Chemoprevention of Basal and Squamous Cell Carcinoma With a Single Course of Fluorouracil, 5%, Cream: A Randomized Clinical Trial.

Importance: Keratinocyte carcinoma (ie, cutaneous basal and squamous cell carcinoma) is the most common cancer in the United States. Objective: To determine whether topical fluorouracil could prevent surgically treated keratinocyte carcinoma. Design, Setting, and Participants: The Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial was a randomized, double-blind, placebo-controlled trial of topical fluorouracil for chemoprevention of keratinocyte carcinoma. Participants were recruited from May 2009 to September 2011 from 12 Veterans Affairs medical centers and followed until June 30, 2013. Participants were veterans (n = 932) with a history of at least 2 keratinocyte carcinomas in the past 5 years; almost all were white males and the median age was 70 years. Interventions: Application of fluorouracil, 5%, (n = 468) or vehicle control cream (n = 464) to the face and ears twice daily for 2 to 4 weeks upon randomization. Main Outcomes and Measures: Surgically treated keratinocyte, basal cell, and squamous cell carcinoma risk on the face and ears in the first year after enrollment; and time to first surgically treated keratinocyte, basal cell, and squamous cell carcinoma. The a priori hypothesis was that fluorouracil would be effective in preventing these cancers. Results: Of 932 participants (916 men [98%]; 926 white [99%]; median age, 70 years), 299 developed a basal cell carcinoma end point (95 in year 1) and 108 developed a squamous cell carcinoma end point (25 in year 1) over 4 years (median follow-up, 2.8 years). Over the entire study, there was no difference between treatment groups in time to first keratinocyte, basal cell, or squamous cell carcinoma. During the first year, however, 5 participants (1%) in the fluorouracil group developed a squamous cell carcinoma vs 20 (4%) in the control group, a 75% (95% CI, 35%-91%) risk reduction (P = .002). The 11% reduction in basal cell carcinoma risk during year 1 (45 [10%] in the fluorouracil group vs 50 [11%] in the control group) was not statistically significant (95% CI, 39% reduction to 31% increase), nor was there a significant effect on keratinocyte carcinoma risk. However, a reduction in keratinocyte carcinomas treated with Mohs surgery was observed. Conclusions and Relevance: A conventional course of fluorouracil to the face and ears substantially reduces surgery for squamous cell carcinoma for 1 year without significantly affecting the corresponding risk for basal cell carcinoma. Trial Registration: clinicaltrials.gov Identifier: NCT00847912.

Corrigendum: Editorial boards of dermatology journals and their potential financial conflict of interest.

The original article was published on August 15, 2018 and corrected on September 15, 2018. The revised version of the article removes a co-author, unintentionally retained during the editorial proofing process. This change appears in the revised online PDF copy of this article.

Editorial boards of dermatology journals and their potential financial conflict of interest.

BACKGROUND: Financial relationships between editorial board members of peer-reviewed journals and pharmaceutical and medical device manufacturing companies can potentially lead to biases and loss of objectivity of the medical literature. The purpose of this study was to evaluate the potential financial conflicts of interest that exist among editorial board members of dermatology journals. METHODS: Editorial board members for 36 dermatology journals were identified and searched using the Open Payments database on the Center for Medicare and Medicaid Services website. The total amount of general payments made to these physician editors were collected and stratified using a tier system: 1) nothing reported, 2) >$0 and <$10,000, 3) >$10,000 and <$100,000, and 4) >$100,000. RESULTS: We identified 551 editors from 36 dermatology journals for use in our analysis. Some form of general payment was made to 87% of these physicians (480 of 551). Four journals had >25% of their editorial staff receiving >$100,000. CONCLUSIONS: Financial relationships exist between editorial board members of dermatology journals and pharmaceutical/medical device manufacturing companies, which could lead to financial conflicts of interest. Publications coming from journals with highly paid physician editors have more potential to be biased.