Real-world Efficacy and Safety of Nivolumab for Advanced Non-Small-cell Lung Cancer: A Retrospective Multicenter Analysis

被引：48

作者：

Kobayashi, Keigo ^{[1
]}

Nakachi, Ichiro ^{[2
]}

Naoki, Katsuhiko ^{[1
]}

Satomi, Ryosuke ^{[3
]}

Nakamura, Morio ^{[4
]}

Inoue, Takashi ^{[5
]}

Tateno, Hiroki ^{[6
]}

Sakamaki, Fumio ^{[7
]}

Sayama, Koichi ^{[8
]}

Terashima, Takeshi ^{[9
]}

Koh, Hidefumi ^{[10
]}

Abe, Takayuki ^{[11
]}

Nishino, Makoto ^{[1
]}

Arai, Daisuke ^{[2
]}

Yasuda, Hiroyuki ^{[1
]}

Kawada, Ichiro ^{[1
]}

Soejima, Kenzo ^{[1
]}

Betsuyaku, Tomoko ^{[1
]}

机构：

[1] Keio Univ, Sch Med, Dept Med, Div Pulm Med, Tokyo, Japan

[2] Saiseikai Utsunomiya Hosp, Dept Internal Med, Pulm Div, 911-1 Takebayashimachi, Utsunomiya, Tochigi 3210974, Japan

[3] Tokyo Med Ctr, Natl Hosp Org, Tokyo, Japan

[4] Tokyo Saiseikai Cent Hosp, Tokyo, Japan

[5] Sano Kousei Gen Hosp, Sano, Japan

[6] Saitama City Hosp, Saitama, Japan

[7] Tokai Univ, Hachioji Hosp, Tokyo, Japan

[8] Kawasaki Municipal Hosp, Kawasaki, Kanagawa, Japan

[9] Ichikawa Gen Hosp, Tokyo Dent Coll, Ichikawashi, Japan

[10] Tachikawa Hosp, Tachikawa, Tokyo, Japan

[11] Keio Univ, Sch Med, Dept Prevent Med & Publ Hlth, Tokyo, Japan

来源：

CLINICAL LUNG CANCER | 2018年 / 19卷 / 03期

关键词：

EGFR mutation; Immunotherapy; Nivolumab; NSCLC; Radiation; RADIATION-THERAPY; CHECKPOINT INHIBITORS; OPEN-LABEL; TRIAL; IMMUNOTHERAPY; DOCETAXEL; BLOCKADE; PHASE-2; TUMOR; PEMBROLIZUMAB;

D O I：

10.1016/j.cllc.2018.01.001

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

We evaluated the real-world efficacy and safety of nivolumab in 142 patients with advanced non-small-cell lung cancer in Japan and identified the clinical characteristics that influence the efficacy. Negative EGFR/ALK mutation status and previous radiotherapy were significantly associated statistically with the treatment response. These findings might aid in the efficient immunotherapeutic management of lung cancer. Background: Nivolumab, an immune checkpoint inhibitor, is now a standard treatment for previously treated advanced non-small-cell lung cancer based on the results from phase III clinical trials. We evaluated the real-world efficacy and safety of nivolumab in a nonselected population and identified the clinical characteristics that influence efficacy. Materials and Methods: A total of 142 patients with advanced non-small-cell lung cancer who were administered nivolumab at Keio University and affiliated hospitals in Japan from January to July 2016 were enrolled. The treatment efficacy and adverse events were retrospectively reviewed, and the clinical characteristics associated with the nivolumab response were evaluated using univariate and stratified analyses and the Cochran-Mantel-Haenszel test. Results: The objective response rate was 17.0% (95% confidence interval [CI], 12.0%-24.0%), the median progression-free survival (PFS) was 58 days (95% CI, 50-67 days), and the proportion of patients with adverse events of any grade was 45.0%. EGFR/ALK mutation status was inversely associated with the treatment response (P < .05), and the difference in PFS for the mutation-positive versus mutation-negative patients was statistically significant (49 vs. 63 days; hazard ratio, 1.9; 95% CI, 1.1-5.2; P = .029). Previous radiotherapy also had a positive association with the treatment response (P = .012). Conclusion: The objective response rate, PFS, and adverse event profiles were comparable to those observed in previous clinical trials. EGFR/ALK mutation-negative status and previous radiotherapy might be key clinical characteristics associated with a positive treatment response. Our findings could aid in the efficient immunotherapeutic management of lung cancer. (C) 2017 Elsevier Inc. All rights reserved.

引用

页码：E349 / E358

页数：10

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