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
| Autor: | Takayuki Yamada, Makoto Arai, Hitoshi Hirakawa, Naomi Kudo, Takashi Fujii, Kiyoaki Tsukahara, Akihiro Homma, Tomoya Yokota, Shin Kariya, Takeharu Ono, Moriyasu Yamauchi, Kenji Hanyu, Nobuya Monden, Nobuhiro Hanai, Ryuji Yasumatsu, Takahiro Asakage, Akihito Watanabe, Tsutomu Ueda, Shunji Takahashi, Koichi Omori, Takahiro Nekado, Yasushi Shimizu, Syuji Yonekura, Daisuke Sano, Tomoko Yamazaki, Mizuo Ando |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Population Recurrent or metastatic head and neck cancer Subsequent chemotherapy Antineoplastic Agents Immunological Japan Internal medicine medicine Humans Adverse effect education Retrospective Studies education.field_of_study business.industry Incidence (epidemiology) Head and neck cancer Retrospective cohort study Long-term survivors Hematology General Medicine medicine.disease Confidence interval Nivolumab Oncology Head and Neck Neoplasms Surgery Original Article Kidney disorder Neoplasm Recurrence Local business Follow-Up Studies |
| Zdroj: | International Journal of Clinical Oncology |
| ISSN: | 1341-9625 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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