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Factors Affecting Nivolumab Therapy Outcome in Patients with Head and Neck Cancer: A Single-Center Analysis
Yoh-Ichiro Iwasa1, Yoh Yokota1, Ryosuke Kitoh1
1Department of Otorhinolaryngology, Shinshu University School of Medicine, Matsumoto, Japan.
Background:
Nivolumab, a programmed death-1 antibody, is an immune checkpoint inhibitor approved in Japan in March 2017 for the treatment of recurrent or metastatic head and neck cancers (RM-HNCs) after platinum drug administration. This study aimed to evaluate the effectiveness and safety of nivolumab and to determine the prognostic factors affecting the treatment outcome, in a real-world setting in Japanese RM-HNCs.
Methods:
Forty-six patients with RM-HNCs treated with nivolumab between April 2017 and April 2021 at Shinshu University Hospital were retrospectively assessed in this cohort study.
Results:
The overall response rate was 17.4%, and the disease control rate was 41.3%. The median first and second progression-free survival (PFS1 and PFS2) were 2.6 and 10.3 months, respectively. The median overall survival (OS) was 14.8 months. Multivariate analysis showed that performance status (PS) (p = 0.003) and a decrease in neutrophil-lymphocyte ratio (NLR) (p = 0.02) were significantly associated with a better OS, and a decrease in NLR (p = 0.035) was associated with a better PFS2.
Conclusions:
This study is the first report of PFS2 in RM-HNCs treated with nivolumab; the long PFS2 may contribute to prolonged OS. We propose that the PS and a decrease in NLR could be useful clinical prognostic markers of nivolumab therapy, which can easily be evaluated in the clinical setting.
Insights
Nivolumab showed effectiveness in treating recurrent or metastatic head and neck cancers (RM-HNCs). Performance status and a decreasing neutrophil-lymphocyte ratio (NLR) are key indicators for better outcomes in patients receiving nivolumab therapy.
Area of Science:
- Oncology
- Immunotherapy
- Head and Neck Cancer Research
Background:
- Nivolumab, a PD-1 antibody, is an immune checkpoint inhibitor.
- Approved in Japan for recurrent or metastatic head and neck cancers (RM-HNCs) post-platinum therapy.
- Real-world effectiveness and safety data in Japanese RM-HNCs are crucial.
Purpose of the Study:
- Evaluate nivolumab effectiveness and safety in Japanese RM-HNCs.
- Identify prognostic factors influencing treatment outcomes.
- Assess real-world data in a clinical setting.
Main Methods:
- Retrospective cohort study of 46 RM-HNC patients treated with nivolumab.
- Data collected from April 2017 to April 2021 at Shinshu University Hospital.
- Analysis of overall response rate, progression-free survival (PFS1, PFS2), and overall survival (OS).
Main Results:
- Overall response rate: 17.4%; Disease control rate: 41.3%.
- Median PFS1: 2.6 months; Median PFS2: 10.3 months.
- Median OS: 14.8 months. Performance status (PS) and decreased neutrophil-lymphocyte ratio (NLR) correlated with better OS and PFS2.
Conclusions:
- This study reports the first PFS2 data for nivolumab in RM-HNCs.
- Longer PFS2 may contribute to prolonged OS.
- PS and decreased NLR are proposed as valuable clinical prognostic markers for nivolumab therapy.
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