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

Publication ,  Conference
Weinstock, MA; Thwin, SS; Siegel, JA; Marcolivio, K; Means, AD; Leader, NF; Shaw, FM; Hogan, D; Eilers, D; Swetter, SM; Chen, SC; Jacob, SE ...
Published in: Jama Dermatol
February 1, 2018

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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Published In

Jama Dermatol

DOI

EISSN

2168-6084

Publication Date

February 1, 2018

Volume

154

Issue

2

Start / End Page

167 / 174

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Skin Neoplasms
  • Skin Cream
  • Risk Assessment
  • Prognosis
  • Mohs Surgery
  • Middle Aged
  • Male
  • Humans
 

Citation

APA
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MLA
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Weinstock, M. A., Thwin, S. S., Siegel, J. A., Marcolivio, K., Means, A. D., Leader, N. F., … Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial (VAKCC) Group, . (2018). Chemoprevention of Basal and Squamous Cell Carcinoma With a Single Course of Fluorouracil, 5%, Cream: A Randomized Clinical Trial. In Jama Dermatol (Vol. 154, pp. 167–174). United States. https://doi.org/10.1001/jamadermatol.2017.3631
Weinstock, Martin A., Soe Soe Thwin, Julia A. Siegel, Kimberly Marcolivio, Alexander D. Means, Nicholas F. Leader, Fiona M. Shaw, et al. “Chemoprevention of Basal and Squamous Cell Carcinoma With a Single Course of Fluorouracil, 5%, Cream: A Randomized Clinical Trial.” In Jama Dermatol, 154:167–74, 2018. https://doi.org/10.1001/jamadermatol.2017.3631.
Weinstock MA, Thwin SS, Siegel JA, Marcolivio K, Means AD, Leader NF, et al. Chemoprevention of Basal and Squamous Cell Carcinoma With a Single Course of Fluorouracil, 5%, Cream: A Randomized Clinical Trial. In: Jama Dermatol. 2018. p. 167–74.
Weinstock, Martin A., et al. “Chemoprevention of Basal and Squamous Cell Carcinoma With a Single Course of Fluorouracil, 5%, Cream: A Randomized Clinical Trial.Jama Dermatol, vol. 154, no. 2, 2018, pp. 167–74. Pubmed, doi:10.1001/jamadermatol.2017.3631.
Weinstock MA, Thwin SS, Siegel JA, Marcolivio K, Means AD, Leader NF, Shaw FM, Hogan D, Eilers D, Swetter SM, Chen SC, Jacob SE, Warshaw EM, Stricklin GP, Dellavalle RP, Sidhu-Malik N, Konnikov N, Werth VP, Keri JE, Robinson-Bostom L, Ringer RJ, Lew RA, Ferguson R, DiGiovanna JJ, Huang GD, Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial (VAKCC) Group. Chemoprevention of Basal and Squamous Cell Carcinoma With a Single Course of Fluorouracil, 5%, Cream: A Randomized Clinical Trial. Jama Dermatol. 2018. p. 167–174.

Published In

Jama Dermatol

DOI

EISSN

2168-6084

Publication Date

February 1, 2018

Volume

154

Issue

2

Start / End Page

167 / 174

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Skin Neoplasms
  • Skin Cream
  • Risk Assessment
  • Prognosis
  • Mohs Surgery
  • Middle Aged
  • Male
  • Humans