Quality of life and cost-effectiveness of preoperative accelerated versus postoperative conventional radiotherapy for oral cavity cancer: Results from the randomised ARTSCAN 2 trial

BACKGROUND AND PURPOSE: The ARTSCAN 2 randomised controlled trial compares accelerated fractionation (AF) radiotherapy (RT) in a preoperative setting with conventional fractionation (CF) RT postoperatively for oral cavity cancer (OCC). Current results indicate no advantage for preoperative AF RT, thereby reinforcing postoperative CF RT as the "gold standard" of care. This analysis of the trial focuses on health-related quality of life (HRQoL) and conducts a health-economic evaluation from a societal perspective. MATERIALS AND METHODS: 240 patients formed the intention-to-treat population. Preoperative AF RT was given twice daily during 4.5 weeks to a total dose of 68 Gy followed by surgery 4-6 weeks later. Postoperative CF RT was given to a total dose of 60 or 66 Gy during 6-7 weeks. In the per protocol population, HRQoL was assessed with the EORTC QLQ-C30, QLQ-H&N35, and HADS questionnaires at five occasions during the five-year follow-up period. Direct and indirect costs were retrieved, and a cost-utility analysis (CUA) was conducted using quality-adjusted life years (QALYs) as outcome measure. RESULTS: HRQoL was analysed in 218 patients (i.e., the per-protocol population), of whom 204 were included in the CUA. Up until two years after treatment, the preoperative AF RT-group featured significantly worse HRQoL in a few of the QLQ-H&N35 scales compared to the postoperative CF RT-group. In the CUA, preoperative AF RT was less effective and more expensive than postoperative CF RT. CONCLUSION: Postoperative CF RT is associated with fewer symptoms in selected head-and-neck-specific domains and is more cost-effective than preoperative AF RT in the treatment of OCC.