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J Am Acad Dermatol. 2018 Nov 17. pii: S0190-9622(18)32914-1. doi: 10.1016/j.jaad.2018.11.024. [Epub ahead of print]

Comparative effectiveness of treatment of actinic keratosis with topical fluorouracil and imiquimod in the prevention of keratinocyte carcinoma: a cohort study.

Author information

1
Division of Research, Kaiser Permanente Northern California, Oakland, CA.
2
Department of Dermatology, Massachusetts General Hospital, Harvard Medical School, Boston, MA; Department of Population Medicine, Harvard Pilgrim Health Care Institute, Harvard Medical School, Boston, MA.
3
Department of Dermatology, Vanderbilt University Medical Center, Nashville, TN.
4
Division of Research, Kaiser Permanente Northern California, Oakland, CA; Department of Dermatology, Massachusetts General Hospital, Harvard Medical School, Boston, MA; Department of Population Medicine, Harvard Pilgrim Health Care Institute, Harvard Medical School, Boston, MA. Electronic address: masgari@partners.org.

Abstract

BACKGROUND:

The effectiveness of 5-fluorouracil compared to imiquimod for preventing keratinocyte carcinoma is unknown.

OBJECTIVE:

To compare the effectiveness of 5-fluorouracil and imiquimod in preventing keratinocyte carcinoma in a real-world practice setting.

METHODS:

We identified 5,700 subjects who filled prescriptions for 5-fluorouracil or imiquimod for actinic keratosis treatment in 2007. An intention-to-treat analysis controlling for potential confounding variables was used to calculate 2- and 5-year cumulative risk differences for subsequent keratinocyte carcinoma overall and in field-treated areas.

RESULTS:

5-fluorouracil was associated with a statistically significant decreased risk of any keratinocyte carcinoma compared to imiquimod (adjusted hazard ratio [aHR] 0.86, 95% CI 0.76-0.97), but there were no significant differences in risk by tumor subtype (squamous cell carcinoma aHR 0.89, 95% CI 0.74-1.07; basal cell carcinoma aHR 0.87, 95% CI 0.74-1.03), or site-specific keratinocyte carcinoma (aHR 0.96, 95% CI 0.81-1.14). There were no significant differences in 2- or 5-year cumulative risk for keratinocyte carcinoma among those treated with 5-fluorouracil versus imiquimod.

LIMITATIONS:

Generalizability to other practice settings may be limited.

CONCLUSIONS:

Whereas 5-fluorouracil was more effective in reducing keratinocyte carcinoma risk overall, we found no differences in the short- or long-term risk of subsequent site-specific keratinocyte carcinoma in a real-world practice setting.

KEYWORDS:

5-fluorouracil; Actinic keratosis; Basal cell carcinoma; Comparative effectiveness; Imiquimod; Keratinocyte carcinoma; Skin cancer; Squamous cell carcinoma

PMID:
30458208
DOI:
10.1016/j.jaad.2018.11.024

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