Prophylactic Topical Treatment for EGFR Inhibitor-Induced Papulopustular Rash: A Randomized Clinical Trial.
Administration, Topical
Adult
Aged
Aged, 80 and over
Anti-Bacterial Agents
/ therapeutic use
Anti-Inflammatory Agents
/ therapeutic use
Chloramphenicol
/ therapeutic use
Double-Blind Method
ErbB Receptors
/ adverse effects
Exanthema
/ chemically induced
Female
Humans
Male
Middle Aged
Neoplasms
/ drug therapy
Prednisolone
/ therapeutic use
Protein Kinase Inhibitors
/ adverse effects
Epidermal growth factor receptor inhibitor
Papulopustular rash
Topical treatment
Trial
Journal
Dermatology (Basel, Switzerland)
ISSN: 1421-9832
Titre abrégé: Dermatology
Pays: Switzerland
ID NLM: 9203244
Informations de publication
Date de publication:
2021
2021
Historique:
received:
01
08
2020
accepted:
29
09
2020
pubmed:
31
12
2020
medline:
16
2
2022
entrez:
30
12
2020
Statut:
ppublish
Résumé
The incidence of epidermal growth factor receptor inhibitor (EGFRI)-induced papulopustular rash is 60-85%. To investigate prophylactic topical treatment for EGFRI-induced rash. A single-center, randomized, double-blind, placebo-controlled trial. Adult cancer patients initiating treatment with EGFRIs were randomized to receive facial topical treatment with chloramphenicol 3% + prednisolone 0.5% (CHL-PRED) ointment, chloramphenicol 3% (CHL) ointment, or aqua cream (AQUA). The primary end points were the incidence of ≥grade 3 rash using the Common Terminology Criteria for Adverse Events (CTCAE), on days 14 and 30. A subanalysis was conducted for incidence of a protocol-specified significant rash, defined as ≥10 facial papulopustular lesions. The per-protocol analysis on day 14 included 69 patients, who received CHL-PRED (21), CHL (23), or AQUA (25). The incidence of CTCAE ≥grade 3 rash was not statistically significant between arms; however, the incidence of the protocol-specified significant rash was: CHL-PRED 14%, CHL 39%, and AQUA 48% (p = 0.03, CHL-PRED vs. AQUA). At 30 days, the CTCAE ≥grade 3 incidence was similar, but the incidences of protocol-specified significant rash were 6%, 16%, and 43% (p = 0.03, CHL-PRED vs. AQUA). No significant differences were found between CHL and CHL-PRED and between CHL and AQUA. Prophylactic topical CHL-PRED was efficacious when compared to AQUA, in the treatment of EGFRI-induced facial papulopustular rash.
Sections du résumé
BACKGROUND
BACKGROUND
The incidence of epidermal growth factor receptor inhibitor (EGFRI)-induced papulopustular rash is 60-85%.
OBJECTIVE
OBJECTIVE
To investigate prophylactic topical treatment for EGFRI-induced rash.
METHODS
METHODS
A single-center, randomized, double-blind, placebo-controlled trial. Adult cancer patients initiating treatment with EGFRIs were randomized to receive facial topical treatment with chloramphenicol 3% + prednisolone 0.5% (CHL-PRED) ointment, chloramphenicol 3% (CHL) ointment, or aqua cream (AQUA). The primary end points were the incidence of ≥grade 3 rash using the Common Terminology Criteria for Adverse Events (CTCAE), on days 14 and 30. A subanalysis was conducted for incidence of a protocol-specified significant rash, defined as ≥10 facial papulopustular lesions.
RESULTS
RESULTS
The per-protocol analysis on day 14 included 69 patients, who received CHL-PRED (21), CHL (23), or AQUA (25). The incidence of CTCAE ≥grade 3 rash was not statistically significant between arms; however, the incidence of the protocol-specified significant rash was: CHL-PRED 14%, CHL 39%, and AQUA 48% (p = 0.03, CHL-PRED vs. AQUA). At 30 days, the CTCAE ≥grade 3 incidence was similar, but the incidences of protocol-specified significant rash were 6%, 16%, and 43% (p = 0.03, CHL-PRED vs. AQUA). No significant differences were found between CHL and CHL-PRED and between CHL and AQUA.
CONCLUSIONS
CONCLUSIONS
Prophylactic topical CHL-PRED was efficacious when compared to AQUA, in the treatment of EGFRI-induced facial papulopustular rash.
Identifiants
pubmed: 33378750
pii: 000511869
doi: 10.1159/000511869
doi:
Substances chimiques
Anti-Bacterial Agents
0
Anti-Inflammatory Agents
0
Protein Kinase Inhibitors
0
Chloramphenicol
66974FR9Q1
Prednisolone
9PHQ9Y1OLM
ErbB Receptors
EC 2.7.10.1
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
988-994Informations de copyright
© 2020 S. Karger AG, Basel.