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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)69-72
Number of pages4
JournalEuropean Journal of Cancer Prevention
Volume33
Issue number1
DOIs
StatePublished - Jan 1 2024

Bibliographical note

Publisher Copyright:
© 2024 Lippincott Williams and Wilkins. All rights reserved.

Keywords

  • clinical trial design
  • non-melanoma skin cancer
  • prevention

ASJC Scopus subject areas

  • Epidemiology
  • Oncology
  • Public Health, Environmental and Occupational Health
  • Cancer Research

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