Evidence map›Paper›PMID 33563634›Full record

SynthesisClinical cancer research : an official journal of the American Association for Cancer Research2021

Impact of Broadening Trial Eligibility Criteria for Patients with Advanced Non-Small Cell Lung Cancer: Real-World Analysis of Select ASCO-

R Donald Harvey, Suanna S Bruinooge, Li Chen, Elizabeth Garrett-Mayer, Whitney Rhodes, Edward Stepanski, Thomas S Uldrick, Gwynn Ison, Sean Khozin, Wendy S Rubinstein and 5 more

Abstract readMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  8. What Is Ailing Oncology Clinical Trials? Can We Fix Them?Current oncology (Toronto, Ont.) · 2024
    Review
  9. Review
  10. Cancer Treatment Disparities in People With HIV in the United States, 2001-2019.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

R Donald Harvey *Winship Cancer Institute of Emory University, Druid Hills, Georgia.ORCID 0000-0002-4217-1313
Suanna S Bruinooge *ASCO, Alexandria, Virginia. suanna.bruinooge@asco.org.ORCID 0000-0002-9936-2719
Li ChenConcertAI, Boston, Massachusetts.
Elizabeth Garrett-MayerASCO, Alexandria, Virginia.ORCID 0000-0003-4709-0333
Whitney RhodesConcertAI, Boston, Massachusetts.
Edward StepanskiConcertAI, Boston, Massachusetts.
Thomas S UldrickFred Hutchinson Cancer Research Center and University of Washington, Seattle, Washington.ORCID 0000-0001-6959-0924
Gwynn IsonFDA, Silver Spring, Maryland.
Sean KhozinJanssen Research and Development, New York, New York.
Wendy S RubinsteinFDA, Silver Spring, Maryland.ORCID 0000-0002-8790-9959
Caroline SchenkelASCO, Alexandria, Virginia.ORCID 0000-0002-3613-8509
Robert S MillerASCO CancerLinQ, Alexandria, Virginia.ORCID 0000-0003-0869-6316
George A KomatsoulisASCO CancerLinQ, Alexandria, Virginia.ORCID 0000-0001-6967-7085
Richard L Schilsky *ASCO, Alexandria, Virginia.ORCID 0000-0003-4474-4303
Edward S Kim *Levine Cancer Institute, Atrium Health, Charlotte, North Carolina.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCancer clinical trials often accrue slowly or miss enrollment targets. Strict eligibility criteria are a major reason. Restrictive criteria also limit opportunities for patient participation while compromising external validity of trial results. We examined the impact of broadening select eligibility criteria on characteristics and number of patients eligible for trials, using recommendations of the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research. EXPERIMENTAL

designA retrospective, observational analysis used electronic health record data from ASCO's CancerLinQ Discovery database. Study cohort included patients with advanced non-small cell lung cancer treated from 2011 to 2018. Patients were grouped by traditional criteria [no brain metastases, no other malignancies, and creatinine clearance (CrCl) ≥ 60 mL/minute] and broadened criteria (including brain metastases, other malignancies, and CrCl ≥ 30 mL/minute).

resultsThe analysis cohort included 10,500 patients. Median age was 68 years, and 73% of patients were White. Most patients had stage IV disease (65%). A total of 5,005 patients (48%) would be excluded from trial participation using the traditional criteria. The broadened criteria, however, would allow 98% of patients (10,346) to be potential participants. Examination of patients included by traditional criteria (5,495) versus those added (4,851) by broadened criteria showed that the number of women, patients aged 75+ years, and those with stage IV cancer was significantly greater using broadened criteria.

conclusionsThis analysis of real-world data demonstrated that broadening three common eligibility criteria has the potential to double the eligible patient population and include trial participants who are more representative of those encountered in practice.

Indexed as

AgedCarcinoma, Non-Small-Cell LungClinical Decision-MakingClinical Trials as TopicDisease ManagementFemaleHumansLung NeoplasmsMaleMiddle AgedResearch DesignRetrospective StudiesTreatment Outcome

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.