Journal article
Evaluating the impact of eligibility criteria in first-line clinical trials for follicular lymphoma: a MER/LEO cohort analysis
Blood advances, Vol.6(15), pp.4413-4423
06/20/2022
DOI: 10.1182/bloodadvances.2022007687
PMCID: PMC9636310
PMID: 35793440
Abstract
Cancer clinical trial eligibility criteria may create patient populations studied in trials that do not reflect the patient populations treated in the real-world setting. Follicular lymphoma (FL) is an indolent lymphoma with heterogeneous presentations across a broad range of individuals, resulting in many acceptable management strategies. We evaluated how first-line clinical trial eligibility criteria impacted the demographic makeup and outcomes of patients with FL for whom systemic therapy might be considered. We compared the characteristics of 196 patients with FL from a single institution to eligibility criteria from 10 first-line FL trials on clinicaltrials.gov. Next, we tabulated eligibility criteria from 24 first-line FL protocols and evaluated their impact on 1198 patients with FL with stages II to IV disease from the prospective Molecular Epidemiology Resource (MER) and Lymphoma Epidemiology of Outcomes (LEO) cohort studies. We found that 39.8% and 52.7% of patients with FL might be excluded from clinical trials based on eligibility criteria derived from clinicaltrials.gov and protocol documents, respectively. Patients excluded because of renal function, prior malignancy, and self-reported serious health conditions tended to be older. Expanding stage requirement from III-IV to II-IV, and platelet requirement from ≥150 000 to ≥75 000 increased population size by 21% and 8%, respectively, in MER and by 16% and 13%, respectively, in LEO, without impacting patient demographics or outcomes. These data suggest that management of older individuals with FL may not be fully informed by recent clinical trials. Moreover, liberalizing stage and platelet criteria might expand the eligible population and allow for quicker trial accrual without impacting outcomes.
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Excluding patients with renal dysfunction, prior malignancies, and serious health conditions resulted in a younger trial population.
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Liberalizing stage and platelet criteria could increase the pool of trial-eligible patients without impacting patient outcomes.
Details
- Title: Subtitle
- Evaluating the impact of eligibility criteria in first-line clinical trials for follicular lymphoma: a MER/LEO cohort analysis
- Creators
- Danny Luan - Cornell UniversityTolulope Fatola - Cornell UniversityAhmed Toure - NewYork–Presbyterian HospitalChristopher R. Flowers - The University of Texas MD Anderson Cancer CenterBrian Link - University of IowaJonathan W. Friedberg - University of RochesterJonathon B. Cohen - Emory UniversityBrad Kahl - Washington University in St. LouisIzidore S. Lossos - University of MiamiLoretta Nastoupil - The University of Texas MD Anderson Cancer CenterMatthew J. Maurer - Mayo ClinicJames R. Cerhan - Mayo ClinicPeter Martin - Cornell University
- Resource Type
- Journal article
- Publication Details
- Blood advances, Vol.6(15), pp.4413-4423
- DOI
- 10.1182/bloodadvances.2022007687
- PMID
- 35793440
- PMCID
- PMC9636310
- NLM abbreviation
- Blood Adv
- ISSN
- 2473-9529
- eISSN
- 2473-9537
- Publisher
- The American Society of Hematology
- Language
- English
- Date published
- 06/20/2022
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Epidemiology; Internal Medicine
- Record Identifier
- 9984359805902771
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