Optimal Treatment for Actinic Keratosis, 0.5% Fluorouracil, Underutilized

NEW YORK – U.S. patients who were treated for actinic keratosis via cryosurgery or fluorouracil failed to receive optimal treatment with these agents, based on a review of more than 16 million patients treated in 2001-2008.

The results "reveal a gap between practice and the evidence in the treatment of AKs [actinic keratoses] by both dermatologists and nondermatologists," reported Dr. Steven R. Feldman and his associates in a poster at the American Academy of Dermatology’s Summer Academy meeting.

"Combination therapy with cryosurgery and topical fluorouracil is underutilized," and when topical fluorouracil is used to treat AKs, "the 0.5% rather than the 5.0% formulation may be preferable to maximize adherence and to minimize cost and adverse events," they wrote.

Their analysis found cryosurgery alone to be the most commonly used treatment in 59% of patients. Neither cryosurgery nor fluorouracil was used in 35% of U.S. patients in 2001-2008. Among the 5% of patients who were treated with a fluorouracil formulation, 3% received the 0.5% formulation, whereas the other 2% received a different formulation (most often the 5.0% strength), reported Dr. Feldman, professor of dermatology and director of the center for dermatology research at Wake Forest University in Winston-Salem, N.C.

Although other treatments for actinic keratosis exist, the researchers noted, "evidence-based medicine supports the use of 0.5% fluorouracil, rather than the 5.0% formulation, for treatment of actinic keratosis. Evidence, including head-to-head clinical trials, indicates that 0.5% fluorouracil has comparable efficacy, greater tolerability, and lower cost, compared with 5.0% fluorouracil. Similar compelling data support the use of combination cryotherapy plus topical fluorouracil rather than either modality alone." (Arch. Dermaol. 2009;145:203-5; Cutis. 2008;81:509-16; J. Drugs Dermatol. 2006;5:133-9). They performed their new analysis "to determine whether current practice reflects the evidence."

They reviewed data from the Centers for Disease Control and Prevention’s National Ambulatory Medical Care Survey. They identified more than 16 million U.S. patients seen with actinic keratosis during the years of 2001-2008 based on ICD-9 coding. Two-thirds of patients received treatment of their actinic keratosis during an office visit.

Dermatologists saw about 90% of these patients. During the period studied, the annual number of patients with AK seen by all physicians and by dermatologists significantly increased, whereas the number seen by nondermatologists did not significantly change.

The data showed that dermatologists did a better job using 0.5% fluorouracil and cryosurgery, compared with nondermatologists. Dermatologists used cryosurgery alone on 62% of their AK patients; they treated 3% with 0.5% fluorouracil, 2% with 5.0% fluorouracil, and 1% with a combination of fluorouracil and cryosurgery.

"Despite the better tolerability and lower cost of the 0.5% fluorouracil formulation, dermatologists prescribed the 5% formulation in over 392,000 patient visits for AK" in 2001-2008. In contrast, nondermatologists used cryosurgery alone on 32% of their AK patients, 0.5% fluorouracil on no patients, 5.0% fluorouracil on 3%, and a combination of fluorouracil and cryosurgery on no patients. Treatments other than cryosurgery or fluorouracil were used by 32% of the dermatologists and by 63% of the nondermatologists.

"Efforts need to be taken to increase physician awareness of the advantages of 0.5% fluorouracil relative to other formulations, and the value of combination therapy," they reported. "Providers who manage AKs should reassess their current treatment practices and adapt them to be consistent with current evidence."

The study was funded by Sanofi-Aventis, which markets a 0.5% formulation of fluorouracil (Carac). Dr. Feldman said that he has received speaking, consulting, or research support from Abbott, Amgen, Astellas, Aventis, Biogen, Centocor, Connetics, Galderma, Genentech, GlaxoSmithKline (Stiefel), Leo, National Biological, Roche, Warner Chilcott, and 3M.

NEW YORK – U.S. patients who were treated for actinic keratosis via cryosurgery or fluorouracil failed to receive optimal treatment with these agents, based on a review of more than 16 million patients treated in 2001-2008.

The results "reveal a gap between practice and the evidence in the treatment of AKs [actinic keratoses] by both dermatologists and nondermatologists," reported Dr. Steven R. Feldman and his associates in a poster at the American Academy of Dermatology’s Summer Academy meeting.

"Combination therapy with cryosurgery and topical fluorouracil is underutilized," and when topical fluorouracil is used to treat AKs, "the 0.5% rather than the 5.0% formulation may be preferable to maximize adherence and to minimize cost and adverse events," they wrote.

Their analysis found cryosurgery alone to be the most commonly used treatment in 59% of patients. Neither cryosurgery nor fluorouracil was used in 35% of U.S. patients in 2001-2008. Among the 5% of patients who were treated with a fluorouracil formulation, 3% received the 0.5% formulation, whereas the other 2% received a different formulation (most often the 5.0% strength), reported Dr. Feldman, professor of dermatology and director of the center for dermatology research at Wake Forest University in Winston-Salem, N.C.

Although other treatments for actinic keratosis exist, the researchers noted, "evidence-based medicine supports the use of 0.5% fluorouracil, rather than the 5.0% formulation, for treatment of actinic keratosis. Evidence, including head-to-head clinical trials, indicates that 0.5% fluorouracil has comparable efficacy, greater tolerability, and lower cost, compared with 5.0% fluorouracil. Similar compelling data support the use of combination cryotherapy plus topical fluorouracil rather than either modality alone." (Arch. Dermaol. 2009;145:203-5; Cutis. 2008;81:509-16; J. Drugs Dermatol. 2006;5:133-9). They performed their new analysis "to determine whether current practice reflects the evidence."

