Abstract 1202
Background
Nivolumab can cause immune-related adverse events requiring caution, including ILD.
Methods
Clinical and chest imaging findings for each ILD case reported by nivolumab-treated patients with NSCLC were assessed by the ILD Expert Central Review Committee. ILD prognosis was evaluated by radiographic findings, including the presence/absence of peritumoral infiltration (PTI), a characteristic of nivolumab-induced ILD. Poor prognostic factors were identified by multivariate Cox regression analysis.
Results
Of patients reported by physicians from December 2015 to March 2016, 325 nivolumab-treated patients with NSCLC assessed for ILD, 238 patients had nivolumab-induced ILD. The main radiographic patterns of ILD were cryptogenic organizing pneumonia/chronic eosinophilic pneumonia-like (127/238 patients, 53.4%), faint infiltration pattern/acute hypersensitivity pneumonia-like (48/238 patients, 20.2%), diffuse alveolar damage (DAD) (26/238 patients, 10.9%), and nonspecific interstitial pneumonia-like (fibrosing organizing pneumonia) (15/238 patients, 6.3%). The ILD mortality rate was 65.4% in patients with DAD pattern and 4.2% to 13.6% in patients with the other patterns. The ILD mortality rate was 11.1% in the 27 patients with PTI and 16.3% in the 209 patients without PTI. The antitumor response was as follows: partial response: 34.0%; stable disease: 33.6%; and progressive disease: 21.4% patients. In 5 of the 37 patients who died due to ILD, the radiographic pattern changed to DAD pattern from other patterns at onset. Multivariate Cox regression analysis identified 5 factors for poor prognosis of ILD: DAD pattern; ≤60 days from start of nivolumab treatment to onset of ILD; pleural effusion present before treatment; abnormal opacities distributed contralateral or bilateral to the tumor; and abnormal change in C-reactive protein level.
Conclusions
Patients with NSCLC with these factors for poor prognosis of nivolumab-induced ILD should be monitored for ILD during nivolumab treatment.
Clinical trial identification
Editorial acknowledgement
Medical writing assistance was provided by Justine Southby, PhD, CMPP, and Hiroko Ebina, BPharm, Ph, MBA, of ProScribe – Envision Pharma Group, and was funded by Ono Pharmaceutical Co., Ltd.
Legal entity responsible for the study
Ono Pharmaceutical Co., Ltd.
Funding
Ono Pharmaceutical Co., Ltd., Osaka, Japan, and Bristol-Myers Squibb K.K., Tokyo, Japan.
Disclosure
K. Oikado: Honoraria (self): Ono Pharmaceutical ; Honoraria (self): AstraZeneca. Y. Saito: Honoraria (self): Ono Pharmaceutical Co., Ltd.; Honoraria (self): Boehringer Ingelheim Co., Ltd.; Honoraria (self): Novartis Pharma K.K.; Honoraria (self): AstraZeneca K.K.; Honoraria (self): Chugai Pharma Co., Ltd.; Honoraria (self): MSD K.K. J. Tominaga: Honoraria (self): Ono Pharmaceutical . M. Sata: Honoraria (self): Ono Pharmaceutical Company. F. Sakai: Honoraria (self): Ono Pharmaceutical ; Honoraria (self): AstraZeneca Co., Ltd.; Honoraria (self): Boehringer Ingelheim Co., Ltd.; Honoraria (self): Bristol-Myers Squibb; Honoraria (self): Merck Serono Co., Ltd; Research grant / Funding (institution): Bayer Co., Ltd.; Research grant / Funding (institution): Eisai Co., Ltd.; Honoraria (self): Shionogi Pharmaceuticals Co., Ltd.; Research grant / Funding (institution): Fuji Pharmaceuticals Co., Ltd.; Honoraria (self), Research grant / Funding (institution): Daiichi Pharmaceuticals; Research grant / Funding (institution), Non-remunerated activity/ies: Toshiba; Honoraria (self), Research grant / Funding (institution): Japanese Ministry of Labour, Health and Welfare; Honoraria (self), Research grant / Funding (institution): Japanese Government of Environment. T. Kato: Honoraria (self), Research grant / Funding (institution): Ono Pharmaceutical Co. Ltd.; Honoraria (self), Research grant / Funding (institution): Bristol-Myers Squibb K.K.; Honoraria (self), Research grant / Funding (institution): AbbVie; Research