Nobuhiro Hanai1, Yasushi Shimizu2, Shin Kariya3, Ryuji Yasumatsu4, Tomoya Yokota5, Takashi Fujii6, Kiyoaki Tsukahara7, Masafumi Yoshida8, Kenji Hanyu9, Tsutomu Ueda10, Hitoshi Hirakawa11, Shunji Takahashi12, Takeharu Ono13, Daisuke Sano14, Moriyasu Yamauchi15, Akihito Watanabe16, Koichi Omori17, Tomoko Yamazaki18, Nobuya Monden19, Naomi Kudo20, Makoto Arai21, Daiju Sakurai22, Takahiro Asakage23, Issei Doi24, Takayuki Yamada25, Akihiro Homma26. 1. Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya, Japan. 2. Department of Medical Oncology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan. 3. Department of Otolaryngology, Head and Neck Surgery, Okayama University Hospital, Okayama, Japan. 4. Department of Otolaryngology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 5. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Nagaizumi, Japan. 6. Department of Head and Neck Surgery, Osaka International Cancer Institute, Osaka, Japan. 7. Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan. 8. Otorhinolaryngology and Head and Neck Surgery, The University of Tokyo Hospital, Tokyo, Japan. 9. Head and Neck Oncology Center, International University of Health and Welfare, Mita Hospital, Tokyo, Japan. 10. Department of Otorhinolaryngology, Head and Neck Surgery, Hiroshima University Hospital, Hiroshima, Japan. 11. Department of Otorhinolaryngology, Head and Neck Surgery, University of the Ryukyu Hospital, Nishihara, Japan. 12. Department of Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan. 13. Department of Otolaryngology, Head and Neck Surgery, Kurume University Hospital, Kurume, Japan. 14. Department of Otolaryngology, Head and Neck Surgery, Yokohama City University Hospital, Yokohama, Japan. 15. Department of Otolaryngology, Head and Neck Surgery, Saga University Hospital, Saga, Japan. 16. Department of Otolaryngology, Head and Neck Surgery, Keiyukai Sapporo Hospital, Sapporo, Japan. 17. Department of Otolaryngology, Head and Neck Surgery, Kyoto University Hospital, Kyoto, Japan. 18. Division of Head and Neck Cancer Oncology, Miyagi Cancer Center, Sendai, Japan. 19. Department of Head and Neck Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan. 20. Department of Otorhinolaryngology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan. 21. Department of Medical Oncology, Chiba University Hospital, Chiba, Japan. 22. Department of Otorhinolaryngology, Head and Neck Surgery, Chiba University Hospital, Chiba, Japan. 23. Department of Head and Neck Surgery, Tokyo Medical and Dental University Medical Hospital, Tokyo, Japan. 24. Medical Affairs, ONO Pharmaceutical Co., Ltd, Osaka, Japan. 25. Japan Medical and Development, Bristol-Myers Squibb K.K., Tokyo, Japan. 26. Department of Otolaryngology, Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita15 Nishi7, Kita-Ku, Sapporo, Hokkaido, 060-8638, Japan. ak-homma@med.hokudai.ac.jp.
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. TRIAL REGISTRATION NUMBER: UMIN-CTR (UMIN000032600), Clinicaltrials.gov (NCT03569436).
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. TRIAL REGISTRATION NUMBER: UMIN-CTR (UMIN000032600), Clinicaltrials.gov (NCT03569436).
Entities:
Keywords:
Multicenter retrospective study; Nivolumab; Real-world clinical practice; Recurrent or metastatic head and neck cancer
Authors: Jeffrey S Weber; F Stephen Hodi; Jedd D Wolchok; Suzanne L Topalian; Dirk Schadendorf; James Larkin; Mario Sznol; Georgina V Long; Hewei Li; Ian M Waxman; Joel Jiang; Caroline Robert Journal: J Clin Oncol Date: 2016-11-14 Impact factor: 44.544
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