Evidence map›Paper›PMID 24419419›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2014

CALGB 30704 (Alliance): A randomized phase II study to assess the efficacy of pemetrexed or sunitinib or pemetrexed plus sunitinib in the second-line treatment of advanced non-small-cell lung cancer.

Rebecca S Heist, Xiaofei Wang, Lydia Hodgson, Gregory A Otterson, Thomas E Stinchcombe, Leena Gandhi, Miguel A Villalona-Calero, Peter Watson, Everett E Vokes, Mark A Socinski and 1 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 8 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

37 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Pooled it
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  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Review
  14. Article
  15. Anti-Angiogenic Therapy inInternational journal of molecular sciences · 2022
    Review
  16. Treatment Sequencing Strategies in Lung Cancer.Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2022
    Article
  17. Article
  18. Observational
  19. Article
  20. Article
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

11 authors.

Rebecca S Heist*Department of Thoracic Oncology, Massachusetts General Hospital, Boston, Massachusetts; †Department of Oncology, Alliance Statistics and Data Center, Duke University Medical Center, Durham, North Carolina; ‡Department of Oncology, Ohio State University Medical Center, Columbus, Ohio; §Department of Oncology, University of North Carolina, Chapel Hill, North Carolina; ‖Department of Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts; ¶Department of Oncology, Kinston Medical Specialists, P.A., Kinston, North Carolina; #Department of Oncology, University of Chicago, Chicago, Illinois; and **Department of Oncology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Xiaofei Wang
Lydia Hodgson
Gregory A Otterson
Thomas E Stinchcombe
Leena Gandhi
Miguel A Villalona-Calero
Peter Watson
Everett E Vokes
Mark A Socinski
Alliance for Clinical Trials in Oncology

Funding

CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Tasleem J Padamsee · 1985 to 2026
$132.3M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
MEDICAL CENTER OF DELAWARE CCOPU10CA045418 · NCI · CHRISTIANA CARE HEALTH SERVICES, INC. · PI GRUBBS, STEPHEN S. · 1987 to 2014
$14.5M
Northern Indiana Cancer Research Corsoortium, CCOPU10CA086726 · NCI · NORTHERN INDIANA CANCER RES CONSORTIUM · PI METHOD, MICHAEL · 2000 to 2014
$9.8M
MOUNT SINAI COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045564 · NCI · MOUNT SINAI MEDICAL CENTER (MIAMI BEACH) · PI SCHWARTZ, MICHAEL ALAN · 1987 to 2014
$9.2M
Heartland Research Consortium CCOPU10CA114558 · NCI · MISSOURI BAPTIST MEDICAL CENTER · PI LYSS, ALAN P · 2005 to 2014
$6.0M
Cancer and Leukemia Group B - The Ohio State UniversityU10CA077658 · NCI · OHIO STATE UNIVERSITY · PI BLOOMFIELD, CLARA D · 1998 to 2013
$6.0M
CANCER &LEUKEMIA GROUP BU10CA032291 · NCI · DANA-FARBER CANCER INSTITUTE · PI BURSTEIN, HAROLD J. · 1985 to 2013
$5.8M
CANCER AND LEUKEMIA GROUP B GRANT REVISED APPLICATIONU10CA041287 · NCI · UNIVERSITY OF CHICAGO · PI KINDLER, HEDY L · 1986 to 2013
$3.9M
CANCER AND LEUKEMIA GROUP BU10CA047559 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI SHEA, THOMAS C. · 1991 to 2013
$1.8M
NCI NIH HHS CA032291NCI NIH HHS CA047559NCI NIH HHS CA114558NCI NIH HHS CA114558-02NCI NIH HHS CA11789NCI NIH HHS CA12046NCI NIH HHS CA16450NCI NIH HHS CA21060NCI NIH HHS CA29165NCI NIH HHS CA31946NCI NIH HHS CA32291NCI NIH HHS CA33601NCI NIH HHS CA41287NCI NIH HHS CA45418NCI NIH HHS CA45564NCI NIH HHS CA45808NCI NIH HHS CA47559NCI NIH HHS CA47642NCI NIH HHS CA71323NCI NIH HHS CA77298NCI NIH HHS CA77406NCI NIH HHS CA77597NCI NIH HHS CA77658NCI NIH HHS CA86726NCI NIH HHS P30 CA016058NCI NIH HHS U10 CA021060NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA032291NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA041287NCI NIH HHS U10 CA045418NCI NIH HHS U10 CA045564NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA047559NCI NIH HHS U10 CA047642NCI NIH HHS U10 CA071323NCI NIH HHS U10 CA077597NCI NIH HHS U10 CA077658NCI NIH HHS U10 CA086726NCI NIH HHS U10 CA114558
6 · The paper itself

Abstract

backgroundSecond-line chemotherapy for advanced non-small cell lung cancer (NSCLC) improves survival modestly but new strategies are needed. This trial was designed to evaluate an antivascular endothelial growth factor strategy with or without standard chemotherapy in previously treated NSCLC.

methodsPatients with stage IIIB/IV NSCLC with performance status 0 to 1 progressive after first-line chemotherapy were eligible for randomization to pemetrexed, sunitinib, or the combination. Patients were stratified by performance status, stage, and sex. Primary objective was 18-week progression-free survival (PFS) rate; secondary objectives included response, overall survival (OS), and toxicity. Target accrual was 225. The study was terminated early because of decreasing accrual rates.

resultsBetween April 2008 and September 2011, 130 patients were registered and randomized; of this, 125 patients were treated. Baseline characteristics in the three arms were well balanced. Toxicity was higher in the sunitinib-containing arms. The 18-week PFS rate in the pemetrexed, sunitinib, and combination arms was 54% (95% confidence interval [CI], 40-71), 37% (95% CI, 25-54), and 48% (95% CI, 35-66), respectively (p = 0.25). Median PFS in the pemetrexed, sunitinib, and combination arms in months was 4.9 (2.1-8.8), 3.3 (2.3-4.2), and 3.7 (2.5-5.8), respectively (p = 0.18). There was an overall statistically significant difference in OS between the three arms: median OS in months was 10.5 (8.3-20.2) for pemetrexed, 8.0 (6.8-13.5) for sunitinib, and 6.7 (4.1-10.1) for the combination (p = 0.03).

conclusionPemetrexed had a superior toxicity profile to either sunitinib or the combination of pemetrexed and sunitinib. The 18-week PFS rate was not significantly different between the arms. OS was significantly better with pemetrexed alone compared with the two sunitinib-containing arms, with the doublet performing worst for OS.

Indexed as

Salvage TherapyAdenocarcinomaAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Large CellCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellFemaleFollow-Up StudiesGlutamatesGuanineHumansIndolesLung NeoplasmsMaleMiddle AgedGlutamatesGuanineIndolesPemetrexedPyrrolesSunitinib

Identifiers

PMID24419419
PMCPMC4284815

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Registered trials

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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.