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The aim of the study was to define the cost-effectiveness of whole-body 18 F-FDG PET, as compared with chest CT, in screening for distant metastases in patients with head and neck squamous cell carcinoma (HNSCC). Methods: In a multicenter prospective study, 145 consecutive patients with high risk factors for distant metastases and scheduled for extensive treatment underwent chest CT and whole-body 18 F-FDG PET for screening of distant metastases. The cost data of 80 patients in whom distant metastases developed or who had a follow-up of at least 12 mo were analyzed. Cost-effectiveness analysis, including sensitivity analysis, was performed to compare the results of 18 F-FDG PET, CT, and a combination of CT and 18 F-FDG PET (CT 1 18 F-FDG PET). Results: Pretreatment screening identified distant metastases in 21% of patients. 18 F-FDG PET had a higher sensitivity (53% vs. 37%) and positive predictive value (80% vs. 75%) than did CT. CT 1 18 F-FDG PET had the highest sensitivity (63%). The average costs in the CT, 18 F-FDG PET, and CT 1 18 F-FDG PET groups amounted to e38,558 ($57,705), e38,355 ($57,402), and e37,954 ($56,801), respectively, in the first year after screening. CT 1 18 F-FDG PET resulted in savings between e203 ($303) and e604 ($903). Sensitivity analysis showed that the dominance of CT 1 18 F-FDG PET was robust. Conclusion: In HNSCC patients with risk factors, pretreatment screening for distant metastases by chest CT is improved by 18 F-FDG PET. The combination of 18 F-FDG PET with CT is the most effective, without leading to additional costs.

Background: For breast and prostate cancer, a gene expression signature of the tumour is associated with the development of distant metastases. Regarding head and neck squamous cell carcinoma (HNSCC), the only known risk factor is the presence of >3 tumour-positive lymph nodes. Aim: To evaluate whether a HNSCC gene expression signature can discriminate between the patients with and without distant metastases. Methods: Patients with HNSCC with and without distant metastases had .3 tumour-positive lymph nodes, and did not differ with respect to other risk factors. Statistical analysis was carried out using Student's t test, as well as statistical analysis of microarrays (SAM), to assess the false discovery rate for each gene. These analyses were supplemented with a newly developed method that computed deviations from gaussianorder statistics (DEGOS). To validate the platform, normal mucosa of the head and neck was included as control. Results: 2963 genes were differently expressed between HNSCC and normal mucosa (t test; p,0.01). More rigorous statistical analysis with SAM confirmed the differential expression of most genes. The comparison of genes in HNSCC with and without metastases showed 150 differently expressed genes (t test; p,0.01), none of which, however, could be confirmed using SAM or DEGOS. Conclusions: No evidence for a metastasis signature is found, and gene expression profiling of HNSCC has seemingly no value in determining the risk of developing distant metastases. The absence of such a signature can be understood when it is realised that, for HNSCC in contrast with breast cancer, the lymph nodes are a necessary in-between station for haematogenous spread.

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