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

Ryuji Yasumatsu, Yasushi Shimizu, Nobuhiro Hanai, Shin Kariya, Tomoya Yokota, Takashi Fujii, Kiyoaki Tsukahara, Mizuo Ando, Kenji Hanyu, Tsutomu Ueda, Hitoshi Hirakawa, Shunji Takahashi, Takeharu Ono, Daisuke Sano, Moriyasu Yamauchi, Akihito Watanabe, Koichi Omori, Tomoko Yamazaki, Nobuya Monden, Naomi KudoMakoto Arai, Syuji Yonekura, Takahiro Asakage, Takahiro Nekado, Takayuki Yamada, Akihiro Homma

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
JournalInternational Journal of Clinical Oncology
DOIs
Publication statusAccepted/In press - 2021

Keywords

  • Long-term survivors
  • Nivolumab
  • Recurrent or metastatic head and neck cancer
  • Subsequent chemotherapy

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology

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