Adapalene Gel 0.1% Versus Placebo as Prophylaxis for Anti-Epidermal Growth Factor Receptor-Induced Acne-Like Rash: A Randomized Left-Right Comparative Evaluation (APPEARANCE).
Acne Vulgaris
/ chemically induced
Adapalene
/ therapeutic use
Aged
Aged, 80 and over
Carcinoma, Non-Small-Cell Lung
/ drug therapy
Colorectal Neoplasms
/ drug therapy
Dermatologic Agents
/ therapeutic use
ErbB Receptors
/ antagonists & inhibitors
Exanthema
/ chemically induced
Female
Follow-Up Studies
Gels
/ chemistry
Head and Neck Neoplasms
/ drug therapy
Humans
Lung Neoplasms
/ drug therapy
Male
Middle Aged
Prognosis
Protein Kinase Inhibitors
/ adverse effects
Journal
The oncologist
ISSN: 1549-490X
Titre abrégé: Oncologist
Pays: England
ID NLM: 9607837
Informations de publication
Date de publication:
07 2019
07 2019
Historique:
received:
01
02
2019
accepted:
18
02
2019
pubmed:
21
3
2019
medline:
10
7
2020
entrez:
21
3
2019
Statut:
ppublish
Résumé
The results of the APPEARANCE trial indicate that adapalene does not prevent acne-like rash over placebo when added to topical moisturizer and oral minocycline but instead may have a detrimental effect. Therefore, adapalene is not recommended as prophylaxis against acne-like rash induced by anti-epidermal growth factor receptor therapies.Given that acne-like rash was completely controlled with placebo in approximately half of patients, predictive measures to identify patients needing intensive prophylaxis are required. Anti-epidermal growth factor receptor (EGFR) therapies are frequently associated with acne-like rash. To evaluate the prophylactic efficacy of adapalene, a topical retinoid used as first-line therapy for acne vulgaris, we conducted a randomized, placebo-controlled, evaluator-blinded, left-right comparative trial. Patients with non-small cell lung, colorectal, or head and neck cancer scheduled to receive anti-EGFR therapies were randomly assigned to once-daily adapalene application on one side of the face, with placebo on the other side. All patients had topical moisturizer coapplied to both sides of the face, and received oral minocycline. The primary endpoint was the difference in total facial lesion count of acne-like rash at 4 weeks. Secondary endpoints included complete control rate (CCR) of acne-like rash (≤5 facial lesions) and global skin assessment (Investigator's Global Assessment [IGA] scale, grade 0-4) at 4 weeks. Two blinded dermatologists independently evaluated the endpoints from photographs. A total of 36 patients were enrolled, of whom 26 were evaluable. Adapalene treatment was associated with a greater lesion count than placebo at 4 weeks, although the difference was not statistically significant (mean, 12.6 vs. 9.8, Adapalene is not recommended as prophylaxis against acne-like rash induced by anti-EGFR therapies.
Sections du résumé
LESSONS LEARNED
The results of the APPEARANCE trial indicate that adapalene does not prevent acne-like rash over placebo when added to topical moisturizer and oral minocycline but instead may have a detrimental effect. Therefore, adapalene is not recommended as prophylaxis against acne-like rash induced by anti-epidermal growth factor receptor therapies.Given that acne-like rash was completely controlled with placebo in approximately half of patients, predictive measures to identify patients needing intensive prophylaxis are required.
BACKGROUND
Anti-epidermal growth factor receptor (EGFR) therapies are frequently associated with acne-like rash. To evaluate the prophylactic efficacy of adapalene, a topical retinoid used as first-line therapy for acne vulgaris, we conducted a randomized, placebo-controlled, evaluator-blinded, left-right comparative trial.
METHODS
Patients with non-small cell lung, colorectal, or head and neck cancer scheduled to receive anti-EGFR therapies were randomly assigned to once-daily adapalene application on one side of the face, with placebo on the other side. All patients had topical moisturizer coapplied to both sides of the face, and received oral minocycline. The primary endpoint was the difference in total facial lesion count of acne-like rash at 4 weeks. Secondary endpoints included complete control rate (CCR) of acne-like rash (≤5 facial lesions) and global skin assessment (Investigator's Global Assessment [IGA] scale, grade 0-4) at 4 weeks. Two blinded dermatologists independently evaluated the endpoints from photographs.
RESULTS
A total of 36 patients were enrolled, of whom 26 were evaluable. Adapalene treatment was associated with a greater lesion count than placebo at 4 weeks, although the difference was not statistically significant (mean, 12.6 vs. 9.8,
CONCLUSION
Adapalene is not recommended as prophylaxis against acne-like rash induced by anti-EGFR therapies.
Identifiants
pubmed: 30890624
pii: theoncologist.2019-0156
doi: 10.1634/theoncologist.2019-0156
pmc: PMC6656472
doi:
Substances chimiques
Dermatologic Agents
0
Gels
0
Protein Kinase Inhibitors
0
Adapalene
1L4806J2QF
EGFR protein, human
EC 2.7.10.1
ErbB Receptors
EC 2.7.10.1
Banques de données
UMIN-CTR
['UMIN000016692']
Types de publication
Clinical Trial, Phase II
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
885-e413Informations de copyright
© AlphaMed Press; the data published online to support this summary are the property of the authors.
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