Evidence map›Paper›PMID 26134227›Full record

ArticleJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2015

Multitrial Evaluation of Progression-Free Survival as a Surrogate End Point for Overall Survival in First-Line Extensive-Stage Small-Cell Lung Cancer.

Nathan R Foster, Lindsay A Renfro, Steven E Schild, Mary W Redman, Xiaofei F Wang, Suzanne E Dahlberg, Keyue Ding, Penelope A Bradbury, Suresh S Ramalingam, David R Gandara and 5 more

Abstract read
In one paragraph

Article in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 5 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

32 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Nathan R Foster*Division of Biomedical Statistics and Informatics, Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; †Department of Radiation Oncology, Mayo Clinic, Scottsdale, Arizona; ‡Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; §Department of Biostatistics and Bioinformatics, Alliance Statistics and Data Center, Duke University, Durham, North Carolina; ‖Department of Biostatistics & Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts; ¶Department of Oncology, NCIC Clinical Trials Group, Queen' University, Kingston, ON, Canada; #Department of Hematology & Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia; **Division of Hematology and Oncology, UC Davis Comprehensive Cancer Center, Sacramento, California; ††Department of Statistics for the Data Center/Operations Office, Japan Clinical Oncology Group Data Center, Center for Research Administration and Support, National Cancer Center, Tokyo, Japan; ‡‡Department of Medical Oncology, Japanese Society of Medical Oncology, Tokyo, Japan; §§Department of Medicine, The University of Chicago Medicine and Biologic Sciences Center, Chicago, Illinois; and ‖‖Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York.
Lindsay A Renfro
Steven E Schild
Mary W Redman
Xiaofei F Wang
Suzanne E Dahlberg
Keyue Ding
Penelope A Bradbury
Suresh S Ramalingam
David R Gandara
Taro Shibata
Nagahiro Saijo
Everett E Vokes
Alex A Adjei
Sumithra J Mandrekar

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
Statistical Methods for Cancer Clinical TrialsP01CA142538 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVIDIAN, MARIE, KOSOROK, MICHAEL R · 2010 to 2019
$21.3M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareUG1CA233180 · NCI · DANA-FARBER CANCER INST · PI Harold John Burstein · 2019 to 2026
$8.6M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareU10CA180867 · NCI · DANA-FARBER CANCER INST · PI BURSTEIN, HAROLD JOHN, KIBEL, ADAM S · 2014 to 2018
$6.2M
NCI NIH HHS CA25224NCI NIH HHS CA31946NCI NIH HHS CA33601NCI NIH HHS P01 CA142538NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA066636NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180867NCI NIH HHS U10 CA180882NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233180
6 · The paper itself

Abstract

introductionWe previously reported that progression-free survival (PFS) may be a candidate surrogate end point for overall survival (OS) in first-line extensive-stage small-cell lung cancer (ES-SCLC) using data from three randomized trials (Foster, Cancer 2011). In this validation study (N0424-Alliance), we assessed the patient-level and trial-level surrogacy of PFS using data from seven new first-line phase II/III ES-SCLC trials and across all 10 trials as well (seven new, three previous).

methodsIndividual patient data were utilized across the seven new trials (2259 patients) and all 10 trials (2855 patients). Patient-level surrogacy (Kendall's τ) was assessed using the Clayton copula bivariate survival model. Trial-level surrogacy was assessed through association of the log hazard ratios on OS and PFS across trials, including weighted (by trial size) least squares regression (WLS R²) of Cox model effects and correlation of the copula effects (copula R²). The minimum effect on the surrogate (MES) needed to detect a nonzero treatment effect on OS was also calculated.

resultsThe median OS and PFS across all 10 trials were 9.8 and 5.9 months, respectively. PFS showed strong surrogacy within the 7 new trials (copula R² = 0.90 [standard error = 0.27], WLS R² = 0.83 [95% confidence interval: 0.43, 0.95]; MES = 0.67, and Kendall's τ = 0.58) and across all 10 trials (copula R² = 0.81 [standard errors = 0.25], WLS R² = 0.77 [95% confidence interval: 0.47-0.91], MES = 0.70, and Kendall's τ = 0.57).

conclusionsPFS demonstrated strong surrogacy for OS in first-line ES-SCLC based on this external validation study of individual patient data. PFS is a good alternative end point to OS and should be considered when resource constraints (time or patient) might make it useful or desirable in place of OS. Additional analyses are needed to assess its appropriateness for targeted agents in this disease setting.

Indexed as

Clinical Trials as TopicEndpoint DeterminationLung NeoplasmsSmall Cell Lung CarcinomaAdultAgedAged, 80 and overClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDisease-Free SurvivalFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicSurvival Analysis

Identifiers

PMID26134227
PMCPMC4493926

What OpenQuestion holds

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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.