Quality of clinical trials for the prevention of keratinocyte cancer.
Journal
International journal of dermatology
ISSN: 1365-4632
Titre abrégé: Int J Dermatol
Pays: England
ID NLM: 0243704
Informations de publication
Date de publication:
Nov 2020
Nov 2020
Historique:
received:
12
01
2020
revised:
25
03
2020
accepted:
06
04
2020
pubmed:
8
5
2020
medline:
22
6
2021
entrez:
8
5
2020
Statut:
ppublish
Résumé
Keratinocyte cancer (KC) is the most common form of cancer in humans. To our knowledge, no previous publications assessing the methodological quality of clinical trials for the prevention of KC have been recently published. We aim to assess the methodological quality of clinical trials focused on the prevention of KC in high-risk groups not receiving immunosuppressive therapy (NRIT) and propose solutions to improve the design of future trials. We searched clinical trials in which the main outcome was the prevention of KC in high-risk NRIT groups using the strategy published in the International Prospective Register of Systematic Reviews (PROSPERO registry), CRD42016045981. Consolidated Standards of Reporting Trials (CONSORT) criteria and the Cochrane Collaboration risk of bias tool were used to assess methodological quality. We analyzed 23 clinical trials. We found a high risk of attrition and reporting bias in 86.9% and 60.9% of the trials, respectively. Regarding the CONSORT criteria, in at least 40% of the trials, the authors omitted the following information: a description of the trial design, the number of losses and exclusions after randomization, the results of subgroup and adjusted analysis, the estimated effect size and the precision of primary and secondary outcomes. Methodological quality was improved in the recently published clinical trials compared to those published before the CONSORT criteria development. All clinical trials should report in detail the information used to assess potential risks of bias.
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
1332-1340Informations de copyright
© 2020 the International Society of Dermatology.
Références
Venables ZC, Nijsten T, Wong KF, et al. Epidemiology of basal and cutaneous squamous cell carcinoma in the United Kingdom 2013-2015: a cohort study. Br J Dermatol 2019;181: 474-482.
Yoon J, Phibbs CS, Chow A, Pomerantz H, Weinstock MA. Costs of keratinocyte carcinoma (nonmelanoma skin cancer) and actinic keratosis treatment in the Veterans Health Administration. Dermatol Surg 2016; 42: 1041-1047.
Wehner MR, Shive ML, Chren MM, et al. Indoor tanning and non-melanoma skin cancer: systematic review and meta-analysis. BMJ 2012; 345: e5909.
Marcil I, Stern RS. Risk of developing a subsequent nonmelanoma skin cancer in patients with a history of nonmelanoma skin cancer: a critical review of the literature and meta-analysis. Arch Dermatol 2000; 136: 1524-1530.
Chandler J, Higgins JPT, Deeks JJ, et al. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.2.0 (updated February 2017), Cochrane, 2017. Available from Cochrane Community.
Morales-Sánchez MA, Peralta-Pedrero ML, Jurado-Santa Cruz F, et al. Interventions for preventing keratinocyte cancer in high-risk groups not receiving immunosuppressive therapy. Cochrane Database Syst Rev 2016; 7: CD012266.
Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomized trials. Int J Surg 2012; 10: 28-55.
Moon TE, Levine N, Cartmel B, et al. Effect of retinol in preventing squamous cell skin cancer in moderate-risk subjects: a randomized, double-blind, controlled trial. Cancer Epidemiol Biomarkers Prev 1997; 6: 949-956.
Hantash BM, Stewart DB, Cooper ZA, et al. Facial resurfacing for nonmelanoma skin cancer prophylaxis. Arch Dermatol 2006; 142: 976-982.
Chen AC, Martin AJ, Choy B, et al. A phase 3 randomized trial of nicotinamide for skin-cancer chemoprevention. N Engl J Med 2015; 373: 1618-1626.
Clark LC, Combs GF Jr, Turnbull BW, et al. Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin. JAMA 1996; 276: 1957.
Dixon AJ, Anderson SJ, Mazzurco JD, et al. Novel photodynamic therapy does not prevent new skin cancers-randomized controlled trial. Dermatol Surg 2014; 40: 412-419.
Elmets CA, Viner JL, Pentland AP, et al. Chemoprevention of nonmelanoma skin cancer with celecoxib: a randomized, double-blind, placebo-controlled trial. J Natl Cancer Inst 2010; 102: 1835-1844.
Greenberg ER, Baron JA, Stukel TA, et al. A clinical trial of beta carotene to prevent basal-cell and squamous-cell cancers of the skin. N Engl J Med 1990; 323: 789-795.
