Impact of broadening clinical trial eligibility criteria for advanced non-small cell lung cancer patients: Real-world analysis.
Impact of broadening clinical trial eligibility criteria for advanced non-small cell lung cancer patients: Real-world analysis.
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扩大晚期非小细胞肺癌患者临床试验资格标准的影响：真实世界分析。
DOI：
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发表时间：
2019
影响因子：
45.3
通讯作者：
S. Bruinooge
中科院分区：
文献类型：
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作者：
R. Harvey;W. Rubinstein;G. Ison;S. Khozin;L. Chen;Robert S. Miller;M. Jun;E. Stepanski;Brigham B. Hyde;T. Uldrick;G. Komatsoulis;J. Roberts;E. Garrett;R. Schilsky;Caroline Schenkel;Edward S. Kim;S. Bruinooge
LBA108背景：限制性试验资格标准限制了数据的普遍性和患者参与的机会。我们比较了符合ASCO和癌症研究之友推荐的传统标准和扩展标准的患者数量和特征。方法：回顾性观察分析，使用ASCO的CancerLinQ数据库中确定的电子病历数据。研究队列包括2011-2018年晚期疾病诊断后就诊≥2次、全身治疗≥1剂的成年aNSCLC患者。需要记录肌酐清除率（CrCl）或Cockcroft-Gault变量。患者按传统标准（无脑转移，无其他恶性肿瘤，CrCl >60 mL/min）和扩展标准（允许脑转移和其他恶性肿瘤，CrCl >30 mL/min）分组。结果：共发现10500例患者（表）。中位年龄67.6岁[IQR 60.3-74.4]。56%是男性，65%是白人。60%是第四阶段，80%是曾经或现在的吸烟者。传统排除标准排除了5005例（47.7%）患者，而扩展标准仅排除了154例（1.5%）患者。扩大标准患者年龄较大（67.5 v 66.1, p<0.001）；更有可能是女性（44% vs 40%）， IV期（60% vs 55%），非鳞状组织（47% vs 45%），从不吸烟（16% vs 13%）。需要额外的分析来区分已治疗/稳定与活动性脑转移。结论：使用ASCO-Friends扩展标准将使近两倍的aNSCLC患者被考虑参加试验（4,851例，46.2%）。更窄的标准只能基于令人信服的排除的科学理由来使用。[表：见正文]
LBA108 Background: Restrictive trial eligibility criteria limit data generalizability and patient opportunity to participate. We compared numbers and characteristics of patients (pts) eligible using traditional vs expanded criteria recommended by ASCO and Friends of Cancer Research. Methods: A retrospective, observational analysis used deidentified EHR data from ASCO’s CancerLinQ database. Study cohort included adult aNSCLC pts with ≥2 visits and ≥1 dose of systemic treatment post-advanced-disease diagnosis from 2011-2018. Recorded creatinine clearance (CrCl) or Cockcroft-Gault variables were required. Pts were grouped by traditional criteria (no brain metastases, no other malignancies and CrCl >60 mL/min) and expanded criteria (brain metastases and other malignancies allowed and CrCl >30 mL/min). Results: 10,500 pts were identified (Table). Median age 67.6 years [IQR 60.3-74.4]. 56% were male, and 65% white. 60% were Stage IV, 80% former or current smokers. 5005 (47.7%) pts were excluded by traditional exclusion criteria, while only 154 (1.5%) pts were excluded by expanded criteria. Expanded criteria patients were older (67.5 v 66.1, p<0.001); and more likely to be female (44% v 40%), Stage IV (60% v 55%), have non-squamous histology (47% v 45%), and never smokers (16% v 13%). Additional analysis is needed to differentiate treated/stable vs. active brain metastases. Conclusions: Use of the ASCO-Friends expanded criteria would enable nearly twice as many aNSCLC pts to be considered for trial participation (4,851 patients, 46.2%). Narrower criteria should only be used based on compelling scientific rationale for exclusion. [Table: see text]