Evidence map›Paper›PMID 21881030›Full record

Trial reportCancer prevention research (Philadelphia, Pa.)2011

A randomized controlled trial of celecoxib to prevent recurrence of nonmuscle-invasive bladder cancer.

Anita L Sabichi, J Jack Lee, H Barton Grossman, Suyu Liu, Ellen Richmond, Bogdan A Czerniak, Jorge De la Cerda, Craig Eagle, Jaye L Viner, J Lynn Palmer and 1 more

Open access · bronzeAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer prevention research (Philadelphia, Pa.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 4 pooled it
4.6field-weighted citation impact, top 6% 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

30 citing papers in PubMed, 4 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Patient-reported outcomes in non-muscle invasive bladder cancer: a mixed-methods systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2021
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Review
  7. Inflammation in Urological Malignancies: The Silent Killer.International journal of molecular sciences · 2023
    Review
  8. Article
  9. Review
  10. Review
  11. Anti-Inflammatory Drugs as Anticancer Agents.International journal of molecular sciences · 2020
    Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Review
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Anita L SabichiDepartment of Medicine, Division of Hematology/Oncology, Baylor College of Medicine, Houston, Texas 77030, USA. sabichi@bcm.edu
J Jack Lee
H Barton Grossman
Suyu Liu
Ellen Richmond
Bogdan A Czerniak
Jorge De la Cerda
Craig Eagle
Jaye L Viner
J Lynn Palmer
Seth P Lerner
Pfizer (United States) · USBaylor College of Medicine · USNational Cancer Institute · USThe University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
PHASE II CLINICAL TRIAL OF CELECOXIB OR (NSAID) IN BLADDN01CN085186 · CN · UNIVERSITY OF TEXAS MD ANDERSON CAN CTR · PI SABICHI, ANITA L · 1998 to 2000
$801k
NCI NIH HHS N01 CN085186NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

Significant morbidity and expense result from frequent recurrences of nonmuscle-invasive bladder cancer (NMIBC) after standard treatment, and carcinoma in situ (Tis) is a poor prognostic factor. Predicated on observational and preclinical data strongly supporting cyclooxygenase-2 (COX-2) in the pathogenesis, and the activity of COX-2 inhibitors, in bladder cancer, we conducted a randomized, double-blind, placebo-controlled trial to determine whether celecoxib could reduce the time-to-recurrence (TTR) in NMIBC patients at high risk for recurrence. A total of 146 patients were randomized to celecoxib (200 mg) or placebo orally twice daily for at least 12 months. The average treatment duration was 1.25 years. Primary intent-to-treat analysis revealed celecoxib did not statistically significantly prolong TTR compared with placebo (P = 0.17, log rank) with a median follow-up of 2.49 years. The recurrence-free rate at 12 months with celecoxib was 88% (95% CI: 0.81-0.96) versus 78% (95% CI: 0.69-0.89) with placebo. After controlling for covariates with Cox regression analysis, recurrence rates did not differ between the two study arms (HR = 0.69; 95% CI: 0.37-1.29). However, celecoxib had a marginally significant effect on reducing metachronous recurrences (vs. placebo) with HR of 0.56 (95% CI: 0.3-1.06; P = 0.075). Celecoxib was well tolerated, with similar adverse events and quality-of-life in both arms. Our clinical trial results do not show a clinical benefit for celecoxib in preventing NMIBC recurrence but further investigation of COX-2 inhibitors in this setting is warranted.

Indexed as

CelecoxibCyclooxygenase 2 InhibitorsDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleNeoplasm GradingNeoplasm InvasivenessNeoplasm Recurrence, LocalNeoplasm StagingPatient CompliancePyrazolesQuality of LifeSulfonamidesSurvival RateCelecoxibCyclooxygenase 2 InhibitorsPyrazolesSulfonamides

Identifiers

PMID21881030
PMCPMC4028708
OpenAlexW2169556484

What OpenQuestion holds

Textmetadata
LicenceTDM
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.