grant / Funding (institution): Astellas; Honoraria (self), Research grant / Funding (institution): AstraZeneca; Honoraria (self): Boehringer Ingelheim; Honoraria (self), Research grant / Funding (institution): Chugai; Honoraria (self), Research grant / Funding (institution): Eli Lilly; Honoraria (self), Research grant / Funding (institution): Kyowa Kirin; Honoraria (self), Research grant / Funding (institution): Merck Sharp and Dohme; Honoraria (self), Research grant / Funding (institution): Novartis; Honoraria (self), Research grant / Funding (institution): Pfizer; Honoraria (self), Research grant / Funding (institution): Taiho; Honoraria (self): F. Hoffmann-La Roche; Honoraria (self), Research grant / Funding (institution): Merck Serono; Honoraria (self): Sumitomo Dainippon; Research grant / Funding (institution): Kyorin; Honoraria (self): Nitto Denko; Research grant / Funding (institution): Regeneron; Honoraria (self): Takeda. T. Iwasawa: Honoraria (self): Ono Pharmaceutical Co., Ltd.; Honoraria (self): Shionogi & Co., Ltd.; Honoraria (self): Nihon Medi-Physics Co., Ltd.; Honoraria (self): AstraZeneca K.K.; Honoraria (self): Boehringer Ingelheim Japan, Inc.; Honoraria (self): Bayer; Honoraria (self): GE Healthcare Japan; Research grant / Funding (institution): Tsuchiya Foundation ; Research grant / Funding (institution): KAKENHI; Honoraria (self): Canon Medical Systems; Honoraria (self): FujiFilm Medical Systems. H. Kenmotsu: Honoraria (self): Ono Pharmaceutical Co., Ltd; Honoraria (self): Bristol-Myers Squibb K.K.; Honoraria (self), Research grant / Funding (institution): AstraZeneca K.K.; Honoraria (self), Research grant / Funding (institution): Boehringer Ingelheim; Honoraria (self), Research grant / Funding (institution): Chugai Pharmacsutical Co, Ltd.; Honoraria (self): Eli Lilly K.K.; Honoraria (self): Kyowa Hakko Kirin Co., Ltd.; Honoraria (self): MSD K.K.; Honoraria (self): Novartis Pharma K.K.; Honoraria (self): Taiho Pharmaceutical Co, Ltd. M. Kusumoto: Advisory / Consultancy, Speaker Bureau / Expert testimony: Ono Pharmaceutical Co., Ltd.; Advisory / Consultancy, Speaker Bureau / Expert testimony: AstraZeneca K.K.; Advisory / Consultancy, Speaker Bureau / Expert testimony: MSD K.K.; Research grant / Funding (institution): Canon Medical Systems Corporation. T. Baba: Honoraria (self): Ono Pharmaceutical Co., Ltd.; Honoraria (self): Bristol-Myers Squibb K.K.; Honoraria (self): AstraZeneca K.K.; Honoraria (self): Boston Scientific Japan Co., Ltd.; Honoraria (self): Nippon Boehringer Ingelheim Co., Ltd.; Honoraria (self): Daiichi Sankyo Co., Ltd.; Honoraria (self): Toray Industries, INC.; Honoraria (self): Shionogi & Co., Ltd.; Honoraria (self): Astellas Pharma Inc.; Honoraria (self): AMCO Inc; Honoraria (self): Asahi Kasei Pharma Corporation; Travel / Accommodation / Expenses: Kyorin Pharmaceutical Co., Ltd.; Honoraria (self): Taiho Pharmaceutical Co., Ltd.; Honoraria (self): MSD K.K. M. Endo: Advisory / Consultancy, Speaker Bureau / Expert testimony: Ono Pharmaceutical. Y. Fujiwara: Research grant / Funding (institution): AbbVie; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): BMS; Research grant / Funding (institution): Chugai; Research grant / Funding (institution): Daiichi-Sankyo; Research grant / Funding (institution): Eisai; Research grant / Funding (institution): Eli Lilly; Research grant / Funding (institution): Incyte; Research grant / Funding (institution): Merck Serono; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): MSD; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Advisory / Consultancy, Speaker Bureau / Expert testimony: Ono; Speaker Bureau / Expert testimony: Sysmex; Speaker Bureau / Expert testimony: Taiho. H. Sugiura: Advisory / Consultancy: Ono Pharmaceutical Co., Ltd.; Advisory / Consultancy: MSD K.K. N. Yanagawa: Honoraria (self): Ono Pharmaceutical Co., Ltd.; Honoraria (self): Miss Piggy Products; Advisory / Consultancy, Research