing interstitial pneumonia (IP) was an independent risk factor for ILD‐induced ICIs (odds ratio [OR] 14.7; 95% confidence interval [CI]: 2.16–99.6, P = 0.006). Conclusions ORR and PFS were significantly better in ILD patients than in irAEs‐non‐ILD and non‐irAEs patients. Pre‐existing history of IP was an independent risk factor for ILD‐induced ICIs.

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“…First, the majority of patients in the ILD group had a low preexisting ILD extent score; therefore more than two‐thirds of the patients in the ILD group could be treated with nivolumab as second‐line chemotherapy. Second, nivolumab‐related pneumonitis resulted in low mortality and was more responsive to immunosuppressive agents than the pneumonitis induced by cytotoxic chemotherapies or molecular‐targeted agents . Finally, frequent chest radiographic examination of preexisting ILD might have led to the early detection of nivolumab‐related ILD, but may also have partially contributed to the higher incidence of nivolumab‐related pneumonitis in the ILD group.…”

Section: Discussionmentioning

confidence: 99%

“…In recent years, immune checkpoint inhibitors (ICIs) have been used for the treatment of non‐small cell lung cancer (NSCLC) in clinical practice . The incidence of ICI‐related pneumonitis, including some fatal cases, is reported as 1–12% . In contrast to cytotoxic chemotherapy or molecular‐targeted agent‐related pneumonitis, most ICI‐related pneumonitis patients appear to be sensitive to treatment with corticosteroids; however, the risk of ICI‐related pneumonitis in patients with preexisting ILD is unknown …”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of nivolumab in non‐small cell lung cancer with preexisting interstitial lung disease

et al. 2018

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BackgroundThe risk of developing lung cancer is high in patients with interstitial lung disease (ILD), as few treatment options are available. Immune checkpoint inhibitors (ICI) are used for the treatment of non‐small cell lung cancer (NSCLC) in clinical practice; however, in patients with preexisting ILD, the risk of ICI‐related pneumonitis is unknown. We evaluated the efficacy and lung toxicity of nivolumab in patients with NSCLC and ILD.MethodsWe retrospectively reviewed the medical records of 216 NSCLC patients who had received nivolumab therapy. The existence of ILD in these patients was determined by lung computed tomography findings; 26 patients had ILD. We evaluated the efficacy of nivolumab by measuring the response rate (RR), progression‐free survival (PFS) duration, and lung toxicity by incidence, severity, and outcome of nivolumab‐related ILD.ResultsThe RR and median PFS of the ILD and non‐ILD groups were 27% versus 13% (P = 0.078) and 2.7 (95% confidence interval [CI], 1.7–5.3) versus 2.9 months (95% CI 2.1–3.4; P = 0.919), respectively. The incidences of total and severe nivolumab‐related pneumonitis were significantly higher in the ILD group than in the non‐ILD group (31% vs. 12%, P = 0.014 and 19% vs. 5%, P = 0.022, respectively). No death from nivolumab‐related pneumonitis occurred. Over 50% of the patients in both groups with nivolumab‐related pneumonitis showed improvement over time.ConclusionRelative to the non‐ILD group, nivolumab‐related pneumonitis was observed more frequently in the ILD group; however, most cases were manageable.

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Nivolumab-induced interstitial lung disease analysis of two phase II studies patients with recurrent or advanced non-small-cell lung cancer

Abstract: Although the risk factors for nivolumab-induced ILD were not identified, careful monitoring including imaging examinations is important in preventing the worsening of ILD in patients receiving nivolumab.

Cited by 94 publications

References 9 publications

Different incidence of interstitial lung disease according to different kinds of EGFR‐tyrosine kinase inhibitors administered immediately before and/or after anti‐PD‐1 antibodies in lung cancer

Different incidence of interstitial lung disease according to different kinds of EGFR‐tyrosine kinase inhibitors administered immediately before and/or after anti‐PD‐1 antibodies in lung cancer

Immune checkpoint inhibitor‐associated interstitial lung diseases correlate with better prognosis in patients with advanced non‐small‐cell lung cancer

Efficacy and safety of nivolumab in non‐small cell lung cancer with preexisting interstitial lung disease

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