| Title: | Effectiveness and safety of nivolumab in patients with head and neck cancer in Japanese real-world clinical practice : a multicenter retrospective clinical study |
| Authors: | Hanai, Nobuhiro Browse this author →KAKEN DB |
| Shimizu, Yasushi Browse this author →KAKEN DB |
| Kariya, Shin Browse this author →KAKEN DB |
| Yasumatsu, Ryuji Browse this author →KAKEN DB |
| Yokota, Tomoya Browse this author |
| Fujii, Takashi Browse this author |
| Tsukahara, Kiyoaki Browse this author |
| Yoshida, Masafumi Browse this author →KAKEN DB |
| Hanyu, Kenji Browse this author |
| Ueda, Tsutomu Browse this author →KAKEN DB |
| Hirakawa, Hitoshi Browse this author |
| Takahashi, Shunji Browse this author |
| Ono, Takeharu Browse this author →KAKEN DB |
| Sano, Daisuke Browse this author |
| Yamauchi, Moriyasu Browse this author →KAKEN DB |
| Watanabe, Akihito Browse this author |
| Omori, Koichi Browse this author →KAKEN DB |
| Yamazaki, Tomoko Browse this author |
| Monden, Nobuya Browse this author →KAKEN DB |
| Kudo, Naomi Browse this author →KAKEN DB |
| Arai, Makoto Browse this author |
| Sakurai, Daiju Browse this author |
| Asakage, Takahiro Browse this author →KAKEN DB |
| Doi, Issei Browse this author |
| Yamada, Takayuki Browse this author |
| Homma, Akihiro Browse this author →KAKEN DB |
| Keywords: | Nivolumab |
| Real-world clinical practice |
| Recurrent or metastatic head and neck cancer |
| Multicenter retrospective study |
| Issue Date: | Mar-2021 |
| Publisher: | Springer |
| Journal Title: | International journal of clinical oncology |
| Volume: | 26 |
| Start Page: | 494 |
| End Page: | 506 |
| Publisher DOI: | 10.1007/s10147-020-01829-0 |
| Abstract: | Background To fill the data gap between clinical trials and real-world settings, this study assessed the overall effectiveness and safety of nivolumab in patients with head and neck cancer (HNC) during Japanese real-world clinical practice. Methods This was a multicenter, retrospective study in Japanese patients with recurrent or metastatic HNC who received nivolumab for the first time between July and December 2017. Data on the clinical use, effectiveness, and safety of nivolumab were extracted from patient medical records. Results Overall, 256 patients were enrolled in this study. The median duration of nivolumab treatment was 72.5 days, with patients receiving a median of 6.0 (range 1-27) doses. Median overall survival (OS) was 9.5 (95% confidence interval [CI] 8.2-12.0) months and the estimated 12-month OS rate was 43.2%. The objective response rate (ORR) was 15.7% overall and 21.1%, 7.1%, and 13.6% in patients with primary nasopharynx, maxillary sinus, and salivary gland tumors, respectively, who had been excluded from CheckMate 141. Grade >= 3 immune-related adverse events occurred in 5.9% of patients. No new safety signals were identified compared with adverse events noted in CheckMate 141. Conclusions The effectiveness and safety of nivolumab in real-world clinical practice are consistent with data from the CheckMate 141 clinical trial. Therapeutic response was also observed in the groups of patients excluded from CheckMate 141. |
| Rights: | This is a post-peer-review, pre-copyedit version of an article published in International journal of clinical oncology. The final authenticated version is available online at: http://dx.doi.org/10.1007/s10147-020-01829-0 |
| Type: | article (author version) |
| URI: | http://hdl.handle.net/2115/84224 |
| 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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