Randomized Trial of Four Treatment Approaches for Actinic Keratosis.
Aged
Aged, 80 and over
Aminolevulinic Acid
/ analogs & derivatives
Diterpenes
/ administration & dosage
Female
Fluorouracil
/ administration & dosage
Follow-Up Studies
Gels
Humans
Imiquimod
/ administration & dosage
Intention to Treat Analysis
Keratosis, Actinic
/ drug therapy
Male
Middle Aged
Patient Compliance
Photochemotherapy
/ adverse effects
Photosensitizing Agents
/ therapeutic use
Proportional Hazards Models
Scalp Dermatoses
/ drug therapy
Single-Blind Method
Skin Cream
Treatment Outcome
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
07 03 2019
07 03 2019
Historique:
entrez:
12
3
2019
pubmed:
12
3
2019
medline:
2
4
2019
Statut:
ppublish
Résumé
Actinic keratosis is the most frequent premalignant skin disease in the white population. In current guidelines, no clear recommendations are made about which treatment is preferred. We investigated the effectiveness of four frequently used field-directed treatments (for multiple lesions in a continuous area). Patients with a clinical diagnosis of five or more actinic keratosis lesions on the head, involving one continuous area of 25 to 100 cm A total of 624 patients were included from November 2014 through March 2017. At 12 months after the end of treatment, the cumulative probability of remaining free from treatment failure was significantly higher among patients who received fluorouracil (74.7%; 95% confidence interval [CI], 66.8 to 81.0) than among those who received imiquimod (53.9%; 95% CI, 45.4 to 61.6), MAL-PDT (37.7%; 95% CI, 30.0 to 45.3), or ingenol mebutate (28.9%; 95% CI, 21.8 to 36.3). As compared with fluorouracil, the hazard ratio for treatment failure was 2.03 (95% CI, 1.36 to 3.04) with imiquimod, 2.73 (95% CI, 1.87 to 3.99) with MAL-PDT, and 3.33 (95% CI, 2.29 to 4.85) with ingenol mebutate (P≤0.001 for all comparisons). No unexpected toxic effects were documented. At 12 months after the end of treatment in patients with multiple actinic keratosis lesions on the head, 5% fluorouracil cream was the most effective of four field-directed treatments. (Funded by the Netherlands Organization for Health Research and Development; ClinicalTrials.gov number, NCT02281682.).
Sections du résumé
BACKGROUND
Actinic keratosis is the most frequent premalignant skin disease in the white population. In current guidelines, no clear recommendations are made about which treatment is preferred.
METHODS
We investigated the effectiveness of four frequently used field-directed treatments (for multiple lesions in a continuous area). Patients with a clinical diagnosis of five or more actinic keratosis lesions on the head, involving one continuous area of 25 to 100 cm
RESULTS
A total of 624 patients were included from November 2014 through March 2017. At 12 months after the end of treatment, the cumulative probability of remaining free from treatment failure was significantly higher among patients who received fluorouracil (74.7%; 95% confidence interval [CI], 66.8 to 81.0) than among those who received imiquimod (53.9%; 95% CI, 45.4 to 61.6), MAL-PDT (37.7%; 95% CI, 30.0 to 45.3), or ingenol mebutate (28.9%; 95% CI, 21.8 to 36.3). As compared with fluorouracil, the hazard ratio for treatment failure was 2.03 (95% CI, 1.36 to 3.04) with imiquimod, 2.73 (95% CI, 1.87 to 3.99) with MAL-PDT, and 3.33 (95% CI, 2.29 to 4.85) with ingenol mebutate (P≤0.001 for all comparisons). No unexpected toxic effects were documented.
CONCLUSIONS
At 12 months after the end of treatment in patients with multiple actinic keratosis lesions on the head, 5% fluorouracil cream was the most effective of four field-directed treatments. (Funded by the Netherlands Organization for Health Research and Development; ClinicalTrials.gov number, NCT02281682.).
Identifiants
pubmed: 30855743
doi: 10.1056/NEJMoa1811850
doi:
Substances chimiques
3-ingenyl angelate
0
Diterpenes
0
Gels
0
Photosensitizing Agents
0
methyl 5-aminolevulinate
585NM85KYM
Aminolevulinic Acid
88755TAZ87
Imiquimod
P1QW714R7M
Fluorouracil
U3P01618RT
Banques de données
ClinicalTrials.gov
['NCT02281682']
Types de publication
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
935-946Subventions
Organisme : undefined
ID : 80-83600-98-3054
Pays : International
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2019 Massachusetts Medical Society.