Jaax S, Scott LW, Wolf JE Jr, et al. General guidelines for a low-fat diet effective in the management and prevention of nonmelanoma skin cancer. Nutr Cancer 1997; 27: 150-156.
Kadakia KC, Barton DL, Loprinzi CL, et al. 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). Cancer 2012; 118: 2128-2137.
Levine N, Moon TE, Cartmel B, et al. Trial of retinol and isotretinoin in skin cancer prevention: a randomized, double-blind, controlled trial. Cancer Epidemiol Biomarkers Prev 1997; 6: 957-961.
Marcus S, Piacquadio D, Houlihan A, et al. Photodynamic therapy (PDT) with aminolevulinic acid (ALA) 20% and blue light reduces occurrence of actinic keratoses (AK) and de novo non-melanoma skin cancers (NMSCs) in patients with field cancerization. J Investig Dermatol 2017; 137: B2.
Naylor MF, Boyd A, Smith DW, et al. High sun protection factor sunscreens in the suppression of actinic neoplasia. Arch Dermatol 1995; 131: 170-175.
Sotiriou E, Apalla Z, Vrani F, et al. Photodynamic therapy vs. imiquimod 5% cream as skin cancer preventive strategies in patients with field changes: a randomized intraindividual comparison study. J Eur Acad Dermatology Venereol 2015; 29: 325-329.
Tangrea JA, Edwards BK, Taylor PR, et al. Long-term therapy with low-dose isotretinoin for prevention of basal cell carcinoma: a multicenter clinical trial. J Natl Cancer Inst 1992; 84: 328-332.
Weinstock MA, Bingham SF, DiGiovanna JJ, et al. Tretinoin and the prevention of keratinocyte carcinoma (basal and squamous cell carcinoma of the skin): a veterans affairs randomized chemoprevention trial. J Invest Dermatol 2012; 132: 1583-1590.
Weinstock MA, Thwin SS, Siegel JA. Chemoprevention of basal and squamous cell carcinoma with a single course of fluorouracil, 5%, cream a randomized clinical trial. JAMA Dermatol 2018; 154: 167-174.
Surjana D, Halliday GM, Martin AJ, et al. Oral nicotinamide reduces actinic keratoses in phase II double-blinded randomized controlled trials. J Invest Dermatol 2012; 132: 1497-1500.
Tang JY, Aszterbaum M, Athar M, et al. Basal Cell carcinoma chemoprevention with nonsteroidal anti-inflammatory drugs in genetically predisposed PTCH1+/- humans and mice. Cancer Prev Res (Phila) 2010; 3: 25-34.
Tang JY, Mackay-Wiggan JM, Aszterbaum M, et al. Inhibiting the hedgehog pathway in patients with the basal-cell nevus syndrome. N Engl J Med 2012; 366: 2180-2188.
Tang JY, Chiou AS, Mackay-Wiggan JM, et al. Tazarotene: randomized, double-blind, vehicle-controlled, and open-label concurrent trials for basal cell carcinoma prevention and therapy in patients with basal cell nevus syndrome. Cancer Prev Res 2014; 7: 292-299.
Tang JY, Ally MS, Chanana AM, et al. Inhibition of the hedgehog pathway in patients with basal-cell nevus syndrome: final results from the multicenter, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol 2016; 17: 1720-1731.
Yarosh D, Klein J, O’Connor A, et al. Effect of topically applied T4 endonuclease V in liposomes on skin cancer in xeroderma pigmentosum: a randomised study. Lancet 2001; 357: 926-929.
Sanclemente G, Pardo H, Sánchez S, et al. Análisis de la calidad de los ensayos clínicos publicados en revistas dermatológicas publicadas en español entre 1997 y 2012. Actas Dermosifiliogr 2016; 107: 44-54.
McGauran N, Wieseler B, Kreis J, et al. Reporting bias in medical research - a narrative review. Trials 2010; 11: 37.
Kim DY, Park HS, Cho S, Yoon HS. The quality of reporting randomized controlled trials in the dermatology literature in an era where the CONSORT statement is a standard. Br J Dermatol 2019; 180: 1361-1367.
Lundh A, Lexchin J, Mintzes B, et al. Industry sponsorship and research outcome: systematic review with meta-analysis. Intensive Care Med 2018; 44: 1603-1612.
PennState Eberly College of Science. STAT 509, design ansd analysis of clinical trials. 2018. Available at: https://online.stat.psu.edu/stat509/node/118/.
European Patients' Academy. Group sequential design. 2015. Available at: https://www.eupati.eu/glossary/group-sequential-design/.