They reviewed data from the Centers for Disease Control and Prevention’s National Ambulatory Medical Care Survey. They identified more than 16 million U.S. patients seen with actinic keratosis during the years of 2001-2008 based on ICD-9 coding. Two-thirds of patients received treatment of their actinic keratosis during an office visit.

Dermatologists saw about 90% of these patients. During the period studied, the annual number of patients with AK seen by all physicians and by dermatologists significantly increased, whereas the number seen by nondermatologists did not significantly change.

The data showed that dermatologists did a better job using 0.5% fluorouracil and cryosurgery, compared with nondermatologists. Dermatologists used cryosurgery alone on 62% of their AK patients; they treated 3% with 0.5% fluorouracil, 2% with 5.0% fluorouracil, and 1% with a combination of fluorouracil and cryosurgery.

"Despite the better tolerability and lower cost of the 0.5% fluorouracil formulation, dermatologists prescribed the 5% formulation in over 392,000 patient visits for AK" in 2001-2008. In contrast, nondermatologists used cryosurgery alone on 32% of their AK patients, 0.5% fluorouracil on no patients, 5.0% fluorouracil on 3%, and a combination of fluorouracil and cryosurgery on no patients. Treatments other than cryosurgery or fluorouracil were used by 32% of the dermatologists and by 63% of the nondermatologists.

"Efforts need to be taken to increase physician awareness of the advantages of 0.5% fluorouracil relative to other formulations, and the value of combination therapy," they reported. "Providers who manage AKs should reassess their current treatment practices and adapt them to be consistent with current evidence."

The study was funded by Sanofi-Aventis, which markets a 0.5% formulation of fluorouracil (Carac). Dr. Feldman said that he has received speaking, consulting, or research support from Abbott, Amgen, Astellas, Aventis, Biogen, Centocor, Connetics, Galderma, Genentech, GlaxoSmithKline (Stiefel), Leo, National Biological, Roche, Warner Chilcott, and 3M.

NEW YORK – U.S. patients who were treated for actinic keratosis via cryosurgery or fluorouracil failed to receive optimal treatment with these agents, based on a review of more than 16 million patients treated in 2001-2008.

The results "reveal a gap between practice and the evidence in the treatment of AKs [actinic keratoses] by both dermatologists and nondermatologists," reported Dr. Steven R. Feldman and his associates in a poster at the American Academy of Dermatology’s Summer Academy meeting.

"Combination therapy with cryosurgery and topical fluorouracil is underutilized," and when topical fluorouracil is used to treat AKs, "the 0.5% rather than the 5.0% formulation may be preferable to maximize adherence and to minimize cost and adverse events," they wrote.

Their analysis found cryosurgery alone to be the most commonly used treatment in 59% of patients. Neither cryosurgery nor fluorouracil was used in 35% of U.S. patients in 2001-2008. Among the 5% of patients who were treated with a fluorouracil formulation, 3% received the 0.5% formulation, whereas the other 2% received a different formulation (most often the 5.0% strength), reported Dr. Feldman, professor of dermatology and director of the center for dermatology research at Wake Forest University in Winston-Salem, N.C.

Although other treatments for actinic keratosis exist, the researchers noted, "evidence-based medicine supports the use of 0.5% fluorouracil, rather than the 5.0% formulation, for treatment of actinic keratosis. Evidence, including head-to-head clinical trials, indicates that 0.5% fluorouracil has comparable efficacy, greater tolerability, and lower cost, compared with 5.0% fluorouracil. Similar compelling data support the use of combination cryotherapy plus topical fluorouracil rather than either modality alone." (Arch. Dermaol. 2009;145:203-5; Cutis. 2008;81:509-16; J. Drugs Dermatol. 2006;5:133-9). They performed their new analysis "to determine whether current practice reflects the evidence."

They reviewed data from the Centers for Disease Control and Prevention’s National Ambulatory Medical Care Survey. They identified more than 16 million U.S. patients seen with actinic keratosis during the years of 2001-2008 based on ICD-9 coding. Two-thirds of patients received treatment of their actinic keratosis during an office visit.

Dermatologists saw about 90% of these patients. During the period studied, the annual number of patients with AK seen by all physicians and by dermatologists significantly increased, whereas the number seen by nondermatologists did not significantly change.

The data showed that dermatologists did a better job using 0.5% fluorouracil and cryosurgery, compared with nondermatologists. Dermatologists used cryosurgery alone on 62% of their AK patients; they treated 3% with 0.5% fluorouracil, 2% with 5.0% fluorouracil, and 1% with a combination of fluorouracil and cryosurgery.

"Despite the better tolerability and lower cost of the 0.5% fluorouracil formulation, dermatologists prescribed the 5% formulation in over 392,000 patient visits for AK" in 2001-2008. In contrast, nondermatologists used cryosurgery alone on 32% of their AK patients, 0.5% fluorouracil on no patients, 5.0% fluorouracil on 3%, and a combination of fluorouracil and cryosurgery on no patients. Treatments other than cryosurgery or fluorouracil were used by 32% of the dermatologists and by 63% of the nondermatologists.

"Efforts need to be taken to increase physician awareness of the advantages of 0.5% fluorouracil relative to other formulations, and the value of combination therapy," they reported. "Providers who manage AKs should reassess their current treatment practices and adapt them to be consistent with current evidence."

The study was funded by Sanofi-Aventis, which markets a 0.5% formulation of fluorouracil (Carac). Dr. Feldman said that he has received speaking, consulting, or research support from Abbott, Amgen, Astellas, Aventis, Biogen, Centocor, Connetics, Galderma, Genentech, GlaxoSmithKline (Stiefel), Leo, National Biological, Roche, Warner Chilcott, and 3M.