Most Read Articles
Rachel Soon, 5 days ago

On 8 August, the first town hall held by the Ministry of Health (MOH) with members of the pharmacy profession took place in Putrajaya. Over 500 pharmacists from across the country and from different areas of practice—community and hospital, public and private, academy and industry—converged to fill the auditorium for the chance to engage in direct dialogue with MOH.

Jackey Suen, 08 Oct 2018

Adding pertuzumab to trastuzumab plus an aromatase inhibitor (AI) improves progression-free survival (PFS) in patients with HER2-positive metastatic or locally advanced breast cancer, the phase II PERTAIN study has shown.

05 Aug 2019
Use of alpha blockers in the treatment of hypertension in women is associated with an increased risk of hypotension and related events as compared with other blood pressure-lowering drugs, as reported in a recent study.
Laura Kho Sui San , 29 May 2019
Anxiety becomes a pathological disorder when it occurs for no detectable reason, persists and interferes with daily activities like work performance and relationships.

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

Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Pharmacist - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
Rachel Soon, 5 days ago

On 8 August, the first town hall held by the Ministry of Health (MOH) with members of the pharmacy profession took place in Putrajaya. Over 500 pharmacists from across the country and from different areas of practice—community and hospital, public and private, academy and industry—converged to fill the auditorium for the chance to engage in direct dialogue with MOH.

Jackey Suen, 08 Oct 2018

Adding pertuzumab to trastuzumab plus an aromatase inhibitor (AI) improves progression-free survival (PFS) in patients with HER2-positive metastatic or locally advanced breast cancer, the phase II PERTAIN study has shown.

05 Aug 2019
Use of alpha blockers in the treatment of hypertension in women is associated with an increased risk of hypotension and related events as compared with other blood pressure-lowering drugs, as reported in a recent study.
Laura Kho Sui San , 29 May 2019
Anxiety becomes a pathological disorder when it occurs for no detectable reason, persists and interferes with daily activities like work performance and relationships.