Evidence map›Paper›PMID 25452446›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015

Randomized, double-blind, placebo-controlled, multicenter phase II study of the efficacy and safety of apricoxib in combination with either docetaxel or pemetrexed in patients with biomarker-selected non-small-cell lung cancer.

Martin J Edelman, Ming T Tan, Mary J Fidler, Rachel E Sanborn, Greg Otterson, Lecia V Sequist, Tracey L Evans, Bryan J Schneider, Roger Keresztes, John S Rogers and 5 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 10% 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

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
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  8. Resolution of eicosanoid/cytokine storm prevents carcinogen and inflammation-initiated hepatocellular cancer progression.Proceedings of the National Academy of Sciences of the United States of America · 2020
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  9. Inhibition of PI3K-AKT Signaling Blocks PGEOncoTargets and therapy · 2020
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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 at 2 institutions in 1 country.

Martin J EdelmanMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA. medelman@umm.edu.
Ming T TanMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA.
Mary J FidlerMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA.
Rachel E SanbornMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA.
Greg OttersonMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA.
Lecia V SequistMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA.
Tracey L EvansMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA.
Bryan J SchneiderMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA.
Roger KeresztesMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA.
John S RogersMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA.
Jorge Antunez de MayoloMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA.
Josephine FelicianoMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA.
Yang YangMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA.
Michelle MedeirosMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA.
Sara L ZaknoenMartin J. Edelman, Josephine Feliciano, Yang Yang, and Michelle Medeiros, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Ming T. Tan, Georgetown University, Washington, DC; Mary J. Fidler, Rush University Medical Center, Chicago, IL; Rachel E. Sanborn, Providence Portland Medical Center, Portland, OR; Greg Otterson, The Ohio State University Comprehensive Cancer Center, Columbus, OH; Lecia V. Sequist, Massachusetts General Hospital Cancer Center, Boston, MA; Tracey L. Evans, University of Pennsylvania, Philadelphia, PA; Bryan J. Schneider, Weill Cornell Medical College, New York City; Roger Keresztes, State University of New York Stony Brook, Stony Brook, NY; John S. Rogers, West Virginia University School of Medicine, Morgantown, WV; Jorge Antunez de Mayolo, Mercy Research Institute, Miami, FL; and Sara L. Zaknoen, Tragara, San Diego, CA.
Georgetown University · USMercy Research · US

Funding

UNIVERSITY OF MARYLAND GREENEBAUM CANCER CENTERSUPPORT GRANTP30CA134274 · NCI · UNIVERSITY OF MARYLAND BALTIMORE · PI FEYRUZ VIRGILIA RASSOOL · 2008 to 2026
$51.0M
NCI NIH HHS P30 CA134274
6 · The paper itself

Abstract

purposeOverexpression of COX-2 correlates with advanced stage and worse outcomes in non-small-cell lung cancer (NSCLC), possibly as a result of elevated levels of COX-2-dependent prostaglandin E2 (PGE2). Exploratory analyses of studies that used COX-2 inhibitors have demonstrated potentially superior outcome in patients in whom the urinary metabolite of PGE2 (PGE-M) is suppressed. We hypothesized that patients with disease defined by PGE-M suppression would benefit from the addition of apricoxib to second-line docetaxel or pemetrexed. PATIENTS AND

methodsPatients with NSCLC who had disease progression after one line of platinum-based therapy, performance status of 0 to 2, and normal organ function were potentially eligible. Only patients with a ≥ 50% decrease in urinary PGE-M after 5 days of treatment with apricoxib could enroll. Docetaxel 75 mg/m(2) or pemetrexed 500 mg/m(2) once every 21 days per the investigator was administered with apricoxib or placebo 400 mg once per day. The primary end point was progression-free survival (PFS). Exploratory analysis was performed regarding baseline urinary PGE-M and outcomes.

resultsIn all, 101 patients completed screening, and 72 of the 80 who demonstrated ≥ 50% suppression were randomly assigned to apricoxib or placebo. Toxicity was similar between the arms. No improvement in PFS was seen with apricoxib versus placebo. The median PFS for the control arm was 97 days (95% CI, 52 to 193 days) versus 85 days (95% CI, 67 to 142 days) for the experimental arm (P = .91).

conclusionApricoxib did not improve PFS, despite biomarker-driven patient selection.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Non-Small-Cell LungCyclooxygenase 2Disease-Free SurvivalDocetaxelDouble-Blind MethodDrug Administration ScheduleFemaleGlutamatesGuanineHumansKaplan-Meier EstimateLung NeoplasmsMale7-hydroxy-5,11-dioxotetranorprostane-1,16-dioic acidapricoxibBiomarkers, TumorCyclooxygenase 2DocetaxelGlutamatesGuaninePemetrexedProstaglandinsPTGS2 protein, humanPyrrolesSulfonamidesTaxoids

Identifiers

PMID25452446
PMCPMC4890680
OpenAlexW2130163382

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.