Efficacy and safety of nivolumab in previously treated patients with non-small cell lung cancer: A multicenter retrospective cohort study. (May 2018)

• Record Type: Journal Article
• Authors: Fujimoto, Daichi; Yoshioka, Hiroshige; Kataoka, Yuki; Morimoto, Takeshi; Kim, Young Hak; Tomii, Keisuke; Ishida, Tadashi; Hirabayashi, Masataka; Hara, Satoshi; Ishitoko, Manabu; Fukuda, Yasushi; Hwang, Moon Hee; Sakai, Naoki; Fukui, Motonari; Nakaji, Hitoshi; Morita, Mitsunori; Mio, Tadashi; Yasuda, Takehiro; Sugita, Takakazu; Hirai, Toyohiro
• Is Part Of: Lung cancer. Volume 119(2018)
• Page Start: 14
• Page End: 20
• Publication Date: 2018-05
• Subjects: AE adverse event -- ALK anaplastic lymphoma kinase -- CR complete response -- DCR disease control rate -- ECOG PS Eastern Cooperative Oncology Group Performance Status -- EGFR epidermal growth factor receptor -- HR hazard ratio -- irAE immune related adverse events -- NSCLC non, small cell lung cancer -- ORR overall response rate -- OS overall survival -- PD progressive disease -- PD-1 programmed cell death 1 -- PD-L1 programmed cell death ligand 1 -- PFS progression-free survival -- PR partial response -- RECIST response evaluation criteria in solid tumors -- SD stable disease; Programmed cell death 1 -- Programmed cell death ligand 1 -- Pneumonitis -- Immune-related adverse event -- Nivolumab; Lungs -- Cancer -- Periodicals; Lung Neoplasms -- Abstracts; Lung Neoplasms -- Periodicals; Poumons -- Cancer -- Périodiques; Lungs -- Cancer; Periodicals; Electronic journals; Electronic journals; 616.99424
• DOI: 10.1016/j.lungcan.2018.02.017
• Languages: English
• ISSNs: 0169-5002

Abstract

Highlights: Nivolumab efficacy is unknown in patients who are categorized into small subgroups. This was a 15-center retrospective study of NSCLC patients who received nivolumab. A total of 613 NSCLC patients who received nivolumab were included. We showed efficacy data from previously underreported patient populations. We described common frequency of pneumonitis and some of its key characteristics. Abstract: Introduction: Nivolumab has been shown to be effective and safe in previously treated patients with advanced non-small cell lung cancer (NSCLC). However, little is known regarding its performance in real-world (i.e., non-trial) settings. Furthermore, nivolumab efficacy is unknown in patients who are ineligible for clinical trials or who are categorized into small subgroups in such trials. Methods: We conducted a 15-center, observational, retrospective cohort study of patients with advanced NSCLC who received nivolumab monotherapy between January and December 2016. Results: Of 613 patients included in our study, 141 had poor performance status (PS) and 106 were EGFR mutation – or ALK rearrangement-positive. The response and disease control rates were 20% and 44%, respectively; the estimated 1-year progression-free survival (PFS) was 18%. Multivariate analysis identified never smoking, poor PS, and EGFR mutation/ ALK rearrangement as independent negative predictors of PFS. The most frequently reported grade ≥3 adverse event was pneumonitis (5% of patients). Severe pneumonitis (grade ≥3) occurred significantly earlier than mild pneumonitis (1.6 vs. 2.3 months, P = 0.031). Patients with pneumonitis achieved higher response rates and longer PFS than those without (37% vs. 18%, and 5.8 vs. 2.1 months, respectively; P = 0.002). Conclusions: Smoking status, PS, and EGFR mutation/ ALK rearrangement were independent predictors of PFS. Our study elucidated nivolumab's efficacy in previously underreported patient populations; i.e., those with poor PS and/or with driver oncogenes. We also found that pneumonitis is not infrequent, and carries key implications for outcomes. These data should be useful for improving the clinical courses of nivolumab-treated patients with NSCLC.