- Clinical trial results show promising evidence that use of fluorouracil 5% (5-FU) reduces risk for keratinocyte carcinoma skin cancer.
- Usage of the skin cream for just one month offers continued protection and risk reduction for up to one year.
- A statistically significant 75 percent risk reduction was observed in high risk individuals who were given 5-FU compared to those who received placebo.
Results from a clinical trial which involved over 900 veterans who were at high risk for skin cancer showed that using a generic skin cream reduced the risk of the cancer. The generic skin cream called fluorouracil 5 percent (5-FU), when used for a period of one month reduces the risk of a squamous cell carcinoma (SCC) by 75 percent within one year; SCC is a cancer that would otherwise need surgery. This would mean that just using the cream for one month appears to prevent cancer for up to a year, said lead author Dr. Martin A. Weinstock, a professor of dermatology in the Warren Alpert Medical School of Brown University and chief of dermatology at the Providence Veterans Affairs Medical Center.The study findings are published in JAMA Dermatology.
The TrialThe Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial was conducted between 2009 and 2013, where 932 veterans who had at least two prior basal cell carcinomas (BCCs) or SCCs were selected. Each one was randomly assigned to either receive the 5-FU cream or another cream but without the active ingredient.The veterans were instructed to apply the cream twice a day on their face and ears for up to four weeks. They were also given a 30 SPF sunscreen and skin cancer information.
The two groups were similar on all accounts other than the cream that they received. Both groups were almost exclusively white and male, with an average age of 71. Also, veterans typically have spent a large amount of time in the sun during their years of service and had the same self-reported degree of prior sun exposure and sunburn.
‘While current prevention methods like sunscreens and oral medications for carcinomas cease to work when no longer in use, 5-FU appeared to provide prolonged protection even after discontinuation.’
Study FindingsAt the end of the first year after treatment initiation, 20 of the 464 veterans who received the placebo cream had developed a squamous cell carcinoma that required surgery. However, in the group that received 5-FU only five of the 468 veterans developed the cancer. The research team noticed a 75 percent risk reduction in the group that received 5-FU.
Among veterans who had a previous history of basal cell carcinoma (BCC) and received 5-FU, 11% risk reduction was noticed after the first year. However, this was not statistically significant. Overall, after four years of treatment initiation, 298 of all participants developed at least one BCC, and 108 had developed at least one SCC.
"This suggests that using the 5-FU can reduce the resources needed to treat these carcinomas," Weinstock said.
"The most remarkable thing about this study is that now we have something to use that doesn't lose its effectiveness when you stop using it," Weinstock said. "But this is the first study of its type. I'm hopeful there will be other studies that show other sorts of regimens that last longer and do a better job over time as science progresses. This is an important first step."
Side effects of the skin creamThe cream does have common side effects like causing redness, itchy, sensitive and crusty skin, but these reduce once the application of the cream stops. At the end of 6 months of the cream treatment, 21 percent of the 5-FU group rated the side effects as "severe," and 40 percent rated them as "moderate."
Weinstock and colleagues are planning further studies, including one to determine the cost-effectiveness of 5-FU treatment.
- In clinical trial, cream reduces squamous cell carcinoma risk - (https://www.eurekalert.org/pub_releases/2018-01/bu-ict010318.php)
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