| 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 |
| Volume: | 27 |
| Start Page: | 95 |
| End Page: | 104 |
| 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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