2019 ASCO Annual Meeting!
Session: Using Real-World Data to Advance Research and Care
Type: Clinical Science Symposium
Time: Monday June 3, 9:45 AM to 11:15 AM
Location: Hall D1
Impact of broadening clinical trial eligibility criteria for advanced non-small cell lung cancer patients: Real-world analysis.
Disparities/Access to Care
Health Services Research, Clinical Informatics, and Quality of Care
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr LBA108)
Author(s): R. Donald Harvey, Wendy S. Rubinstein, Gwynn Ison, Sean Khozin, Li Chen, Robert S. Miller, Monika Jun, Edward Stepanski, Brigham Hyde, Thomas S. Uldrick, George Anthony Komatsoulis, Jeremy Roberts, Elizabeth Garrett-Mayer, Richard L. Schilsky, Caroline Schenkel, Edward S. Kim, Suanna S. Bruinooge; Winship Cancer Institute of Emory University, Atlanta, GA; American Society of Clinical Oncology’s CancerLinQ, Alexandria, VA; U.S. Food and Drug Administration, College Park, MD; U.S. Food and Drug Administration, Silver Spring, MD; Concerto HealthAI, Boston, MA; HIV/AIDS Malignancy Branch, CCR, NCI, Bethesda, MD; American Society of Clinical Oncology’s (ASCO) CancerLinQ, Alexandria, VA; Medical University of South Carolina, Charleston, SC; American Society of Clinical Oncology, Alexandria, VA; Levine Cancer Institute, Charlotte, NC
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.
|Original cohort||10,500 (100%)|
|Pts excluded for brain mets||2,226 (21.2%)|
|Pts excluded for prior/concurrent malignancy||2,254 (21.5%)|
|Pts excluded for CrCl < 60 mL/min||1,509 (14.4%)|
|Pts excluded by one of 3 traditional criteria||5,005 (47.7%)|
|Total pts included by traditional criteria||5,495 (52.3%)|
(Permits brain mets and prior/concurrent malignancy)
|Pts excluded for CrCl < 30 mL/min||154 (1.5%)|
|Total pts included by ASCO-Friends criteria||10,346 (98.5%)|