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Effectiveness and safety of nivolumab in patients with head and neck cancer in Japanese real-world clinical practice : a multicenter retrospective clinical study

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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:
Type: article (author version)
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)

Submitter: 本間 明宏

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