Evidence map›Paper›PMID 24614012›Full record

Trial reportCancer prevention research (Philadelphia, Pa.)2014

A randomized, double-blind, placebo-controlled phase II clinical trial of lovastatin for various endpoints of melanoma pathobiology.

Kenneth G Linden, Sancy A Leachman, Jonathan S Zager, James G Jakowatz, Jaye L Viner, Christine E McLaren, Ronald J Barr, Philip M Carpenter, Wen-Pin Chen, Craig A Elmets and 4 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer prevention research (Philadelphia, Pa.), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 27% 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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Suppression of CaThe EMBO journal · 2022
    Article
  11. Review
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  13. Article
  14. Review
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  16. Vitamin D signaling and melanoma: role of vitamin D and its receptors in melanoma progression and management.Laboratory investigation; a journal of technical methods and pathology · 2017
    Review
  17. 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

14 authors at 8 institutions in 2 countries.

Kenneth G LindenDepartment of Dermatology and The Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, 101 The City Drive, Orange, CA 92868. kglinden@uci.edu.
Sancy A Leachman
Jonathan S Zager
James G Jakowatz
Jaye L Viner
Christine E McLaren
Ronald J Barr
Philip M Carpenter
Wen-Pin Chen
Craig A Elmets
Joseph A Tangrea
Sung-Jig Lim
Alistair J Cochran
Frank L Meyskens
National Cancer Institute · USHuntsman Cancer Institute · USMoffitt Cancer Center · USTakeda (United States) · USUniversity of Utah · USKyung Hee University · KRUniversity of Alabama at Birmingham · USUniversity of California, Los Angeles · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI Christine O'Connell · 1998 to 2026
$93.5M
Univ.of Calif., Irvine Cancer Center Support GrantP30CA062203 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Melanie Funes · 1994 to 2026
$57.9M
PHASE I and II CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS-261035-261035160N01CN035160 · CN · REGENTS OF THE UNIVERSITY OF · PI MEYSKENS, FRANK L. · 2004 to 2006
–
NCI NIH HHS N01 CN035160NCI NIH HHS N0-1 CN-35160NCI NIH HHS P30 CA062203NCI NIH HHS P30 CA076292NCI NIH HHS P30 CA-62203
6 · The paper itself

Abstract

On the basis of large cardiovascular clinical trials of lipid-lowering agents that showed a considerable decrease in the incidence of primary melanomas in the active agent arm, we have carried out a randomized, double-blind clinical trial examining the impact of lovastatin on various biomarkers of melanoma pathogenesis. Subjects with at least two clinically atypical nevi were randomized to receive oral lovastatin or placebo for a 6-month period. Clinical, histopathologic, and molecular biomarkers were evaluated for change in the two groups. Eighty subjects were randomized, evaluable, and included in the analyses. Lovastatin showed no benefit in comparison with placebo in the primary endpoint of decreasing the level of histopathologic atypia, nor in any of the secondary endpoints of decreasing clinical atypia, impact on nevus number, nor in showing significant changes in any of the molecular biomarkers. There were no significant differences in adverse event profiles for lovastatin compared with placebo. The lovastatin arm did show a significant and considerable decrease in total serum cholesterol and serum low-density lipoprotein (LDL) levels compared with placebo, an expected result. This finding bolsters confidence in subject compliance. Given the results of this trial, it is concluded that if lovastatin were to lower the incidence of melanoma, it would appear not to be doing so by reversing atypia of precursor atypical nevi over the 6-month time frame studied. Further research into the pathogenesis of melanoma and in other potential chemopreventive agents is needed.

Indexed as

AdultAnticholesteremic AgentsBiomarkers, TumorCell Transformation, NeoplasticDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansLovastatinMaleMelanomaMiddle AgedNevusPlacebosSkin NeoplasmsAnticholesteremic AgentsBiomarkers, TumorLovastatinPlacebos

Identifiers

PMID24614012
PMCPMC4208700
OpenAlexW2071625393

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.