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Fluorouracil cream most effective for treating actinic keratosis lesions

Elaine Soliven
30 Apr 2019

The use of 5% fluorouracil cream was most effective among a panel of four treatments commonly used for treating multiple actinic keratosis (AK) lesions on the head, according to a recent study.

This multicentre, single-blind study included 624 patients (median age 73 years) diagnosed with multiple AK lesions on the head who were randomized in a 1:1:1:1 ratio to receive 5% fluorouracil cream (n=155), 5% imiquimod cream (n=156), MAL-PDT* (n=156), or 0.015% ingenol mebutate gel (n=157) at four Dutch hospitals. Grades I–III AK lesions were assessed using a 3-point Olsen grading system. The study’s primary endpoint was the number of patients who remained free from treatment failure (defined as ≥75 percent reduction in AK lesions) at 12 months of treatment. Patients were followed up at 3 and 12 months. [N Engl J Med 2019;380:935-946]

In the modified intention-to-treat analysis, 74.7 percent of patients treated with fluorouracil cream were free from treatment failure compared with those who received imiquimod cream (53.9 percent, hazard ratio [HR], 2.03; p=0.001), MAL-PDT (37.7 percent, HR, 2.73; p<0.001), or ingenol mebutate gel at 12 months (28.9 percent, HR, 3.33; p<0.001).

In the per-protocol population comprising 555 patients, there were also significantly more patients in the fluorouracil group who were free from treatment failure (76.4 percent) than the imiquimod (56.7 percent, HR, 2.03; p=0.001), MAL-PDT (42.4 percent, HR, 2.63; p<0.001), or ingenol mebutate groups (31.8 percent, HR, 3.33; p<0.001).

Furthermore, treatment success rate was higher in the fluorouracil group than those in the imiquimod, MAL-PDT, or ingenol mebutate groups at 12 months (82.4 percent vs 71.0 percent, 49.6 percent, or 42.9 percent, respectively) in the modified intention-to-treat population.

Similar results were seen in the per-protocol analysis which showed a higher treatment success rate with fluorouracil than with imiquimod, MAL-PDT, or ingenol mebutate (82.0 percent vs 70.2 percent, 50.9 percent, or 42.4 percent, respectively).

“Findings from the modified intention-to-treat analysis and the per-protocol analysis were similar, which indicates the robustness of the results,” the researchers said.

When the modified intention-to-treat analysis was further stratified by patients with multiple grade I–III lesions, treatment success rate was higher among patients on fluorouracil than those who were received imiquimod cream, MAL-PDT, or ingenol mebutate gel (75.3 percent vs 52.6 percent, 38.7 percent, or 30.2 percent, respectively). “An important gap in the current literature is that most studies assessing the effectiveness of field-directed treatments exclude grade III AK lesions … [In our cohort, we] included patients with grade III AK lesions; in this way, it is more representative of patients seen in daily practice,” the researchers noted.

Overall, the use of fluorouracil was not associated with a higher rate of adverse events (AEs), and majority of patients reported satisfaction and sustained improvement with regard to health-related quality of life at the end of treatment. Additionally, no serious AEs were observed, and none of the patients discontinued treatment due to a drug-related AEs.

The findings were consistent with a previous network meta-analysis, which showed that 5% fluorouracil was the most effective treatment with regard to a complete clearance of all lesions, said the researchers. [Br J Dermatol 2013;169:250-259]

“However, in the 2015 European Dermatology Forum guidelines, the majority of experts did not express a preference for any of the most commonly prescribed treatments. They agreed that 3.75% imiquimod, ALA-PDT**, MAL-PDT, ingenol mebutate (0.015% or 0.050%), and 0.5% fluorouracil were equally effective in patients with multiple AK lesions,” the researchers said. [J Eur Acad Dermatol Venereol 2015;29:2069-2079]

“This trial showed that 5% fluorouracil [cream] was significantly more effective than imiquimod [cream], MAL-PDT, or ingenol mebutate [gel] at 12 months after the end of treatment for multiple [grade I–III] AK lesions in a continuous area,” said the researchers.

“No new toxic effects were identified in this trial,” they added.

 

*MAL-PDT: Methyl aminolevulinate photodynamic therapy

**ALA-PDT: Aminolevulinic acid photodynamic therapy

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Most Read Articles
29 Jul 2020
Adjunctive perampanel appears to be safe and effective for long-term treatment of patients with tonic‐clonic seizures, according to a posthoc analysis.
11 Aug 2020
During the Allergic Rhinitis (AR) Boot Camp held in conjunction with the Bayer Pharmacist Congress 2020, Professor Dr Baharudin Abdullah discussed the management of AR in the primary care setting and the importance of using patient profiles to guide the choice of antihistamines.
Elaine Soliven, 18 Sep 2020
Adding mepolizumab to standard of care treatment significantly reduces nasal polyp size and obstruction in adults with chronic rhinosinusitis with nasal polyps (CRSwNP), according to the SYNAPSE* study presented at ERS 2020.
Jairia Dela Cruz, 18 Feb 2020
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