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

• Published in: International journal of clinical oncology 2022-01, Vol.27 (1), p.95-104
• Main Authors: Yasumatsu, Ryuji, Shimizu, Yasushi, Hanai, Nobuhiro, Kariya, Shin, Yokota, Tomoya, Fujii, Takashi, Tsukahara, Kiyoaki, Ando, Mizuo, Hanyu, Kenji, Ueda, Tsutomu, Hirakawa, Hitoshi, Takahashi, Shunji, Ono, Takeharu, Sano, Daisuke, Yamauchi, Moriyasu, Watanabe, Akihito, Omori, Koichi, Yamazaki, Tomoko, Monden, Nobuya, Kudo, Naomi, Arai, Makoto, Yonekura, Syuji, Asakage, Takahiro, Nekado, Takahiro, Yamada, Takayuki, Homma, Akihiro
• Format: Article
• Language: English
• Subjects: Antineoplastic Agents, Immunological - adverse effects; Cancer Research; Chemotherapy; Follow-Up Studies; Head & neck cancer; Head and Neck Neoplasms - drug therapy; Humans; Immunotherapy; Japan; Medicine; Medicine & Public Health; Metastases; Monoclonal antibodies; Neoplasm Recurrence, Local - drug therapy; Nivolumab - adverse effects; Oncology; Original; Original Article; Paclitaxel; Patients; Population studies; Retrospective Studies; Safety; Surgical Oncology; Survival; Targeted cancer therapy
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-021-02047-y

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.