312 - A Phase II Trial of Hypofractionated Radiotherapy for Older Adults with Head and Neck Squamous Cell Carcinoma
Presenter(s)
D. R. Dickstein1, G. Van Hyfte2, O. Factor1, E. J. Lehrer3, A. Powers4, S. Reed1, E. Nvepu1, L. Worona5, S. Sharma6, K. Sindhu1, J. T. Liu1, V. Gupta1, S. A. Roof4, D. Kirke4, M. Posner7, K. Misiukiewicz5, E. Genden4, and R. L. Bakst1; 1Department of Radiation Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, 2Department of Population Health Science & Policy, Icahn School of Medicine at Mount Sinai, New York, NY, 3Department of Radiation Oncology, Mayo Clinic, Rochester, MN, 4Department of Otolaryngology, Head & Neck Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, 5Division of Hematology and Medical Oncology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, 6Summit Health, Berkeley Heights, NJ, 7Tampa General Hospital Cancer Institute/Cancer Center of South Florida, Palm Springs, FL
Purpose/Objective(s):
Older adults with head and neck squamous cell carcinoma (HNSCC) remain underrepresented in clinical trials, resulting in gaps in consensus regarding optimal management. Treatment for this population is often complicated by morbidity and treatment interruptions due to toxicity and treatment length, leading to worse disease control. This phase II trial evaluated the efficacy, safety, and impact on quality of life of hypofractionated radiotherapy (RT) in older adults with HNSCC.Materials/Methods:
Participants (pts) with HNSCC at least 70 years old and ECOG 1+ were enrolled to definitive (def) RT (45 Gy in 15 daily fractions) or adjuvant (adj) RT (40.5 Gy in 15 daily fractions) without systemic therapy on a prospective trial (NCT04284540). Inclusion criteria for the def arm comprised pts deemed unfit for standard of care and the adj arm additionally included pts with adverse features on pathology following resection. The primary endpoint was locoregional control (LRC) at 6 months. Secondary endpoints included overall survival (OS) and disease-free survival (DFS) at 1 year, toxicity graded with CTCAE version 4.0, and health-related quality of life measured with the FACT-H&N trial outcome index (range: 0-96).Results:
From 2019 to 2024, 34 pts underwent hypofractionated RT (19 adj; 15 def). Median age was 83 years (interquartile range [IQR]: 79-86); 71% had Stage III/IV disease. Median follow-up was 17 months (IQR: 10-40) for all pts and 23 months (IQR: 10-40) for alive pts. Four pts (all def) died from unrelated causes before primary endpoint evaluation. LRC at 6-months was 82.9% (95% CI: 67.0%-100.0%) for the adj cohort (n=19) and 86.1% (62.9%-98.1%) for the def cohort (n=11). OS and DFS at 1 year were 81.4% (95% CI: 64.5%-100.0%) and 72.0% (95% CI: 53.9%-96.3%), respectively, for adj pts, and 72.2% (95% CI: 52.4%-99.6%) and 58.3% (95% CI: 34.0%-100.0%), respectively, for def pts. Six pts developed grade 3+ toxicity (adj: 2 dysphagia, 2 odynophagia; def: 1 dysphagia, 1 odynophagia). Six pts experienced treatment interruptions (adj: 2; def: 4), none related to toxicity. Of pts who completed questionnaires at baseline and 1-year (52%), quality of life improved significantly in adj pts (baseline: 52 [IQR: 44-69]; 1-year: 67 [IQR: 60-77]; p=0.02) but not in def pts (baseline: 69 [IQR: 47-73] to 1-year: 81 [IQR: 65-92]; p=0.85).Conclusion:
This trial is the first to evaluate RT with curative intent specifically for older adults with HNSCC. Our findings demonstrate that this approach is well-tolerated and offers excellent locoregional control while maintaining patient-reported quality of life. Hypofractionated RT is an effective and safe treatment option for older adults with HNSCC who are unable to tolerate standard fractionation or concurrent systemic therapy.