ArticleInternational journal of clinical oncology2021
Real-world safety and effectiveness of nivolumab for recurrent or metastatic head and neck cancer in Japan: a post-marketing surveillance.
Article in International journal of clinical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed, 11 citations in OpenAlex.
- Article
- Real-world safety and effectiveness of nivolumab in patients with cancer of unknown primary: results from a nationwide post-marketing surveillance in Japan.International journal of clinical oncology · 2026Observational
- Article
- Assessing individual head and neck squamous cell carcinoma patient response to therapy through integration of functional and genomic data.Scientific reports · 2025Article
- Real-world safety of nivolumab in patients with malignant pleural mesothelioma in Japan: post-marketing surveillance study.Japanese journal of clinical oncology · 2024Article
- Article
- Safety of nivolumab monotherapy in five cancer types: pooled analysis of post-marketing surveillance in Japan.International journal of clinical oncology · 2024Article
- Post-marketing surveillance of the safety and effectiveness of nivolumab for classic Hodgkin lymphoma in Japan.International journal of hematology · 2024Observational
- Safety and effectiveness of nivolumab in Japanese patients with malignant melanoma: Final analysis of a post-marketing surveillance.The Journal of dermatology · 2022Article
- Pulmonary adverse events following immune checkpoint inhibitors.Current opinion in pulmonary medicine · 2022Review
- Post-treatment Neutrophil/Lymphocyte Ratio Is a Prognostic Factor in Head and Neck Cancers Treated With Nivolumab.Cancer diagnosis & prognosisArticle
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOn the basis of phase III CheckMate 141 results, nivolumab was approved for recurrent or metastatic head and neck cancer after undergoing platinum-containing chemotherapy in Japan. This post-marketing surveillance aimed to evaluate the safety and effectiveness of nivolumab for head and neck cancer in the real-world setting.
methodsAll patients with head and neck cancer who planned to receive nivolumab were centrally registered. This study monitored 607 patients for 6 months to assess nivolumab's safety, especially treatment-related adverse events (TRAEs) of special interest, and effectiveness.
resultsTRAEs occurred in 36.1% patients, with no new safety signals. The most common TRAEs with grade ≥ 3 were interstitial lung disease (1.2%), diarrhea (0.8%), and hepatic function abnormal (0.7%). Meanwhile, thyroid dysfunction (10.2%), hepatic dysfunction (5.3%), and interstitial lung disease (4.1%) were the most common TRAE categories of special interest. Although the median time to the onset of each TRAE category of special interest was mostly 1-2 months, most of them occurred throughout the observation period; nonetheless, the majority of patients recovered or remitted. The 6-month survival rate was 55.9%.
conclusionJapanese patients with head and neck cancer treated with nivolumab in the real-world setting manifested no new safety signals. CLINICAL
trial registrationclinicaltrials.jp: JapicCTI-184071.
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