Evidence map›Paper›PMID 28489511›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2017

Phase III Randomized, Placebo-Controlled, Double-Blind Trial of Celecoxib in Addition to Standard Chemotherapy for Advanced Non-Small-Cell Lung Cancer With Cyclooxygenase-2 Overexpression: CALGB 30801 (Alliance).

Martin J Edelman, Xiaofei Wang, Lydia Hodgson, Richard T Cheney, Maria Q Baggstrom, Sachdev P Thomas, Ajeet Gajra, Erin Bertino, Karen L Reckamp, Julian Molina and 9 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01041781 (A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer), which is not on this map. Cited by 58 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 4 pooled it
7.3field-weighted citation impact, top 2% 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.

NCT01041781 phase3terminatednot on this map

A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan2010 to 2018Enrolled313ConditionsLung CancerArmscarboplatin, celecoxib, gemcitabine hydrochloride, pemetrexed disodium, placebo
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 4 syntheses or guidelines pooled it, 76 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Time-to-Treatment-Failure and Related Outcomes Among 1000+ Advanced Non-Small Cell Lung Cancer Patients: Comparisons Between Older Versus Younger Patients (Alliance A151711).Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2018
    Trial
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Unlocking Lung Cancer Cell Dormancy: An Epigenetic Perspective.International journal of molecular sciences · 2025
    Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Celecoxib in oncology: targeting the COX-2/PGEFrontiers in pharmacology · 2025
    Review
  18. Article
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 1 institution in 1 country.

Martin J EdelmanMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Xiaofei WangMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Lydia HodgsonMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Richard T CheneyMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Maria Q BaggstromMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Sachdev P ThomasMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Ajeet GajraMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Erin BertinoMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Karen L ReckampMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Julian MolinaMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Joan H SchillerMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Kisha Mitchell-RichardsMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Paula N FriedmanMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Jon RitterMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Ginger MilneMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Olwen M HahnMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Thomas E StinchcombeMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Everett E VokesMartin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Alliance for Clinical Trials in Oncology
University of Maryland, Baltimore · US

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
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
Yale Pathology Tissue Services Shared ResourceP30CA016359 · NCI · YALE UNIVERSITY · PI DAVID L RIMM · 1985 to 2026
$85.0M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
Washington University/ Siteman Cancer Center Lead Academic SiteU10CA180833 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L, KOZOWER, BENJAMIN D · 2014 to 2018
$7.6M
OSU as Network Lead Academic Participating Site for the NCI NCTNU10CA180850 · NCI · OHIO STATE UNIVERSITY · PI BLUM, KRISTIE A, CHAKRAVARTI, ARNAB · 2014 to 2018
$6.8M
Naional Cancer Institute, Naitonal Clinical Trials Network U10 Lead Academic SiteU10CA180790 · NCI · MAYO CLINIC ROCHESTER · PI ALBERTS, STEVEN R, BOUGHEY, JUDY CAROLINE · 2014 to 2018
$6.6M
Cancer and Leukemia Group B - The Ohio State UniversityU10CA077658 · NCI · OHIO STATE UNIVERSITY · PI BLOOMFIELD, CLARA D · 1998 to 2013
$6.0M
WUSM CANCER AND LEUKEMIA GROUP BU10CA077440 · NCI · WASHINGTON UNIVERSITY · PI BARTLETT, NANCY L · 1998 to 2013
$4.4M
CANCER AND LEUKEMIA GROUP B--RPCI/SUNYABU10CA059518 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI LEVINE, ELLIS G · 1993 to 2013
$4.0M
CANCER AND LEUKEMIA GROUP B GRANT REVISED APPLICATIONU10CA041287 · NCI · UNIVERSITY OF CHICAGO · PI KINDLER, HEDY L · 1986 to 2013
$3.9M
NCI NIH HHS P30 CA016359NCI NIH HHS U10 CA021060NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA041287NCI NIH HHS U10 CA047559NCI NIH HHS U10 CA059518NCI NIH HHS U10 CA077440NCI NIH HHS U10 CA077658NCI NIH HHS U10 CA180790NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180833NCI NIH HHS U10 CA180838NCI NIH HHS U10 CA180850NCI NIH HHS U10 CA180866NCI NIH HHS U10 CA180870NCI NIH HHS U10 CA180882
6 · The paper itself

Abstract

Purpose Tumor overexpression of cyclooxygenase-2 (COX-2) has been associated with worse outcome in non-small-cell lung cancer (NSCLC). In Cancer and Leukemia Group B (CALGB) 30203, we found that the selective COX-2 inhibitor celecoxib in addition to chemotherapy in advanced NSCLC improved progression-free and overall survival in patients with moderate to high COX-2 expression by immunohistochemistry (IHC). CALGB 30801 (Alliance) was designed to prospectively confirm that finding. Patients and Methods Patients with NSCLC (stage IIIB with pleural effusion or stage IV according to American Joint Committee on Cancer [sixth edition] criteria) were preregistered, and biopsy specimens were analyzed for COX-2 by IHC. Patients with COX-2 expression ≥ 2, performance status of 0 to 2, and normal organ function were eligible. Chemotherapy was determined by histology: carboplatin plus pemetrexed for nonsquamous NSCLC and carboplatin plus gemcitabine for squamous histology. Patients were randomly assigned to celecoxib (400 mg twice per day; arm A) or placebo (arm B). The primary objective was to demonstrate improvement in progression-free survival in patients with COX-2 index ≥ 4 with hazard ratio of 0.645 with approximately 85% power at two-sided significance level of .05. Results The study was halted for futility after 312 of the planned 322 patients with COX-2 index ≥ 2 were randomly assigned. There were no significant differences between the groups (hazard ratio, 1.046 for COX-2 ≥ 4). Subset analyses evaluating histology, chemotherapy regimen, and incremental COX-2 expression did not demonstrate any advantage for COX-2 inhibition. Elevation of baseline urinary metabolite of prostaglandin E2, indicating activation of the COX-2 pathway, was a negative prognostic factor. Values above the third quartile may have been a predictive factor. Conclusion COX-2 expression by IHC failed to select patients who could benefit from selective COX-2 inhibition. Urinary metabolite of prostaglandin E2 may be able to identify patients who could benefit from COX-2 inhibition.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Small CellCelecoxibCyclooxygenase 2Cyclooxygenase 2 InhibitorsDinoprostoneDisease-Free SurvivalDouble-Blind MethodFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingPemetrexedCarboplatinCelecoxibCyclooxygenase 2Cyclooxygenase 2 InhibitorsDinoprostonePemetrexedPTGS2 protein, human

Identifiers

PMID28489511
PMCPMC5493050
OpenAlexW2613962944

What OpenQuestion holds

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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.