Evidence map›Paper›PMID 21882176›Full record

Trial reportCancer2012

Randomized controlled trial of acitretin versus placebo in patients at high-risk for basal cell or squamous cell carcinoma of the skin (North Central Cancer Treatment Group Study 969251).

Kunal C Kadakia, Debra L Barton, Charles L Loprinzi, Jeff A Sloan, Clark C Otley, Brent B Diekmann, Paul J Novotny, Steven R Alberts, Paul J Limburg, Mark R Pittelkow

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00003611 (Chemoprevention Trial of Acitretin Versus Placebo in Solid Organ Transplant Recipients With Multiple Prior Treated Skin Cancers), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
2.2field-weighted citation impact, top 13% 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.

NCT00003611 nacompletednot on this map

Chemoprevention Trial of Acitretin Versus Placebo in Solid Organ Transplant Recipients With Multiple Prior Treated Skin Cancers

TypeinterventionalSponsorAlliance for Clinical Trials in OncologyRan2000 to 2003Enrolled129ConditionsNon-melanomatous Skin CancerArmsacitretin, placebo
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 86 citations in OpenAlex.

  1. Pooled it
  2. Guidelines of care for the management of cutaneous squamous cell carcinoma.Journal of the American Academy of Dermatology · 2018
    Guideline
  3. Management of Skin Cancer in the High-Risk Patient.Current treatment options in oncology · 2016
    Pooled it
  4. Review
  5. Review
  6. The evolving treatment landscape for CSCC.Archives of dermatological research · 2025
    Review
  7. Review
  8. Review
  9. Immunomodulators for Non-Melanoma Skin Cancers: Updated Perspectives.Clinical, cosmetic and investigational dermatology · 2023
    Review
  10. An update on clinical trials for chemoprevention of human skin cancer.Journal of cancer metastasis and treatment · 2023
    Article
  11. Review
  12. Review
  13. Investigative Landscape in Advanced Non-Melanoma Skin Cancers.Current treatment options in oncology · 2021
    Review
  14. Article
  15. Article
  16. Review
  17. Post renal-transplant malignancy surveillance.Clinical medicine (London, England) · 2020
    Review
  18. [Alternative treatment options for periorbital basal cell carcinoma].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2020
    Review
  19. Article
  20. Article
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

10 authors at 2 institutions in 1 country.

Kunal C KadakiaDivision of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Debra L Barton
Charles L Loprinzi
Jeff A Sloan
Clark C Otley
Brent B Diekmann
Paul J Novotny
Steven R Alberts
Paul J Limburg
Mark R Pittelkow
Mayo Clinic · USWinnMed · US

Funding

SUPPLEMENTU10CA037404 · NCI · MAYO CLINIC ROCHESTER · PI LOPRINZI, CHARLES L · 1985 to 2014
$34.8M
CANCER CHEMOPREVENTION--ROLE OF INFECTION/IMMUNITYR01CA079429 · NCI · MAYO CLINIC COLL OF MEDICINE, ROCHESTER · PI LOPRINZI, CHARLES L · 1999 to 2003
$2.0M
Survivorship research established investigator awardK05CA124477 · NCI · MAYO CLINIC ROCHESTER · PI LOPRINZI, CHARLES L · 2008 to 2012
$777k
NCI NIH HHS CA-124477NCI NIH HHS CA-37404NCI NIH HHS K05 CA124477NCI NIH HHS R01 CA079429NCI NIH HHS U10 CA037404
6 · The paper itself

Abstract

backgroundChemoprevention with systemic retinoids has demonstrated promise in decreasing the incidence of new primary nonmelanoma skin cancers (NMSCs) in immunocompromised post-transplantation recipients. There is limited evidence for the use of systemic retinoids in the nontransplantation patient. To the authors' knowledge, this is the first randomized controlled trial to assess the efficacy of acitretin as a chemopreventive agent in nontransplantation patients at high-risk for NMSC.

methodsThe study was designed as a prospective, randomized, double-blind, placebo-controlled clinical trial. To test the possible skin cancer-preventing effect of a 2-year treatment with acitretin, 70 nontransplantation patients aged ≥18 years who had a history of ≥2 NMSCs within 5 years of trial onset were randomized to receive either placebo or acitretin 25 mg orally 5 days per week. The primary outcome measure was the rate of new NMSC development.

resultsSeventy patients were randomized to receive either acitretin alone (N = 35) or placebo (N = 35). During the 2-year treatment period, the patients who received acitretin did not have a statistically significant reduction in the rate of new primary NMSCs (odds ratio, 0.41; 95% confidence interval, 0.15-1.13; 54% vs 74%; P = .13). However, using the incidence of new NMSC, the time to new NMSC, and total NMSC counts, an umbrella test indicated a significant trend that favored the use of acitretin (chi-square statistic, 3.94; P = .047). The patients who received acitretin reported significantly more mucositis and skin toxicities compared with the patients who received placebo.

conclusionsAlthough there was not a statistically significant benefit observed with the use of acitretin, this may have been the result of low statistical power.

Indexed as

AcitretinAgedAged, 80 and overAntineoplastic AgentsBasal Cell CarcinomaCarcinoma, Squamous CellDouble-Blind MethodFemaleHumansMaleMiddle AgedNeoplasms, Second PrimaryPlacebosRetinoidsRiskSkin NeoplasmsAcitretinAntineoplastic AgentsPlacebosRetinoids

Identifiers

PMID21882176
PMCPMC3365547
OpenAlexW2001563626

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.