Evidence map›Paper›PMID 24189513›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2013

Phase II trial of carboplatin, paclitaxel, cetuximab, and bevacizumab followed by cetuximab and bevacizumab in advanced nonsquamous non-small-cell lung cancer: SWOG S0536.

Edward S Kim, James Moon, Roy S Herbst, Mary W Redman, Shaker R Dakhil, Mario R Velasco, Fred R Hirsch, Philip C Mack, Karen Kelly, John V Heymach and 1 more

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

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 15% 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

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Review
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  13. Article
  14. Molecular targeted therapy for the treatment of gastric cancer.Journal of experimental & clinical cancer research : CR · 2016
    Review
  15. Article
  16. Article
  17. Design of a phase III clinical trial with prospective biomarker validation: SWOG S0819.Clinical cancer research : an official journal of the American Association for Cancer Research · 2012
    Article
  18. Article
  19. Review
  20. 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

11 authors at 8 institutions in 1 country.

Edward S Kim*Levine Cancer Institute, Charlotte, North Carolina; †SWOG Statistical Center, Seattle, Washington; ‡Yale Cancer Center, New Haven, Connecticut; §Cancer Center of Kansas and Wichita CCOP, Wichita, Kansas; ‖Central Illinois CCOP and Cancer Care Specialists, Decatur, Illinois; ¶University of Colorado Cancer Center, Aurora, Colorado; #University of California Davis Cancer Center, Sacramento, California; and **MD Anderson Cancer Center, Houston, Texas.
James Moon
Roy S Herbst
Mary W Redman
Shaker R Dakhil
Mario R Velasco
Fred R Hirsch
Philip C Mack
Karen Kelly
John V Heymach
David R Gandara
University of California, Davis · USCancer Research And Biostatistics · USCancer Care Specialists of Illinois · USCancer Center of Kansas · USLevine Cancer Institute · USThe University of Texas MD Anderson Cancer Center · USUniversity of Colorado Cancer Center · USYale Cancer Center · US

Funding

SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
University of Colorado Cancer Center Support Grant - Lung Cancer Patient-Derived Xenografts with Autologous Human Immune SystemsP30CA046934 · NCI · UNIVERSITY OF COLORADO DENVER · PI James V Degregori · 1988 to 2026
$117.0M
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
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
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
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045807 · NCI · VOLUNTARY HOSPITALS OF AMERICA-ILLINOIS · PI WADE, JAMES L · 1987 to 2014
$16.0M
DAYTON CLINICAL ONCOLOGY PROGRAMU10CA035090 · NCI · KETTERING MEDICAL CENTER · PI GROSS, HOWARD M · 1985 to 2014
$12.0M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035261 · NCI · GRANT/RIVERSIDE METHODIST HOSPITALS · PI KUEBLER, PHILIP J. · 1985 to 2014
$10.6M
NCI NIH HHS CA105409NCI NIH HHS CA12644NCI NIH HHS CA16385NCI NIH HHS CA20319NCI NIH HHS CA22433NCI NIH HHS CA35090NCI NIH HHS CA35128NCI NIH HHS CA35261NCI NIH HHS CA35281NCI NIH HHS CA45377NCI NIH HHS CA45450NCI NIH HHS CA45461NCI NIH HHS CA45808NCI NIH HHS CA46113NCI NIH HHS CA46282NCI NIH HHS CA58416NCI NIH HHS CA58882NCI NIH HHS CA63848NCI NIH HHS CA74647NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035119NCI NIH HHS N01 CA035176NCI NIH HHS N01 CA035178NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045560NCI NIH HHS N01 CA045807NCI NIH HHS N01 CA046441NCI NIH HHS N01 CA067575NCI NIH HHS P30 CA046934NCI NIH HHS P30 CA093373NCI NIH HHS U10 CA012644NCI NIH HHS U10 CA016385NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA022433NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA035128NCI NIH HHS U10 CA035176NCI NIH HHS U10 CA035178NCI NIH HHS U10 CA035261NCI NIH HHS U10 CA035281NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA045377NCI NIH HHS U10 CA045450NCI NIH HHS U10 CA045461NCI NIH HHS U10 CA045560NCI NIH HHS U10 CA045807NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046113NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA058416NCI NIH HHS U10 CA058882NCI NIH HHS U10 CA063848NCI NIH HHS U10 CA067575NCI NIH HHS U10 CA074647NCI NIH HHS U10 CA105409NCI NIH HHS U10 CA180846NCI NIH HHS UG1 CA233340
6 · The paper itself

Abstract

introductionCetuximab and bevacizumab have each been demonstrated to prolong survival when added to chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC). However, the potential benefit of combining cetuximab and bevacizumab together with a platinum-based doublet had not been explored. We designed this phase II trial to evaluate the safety, tolerability, and efficacy of the combination of carboplatin, paclitaxel, cetuximab, and bevacizumab in chemotherapy-naive patients with advanced, nonsquamous NSCLC.

methodsPatients received with up to six cycles of carboplatin (area under curve 6), paclitaxel (200 mg/m(2)), cetuximab (400 mg/m(2) day 1 then 250 mg/m(2) weekly), and bevacizumab (15 mg/kg) every 21 days. Patients with an objective response or stable disease received maintenance cetuximab (250 mg/m(2) weekly) and bevacizumab (15 mg/kg every 21 days) until disease progression. The primary endpoint was safety as defined by the frequency and severity of hemorrhagic toxicities. Secondary endpoints included response rate, progression-free survival, overall survival, and toxicity. Molecular biomarkers were assessed in an exploratory manner.

resultsThe primary endpoint of grade 4 or higher hemorrhage of 2% (95% confidence interval: 0%-7%) met prespecified criteria for safety. One hundred ten patients were enrolled. There were four treatment-related deaths including lung hemorrhage (2), infection (1), and unknown (1). Median progression-free survival was 7 months and median overall survival was 15 months. The response rate was 56% with an overall disease control rate of 77%.

conclusionThis regimen was safe, feasible, and effective as a frontline treatment of advanced NSCLC, providing the basis for the ongoing phase III trial S0819.

Indexed as

AdenocarcinomaAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCarcinoma, Non-Small-Cell LungCetuximabFeasibility StudiesFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedAntibodies, Monoclonal, HumanizedBevacizumabCarboplatinCetuximabPaclitaxel

Identifiers

PMID24189513
PMCPMC4072123
OpenAlexW2139697170

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.