Real-world effectiveness and safety of nivolumab in patients with non-small cell lung cancer: A multicenter retrospective observational study in Japan

被引：59

作者：

Morita, Ryo ^{[1
]}

Okishio, Kyoichi ^{[2
]}

Shimizu, Junichi ^{[3
]}

Saito, Haruhiro ^{[4
]}

Sakai, Hiroshi ^{[5
]}

Kim, Young Hak ^{[6
]}

Hataji, Osamu ^{[7
]}

Yomota, Makiko ^{[8
]}

Nishio, Makoto ^{[9
]}

Aoe, Keisuke ^{[10
]}

Kanai, Osamu ^{[11
]}

Kumagai, Toru ^{[12
]}

Kibata, Kayoko ^{[13
]}

Tsukamoto, Hiroaki ^{[14
]}

Oizumi, Satoshi ^{[15
]}

Fujimoto, Daichi ^{[16
]}

Tanaka, Hiroshi ^{[17
]}

Mizuno, Keiko ^{[18
]}

Masuda, Takeshi ^{[19
]}

Kozuki, Toshiyuki ^{[20
]}

Haku, Takashi ^{[21
]}

Suzuki, Hiroyuki ^{[22
]}

Okamoto, Isamu ^{[23
]}

Hoshiyama, Hirotoshi ^{[24
]}

Ueda, Junya ^{[25
]}

Ohe, Yuichiro ^{[1
]}

机构：

[1] Natl Canc Ctr, Dept Thorac Oncol, Tokyo, Japan

[2] Natl Hosp Org Kinki Chuo Chest Med Ctr, Dept Thorac Oncol, Osaka, Japan

[3] Aichi Canc Ctr Hosp, Dept Thorac Oncol, Nagoya, Aichi, Japan

[4] Kanagawa Canc Ctr, Dept Thorac Oncol, Yokohama, Kanagawa, Japan

[5] Saitama Canc Ctr, Dept Thorac Oncol, Saitama, Japan

[6] Kyoto Univ Hosp, Dept Resp Med, Kyoto, Japan

[7] Matsusaka Municipal Hosp, Dept Resp Ctr, Matsusaka, Mie, Japan

[8] Komagome Hosp, Dept Thorac Oncol & Resp Med, Tokyo Metropolitan Canc & Infect Dis Ctr, Tokyo, Japan

[9] Japanese Fdn Canc Res, Dept Thorac Med Oncol, Canc Inst Hosp, Tokyo, Japan

[10] Natl Hosp Org Yamaguchi Ube Med Ctr, Dept Med Oncol, Yamaguchi, Japan

[11] Natl Hosp Org Kyoto Med Ctr, Div Resp Med, Kyoto, Japan

[12] Osaka Int Canc Inst, Dept Thorac Oncol, Osaka, Japan

[13] Kansai Med Univ Hosp, Dept Thorac Oncol, Osaka, Japan

[14] Natl Hosp Org Himeji Med Ctr, Dept Resp Med, Himeji, Hyogo, Japan

[15] Natl Hosp Org Hokkaido Canc Ctr, Dept Resp Med, Sapporo, Hokkaido, Japan

[16] Kobe City Med Ctr, Dept Resp Med, Gen Hosp, Kobe, Hyogo, Japan

[17] Niigata Canc Ctr Hosp, Dept Internal Med, Niigata, Japan

[18] Kagoshima Univ Hosp, Dept Pulm Med, Kagoshima, Japan

[19] Hiroshima Univ Hosp, Dept Resp Internal Med, Hiroshima, Japan

[20] Natl Hosp Org Shikoku Canc Ctr, Dept Thorac Oncol & Med, Shikoku, Ehime, Japan

[21] Tokushima Prefectural Cent Hosp, Resp Med, Tokushima, Japan

[22] Fukushima Med Univ, Dept Chest Surg, Fukushima, Japan

[23] Kyushu Univ, Grad Sch Med Sci, Res Inst Dis Chest, Fukuoka, Japan

[24] Bristol Myers Squibb KK, Tokyo, Japan

[25] Ono Pharmaceut Co Ltd, Osaka, Japan

来源：

LUNG CANCER | 2020年 / 140卷

关键词：

Nivolumab; Non-small cell lung cancer; Real-world effectiveness; Programmed death-ligand 1; Japan; CHECKPOINT INHIBITORS; EFFICACY; DOCETAXEL;

D O I：

10.1016/j.lungcan.2019.11.014

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Objectives: To describe the treatment patterns and determine the effectiveness and safety of nivolumab treatment for non-small cell lung cancer (NSCLC) in real-world setting in Japan. Materials and methods: Japanese patients with NSCLC who received nivolumab were analyzed retrospectively. Patients who had started nivolumab treatment between April 2016 and December 2016 were enrolled. Information regarding patient demographics and clinical backgrounds, treatment patterns from diagnosis to post-nivolumab treatment, effectiveness and safety of nivolumab treatment and that of treatments just before and after nivolumab treatment, and programmed death-ligand 1 (PD-L1) expression status, if available, were collected. Factors associated with nivolumab effectiveness identified by univariate and multivariate analyses were further investigated for plotting Kaplan-Meier curves of epidermal growth factor receptor (EGFR) gene mutation status, PD-L1 expression status, and Eastern Cooperative Oncology Group performance status (ECOG PS). Results: In this study, 901 NSCLC patients were enrolled. Nivolumab was used the most as a second line treatment with a median number of nivolumab doses of five. The median overall survival (OS) was 14.6 months, one-year survival rate was 54.3 %, and median progression-free survival (PFS) was 2.1 months. The objective response rate was 20.5 % and disease control rate was 57.4 %. According to multivariate analyses, better OS and PFS were associated with favorable ECOG PS and absence of liver metastasis. Better PFS was observed in patients without EGFR mutation and patients with smoking history. PFS and best overall response in PD-L1 expression subgroups were expression level-dependent. The overall incidence of irAEs was 45.8 %, and the incidence of adverse events of grade 3 or higher was 14.0 %. Conclusion: The real-world effectiveness and safety of nivolumab is consistent with that reported by previous clinical trials and other real-world data. Subgroup analysis showed that ECOG PS, EGFR mutation status, smoking status, and PD-L1 were associated with the effectiveness of nivolumab.

引用

页码：8 / 18

页数：11

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