Evidence map›Paper›PMID 31335166›Full record

ArticleJCO clinical cancer informatics2019

An Exploratory Analysis of Real-World End Points for Assessing Outcomes Among Immunotherapy-Treated Patients With Advanced Non-Small-Cell Lung Cancer.

Mark Stewart, Andrew D Norden, Nancy Dreyer, Henry Joe Henk, Amy P Abernethy, Elizabeth Chrischilles, Lawrence Kushi, Aaron S Mansfield, Sean Khozin, Elad Sharon and 8 more

Registry-linked trialAbstract read
In one paragraph

Article in JCO clinical cancer informatics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05700344 (Multicentric, Observational Study to Evaluate Real World Data of Avelumab in First Line Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma, a SOGUG Study), which is not on this map. Cited by 80 papers.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed
–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.

NCT05700344 completednot on this mapstarted 2022, after this paper: background citation

Multicentric, Observational Study to Evaluate Real World Data of Avelumab in First Line Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma, a SOGUG Study

TypeobservationalSponsorSpanish Oncology Genito-Urinary GroupRan2022 to 2023Enrolled125ConditionsMetastatic Urothelial CarcinomaArmsAvelumab
3 · Its place in the literature

Who cites it

80 citing papers in PubMed.

  1. Article
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  7. Clinical and Genomic Factors Associated with Elacestrant Outcomes in ESR1-Mutant Metastatic Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
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  11. Observational
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20 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Mark StewartFriends of Cancer Research, Washington, DC.
Andrew D NordenCota Healthcare, New York, NY.
Nancy DreyerIQVIA, Durham, NC.
Henry Joe HenkOptumLabs, Cambridge, MA.
Amy P AbernethyFlatiron Health, New York, NY.
Elizabeth ChrischillesUniversity of Iowa College of Public Health, Iowa City, IA.
Lawrence KushiKaiser Permanente, Oakland, CA.
Aaron S MansfieldMayo Clinic, Rochester, MN.
Sean KhozinUS Food and Drug Administration, Bethesda, MD.
Elad SharonNational Cancer Institute, Bethesda, MD.
Srikesh ArunajadaiCota Healthcare, New York, NY.
Ryan CarnahanUniversity of Iowa College of Public Health, Iowa City, IA.
Jennifer B ChristianIQVIA, Durham, NC.
Rebecca A MiksadFlatiron Health, New York, NY.
Lori C SakodaKaiser Permanente, Oakland, CA.
Aracelis Z TorresFlatiron Health, New York, NY.
Emily ValiceKaiser Permanente, Oakland, CA.
Jeff AllenFriends of Cancer Research, Washington, DC.

Funding

Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Felicity Enders · 1985 to 2026
$151.3M
Paul Calabresi Program in Clinical/Translational Research at Mayo ClinicK12CA090628 · NCI · MAYO CLINIC ROCHESTER · PI WEROHA, SARAVUT · 2001 to 2025
$19.7M
CRN4: Cancer Research Resources & Collaboration in Integrated Health Care SystemsU24CA171524 · NCI · KAISER FOUNDATION RESEARCH INSTITUTE · PI KUSHI, LAWRENCE H · 2012 to 2016
$16.0M
Evaluating a Risk Prediction Model for Lung CancerK07CA188142 · NCI · KAISER FOUNDATION RESEARCH INSTITUTE · PI SAKODA, LORI · 2015 to 2019
$920k
NCI NIH HHS K07 CA188142NCI NIH HHS K12 CA090628NCI NIH HHS P30 CA015083NCI NIH HHS U24 CA171524
6 · The paper itself

Abstract

purposeThis pilot study examined the ability to operationalize the collection of real-world data to explore the potential use of real-world end points extracted from data from diverse health care data organizations and to assess how these relate to similar end points in clinical trials for immunotherapy-treated advanced non-small-cell lung cancer. PATIENTS AND

methodsResearchers from six organizations followed a common protocol using data from administrative claims and electronic health records to assess real-world end points, including overall survival (rwOS), time to next treatment, time to treatment discontinuation (rwTTD), time to progression, and progression-free survival, among patients with advanced non-small-cell lung cancer treated with programmed death 1/programmed death-ligand 1 inhibitors in real-world settings. Data sets included from 269 to 6,924 patients who were treated between January 2011 and October 2017. Results from contributors were anonymized.

resultsCorrelations between real-world intermediate end points (rwTTD and time to next treatment) and rwOS were moderate to high (range, 0.6 to 0.9). rwTTD was the most consistent end points as treatment detail was available in all data sets. rwOS at 1 year post-programmed death-ligand 1 initiation ranged from 40% to 57%. In addition, rwOS as assessed via electronic health records and claims data fell within the range of median OS values observed in relevant clinical trials. Data sources had been used extensively for research with ongoing data curation to assure accuracy and practical completeness before the initiation of this research.

conclusionThese findings demonstrate that real-world end points are generally consistent with each other and with outcomes observed in randomized clinical trials, which substantiates the potential validity of real-world data to support regulatory and payer decision making. Differences observed likely reflect true differences between real-world and protocol-driven practices.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalB7-H1 AntigenCarcinoma, Non-Small-Cell LungDatabases, FactualElectronic Health RecordsFemaleHumansImmunotherapyLung NeoplasmsMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingAntineoplastic Agents, ImmunologicalB7-H1 AntigenCD274 protein, human

Identifiers

PMID31335166
PMCPMC6873914

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Registered trials

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.