增强型导航与标准导航促进头颈癌辅助放疗及时启动的随机试验
Randomized Trial of Enhanced Versus Standard Navigation to Promote Timely Initiation of Adjuvant Radiotherapy for Head and Neck Cancer.
作者信息
Graboyes Evan M, DeMass Reid, Sterba Katherine R, Chera Bhisham S, Kistner-Griffin Emily, Hill Elizabeth G, McCay Jessica, Newman Jason G, Albergotti W Greer, Kejner Alex E, Skoner Judith M, Harper Jennifer L, Kaczmar John, Lee Byung Joo, Zimmerman Savannah A, Warren Graham W, Alberg Anthony J, Calhoun Elizabeth A, Nussenbaum Brian, Hughes Halbert Chanita
机构信息
Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, SC.
Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.
出版信息
JCO Oncol Pract. 2025 Jan 6:OP2400901. doi: 10.1200/OP-24-00901.
PURPOSE
National Comprehensive Cancer Network Guidelines recommend initiating postoperative radiation therapy (PORT) within 6 weeks of surgery for patients with head and neck squamous cell carcinoma (HNSCC), but delays affect 50% of patients, disproportionately burden minoritized groups, and contribute to worse oncologic outcomes. This trial evaluates the efficacy of Navigation for Disparities and Untimely Radiation thErapy (NDURE), an enhanced navigation-based intervention, relative to usual care (UC) patient navigation for starting timely PORT.
METHODS
Adults with locally advanced HNSCC planning to undergo surgery and PORT were randomly assigned 1:1 to standard multidisciplinary head and neck oncology care and either NDURE, a multilevel navigation-based intervention to enhance key processes of care and overcome barriers to timely PORT, or UC, which consisted of standard patient navigation. The primary end point, initiation of timely PORT, defined as ≤6 weeks after surgery, was evaluated using a generalized linear model binary regression with identity link, adjusting for random assignment stratification variables (race, predicted PORT location). Secondary end points were time to PORT (TTP) and treatment package time (TPT; the time from surgery to PORT completion).
RESULTS
Among 176 eligible patients randomly assigned to NDURE (n = 88) or UC (n = 88), 145 (NDURE, n = 67; UC, n = 78) underwent surgery, had a pathologic indication for PORT, and were evaluable for the primary end point. NDURE improved initiation of timely PORT relative to UC (model-based initiation of timely PORT, 74% 39%; risk difference, 35% [90% CI, 23 to 48]). NDURE increased the rate of PORT initiation (TTP hazard ratio [HR], 1.82 [90% CI, 1.32 to 2.50]) and treatment package completion (TPT HR, 1.67 [90% CI, 1.22 to 2.29]) relative to UC.
CONCLUSION
In this randomized clinical trial of patients with HNSCC undergoing surgery and PORT, NDURE improved initiation of timely PORT, TTP, and TPT.
目的
美国国立综合癌症网络指南建议，头颈部鳞状细胞癌（HNSCC）患者术后放疗（PORT）应在术后6周内开始，但延迟放疗影响了50%的患者，对少数族裔群体造成了不成比例的负担，并导致更差的肿瘤学结局。本试验评估了“差异与放疗延迟导航（NDURE）”这一强化的基于导航的干预措施相对于常规护理（UC）患者导航以实现及时开始PORT的疗效。
方法
计划接受手术和PORT的局部晚期HNSCC成年患者按1:1随机分配，分别接受标准的多学科头颈肿瘤护理以及NDURE（一种基于导航的多级干预措施，以加强关键护理流程并克服及时进行PORT的障碍）或UC（包括标准的患者导航）。主要终点为及时开始PORT，定义为术后≤6周，使用具有恒等链接的广义线性模型二元回归进行评估，并根据随机分配分层变量（种族、预测的PORT部位）进行调整。次要终点为PORT时间（TTP）和治疗套餐时间（TPT；从手术到PORT完成的时间）。
结果
在176例随机分配至NDURE组（n = 88）或UC组（n = 88）的符合条件的患者中，145例（NDURE组，n = 67；UC组，n = 78）接受了手术，有PORT的病理指征，且可对主要终点进行评估。与UC相比，NDURE改善了及时开始PORT的情况（基于模型的及时开始PORT的比例，74%对39%；风险差异，35%[90%CI，23%至48%]）。与UC相比，NDURE提高了PORT开始率（TTP风险比[HR]，1.82[90%CI，1.32至2.50]）和治疗套餐完成率（TPT HR，1.67[90%CI，1.22至2.29]）。
结论
在这项针对接受手术和PORT的HNSCC患者的随机临床试验中，NDURE改善了及时开始PORT的情况、TTP和TPT。
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