grant / Funding (institution): Croak, Inc.; Research grant / Funding (institution), Non-remunerated activity/ies: Sunlight Stop. Inc. Y. Ito: Full / Part-time employment, Employee of the sponsor company: Ono Pharmaceutical Co., LTD. T. Sakamoto: Full / Part-time employment, Employee of the sponsor company: Ono Pharmaceutical Co., LTD. Y. Ohe: Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Chugai; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Ono; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Lilly; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): BMS; Advisory / Consultancy, Research grant / Funding (institution): Kyorin; Advisory / Consultancy: Celltrion; Advisory / Consultancy: Amgen; Speaker Bureau / Expert testimony: Boehringer Ingelheim; Speaker Bureau / Expert testimony: Bayer; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Pfizer; Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Taiho; Research grant / Funding (institution): Dainippon-Sumitomo; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Kissei; Research grant / Funding (institution): Daiichi-Sankyo; Research grant / Funding (institution): Janssen. K. Kuwano: Honoraria (self), Research grant / Funding (institution): Ono; Honoraria (self), Research grant / Funding (institution): Boehringer; Honoraria (self), Research grant / Funding (institution): Glaxo; Honoraria (self), Research grant / Funding (institution): Daiichi Sankyo; Honoraria (self): AstraZeneca; Honoraria (self), Research grant / Funding (institution): Shionogi; Honoraria (self): Eisai; Honoraria (self), Research grant / Funding (institution): Chugai; Honoraria (self): MSD; Honoraria (self): Taiho; Honoraria (self), Research grant / Funding (institution): Astellas; Honoraria (self), Research grant / Funding (institution): Kyorin; Honoraria (self): Tsumura. All other authors have declared no conflicts of interest.
Resources from the same session
1084 - Dissociated responses in patients with metastatic solid tumors treated with immunotherapy
Presenter: Pauline Vaflard
Session: Poster Display session 3
Resources:
Abstract
4600 - Patterns and outcomes related to rapid progressive disease in a cohort of advanced solid tumors treated with immune checkpoint inhibitors (ICIs).
Presenter: Lucio Ghiglione
Session: Poster Display session 3
Resources:
Abstract
3547 - Real World Outcomes of Immune-Related Adverse Events (irAEs) among Patients Receiving Immune Checkpoint Inhibitors (ICIs) in Hospital Settings
Presenter: Saby George
Session: Poster Display session 3
Resources:
Abstract
1124 - Sex-based heterogeneity of efficacy of anticancer immunotherapy
Presenter: Fabio Conforti
Session: Poster Display session 3
Resources:
Abstract
4133 - Comparative efficacy and safety of PD-1/PD-L1 inhibitors for patients with solid tumors: a systematic review and Bayesian network meta-analysis
Presenter: Qingyuan Huang
Session: Poster Display session 3
Resources:
Abstract
2548 - Excess weight and efficacy of anti-PD-1 antibodies in advanced cancer patients
Presenter: Jacobo Rogado
Session: Poster Display session 3
Resources:
Abstract
2228 - Safety and efficacy of anti-PD-1 inhibitor ABBV-181 in lung and head and neck carcinoma
Presenter: Antoine Italiano
Session: Poster Display session 3
Resources:
Abstract
2333 - Efficacy and safety of immune checkpoint inhibitors (ICIs) for treatment of advanced solid tumours in octogenarian patients
Presenter: Soraya Mebarki
Session: Poster Display session 3
Resources:
Abstract
4847 - Association of programmed cell death 1 (PD-1) inhibitor therapy with overall survival (OS) in stage IV melanoma treated with targeted therapies
Presenter: Aracelis Torres
Session: Poster Display session 3
Resources:
Abstract
2215 - Clinical outcomes of immune checkpoint inhibitors in older and younger patients with advanced solid tumours in a real-life setting
Presenter: Pauline Corbaux
Session: Poster Display session 3
Resources:
Abstract