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

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

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Abstract

Objectives Drug-induced interstitial lung disease (ILD) is often associated with high mortality; however it is difficult to predict and manage. we examined the clinical findings and imaging characteristics of nivolumab induced ILD reported in the two phase II studies patients with recurrent or advanced non-small-cell lung cancer. Materials and methods We examined the clinical findings and imaging characteristics of all cases of ILD reported in two phase II trials of nivolumab, an anti-programmed death-1 antibody, in Japanese patients with recurrent or advanced non-small-cell lung cancer. These studies are registered with the Japan Pharmaceutical Information Center, numbers JapicCTI-132072, JapicCTI-132073. Results Eight (7.2%; two with squamous cell carcinoma, six with non-squamous cell carcinoma) of the 111 patients included in these two studies experienced ILD, and a causal relationship with nivolumab could not be ruled out in any of them. ILD of ≥grade 3 severity was found in four patients (3.6%), and ILD was considered a serious treatment-related adverse event in seven patients (6.3%). All of the patients who experienced ILD were male and had a history of smoking, with a median age of 65 years (range 52–78 years). In seven of the eight patients who experienced ILD, their events were rapidly resolving or resolved spontaneously or with steroid therapy; one patient died of respiratory failure without resolution of ILD, after docetaxel treatment was initiated following nivolumab discontinuation. Chest computed tomography images for the seven patients with resolving or resolution of ILD showed a pattern of organizing pneumonia or nonspecific interstitial pneumonia without traction bronchiectasis, while the patient who died had traction bronchiectasis. Conclusion 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.

Original languageEnglish
Pages (from-to)111-118
Number of pages8
JournalLung Cancer
Volume104
DOIs
Publication statusPublished - Feb 1 2017

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Interstitial Lung Diseases
Non-Small Cell Lung Carcinoma
Bronchiectasis
Traction
docetaxel
nivolumab
Information Centers
Respiratory Insufficiency
Pharmaceutical Preparations
Squamous Cell Carcinoma
Pneumonia
Japan
Thorax
Therapeutics
Smoking
Steroids
Tomography

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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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. / 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.

In: Lung Cancer, Vol. 104, 01.02.2017, p. 111-118.

Research output: Contribution to journalArticle

Kato, T, Masuda, N, Nakanishi, Y, Takahashi, M, Hida, T, Sakai, H, Atagi, S, Fujita, S, Tanaka, H, Takeda, K, Satouchi, M, Namba, Y & Tamura, T 2017, 'Nivolumab-induced interstitial lung disease analysis of two phase II studies patients with recurrent or advanced non-small-cell lung cancer', Lung Cancer, vol. 104, pp. 111-118. https://doi.org/10.1016/j.lungcan.2016.12.016
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. / Nivolumab-induced interstitial lung disease analysis of two phase II studies patients with recurrent or advanced non-small-cell lung cancer. In: Lung Cancer. 2017 ; Vol. 104. pp. 111-118.
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abstract = "Objectives Drug-induced interstitial lung disease (ILD) is often associated with high mortality; however it is difficult to predict and manage. we examined the clinical findings and imaging characteristics of nivolumab induced ILD reported in the two phase II studies patients with recurrent or advanced non-small-cell lung cancer. Materials and methods We examined the clinical findings and imaging characteristics of all cases of ILD reported in two phase II trials of nivolumab, an anti-programmed death-1 antibody, in Japanese patients with recurrent or advanced non-small-cell lung cancer. These studies are registered with the Japan Pharmaceutical Information Center, numbers JapicCTI-132072, JapicCTI-132073. Results Eight (7.2{\%}; two with squamous cell carcinoma, six with non-squamous cell carcinoma) of the 111 patients included in these two studies experienced ILD, and a causal relationship with nivolumab could not be ruled out in any of them. ILD of ≥grade 3 severity was found in four patients (3.6{\%}), and ILD was considered a serious treatment-related adverse event in seven patients (6.3{\%}). All of the patients who experienced ILD were male and had a history of smoking, with a median age of 65 years (range 52–78 years). In seven of the eight patients who experienced ILD, their events were rapidly resolving or resolved spontaneously or with steroid therapy; one patient died of respiratory failure without resolution of ILD, after docetaxel treatment was initiated following nivolumab discontinuation. Chest computed tomography images for the seven patients with resolving or resolution of ILD showed a pattern of organizing pneumonia or nonspecific interstitial pneumonia without traction bronchiectasis, while the patient who died had traction bronchiectasis. Conclusion 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.",
author = "Terufumi Kato and Noriyuki Masuda and Yoichi Nakanishi and Masashi Takahashi and Toyoaki Hida and Hiroshi Sakai and Shinji Atagi and Shiro Fujita and Hiroshi Tanaka and Koji Takeda and Miyako Satouchi and Yoshinobu Namba and Tomohide Tamura",
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T1 - Nivolumab-induced interstitial lung disease analysis of two phase II studies patients with recurrent or advanced non-small-cell lung cancer

