Locally advanced head and neck squamous cell carcinoma (LA-HNSCC) often requires postoperative chemoradiation with high risk of toxicity. Disease-free survival (DFS) after 2 years is approximately 70%. Combining nivolumab (N), a PD-1-inhibitor and ipilimumab (I), a CTLA4- inhibitor, may improve DFS due to antitumor effects of immunotherapy. The IMSTAR-HN study compares neoadjuvant N and N ± I 6 months after adjuvant therapy versus standard therapy as first-line treatment for LA-HNSCC. Eligible patients have treatment-naive LA-HNSCC, Eastern cooperative oncology group performance score (PS) ≤1 and no distant metastasis. 276 patients will be randomized into two arms. Primary end point is DFS and secondary end point includes locoregional control (LRC) and overall survival (OS). This study is one of the first in HNSCCs implementing immunotherapy in first-line treatment in a curative setting. Clinical Trial Registration: NCT03700905 ( ClinicalTrials.gov )
Representatives of the statutory health insurance (n=46) and policy makers at the local, federal and state level (n=136) were interviewed in 2 nationwide online surveys about the significance and degree of implementation of prevention. The group comparison between the decision-makers shows significant differences in terms of attitudes towards health prevention. The political leaders are demanding an improvement of the GKV-benefit package and the obstacles require the cooperation of urgent attention.
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