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SCOTTSDALE – A single course of topical 5-fluorouracil (5-FU) prevented 62% more actinic keratoses than placebo, and this chemopreventive effect persisted for up to 3 years, according to an analysis of the Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial (VAKCCT) trial.
Other studies have shown that 5-FU effectively treats precancerous AKs, but have not examined whether 5-FU can prevent AKs, Dr. Joanna Walker said in an interview at the annual meeting of the Society for Investigative Dermatology.
Clinicians should consider preventive 5-FU in patients who are at high risk for basal cell and squamous cell carcinomas, especially if a skin check reveals multiple AKs, said Dr. Walker of the department of dermatology, Brown University, Providence, RI.
The VAKCCT was a randomized, double-blind, placebo-controlled study conducted at 12 Veterans Affairs dermatology clinics. The 319 patients in the analysis were nearly all elderly men with extensive sun damage, with a total of 2,386 AKs at baseline, for an average of five lesions per patient. Patients also had a history of at least two keratinocyte carcinomas in the past 5 years, including at least one lesion on the face or ears, and no recent history of 5-FU exposure.
The clinically and demographically similar study arms were randomized to either 5% topical 5-FU cream or a vehicle control cream, applied twice daily for 2-4 weeks. Both groups received cryotherapy for existing AKs, and were given free SPF 30 sunscreen. At each 6-month follow-up visit, the researchers counted existing AKs and new lesions.
At month 6, the treatment group had 62% fewer new AKs than the placebo group (average per patient, 1.78 and 4.73, respectively), a statistically significant difference. At months 12, 18, 24, 30, and 36, respectively, the treatment group had 50%, 40%, 41%, 25%, and 35% fewer new AKs than the placebo group, and these differences all were statistically significant. Furthermore, at month 6, only 56% of treated patients had at least one new AK, compared with 78% of the control group (incidence rate ratio, 0.72; 95% confidence interval, 0.54-0.95).
This chemopreventive effect remained significant for 24 months, the investigators reported. “Individuals with at least five AKs at the time of 5-FU treatment had an even more dramatic reduction in new AKs,” Dr. Walker noted. “There is now high-quality evidence supporting the use of topical 5-FU for AK chemoprevention. I think this is important information that we can take back to the clinic when we are trying to convince our patients to go through a course of 5-FU.”
The rate of new AKs in the placebo group fell during the first 2.5 years of the study and then stabilized. “For both groups, there was a dramatic increase in the use of sunscreen during the trial, and we hypothesized that the decrease in AKs in the control group was due to increased use of sun-protective measures,” Dr. Walker said.
The research was funded by the Cooperative Studies Program of the U.S. Department of Veterans Affairs. Dr. Walker had no disclosures.
SCOTTSDALE – A single course of topical 5-fluorouracil (5-FU) prevented 62% more actinic keratoses than placebo, and this chemopreventive effect persisted for up to 3 years, according to an analysis of the Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial (VAKCCT) trial.
Other studies have shown that 5-FU effectively treats precancerous AKs, but have not examined whether 5-FU can prevent AKs, Dr. Joanna Walker said in an interview at the annual meeting of the Society for Investigative Dermatology.
Clinicians should consider preventive 5-FU in patients who are at high risk for basal cell and squamous cell carcinomas, especially if a skin check reveals multiple AKs, said Dr. Walker of the department of dermatology, Brown University, Providence, RI.
The VAKCCT was a randomized, double-blind, placebo-controlled study conducted at 12 Veterans Affairs dermatology clinics. The 319 patients in the analysis were nearly all elderly men with extensive sun damage, with a total of 2,386 AKs at baseline, for an average of five lesions per patient. Patients also had a history of at least two keratinocyte carcinomas in the past 5 years, including at least one lesion on the face or ears, and no recent history of 5-FU exposure.
The clinically and demographically similar study arms were randomized to either 5% topical 5-FU cream or a vehicle control cream, applied twice daily for 2-4 weeks. Both groups received cryotherapy for existing AKs, and were given free SPF 30 sunscreen. At each 6-month follow-up visit, the researchers counted existing AKs and new lesions.
