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

Ryo Morita, Kyoichi Okishio, Junichi Shimizu, Haruhiro Saito, Hiroshi Sakai, Young Hak Kim, Osamu Hataji, Makiko Yomota, Makoto Nishio, Keisuke Aoe, Osamu Kanai, Toru Kumagai, Kayoko Kibata, Hiroaki Tsukamoto, Satoshi Oizumi, Daichi Fujimoto, Hiroshi Tanaka, Keiko Mizuno, Takeshi Masuda, Toshiyuki KozukiTakashi Haku, Hiroyuki Suzuki, Isamu Okamoto, Hirotoshi Hoshiyama, Junya Ueda, Yuichiro Ohe

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)8-18
Number of pages11
JournalLung Cancer
Volume140
DOIs
Publication statusPublished - Feb 2020

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Non-Small Cell Lung Carcinoma
Observational Studies
Japan
Retrospective Studies
Safety
Disease-Free Survival
Ligands
Therapeutics
Epidermal Growth Factor Receptor
Mutation
nivolumab
Multivariate Analysis
Smoking
Pragmatic Clinical Trials
erbB-1 Genes
Survival
Status Epilepticus
Incidence
Survival Rate
History

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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Real-world effectiveness and safety of nivolumab in patients with non-small cell lung cancer : A multicenter retrospective observational study in Japan. / Morita, Ryo; Okishio, Kyoichi; Shimizu, Junichi; Saito, Haruhiro; Sakai, Hiroshi; Kim, Young Hak; Hataji, Osamu; Yomota, Makiko; Nishio, Makoto; Aoe, Keisuke; Kanai, Osamu; Kumagai, Toru; Kibata, Kayoko; Tsukamoto, Hiroaki; Oizumi, Satoshi; Fujimoto, Daichi; Tanaka, Hiroshi; Mizuno, Keiko; Masuda, Takeshi; Kozuki, Toshiyuki; Haku, Takashi; Suzuki, Hiroyuki; Okamoto, Isamu; Hoshiyama, Hirotoshi; Ueda, Junya; Ohe, Yuichiro.

In: Lung Cancer, Vol. 140, 02.2020, p. 8-18.

Research output: Contribution to journalArticle

Morita, R, Okishio, K, Shimizu, J, Saito, H, Sakai, H, Kim, YH, Hataji, O, Yomota, M, Nishio, M, Aoe, K, Kanai, O, Kumagai, T, Kibata, K, Tsukamoto, H, Oizumi, S, Fujimoto, D, Tanaka, H, Mizuno, K, Masuda, T, Kozuki, T, Haku, T, Suzuki, H, Okamoto, I, Hoshiyama, H, Ueda, J & Ohe, Y 2020, 'Real-world effectiveness and safety of nivolumab in patients with non-small cell lung cancer: A multicenter retrospective observational study in Japan', Lung Cancer, vol. 140, pp. 8-18. https://doi.org/10.1016/j.lungcan.2019.11.014
Morita, Ryo ; Okishio, Kyoichi ; Shimizu, Junichi ; Saito, Haruhiro ; Sakai, Hiroshi ; Kim, Young Hak ; Hataji, Osamu ; Yomota, Makiko ; Nishio, Makoto ; Aoe, Keisuke ; Kanai, Osamu ; Kumagai, Toru ; Kibata, Kayoko ; Tsukamoto, Hiroaki ; Oizumi, Satoshi ; Fujimoto, Daichi ; Tanaka, Hiroshi ; Mizuno, Keiko ; Masuda, Takeshi ; Kozuki, Toshiyuki ; Haku, Takashi ; Suzuki, Hiroyuki ; Okamoto, Isamu ; Hoshiyama, Hirotoshi ; Ueda, Junya ; Ohe, Yuichiro. / Real-world effectiveness and safety of nivolumab in patients with non-small cell lung cancer : A multicenter retrospective observational study in Japan. In: Lung Cancer. 2020 ; Vol. 140. pp. 8-18.
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abstract = "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.",
author = "Ryo Morita and Kyoichi Okishio and Junichi Shimizu and Haruhiro Saito and Hiroshi Sakai and Kim, {Young Hak} and Osamu Hataji and Makiko Yomota and Makoto Nishio and Keisuke Aoe and Osamu Kanai and Toru Kumagai and Kayoko Kibata and Hiroaki Tsukamoto and Satoshi Oizumi and Daichi Fujimoto and Hiroshi Tanaka and Keiko Mizuno and Takeshi Masuda and Toshiyuki Kozuki and Takashi Haku and Hiroyuki Suzuki and Isamu Okamoto and Hirotoshi Hoshiyama and Junya Ueda and Yuichiro Ohe",
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T1 - Real-world effectiveness and safety of nivolumab in patients with non-small cell lung cancer

T2 - A multicenter retrospective observational study in Japan

AU - Morita, Ryo

AU - Okishio, Kyoichi

AU - Shimizu, Junichi

AU - Saito, Haruhiro

AU - Sakai, Hiroshi

AU - Kim, Young Hak

AU - Hataji, Osamu

AU - Yomota, Makiko

AU - Nishio, Makoto

AU - Aoe, Keisuke

AU - Kanai, Osamu

AU - Kumagai, Toru

AU - Kibata, Kayoko

AU - Tsukamoto, Hiroaki

AU - Oizumi, Satoshi

AU - Fujimoto, Daichi

AU - Tanaka, Hiroshi

AU - Mizuno, Keiko

AU - Masuda, Takeshi

AU - Kozuki, Toshiyuki

AU - Haku, Takashi

AU - Suzuki, Hiroyuki

AU - Okamoto, Isamu

AU - Hoshiyama, Hirotoshi

AU - Ueda, Junya

AU - Ohe, Yuichiro

PY - 2020/2

Y1 - 2020/2

N2 - 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.

AB - 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.

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