Effects of NDURE on Timely Adjuvant Radiotherapy in HNSCC : Subgroup Analysis of an RCT

Objective Delays in initiating postoperative radiation therapy (PORT) are common, disproportionately burden medically underserved populations, and contribute to worse oncologic outcomes. NDURE is an enhanced navigation‐based intervention that improved initiation of timely PORT relative to usual care (UC) within a randomized clinical trial (RCT). This study evaluates the effect of NDURE on timely PORT across demographic and clinical subgroups. Methods In this exploratory, post hoc subgroup analysis from a single‐center RCT, adults with locally advanced HNSCC undergoing surgery and PORT were randomized 1:1 to NDURE or UC. The primary outcome was initiation of timely PORT (≤ 6 weeks of surgery). The effect of NDURE relative to UC was assessed across demographic and clinical subgroups, modeling the primary outcome using a generalized linear model. Results Among 145 evaluable patients (NDURE, n = 67; UC, n = 78), NDURE improved timely PORT relative to UC across nearly all demographic subgroups, including age ≥ 65 years (RD = 43%, 95% CI, 19% to 64%), Black race (RD = 46%, 95% CI, 10% to 73%), and non‐partnered status (RD = 32%, 95% CI, 8% to 53%). NDURE improved timely PORT relative to UC across nearly all clinical subgroups including AJCC stage IV (RD = 39%, 95% CI, 21% to 55%), free flap reconstruction (RD = 40%, 95% CI, 21% to 56%), and patients experiencing a postoperative complication (RD = 39%, 95% CI, 14% to 61%). Conclusions NDURE is a broadly effective strategy to improve delivery of timely PORT with potential to attenuate disparities for those at greatest risk. Level of Evidence 2. Trial Registration: ClinicalTrials.gov identifier: NCT04030130.