JAMA dermatology · 2018
Chemoprevention of Basal and Squamous Cell Carcinoma With a Single Course of Fluorouracil, 5%, Cream: A Randomized Clinical Trial.
Сравнительное исследованиеСтатьяРандомизированное исследованиеПоддержка правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Weinstock Martin A, Thwin Soe Soe, Siegel Julia A, Marcolivio Kimberly, Means Alexander D, Leader Nicholas F, Shaw Fiona M, Hogan Daniel, Eilers David, Swetter Susan M, Chen Suephy C, Jacob Sharon E, Warshaw Erin M, Stricklin George P, Dellavalle Robert P, Sidhu-Malik Navjeet, Konnikov Nellie, Werth Victoria P, Keri Jonette E, Robinson-Bostom Leslie, Ringer Robert J, Lew Robert A, Ferguson Ryan, DiGiovanna John J, Huang Grant D, Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial (VAKCC) Group
Аннотация
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.
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.
Предметные рубрики MeSH
Administration, CutaneousAdultAgedAged, 80 and overBasal Cell CarcinomaCarcinoma, Squamous CellChemopreventionDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFluorouracilHumansMaleMiddle AgedMohs SurgeryPrognosisRisk AssessmentSkin CreamSkin NeoplasmsSurvival AnalysisTreatment Outcome