AU - Kato, Terufumi

AU - Masuda, Noriyuki

AU - Nakanishi, Yoichi

AU - Takahashi, Masashi

AU - Hida, Toyoaki

AU - Sakai, Hiroshi

AU - Atagi, Shinji

AU - Fujita, Shiro

AU - Tanaka, Hiroshi

AU - Takeda, Koji

AU - Satouchi, Miyako

AU - Namba, Yoshinobu

AU - Tamura, Tomohide

PY - 2017/2/1

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N2 - Objectives Drug-induced interstitial lung disease (ILD) is often associated with high mortality; however it is difficult to predict and manage. we examined the clinical findings and imaging characteristics of nivolumab induced ILD reported in the two phase II studies patients with recurrent or advanced non-small-cell lung cancer. Materials and methods We examined the clinical findings and imaging characteristics of all cases of ILD reported in two phase II trials of nivolumab, an anti-programmed death-1 antibody, in Japanese patients with recurrent or advanced non-small-cell lung cancer. These studies are registered with the Japan Pharmaceutical Information Center, numbers JapicCTI-132072, JapicCTI-132073. Results Eight (7.2%; two with squamous cell carcinoma, six with non-squamous cell carcinoma) of the 111 patients included in these two studies experienced ILD, and a causal relationship with nivolumab could not be ruled out in any of them. ILD of ≥grade 3 severity was found in four patients (3.6%), and ILD was considered a serious treatment-related adverse event in seven patients (6.3%). All of the patients who experienced ILD were male and had a history of smoking, with a median age of 65 years (range 52–78 years). In seven of the eight patients who experienced ILD, their events were rapidly resolving or resolved spontaneously or with steroid therapy; one patient died of respiratory failure without resolution of ILD, after docetaxel treatment was initiated following nivolumab discontinuation. Chest computed tomography images for the seven patients with resolving or resolution of ILD showed a pattern of organizing pneumonia or nonspecific interstitial pneumonia without traction bronchiectasis, while the patient who died had traction bronchiectasis. Conclusion 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.

AB - Objectives Drug-induced interstitial lung disease (ILD) is often associated with high mortality; however it is difficult to predict and manage. we examined the clinical findings and imaging characteristics of nivolumab induced ILD reported in the two phase II studies patients with recurrent or advanced non-small-cell lung cancer. Materials and methods We examined the clinical findings and imaging characteristics of all cases of ILD reported in two phase II trials of nivolumab, an anti-programmed death-1 antibody, in Japanese patients with recurrent or advanced non-small-cell lung cancer. These studies are registered with the Japan Pharmaceutical Information Center, numbers JapicCTI-132072, JapicCTI-132073. Results Eight (7.2%; two with squamous cell carcinoma, six with non-squamous cell carcinoma) of the 111 patients included in these two studies experienced ILD, and a causal relationship with nivolumab could not be ruled out in any of them. ILD of ≥grade 3 severity was found in four patients (3.6%), and ILD was considered a serious treatment-related adverse event in seven patients (6.3%). All of the patients who experienced ILD were male and had a history of smoking, with a median age of 65 years (range 52–78 years). In seven of the eight patients who experienced ILD, their events were rapidly resolving or resolved spontaneously or with steroid therapy; one patient died of respiratory failure without resolution of ILD, after docetaxel treatment was initiated following nivolumab discontinuation. Chest computed tomography images for the seven patients with resolving or resolution of ILD showed a pattern of organizing pneumonia or nonspecific interstitial pneumonia without traction bronchiectasis, while the patient who died had traction bronchiectasis. Conclusion 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.

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