Chemoprevention for keratinocytic (pre)cancers: balancing the risks and benefits.
OBJECTIVE
Can celecoxib reduce the incidence of actinic keratoses (AKs) and keratinocytic cancers?


METHODS
Randomized, double-blind, placebo-controlled phase 2-3 clinical trial.


METHODS
Eight centers in the United States participated and included 240 patients from January 2001 to November 2006, when the Food and Drug Administration requested termination of this trial after the worldwide withdrawal of rofecoxib.


METHODS
The study population comprised individuals 18 years or older with Fitzpatrick skin type I to III, with 10 to 40 AKs on the upper extremities, neck, face, and scalp at baseline and a previous histological diagnosis of a keratinocytic (pre)malignant neoplasm.


METHODS
Celecoxib (200 mg) or placebo twice daily.


METHODS
The ratio of new AKs per patient at completion of the study to the number of AKs at randomization. EXPLORATORY POST HOC ANALYSIS: The mean cumulative number of keratinocytic skin cancers per patient.


RESULTS
There was no difference in the incidence of AKs between the 2 groups at month 9 after randomization. The adjusted rate ratios for the celecoxib arm compared with the placebo arm were 0.41 (95% CI, 0.23-0.72) for keratinocytic skin cancers, 0.40 (95% CI, 0.18-0.93) for basal cell carcinomas (BCCs), and 0.42 (95% CI, 0.19-0.93) for squamous cell carcinomas (SCCs).


CONCLUSIONS
Celecoxib might be effective for prevention of keratinocytic cancers but not for actinic keratoses.
Loes M
LM
Hollestein
Els R
ER
Koomen
Tamar
T
Nijsten