Non-melanoma skin cancer event rates in a formalized clinical trial setting: considerations for clinical trial design

Taja Lozar; Kyungmann Kim; Thomas C. Havighurst; Gary S. Wood; Jill M. Kolesar; Howard H. Bailey

doi:10.1097/CEJ.0000000000000829

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Non-melanoma skin cancer event rates in a formalized clinical trial setting: considerations for clinical trial design

Journal article

Peer reviewed

Non-melanoma skin cancer event rates in a formalized clinical trial setting: considerations for clinical trial design

Taja Lozar, Kyungmann Kim, Thomas C. Havighurst, Gary S. Wood, Jill M. Kolesar and Howard H. Bailey

European journal of cancer prevention, Vol.33(1), pp.69-72

01/01/2024

DOI: 10.1097/CEJ.0000000000000829

PMCID: PMC10761598

PMID: 37401516

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https://pmc.ncbi.nlm.nih.gov/articles/PMC10761598/pdf/nihms-1910708.pdfView

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Abstract

Background Here we report clinical risk factors and event rates for the development of new non-melanoma skin cancer (NMSC) in a randomized, double-blind, placebo-controlled trial of the irreversible ornithine decarboxylase (ODC) inhibitor, difluromethylornithine (DFMO), over a 3-5-year follow-up. Methods 147 placebo patients (white; mean age 60.2 years; 60% male) were evaluated for event rates and association of initial skin biomarkers and baseline patient characteristics with the development of squamous cell (SCC) and basal cell (BCC) carcinomas. Results Post-study evaluation (median follow-up 4.4 years) indicates the measures of prior NMSCs (P <= 0.001), prior BCCs (P <= 0.001), prior SCCs (P = 0.011), prior tumor rate (P = 0.002), hemoglobin (P = 0.022), and gender (P = 0.045) as significant predictors for new NMSC development. Similarly, all measures of prior BCCs and NMSCs (P < 0.001), prior tumor rate (P = 0.014), and SCCs in the prior 2 years (P = 0.047) were statistically significant predictors for new BCC development. Total prior NMSCs and those in the prior 5 years (P < 0.001), total prior SCCs and those in the prior 5 years (P < 0.001), total prior BCCs and those in the prior 5 years (P <= 0.001), prior tumor rate (P = 0.011) as well as age (P = 0.008), hemoglobin (P = 0.002), and gender (P = 0.003) were statistically significant predictors of new SCC development. TPA-induced ODC activity at baseline showed no statistically significant association with the development of new NMSC (P = 0.35), new BCCs (P = 0.62), or new SCCs (P = 0.25). Conclusion In the studied population, the history of and rate at which prior NMSCs occur are predictive and should be controlled for in future NMSC prevention trials.

Life Sciences & Biomedicine

Oncology

Science & Technology

Details

Title: Subtitle: Non-melanoma skin cancer event rates in a formalized clinical trial setting: considerations for clinical trial design
Creators: Taja Lozar - University of Wisconsin Carbone Cancer Center
Kyungmann Kim - University of Wisconsin Carbone Cancer Center
Thomas C. Havighurst - University of Wisconsin Carbone Cancer Center
Gary S. Wood - University of Wisconsin Carbone Cancer Center
Jill M. Kolesar - University of Wisconsin Carbone Cancer Center
Howard H. Bailey - University of Wisconsin Carbone Cancer Center
Resource Type: Journal article
Publication Details: European journal of cancer prevention, Vol.33(1), pp.69-72
DOI: 10.1097/CEJ.0000000000000829
PMID: 37401516
PMCID: PMC10761598
NLM abbreviation: Eur J Cancer Prev
ISSN: 0959-8278
eISSN: 1473-5709
Publisher: Lippincott Williams & Wilkins
Number of pages: 4
Grant note: P30 CA014520; U01 CA077158 / NIH; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA
Language: English
Date published: 01/01/2024
Academic Unit: Pharmacy; Pharmaceutical Sciences and Experimental Therapeutics
Record Identifier: 9984695786102771

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