Evidence map›Paper›PMID 24752945›Full record

Trial reportCancer2014

A phase 2 cooperative group adjuvant trial using a biomarker-based decision algorithm in patients with stage I non-small cell lung cancer (SWOG-0720, NCT00792701).

Gerold Bepler, Ralph G Zinner, James Moon, Royce Calhoun, Kemp Kernstine, Charles C Williams, Philip C Mack, Vasco Oliveira, Zhong Zheng, Philip J Stella and 2 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.4field-weighted citation impact, top 12% of its field
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

4 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Observational
  3. Review
  4. Biomarkers in early-stage non-small-cell lung cancer: current concepts and future directions.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2014
    Review
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

12 authors at 7 institutions in 1 country.

Gerold BeplerKarmanos Cancer Institute, Detroit, Michigan.
Ralph G Zinner
James Moon
Royce Calhoun
Kemp Kernstine
Charles C Williams
Philip C Mack
Vasco Oliveira
Zhong Zheng
Philip J Stella
Mary W Redman
David R Gandara
University of California, Davis · USMoffitt Cancer Center · USThe Barbara Ann Karmanos Cancer Institute · USThe University of Texas at Austin · USCancer Research And Biostatistics · USCity of Hope · USMichigan Cancer Research Consortium · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Catherine M. Tangen · 2014 to 2026
$115.2M
Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Laura Marcu · 2002 to 2026
$84.9M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI PAUL M STEMMER · 1985 to 2026
$68.4M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
UPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5M
MICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2M
GRAND RAPIDS CLINICAL ONCOLOGY PROGRAMU10CA035178 · NCI · SPECTRUM HEALTH HOSPITALS · PI PADULA, GILBERT DARIN ANTHONY · 1985 to 2014
$16.2M
DAYTON CLINICAL ONCOLOGY PROGRAMU10CA035090 · NCI · KETTERING MEDICAL CENTER · PI GROSS, HOWARD M · 1985 to 2014
$12.0M
NCI NIH HHS CA014028NCI NIH HHS CA016385NCI NIH HHS CA020319NCI NIH HHS CA022453NCI NIH HHS CA027057NCI NIH HHS CA032102NCI NIH HHS CA035090NCI NIH HHS CA035119NCI NIH HHS CA035178NCI NIH HHS CA035261NCI NIH HHS CA035431NCI NIH HHS CA038926NCI NIH HHS CA042777NCI NIH HHS CA045377NCI NIH HHS CA045560NCI NIH HHS CA045807NCI NIH HHS CA046113NCI NIH HHS CA046368NCI NIH HHS CA046441NCI NIH HHS CA063844NCI NIH HHS CA063848NCI NIH HHS CA067575NCI NIH HHS CA067663NCI NIH HHS CA073590NCI NIH HHS CA074647NCI NIH HHS CA076429NCI NIH HHS CA105409NCI NIH HHS CA129343NCI NIH HHS P30 CA016672NCI NIH HHS P30 CA022453NCI NIH HHS P30 CA093373NCI NIH HHS R01 CA129343NCI NIH HHS R01 CA140314NCI NIH HHS U10 CA014028NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180835NCI NIH HHS U10 CA180846NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233340
6 · The paper itself

Abstract

backgroundThis cooperative group adjuvant phase 2 trial in patients with completely resected stage I non-small cell lung cancer with tumor diameters measuring ≥ 2 cm was designed to assess the feasibility and preliminary efficacy of assigning patients to therapy or observation using a molecularly based decision algorithm.

methodsAt least a lobectomy and sampling of recommended mediastinal lymph node stations, good Zubrod performance status, adequate organ function, and a formalin-fixed and paraffin-embedded tumor specimen were required. Excision repair cross-complementing group 1 (ERCC1) and ribonucleotide reductase M1 (RRM1) were analyzed using immunofluorescence-based in situ automated quantitative image analysis and categorized as high or low using prespecified cutoff values. Patients with high ERCC1 and RRM1 were assigned to observation and all others to 4 cycles of cisplatin and gemcitabine. Feasibility was defined as treatment assignment within 84 days from surgery in > 85% of patients. Secondary objectives were to estimate the 2-year survival.

resultsTreatment assignment met the feasibility criteria in 88% of eligible patients (71 of 81 patients). The collective 2-year disease-free and overall survival rates were 80% and 96%, respectively. Protein levels for RRM1 fell within the previously established range, ERCC1 levels were slightly lower than expected, and they were significantly correlated (correlation coefficient, 0.4). The rates of assignment of patients to observation (22%) and chemotherapy (78%) were as expected.

conclusionsGene expression analysis for treatment assignment is feasible. Survival results are encouraging and require future validation. Real-time performance of quantitative in situ ERCC1 and RRM1 analysis requires further development.

Indexed as

AlgorithmsDecision MakingAdultAgedAged, 80 and overBiomarkers, TumorCarcinoma, Non-Small-Cell LungChemotherapy, AdjuvantDisease-Free SurvivalDNA-Binding ProteinsEndonucleasesFemaleHumansLung NeoplasmsMaleMiddle AgedBiomarkers, TumorDNA-Binding ProteinsEndonucleasesERCC1 protein, humanRibonucleoside Diphosphate ReductaseRRM1 protein, humanTumor Suppressor Proteinsadjuvant therapyERCC1 (excision repair cross-complementing group 1)lung cancerpersonalized medicineRRM1 (ribonucleotide reductase M1)

Identifiers

PMID24752945
PMCPMC4140446
OpenAlexW1584965179

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.