Validation and comparison of quality-of-life measures for topical 5-fluorouracil treatment: results from a randomized controlled trial

Pomerantz, Hyemin; Chren, MM; Lew, Robert A.; Weinstock, Martin A.

doi:10.1111/ced.13089

Cited by 4 publications

(3 citation statements)

References 21 publications

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“…There were no differences between groups for the overall study period ( Table 3). (20) 86 (19) Abbreviations: AK, actinic keratosis; BCC, basal cell carcinoma; KC, keratinocyte carcinoma; SCC, squamous cell carcinoma. a Some percentages may not equal 100% owing to participant's refusal to answer the question, or identification as multiracial.…”

Section: Discussionmentioning

confidence: 99%

“…The VAKCC Trial (Cooperative Studies Program 562) was a double-blind, vehicle-controlled trial for chemoprevention of KCs in veterans at high risk for these cancers. Detailed methods, including sample size calculations, are described elsewhere 5,9,[13][14][15][16][17][18][19][20] and in eAppendix 2 in Supplement 2. Participants with a history of at least 2 KCs in the 5 years prior to enrollment, at least 1 of which was on the face or ears, were recruited from 12 Veterans Affairs (VA) medical centers.…”

Section: Study Design and Interventionsmentioning

confidence: 99%

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Chemoprevention of Basal and Squamous Cell Carcinoma With a Single Course of Fluorouracil, 5%, Cream

Weinstock

Thwin

Siegel³

et al. 2018

JAMA Dermatol

101

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; for the Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial (VAKCC) Group 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

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Section: Discussionmentioning

confidence: 99%

Section: Study Design and Interventionsmentioning

confidence: 99%

Chemoprevention of Basal and Squamous Cell Carcinoma With a Single Course of Fluorouracil, 5%, Cream

Weinstock

Thwin

Siegel³

et al. 2018

JAMA Dermatol

101

View full text Add to dashboard Cite

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“…Results of other studies which reported the impact of AK treatment on HRQoL scores varied from no impact with imiquimod treatment to a temporary impact with PDT and fluorouracil. (Gholam et al, 2013, Pomerantz et al, 2017, Waalboer-Spuij et al, 2015 These studies had a short follow-up period (4 to 8 weeks) and did not compare multiple treatment modalities. The strength of our study is that data were collected in a large multicenter RCT with one year follow-up and allows for HRQoL comparison between different treatment groups.…”

Section: J O U R N a L P R E -P R O O Fmentioning

confidence: 99%

The Effect of Four Approaches to Treat Actinic Keratosis on the Health-Related QOL, as Assessed by the Skindex-29 and Actinic Keratosis QOL

Ahmady

Jansen

Nelemans

et al. 2021

Journal of Investigative Dermatology

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Effects of new keratinocyte carcinomas on skin-related quality of life: Results from the Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial

Siegel

Beatson

Chren

et al. 2019

Journal of the American Academy of Dermatology

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Validation and comparison of quality-of-life measures for topical 5-fluorouracil treatment: results from a randomized controlled trial

Abstract: Our study validated Skindex symptom, Skindex function and SCI social subscales for QoL measurement during treatment with topical 5-FU. The study could not provide evidence for construct validity of the other subscales. Skindex was more responsive than SCI in the context of 5-FU treatment.

Cited by 4 publications

References 21 publications

Chemoprevention of Basal and Squamous Cell Carcinoma With a Single Course of Fluorouracil, 5%, Cream

Chemoprevention of Basal and Squamous Cell Carcinoma With a Single Course of Fluorouracil, 5%, Cream

The Effect of Four Approaches to Treat Actinic Keratosis on the Health-Related QOL, as Assessed by the Skindex-29 and Actinic Keratosis QOL

Effects of new keratinocyte carcinomas on skin-related quality of life: Results from the Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial

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