Willdragon Wang, Dylan G Scholes, Alex C Watts, Megan A Roy, Sunil Singhal, John C Kucharczuk, Doraid Jarrar, Jarrod Predina, Taine T V Pechet, Lova L Sun, Aditi P Singh, Roger B Cohen, Corey J Langer, Charu Aggarwal, Melina E Marmarelis
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引用次数: 0
Abstract
Purpose: Adjuvant targeted therapies and perioperative chemoimmunotherapy have made it imperative to perform molecular testing in early-stage nonsquamous (NSq) non-small cell lung cancer (NSCLC). We present a prospective clinical trial evaluating an electronic medical record (EMR)-based nudge intervention to promote timely completion of comprehensive molecular testing (cMT) in patients with early-stage NSq NSCLC.
Methods: The EMBER-Lung trial prospectively enrolled patients undergoing surgical resection. The intervention included an EMR-based nudge at the time of the first postoperative visit, prompting the clinician to accept an order for cMT if NSq NSCLC histology. Following completion of cMT, if an actionable alteration was found, a reflex alert summarizing therapeutic options was sent to the patient's care team. The primary end point was the proportion of patients who underwent cMT in the real-world control and nudge intervention cohorts. Clinical characteristics and outcomes of the control and nudge intervention cohorts were compared using Pearson Chi-squared test, Fisher exact test, or Z score.
Results: Between July 2021 and November 2023, 460 patients were included (243 nudge and 217 control patients). The median age was 68.4 years, 64.3% female; 74.1% had a smoking history and mostly stage I (I/II/III; 75.9%, 14.1%, 10.0%, respectively). The proportion of patients with cMT increased in the nudge intervention (80/217, 36.9% v 197/243, 81.1%, P < .00001) across all stages (I to III). A greater proportion of patients with classical EGFR mutations and KRAS G12C mutations were detected in the nudge intervention setting (EGFR: 14/217, 6.5% v 41/243, 16.9%, P < .001; KRAS G12C: 12/217, 5.5%, v 33/243, 13.6%, P < .01).
Conclusion: In well-matched control and nudge intervention cohorts, an EMR-based nudge after resection of early-stage NSq NSCLC was feasible and increased the proportion of patients with cMT. Future research will incorporate this earlier, at the time of biopsy, to inform neoadjuvant therapy.
目的:辅助靶向治疗和围手术期化疗免疫治疗使得早期非鳞状非小细胞肺癌(NSCLC)的分子检测势在必行。我们提出了一项前瞻性临床试验,评估基于电子病历(EMR)的轻推干预,以促进早期NSq NSCLC患者及时完成综合分子检测(cMT)。方法:EMBER-Lung试验前瞻性纳入手术切除患者。干预措施包括在术后第一次就诊时进行基于emr的轻推,提示临床医生接受NSq NSCLC组织学的cMT命令。在完成cMT后,如果发现可操作的改变,则反射警报将总结治疗方案发送给患者的护理团队。主要终点是在现实世界对照和轻推干预队列中接受cMT的患者比例。采用Pearson卡方检验、Fisher精确检验或Z评分比较对照组和轻推干预组的临床特征和结局。结果:2021年7月至2023年11月,纳入460例患者(轻推243例,对照组217例)。中位年龄68.4岁,女性占64.3%;74.1%有吸烟史,以I/II/III期为主(分别为75.9%、14.1%、10.0%)。在所有阶段(I至III),轻推干预中cMT患者比例增加(80/217,36.9% vs 197/243, 81.1%, P < 0.00001)。在轻推干预组中检测到经典EGFR突变和KRAS G12C突变的患者比例更高(EGFR: 14/217, 6.5% vs 41/243, 16.9%, P < 0.001; KRAS G12C: 12/217, 5.5%, v 33/243, 13.6%, P < 0.01)。结论:在匹配良好的对照和轻推干预队列中,早期NSq NSCLC切除术后基于emr的轻推是可行的,并且增加了cMT患者的比例。未来的研究将在活检时将其纳入早期,以告知新辅助治疗。