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ABSTRACT: Background
On 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.Methods
All 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.Results
TRAEs 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%.Conclusion
Japanese patients with head and neck cancer treated with nivolumab in the real-world setting manifested no new safety signals.Clinical trial registration
clinicaltrials.jp: JapicCTI-184071.
SUBMITTER: Tahara M
PROVIDER: S-EPMC8364900 | biostudies-literature |
REPOSITORIES: biostudies-literature