At month 6, the treatment group had 62% fewer new AKs than the placebo group (average per patient, 1.78 and 4.73, respectively), a statistically significant difference. At months 12, 18, 24, 30, and 36, respectively, the treatment group had 50%, 40%, 41%, 25%, and 35% fewer new AKs than the placebo group, and these differences all were statistically significant. Furthermore, at month 6, only 56% of treated patients had at least one new AK, compared with 78% of the control group (incidence rate ratio, 0.72; 95% confidence interval, 0.54-0.95).
This chemopreventive effect remained significant for 24 months, the investigators reported. “Individuals with at least five AKs at the time of 5-FU treatment had an even more dramatic reduction in new AKs,” Dr. Walker noted. “There is now high-quality evidence supporting the use of topical 5-FU for AK chemoprevention. I think this is important information that we can take back to the clinic when we are trying to convince our patients to go through a course of 5-FU.”
The rate of new AKs in the placebo group fell during the first 2.5 years of the study and then stabilized. “For both groups, there was a dramatic increase in the use of sunscreen during the trial, and we hypothesized that the decrease in AKs in the control group was due to increased use of sun-protective measures,” Dr. Walker said.
The research was funded by the Cooperative Studies Program of the U.S. Department of Veterans Affairs. Dr. Walker had no disclosures.
SCOTTSDALE – A single course of topical 5-fluorouracil (5-FU) prevented 62% more actinic keratoses than placebo, and this chemopreventive effect persisted for up to 3 years, according to an analysis of the Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial (VAKCCT) trial.
Other studies have shown that 5-FU effectively treats precancerous AKs, but have not examined whether 5-FU can prevent AKs, Dr. Joanna Walker said in an interview at the annual meeting of the Society for Investigative Dermatology.
Clinicians should consider preventive 5-FU in patients who are at high risk for basal cell and squamous cell carcinomas, especially if a skin check reveals multiple AKs, said Dr. Walker of the department of dermatology, Brown University, Providence, RI.
The VAKCCT was a randomized, double-blind, placebo-controlled study conducted at 12 Veterans Affairs dermatology clinics. The 319 patients in the analysis were nearly all elderly men with extensive sun damage, with a total of 2,386 AKs at baseline, for an average of five lesions per patient. Patients also had a history of at least two keratinocyte carcinomas in the past 5 years, including at least one lesion on the face or ears, and no recent history of 5-FU exposure.
The clinically and demographically similar study arms were randomized to either 5% topical 5-FU cream or a vehicle control cream, applied twice daily for 2-4 weeks. Both groups received cryotherapy for existing AKs, and were given free SPF 30 sunscreen. At each 6-month follow-up visit, the researchers counted existing AKs and new lesions.
At month 6, the treatment group had 62% fewer new AKs than the placebo group (average per patient, 1.78 and 4.73, respectively), a statistically significant difference. At months 12, 18, 24, 30, and 36, respectively, the treatment group had 50%, 40%, 41%, 25%, and 35% fewer new AKs than the placebo group, and these differences all were statistically significant. Furthermore, at month 6, only 56% of treated patients had at least one new AK, compared with 78% of the control group (incidence rate ratio, 0.72; 95% confidence interval, 0.54-0.95).
This chemopreventive effect remained significant for 24 months, the investigators reported. “Individuals with at least five AKs at the time of 5-FU treatment had an even more dramatic reduction in new AKs,” Dr. Walker noted. “There is now high-quality evidence supporting the use of topical 5-FU for AK chemoprevention. I think this is important information that we can take back to the clinic when we are trying to convince our patients to go through a course of 5-FU.”
The rate of new AKs in the placebo group fell during the first 2.5 years of the study and then stabilized. “For both groups, there was a dramatic increase in the use of sunscreen during the trial, and we hypothesized that the decrease in AKs in the control group was due to increased use of sun-protective measures,” Dr. Walker said.
The research was funded by the Cooperative Studies Program of the U.S. Department of Veterans Affairs. Dr. Walker had no disclosures.
AT THE 2016 SID ANNUAL MEETING
Key clinical point: One course of topical 5-fluorouracil was effective and durable in preventing new actinic keratoses in high-risk patients.
Major finding: At month 6, the treatment group had 62% fewer new AKs than the placebo group, and the difference remained significant at month 36.
Data source: The double-blind controlled study evaluated 5-FU vs. a vehicle cream in 319 veterans, most of whom were elderly men.
Disclosures: The study was funded by the Cooperative Studies Program of the U.S. Department of Veterans Affairs. Dr. Walker had no disclosures.
