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. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04030130.