TY - JOUR
T1 - A Phase 2 Study of Atezolizumab for Pretreated NSCLC With Idiopathic Interstitial Pneumonitis
AU - Ikeda, Satoshi
AU - Kato, Terufumi
AU - Kenmotsu, Hirotsugu
AU - Ogura, Takashi
AU - Iwasawa, Shunichiro
AU - Sato, Yuki
AU - Harada, Toshiyuki
AU - Kubota, Kaoru
AU - Tokito, Takaaki
AU - Okamoto, Isamu
AU - Furuya, Naoki
AU - Yokoyama, Toshihide
AU - Hosokawa, Shinobu
AU - Iwasawa, Tae
AU - Yamanaka, Takeharu
AU - Okamoto, Hiroaki
N1 - Funding Information:
This study was supported by the Chugai Pharmaceutical Co., Ltd. (Tokyo, Japan). The authors thank the patients, their families, the Thoracic Oncology Research Group (TORG) data center staff, and all the investigators who participated in the TORG1936/AMBITIOUS study. All data generated or analyzed in this study are included in this published article. Dr. Ikeda contributed to the conceptualization, methodology, investigation, visualization, project administration, funding acquisition, and writing (original draft) of the manuscript. Dr. Kato contributed to the conceptualization, methodology, project administration, funding acquisition, and writing (review and editing) of the manuscript. Drs. Kenmotsu and Ogura contributed to the conceptualization, methodology, and writing (review and editing) of the manuscript. Dr. S. Iwasawa contributed to the methodology, investigation, and writing (review and editing) of the manuscript. Drs. Sato, Harada, Kubota, Tokito, I. Okamoto, Furuya, Yokoyama, and Hosokawa contributed to the investigation and writing (review and editing) of the manuscript. Drs. T. Iwasawa and Yamanaka contributed to the methodology, formal analysis, and writing (review and editing) of the manuscript. Dr. H. Okamoto contributed to the methodology, supervision, project administration, and writing (review and editing) of the manuscript.
Publisher Copyright:
© 2020 International Association for the Study of Lung Cancer
PY - 2020/12
Y1 - 2020/12
N2 - Introduction: Interstitial pneumonia (IP) is one of the most common and poor prognostic comorbidities in patients with NSCLC and a known risk factor for pneumonitis. Atezolizumab monotherapy is an established treatment for recurrent NSCLC and reported to have a lower risk of pneumonitis than programmed cell death protein 1 inhibitors. This study aimed to assess the safety and efficacy of atezolizumab monotherapy in patients with pretreated advanced or recurrent NSCLC with idiopathic IP. Methods: Patients with advanced or recurrent NSCLC with comorbid idiopathic, chronic fibrotic IP with % forced vital capacity of greater than 70% and no history of immune checkpoint inhibitors were enrolled. The patients received atezolizumab (1200 mg) every 3 weeks until the discontinuation criteria were met. The primary end point of this study was the 1-year survival rate. A sample size of 38 patients was set. Results: This study was terminated early owing to high incidence of pneumonitis. A total of 17 patients were enrolled, with a median age of 70 years. The median % forced vital capacity and % diffusing capacity for carbon monoxide at baseline were 85.4% and 54.4%, respectively. The incidence of pneumonitis was 29.4% (5 of 17) for all grades, 23.5% (4 of 17) for grade greater than or equal to 3, and 5.9% (1 of 17) for grade 5. A total of 57.1% patients (4 of 7) with honeycomb lung developed pneumonitis with a grade greater than or equal to 3, whereas only one patient (10%) without honeycomb lung (n = 10) with grade 1 pneumonitis was found. Conclusions: Patients with NSCLC with comorbid IP as defined by the selection criteria for this study might have an increased risk of immune checkpoint inhibitor–induced pneumonitis.
AB - Introduction: Interstitial pneumonia (IP) is one of the most common and poor prognostic comorbidities in patients with NSCLC and a known risk factor for pneumonitis. Atezolizumab monotherapy is an established treatment for recurrent NSCLC and reported to have a lower risk of pneumonitis than programmed cell death protein 1 inhibitors. This study aimed to assess the safety and efficacy of atezolizumab monotherapy in patients with pretreated advanced or recurrent NSCLC with idiopathic IP. Methods: Patients with advanced or recurrent NSCLC with comorbid idiopathic, chronic fibrotic IP with % forced vital capacity of greater than 70% and no history of immune checkpoint inhibitors were enrolled. The patients received atezolizumab (1200 mg) every 3 weeks until the discontinuation criteria were met. The primary end point of this study was the 1-year survival rate. A sample size of 38 patients was set. Results: This study was terminated early owing to high incidence of pneumonitis. A total of 17 patients were enrolled, with a median age of 70 years. The median % forced vital capacity and % diffusing capacity for carbon monoxide at baseline were 85.4% and 54.4%, respectively. The incidence of pneumonitis was 29.4% (5 of 17) for all grades, 23.5% (4 of 17) for grade greater than or equal to 3, and 5.9% (1 of 17) for grade 5. A total of 57.1% patients (4 of 7) with honeycomb lung developed pneumonitis with a grade greater than or equal to 3, whereas only one patient (10%) without honeycomb lung (n = 10) with grade 1 pneumonitis was found. Conclusions: Patients with NSCLC with comorbid IP as defined by the selection criteria for this study might have an increased risk of immune checkpoint inhibitor–induced pneumonitis.
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U2 - 10.1016/j.jtho.2020.08.018
DO - 10.1016/j.jtho.2020.08.018
M3 - Article
C2 - 32858235
AN - SCOPUS:85091248226
SN - 1556-0864
VL - 15
SP - 1935
EP - 1942
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 12
ER -