Effectiveness of nivolumab affected by prior cetuximab use and neck dissection in Japanese patients with recurrent or metastatic head and neck cancer: results from a retrospective observational study in a real-world setting

Shin Kariya, Yasushi Shimizu, Nobuhiro Hanai, Ryuji Yasumatsu, Tomoya Yokota, Takashi Fujii, Kiyoaki Tsukahara, Masafumi Yoshida, Kenji Hanyu, Tsutomu Ueda, Hitoshi Hirakawa, Shunji Takahashi, Takeharu Ono, Daisuke Sano, Moriyasu Yamauchi, Akihito Watanabe, Koichi Omori, Tomoko Yamazaki, Nobuya Monden, Naomi Kudo, Makoto Arai, Shuji Yonekura, Takahiro Asakage, Akinori Fujiwara, Takayuki Yamada, Akihiro Homma, Shin Kariya, Yasushi Shimizu, Nobuhiro Hanai, Ryuji Yasumatsu, Tomoya Yokota, Takashi Fujii, Kiyoaki Tsukahara, Masafumi Yoshida, Kenji Hanyu, Tsutomu Ueda, Hitoshi Hirakawa, Shunji Takahashi, Takeharu Ono, Daisuke Sano, Moriyasu Yamauchi, Akihito Watanabe, Koichi Omori, Tomoko Yamazaki, Nobuya Monden, Naomi Kudo, Makoto Arai, Shuji Yonekura, Takahiro Asakage, Akinori Fujiwara, Takayuki Yamada, Akihiro Homma

Abstract

Background: To examine the effect of prior use of cetuximab and neck dissection on the effectiveness of nivolumab, we conducted a large-scale subgroup analysis in Japanese patients with recurrent/metastatic head and neck cancer.

Methods: Data on the effectiveness of nivolumab were extracted from patient medical records. All patients were analyzed for effectiveness by prior cetuximab use. In the analyses for prior neck dissection, only patients with locally advanced disease were included.

Results: Of 256 patients analyzed, 155 had received prior cetuximab. Nineteen of 50 patients with local recurrence underwent neck dissection. The objective response rate was 14.7 vs 17.2% (p = 0.6116), median progression-free survival was 2.0 vs 3.1 months (p = 0.0261), and median overall survival was 8.4 vs 12 months (p = 0.0548) with vs without prior cetuximab use, respectively. The objective response rate was 23.1 vs 25.9% (p = 0.8455), median progression-free survival was 1.8 vs 3.0 months (p = 0.6650), and median overall survival was 9.1 vs 9.9 months (p = 0.5289) with vs without neck dissection, respectively.

Conclusions: These findings support the use of nivolumab for patients with recurrent/metastatic head and neck cancer regardless of prior cetuximab use or neck dissection history.

Trial registration number: UMIN-CTR (UMIN000032600), Clinicaltrials.gov (NCT03569436).

Keywords: Cetuximab; Immune microenvironment; Neck dissection; Nivolumab; Recurrent or metastatic head and neck cancer.

Conflict of interest statement

N. Hanai, K. Omori, and A. Homma report grants from Bristol-Myers Squibb K.K. and Ono Pharmaceutical Co., Ltd. during the conduct of the study. S. Takahashi reports grants and personal fees from AstraZeneca, Bayer, Bristol-Myers Squibb K.K., Chugai Pharma, MSD, and Ono Pharmaceutical Co., Ltd. during the conduct of the study. K. Tsukahara reports personal fees from Bristol-Myers Squibb K.K. and Ono Pharmaceutical Co., Ltd. during the conduct of the study. T. Ueda reports grant from Ono Pharmaceutical Co., Ltd. during the conduct of the study. T. Yamazaki reports grants from AstraZeneca K.K., Bristol-Myers Squibb K.K. and Ono Pharmaceutical Co., Ltd. during the conduct of the study. R. Yasumatsu reports grants from Ono Pharmaceutical Co., Ltd. during the conduct of the study. T. Yokota reports advisory role for Merck Biopharma and personal fees from Bristol-Myers Squibb K.K, Merck Biopharma, and Ono Pharmaceutical Co., Ltd. during the conduct of the study. A. Fujiwara is an employee of Ono Pharmaceutical Co., Ltd. T. Yamada is an employee of Bristol-Myers Squibb K.K. M. Arai, T. Asakage, T. Fujii, K. Hanyu, H. Hirakawa, S. Kariya, N. Kudo, N. Monden, T. Ono, D. Sano, Y. Shimizu, A. Watanabe, M. Yamauchi, S. Yonekura, and M. Yoshida have nothing to disclose during the conduct of the study.

Figures

Fig. 1
Fig. 1
Overall effectiveness outcomes based on prior cetuximab use. a Progression-free survival in patients with and without prior cetuximab use. b Overall survival in patients with and without prior cetuximab use. CI confidence interval, NE not evaluable, OS overall survival, PFS progression-free survival
Fig. 2
Fig. 2
Overall effectiveness outcomes based on prior neck dissection. a Progression-free survival in patients with and without prior neck dissection. b Overall survival in patients with and without prior neck dissection. CI confidence interval, NE not evaluable, OS overall survival, PFS progression-free survival

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