Noninferiority randomized trial of hypofractionated split-course versus standard radiotherapy in frail older patients with HNSCC

The noninferiority randomized ELAN-RT trial, at 30 centers in France and Monaco, compared standard fractionated radiotherapy (SF-RT; 70 Gy in 35 fractions over 7 weeks; n=100) versus hypofractionated split-course radiotherapy (HSC-RT; 55Gy in 20 fractions, two courses of 2 weeks with 2 weeks stop; n=101) for stage II-IV head and neck squamous cell carcinoma (HNSCC) in patients aged 70 years or older, assessed as frail by geriatric evaluation. Median age of the 201 patients was 82 years; 72% were male. The primary endpoint was proportion of patients alive with complete locoregional response at 6 months. The median follow-up was 56.6 months. In the ITT population, 35% of patients in the HSC-RT group and 33% of patients in the SF-RT group were alive with complete locoregional response at 6 months; whereas in the PP population the corresponding percentages were 36% and 35%. Median overall survival was 13.0 months (95% CI 10.3-17.0) in the HSC-RT group versus 18.9 months (14.3-30.9) in the SF-RT group. Acute adverse events grade 3-5 occurred in 36% of patients in the HSC-RT group and 47% of patients in the SF-RT group (p=0.13). The authors conclude that compared with SF-RT. HSC-RT did not decrease the 6-month complete locoregional response rate and could be an option for frail older patients; however, given the survival results, it should only be offered to patients deemed unsuitable for SF-RT after geriatric assessment.