Health and economic outcomes of two different follow up strategies in effectively cured advanced head and neck cancer patients–Trial in progress

Abstract

Background: Optimal timing and type of examinations for the follow up (FUP) of head and neck squamous cell cancer (HNSCC) survivors have not been established yet. There is a need to find out which is the most cost-effective FUP program in this population. The present trial aims at comparing a more intensive radiologic FUP approach with a less intensive one, also evaluating its economical impact on healthcare system. Methods: This is an Investigator Initiated randomized, phase II, multicenter trial. Patients with stage III-IV SCC of oral cavity, oropharynx, larynx or hypopharynx having already received radiation therapy as part of curative treatment and in complete remission at six months are randomized in two arms according to different FUP approaches. A non intensive FUP approach foresees only a radiologic evaluation within 6 months since treatment end and subsequently only at signs or symptoms occurrence (according to NCCN guidelines). An intensive FUP approach consists of scheduled radiologic evaluations 2 times/year in the first 2 years and 1 time/year in the third year; PET scans are requested yearly for patients with smoking history. FUP visits consist of physical and fiberoptic endoscopic examinations of head and neck district, laboratory tests, quality of life questionnaires and evaluation of out-of-pocket costs and productivity losses; timing of FUP visits is the same in both arms. An estimated 330 patients are being enrolled; health outcomes and costs will be assessed over the next two years of follow up. The percentage of potentially salvageable recurrences or second primaries, the cause-specific survival and the overall survival of recurring patients will be evaluated in both arms. Incremental cost-effectiveness (cost/life year gained) and cost-utility ratios (cost/QALY) will be calculated referring to WHO thresholds of 1-3 times per capita gross domestic product. Results: The trial started in September 2014 and as of April 2015 10 Centers have received approval from the Ethical Committee. Conclusions: According to study results, either a dominant strategy will be found (i.e. one of the arms is more effective and less expensive than the other) or one arm will be more effective but also more expensive. In the latter case, incremental cost/effectiveness and cost/utility ratios will be calculated and compared to thresholds used to judge whether or not an intervention is considered cost/effective or cost/useful.