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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
Jairia Dela Cruz, 15 May 2019
Postmenopausal women with hormone receptor (HR)-positive breast cancer fare well with the addition of denosumab to aromatase inhibitors, with data from the phase III ABCSG-18 trial showing that the antiresorptive drug cuts the risk of fractures and confers a modest but significant improvement in disease-free survival with a favourable tolerability profile.
14 May 2019
At the recent GLYCEMIC GUARDIANS™ dinner symposium, three eminent speakers spoke on theindispensable role of medical nutrition therapy (MNT) in improving outcomes for patients with type2 diabetes (T2D).
Rachel Soon, 22 Jun 2018

“Every patient is unique.” For compounding pharmacist Sarah Abdullah, tailoring medicines to a person’s needs is nothing new after years of working in the clean rooms of Putrajaya Hospital. Now managing her own enterprise, the also-council member of the Malaysian Community Pharmacy Guild (MCPG) spoke to MIMS Pharmacist about her experiences in the field to date.

Pearl Toh, 24 Apr 2019
Adding high-dose vitamin D3 to standard chemotherapy for metastatic colorectal cancer (mCRC) may confer potential benefit to previously untreated patients in terms of progression-free survival (PFS) compared with supplemental standard-dose vitamin D3, suggests the phase II SUNSHINE* study.