Evidence map›Paper›PMID 22293631›Full record

Trial reportCancer prevention research (Philadelphia, Pa.)2012

A phase 2 cancer chemoprevention biomarker trial of isoflavone G-2535 (genistein) in presurgical bladder cancer patients.

Edward Messing, Jason R Gee, Daniel R Saltzstein, KyungMann Kim, Anthony diSant'Agnese, Jill Kolesar, Linda Harris, Adrienne Faerber, Thomas Havighurst, Jay M Young and 9 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer prevention research (Philadelphia, Pa.), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 8% 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

45 citing papers in PubMed, 1 synthesis or guideline pooled it, 91 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Soy food frequency questionnaire does not correlate with baseline isoflavone levels in patients with bladder cancer.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2015
    Trial
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Molecular Pathways of Genistein Activity in Breast Cancer Cells.International journal of molecular sciences · 2024
    Review
  14. Drug repurposing for cancer therapy.Signal transduction and targeted therapy · 2024
    Review
  15. Review on Natural Agents as Aromatase Inhibitors: Management of Breast Cancer.Combinatorial chemistry & high throughput screening · 2024
    Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 9 institutions in 1 country.

Edward MessingUniversity of Rochester Medical Center, Rochester, New York, USA.
Jason R Gee
Daniel R Saltzstein
KyungMann Kim
Anthony diSant'Agnese
Jill Kolesar
Linda Harris
Adrienne Faerber
Thomas Havighurst
Jay M Young
Mitchell Efros
Robert H Getzenberg
Marcia A Wheeler
Joseph Tangrea
Howard Parnes
Margaret House
J Erik Busby
Raymond Hohl
Howard Bailey
National Cancer Institute · USUrology San Antonio · USUniversity of Iowa · USUniversity of Rochester Medical Center · USAccumed Research Associates · USJohns Hopkins University · USOrange County Research Center · USUniversity of Alabama at Birmingham · USUniversity of Wisconsin Carbone Cancer Center · US

Funding

UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI Christian Capitini · 1985 to 2026
$142.6M
INSTITUTIONAL CTSA (UW-MADISON): CLINICAL TRIALSUL1RR025011 · NCRR · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2007 to 2011
$29.5M
PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTSN01CN35153 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI BAILEY, HOWARD H. · 2007 to 2011
$5.9M
PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS -261035153N01CN035153 · CN · UNIVERSITY OF WISCONSIN - MAD · PI BAILEY, HOWARD H. · 2004 to 2006
–
NCI NIH HHS N01 CN035153NCI NIH HHS N01 CN35153NCI NIH HHS P30 CA014520NCRR NIH HHS 1UL1RR025011NCRR NIH HHS UL1 RR025011
6 · The paper itself

Abstract

The soy compound genistein has been observed preclinically to inhibit bladder cancer growth with one potential mechanism being the inhibition of epidermal growth factor receptor phosphorylation (p-EGFR). A phase 2 randomized, placebo-controlled trial investigated whether daily, oral genistein (300 or 600 mg/d as the purified soy extract G-2535) for 14 to 21 days before surgery alters molecular pathways in bladder epithelial tissue in 59 subjects diagnosed with urothelial bladder cancer (median age, 71 years). G-2535 treatment was well tolerated; observed toxicities were primarily mild to moderate gastrointestinal or metabolic and usually not attributed to study drug. Genistein was detected in plasma and urine of subjects receiving G-2535 at concentrations greater than placebo subjects' but were not dose-dependent. Reduction in bladder cancer tissue p-EGFR staining between the placebo arm and the combined genistein arms was significant at the protocol-specified significance level of 0.10 (P = 0.07). This difference was most prominent when comparing the 300-mg group with placebo (P = 0.015), but there was no significant reduction in p-EGFR staining between the 600-mg group and placebo. No difference in normal bladder epithelium p-EGFR staining was observed between treatment groups. No significant differences in tumor tissue staining between treatment groups were observed for COX-2, Ki-67, activated caspase-3, Akt, p-Akt, mitogen-activated protein kinase (MAPK), or p-MAPK. No significant differences in urinary survivin or BLCA-4 levels between treatment groups were observed. Genistein displayed a possible bimodal effect (more effective at the lower dose) on bladder cancer tissue EGFR phosphorylation that should be evaluated further, possibly in combination with other agents.

Indexed as

AgedAged, 80 and overAnticarcinogenic AgentsBiomarkersCombined Modality TherapyErbB ReceptorsFemaleGenisteinGlycine maxHumansIsoflavonesMaleMiddle AgedPlacebosTime FactorsUrinary Bladder NeoplasmsAnticarcinogenic AgentsBiomarkersdaidzeinErbB ReceptorsGenisteinIsoflavonesPlacebos

Identifiers

PMID22293631
PMCPMC3324663
OpenAlexW2164390929

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.