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Outcomes of long-term nivolumab and subsequent chemotherapy in Japanese patients with head and neck cancer: 2-year follow-up from a multicenter real-world study

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Title: Outcomes of long-term nivolumab and subsequent chemotherapy in Japanese patients with head and neck cancer: 2-year follow-up from a multicenter real-world study
Authors: Yasumatsu, Ryuji Browse this author
Shimizu, Yasushi Browse this author →KAKEN DB
Hanai, Nobuhiro Browse this author
Kariya, Shin Browse this author
Yokota, Tomoya Browse this author
Fujii, Takashi Browse this author
Tsukahara, Kiyoaki Browse this author
Ando, Mizuo Browse this author
Hanyu, Kenji Browse this author
Ueda, Tsutomu Browse this author
Hirakawa, Hitoshi Browse this author
Takahashi, Shunji Browse this author
Ono, Takeharu Browse this author
Sano, Daisuke Browse this author →KAKEN DB
Yamauchi, Moriyasu Browse this author
Watanabe, Akihito Browse this author
Omori, Koichi Browse this author
Yamazaki, Tomoko Browse this author
Monden, Nobuya Browse this author
Kudo, Naomi Browse this author
Arai, Makoto Browse this author
Yonekura, Syuji Browse this author
Asakage, Takahiro Browse this author
Nekado, Takahiro Browse this author
Yamada, Takayuki Browse this author
Homma, Akihiro Browse this author →KAKEN DB
Keywords: Nivolumab
Long-term survivors
Recurrent or metastatic head and neck cancer
Subsequent chemotherapy
Issue Date: 23-Dec-2021
Publisher: Springer
Journal Title: International journal of clinical oncology
Publisher DOI: 10.1007/s10147-021-02047-y
Abstract: Background We have previously reported the effectiveness and safety of nivolumab in patients with head and neck cancer (HNC) in real-world clinical practice in Japan. Here, we report long-term outcomes from this study in the overall population and subgroups stratified by subsequent chemotherapy. Methods In this multicenter, retrospective observational study, Japanese patients with recurrent or metastatic (R/M) HNC receiving nivolumab were followed up for 2 years. Effectiveness endpoints included overall survival (OS), OS rate, progression-free survival (PFS), and PFS rate. Safety endpoints included the incidence of immune-related adverse events (irAEs). Results Overall, 256 patients received a median of 6.0 doses (range: 1-52) of nivolumab over a median duration of 72.5 days (range: 1-736). Median OS was 9.5 months [95% confidence interval (CI) 8.2-12.0] and median PFS was 2.1 months (95% CI 1.8-2.7). A significant difference between 2-year survivors (n = 62) and non-2-year survivors was observed by median age (P = 0.0227) and ECOG PS (P = 0.0001). Of 95 patients who received subsequent chemotherapy, 54.7% received paclitaxel +/- cetuximab. The median OS and PFS from the start of paclitaxel +/- cetuximab were 6.9 months (95% CI 5.9-11.9) and 3.5 months (95% CI 2.3-5.5), respectively. IrAEs were reported in 17.2% of patients. Endocrine (7.0%) and lung (4.3%) disorders were the most common irAEs; kidney disorder (n = 1) was newly identified in this follow-up analysis. Conclusions Results demonstrated the long-term effectiveness of nivolumab and potential effectiveness of subsequent chemotherapy in patients with R/M HNC in the real-world setting. Safety was consistent with that over the 1-year follow-up.
Type: article
URI: http://hdl.handle.net/2115/83677
Appears in Collections:医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

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