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Celecoxib chemoprevention may reduce nonmelanoma skin cancers
Elmets CE. J Natl Cancer Inst. 2010;102:1-10.
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Celecoxib was associated with a nearly 60% reduction in nonmelanoma skin cancers among a cohort of patients with actinic keratoses, according to recent study results.
The efficacy and safety of celecoxib (Celebrex, Pfizer) were evaluated as a chemopreventive agent for actinic keratoses and nonmelanoma skin cancers, including cutaneous squamous cell carcinomas (SCCs) and basal cell carcinomas (BCCs).
Celecoxib 200 mg or placebo was randomly assigned to 240 patients aged 37 to 87 years. Treatment regimens were administered orally twice daily for 9 months. Eligible patients had 10 to 40 actinic keratoses.
No statistically significant differences in actinic keratosis incidence were observed between the two groups at 9 months.
However, there were fewer nonmelanoma skin cancers in the celecoxib arm than in the placebo arm at 11 months (mean cumulative tumor number per patient, 0.14 vs. 0.35; RR=0.43; 95% CI, 0.24-0.75). This trend remained (RR=0.41; 95% CI, 0.23-0.72) after adjusting for age, sex, Fitzpatrick skin type, history of actinic keratosis at randomization, nonmelanoma skin cancer history and patient time on study.
After these same adjustments, BCCs (RR=0.40; 95% CI, 0.18-0.93) and SCCs (RR=0.42; 95% CI, 0.19-0.93) also were lower in the treatment group than in the placebo group at the 11-month mark. The mean number of BCCs per patient in the celecoxib group was 0.07 (95% CI, 0.03-0.13) compared with 0.16 (95% CI, 0.1-0.25) in the placebo group; for SCCs, the per-patient rate was 0.07 (95% CI, 0.04-0.14) in the celecoxib group and 0.19 (95% CI, 0.12-0.28) in the placebo group.
At least one adverse event was reported by 84% of patients in the treatment group and 85% of patients in the placebo group (P=.95).
Evaluations occurred at 3, 6, 9 and 11 months after randomization. The primary outcome — the number of new actinic keratoses at the 9-month visit — was calculated in an intent-to-treat analysis as a percentage of the number of actinic keratoses at the time of randomization.
A further exploratory analysis was conducted to determine the number of nonmelanoma skin cancers combined and SCCs and BCCs separately per patient at the 11-month mark. Adjustments for patient characteristics and time on study were made for this analysis. Adverse event data also were reported.
“It is possible that a combination of medications that include sunscreens as well as cyclooxygenase inhibitors and/or other chemopreventive agents could be taken on a regular basis by individuals at risk for development of nonmelanoma skin cancers to reduce the incidence of this exceptionally common malignancy,” the researchers wrote.
The trial was conducted at eight US academic medical centers between Jan. 18, 2001, and Nov. 3, 2006.
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