A pilot trial of nivolumab treatment for advanced non-small cell lung cancer patients with mild idiopathic interstitial pneumonia

Fujimoto, Daichi; Morimoto, Takeshi; Ito, Jiro; Sato, Yuki; Ito, Mitsuru; Teraoka, Shunsuke; Otsuka, Kojiro; Nagata, Kazuma; Nakagawa, Atsushi; Tomii, Keisuke

doi:10.1016/j.lungcan.2017.06.008

Cited by 74 publications

(72 citation statements)

References 30 publications

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“…In our study, none of the patients with preexisting ILD experienced ILD‐AEs or pneumonitis, although the number of the patients was small (n = 6). PFS did not differ significantly between patients with and without ILD (not reached vs 2.56 months, P = .248), consistent with previous studies …”

Section: Discussionsupporting

confidence: 91%

“…Moreover, EGFR tyrosine kinase inhibitors, a novel standard therapy for EGFR‐mutant NSCLC patients, were found to cause pneumonitis more commonly in NSCLC patients with preexisting ILD than in those without . On a theoretical basis, ICIs have the potential to worsen ILD in NSCLC patients, so most clinical trials have excluded patients with preexisting ILD . In general, ICI‐associated pneumonitis occurs in 3‐12% of NSCLC patients .…”

Section: Discussionmentioning

confidence: 99%

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PD‐1 inhibitors for non‐small cell lung cancer patients with special issues: Real‐world evidence

et al. 2020

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Background Immune checkpoint inhibitors (ICIs) have provided new therapeutic options for non‐small cell lung cancer(NSCLC) patients. However, due to concerning increases in immune‐related adverse events, clinical trials usually exclude patients with special issues such as viral hepatitis, tuberculosis (Tbc), interstitial lung disease (ILD) and autoimmune disease. Methods We retrospectively reviewed the medical records of NSCLC patients who received ICIs, and analyzed the clinical outcomes of patients with special issues. Results Between January 2015 and October 2018, 237 patients received ICIs. Of these patients, 26% (61/237) had special issues: 32 had hepatitis B viral (HBV) infections, 20 Tbc, six ILD, one HIV infection, one Behçet's disease and a past HBV infection, and one rheumatoid arthritis. The incidence of hepatitis tended to be higher in patients with HBV infections than in those without (18.8% vs 8.91%, P = .082). Severe hepatitis (grade 3 or higher) was more common in HBV‐infected patients (12.5% vs 1.9%, P = .0021), but the AEs were well‐managed. During ICI treatment, three of the 20 patients with a history of pulmonary Tbc developed active pulmonary Tbc, considered reactivations. No aggravation of ILD was noted. One RA patient experienced a disease flare and was treated with a low‐dose steroid. There was no significant difference in the overall response rate or progression‐free survival between patients with and without special issues. Conclusion Given the relatively low incidence of immune‐related AEs and the comparability of clinical outcomes, ICIs can be treatment option of NSCLC patients with special issues.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

PD‐1 inhibitors for non‐small cell lung cancer patients with special issues: Real‐world evidence

et al. 2020

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“…However, this finding may be biased because of the low proportion of patients with a poor ECOG‐PS score, which is reported to be associated with the efficacy of nivolumab treatment (17% in patients who developed pneumonitis vs. 27% in those who did not) . Another pilot trial reported similar favorable efficacy of nivolumab in patients with NSCLC and ILD, and demonstrated a high RR of 50% . One reason for the efficacy of nivolumab in the ILD group may be the high proportion of patients without EGFR mutations or with a smoking history (as evidenced in patients with NSCLC and ILD), which appeared to be associated with a better treatment outcome in patients treated with ICIs .…”

Section: Discussionmentioning

confidence: 99%

“…28 Another pilot trial reported similar favorable efficacy of nivolumab in patients with NSCLC and ILD, and demonstrated a high RR of 50%. 29 One reason for the efficacy of nivolumab in the ILD group may be the high proportion of patients without EGFR mutations or with a smoking history (as evidenced in patients with NSCLC and ILD), 27 which appeared to be associated with a better treatment outcome in patients treated with ICIs. 28,30 Another explanation may be the tumor mutation burden, as a high tumor mutation burden is associated with a better response to nivolumab.…”

Section: Discussionmentioning

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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“…The patient was treated with nivolumab safely for eight months, which resulted in stable disease. The second study prospectively investigated the safety of nivolumab for advanced NSCLC patients with “mild” (defined as a %VC of ≥ 80%) idiopathic interstitial pneumonia with a possible UIP or a pattern inconsistent with UIP on a chest HRCT scan, to exclude the possibility of acute exacerbation 6. None of the six patients studied developed pneumonitis within 12 weeks, three achieved a partial response, and the disease control rate was 100%.…”

Section: Discussionmentioning

confidence: 99%

Durable response to nivolumab in a lung adenocarcinoma patient with idiopathic pulmonary fibrosis

et al. 2018

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The efficacy and safety of immune‐checkpoint inhibitors in non‐small cell lung cancer patients with idiopathic pulmonary fibrosis (IPF) remain unknown. Herein, we describe the case of a 62‐year‐old man with multiple pleural tumors and carcinomatous pleurisy. High‐resolution computed tomography indicated usual interstitial pneumonia, and a respiratory function test revealed a restrictive disorder and decreased diffusion capacity. He was diagnosed with lung adenocarcinoma and IPF. After failure of initial chemotherapy, he was treated with nivolumab and achieved a complete response without any sign of exacerbation of IPF. The response to nivolumab has persisted for > 1 year. This is the first report of a non‐small cell lung cancer patient with IPF who has been treated with immune‐checkpoint inhibitors for such a long period and achieved a sustained response.

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A pilot trial of nivolumab treatment for advanced non-small cell lung cancer patients with mild idiopathic interstitial pneumonia

Cited by 74 publications

References 30 publications

PD‐1 inhibitors for non‐small cell lung cancer patients with special issues: Real‐world evidence

PD‐1 inhibitors for non‐small cell lung cancer patients with special issues: Real‐world evidence

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

Durable response to nivolumab in a lung adenocarcinoma patient with idiopathic pulmonary fibrosis

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