Acta Dermato-Venereologica 99-7CompleteContent | Page 29
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SHORT COMMUNICATION
Characteristics of Keratinocyte Carcinomas and Patients with Keratinocyte Carcinomas Following
a Single 2–4 Week Course of Topical 5-fluorouracil on the Face and Ears
Meghan BEATSON 1–3 , Alexander D. MEANS 1,2,4 , Nicholas F. LEADER 1,2 , Leslie ROBINSON-BOSTOM 1,2 , Martin A.
WEINSTOCK 1,2 ; VAKCC Trial group
Center for Dermatoepidemiology-111D, Veterans Affairs Medical Center, 830 Chalkstone Avenue, Providence, RI 02908-4799, 2 Department
of Dermatology, Alpert Medical School of Brown University, Providence, RI, 3 George Washington University School of Medicine, Washington,
DC, and 4 Department of Dermatology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA. E-mail: [email protected]
1
Accepted Mar 21, 2019; E-published Mar 21, 2019
It was recently reported that 5-fluorouracil (5-FU) is
effective for prevention of squamous cell carcinoma
(SCC) for one year, but not for basal cell carcinoma
(BCC) (1). Additionally, a history of 5-FU exposure has
been associated with more aggressive BCC subtypes,
and we wanted to confirm this finding prospectively by
determining the influence of 5-FU on the histopatholo-
gic characteristics of BCC and SCC (2). We evaluated
whether 5-FU was effective for prevention of specific
subtypes of BCC or SCC or was effective in specific
subpopulations of our high risk group of veterans with
at least 2 prior keratinocyte carcinomas (KCs) in the
Veterans Affairs Keratinocyte Carcinoma Chemopreven-
tion (VAKCC) Trial.
The VAKCC Trial followed 932 veterans at high risk
for development of KC for a median of 2.8 years, where
participants were randomized to apply topical 5-FU or
vehicle control cream to the face and ears twice daily for
up to 4 and at least 2 weeks (1). All participants were
free of suspicious skin lesions suggestive of any type
of skin cancer at the initial full body skin examination.
Total body skin examinations, with biopsies as clinically
indicated, were performed every 6–12 months. All skin
biopsies were read by a single central board-certified
dermatopathologist. The Veteran’s Affairs Central
Institutional Review Board approved this trial, all par-
ticipants gave written, informed consent, and Declara-
tion of Helsinki Principles were followed, as described
elsewhere (1).
MATERIAL, METHODS AND RESULTS
Data for patient age, tumor size, anatomic location, and histo-
pathologic subtypes were collected (1). Anatomic locations were
first divided into left and right halves of the head, and then sub-
classified based on eye, ear, nose, cheek, chin, forehead, temple,
or mouth location. Histopathologic subtypes were classified ac-
cording to commonly utilized dermatopathology criteria noted in
the legend of Table I (3).
All analyses were done using Stata statistical software (release
8.0, StataCorp, College Station, TX). To determine the charac-
teristics of BCC and SCC in year 1 and overall, t-tests were
performed comparing 5-FU to control groups for lesion size by
individual participant and total lesion count. Age was stratified a
posteriori into “very old” ≥ 85 years old, as defined by Linos et
al. (4) and “not very old” (< 85 years old). Pearson’s chi-squared
tests and Fischer’s exact tests were performed comparing 5-FU
to control groups for development of BCC and SCC by location
and histopathologic subtype by participant and total lesion count
in year 1 and overall. We assigned an alpha value of 0.05. This
alpha value should be interpreted in the context of our exploratory
examination with multiple comparisons performed.
Participants had a mean age of 71.1 years and 98% were men
(1). There were no significant differences between the 5-FU and
control groups with respect to other demographic characteristics
such as age, education, military service history, self-reported Fitz-
patrick skin type, sunburn, marital status, geographic residence,
weight, height, or skin cancer history, as previously reported (1).
There were fewer superficial BCCs in the 5-FU group vs.
control group (Table I). In year 1, there was a smaller number of
total BCCs among those at least 85 years old in the 5-FU group
vs. control group, but there was no substantial difference in the
risk of these individuals at least 85 years old developing a BCC
(Table II). One of the BCCs in the participants ≥ 85 years old was
superficial type. Among the same elderly group, there was also
Table I. Histopathologic subtype of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)
5-FU
Control
p-value
Number of BCCs by subtype
Year 1
Overall study period
Nodular or micronodular
Aggressive a
Superficial
Nodular or micronodular
Aggressive
Superficial
Overall study period
Nodular or micronodular
Aggressive
Superficial
Nodular or micronodular
Aggressive
Superficial
p-value d
4 13 0.62
0
1
46
5
20 0
10
42
10
27 0.29
Number of SCCs by subtype
36 45
20
1
182
57
7 17
5
162
69
17
0.21
0.04
Number of participants with BCC by subtype c
Year 1
Control
5-FU
30
15
0
118
32
1
SCC invasive or transected
Aggressive b
SCCIS/KA
SCC invasive or transected
Aggressive
SCCIS/KA
Number of participants with SCC by subtype c
33
13
3
94
43
9
0.21
0.005
SCC invasive or transected
Aggressive
SCCIS/KA
SCC invasive or transected
Aggressive
SCCIS/KA
0
4
1
33
5
14
2
10
8
29
7
20
0.45
0.47
a
Aggressive BCC subtypes: infiltrative/morpheaform, nodular/infiltrative, basosquamous. b Aggressive SCC subtypes: sclerosing, basosquamous, small cell, poorly or
undifferentiated (high mitotic rate, high degree of nuclear polymorphism), perineural/perivascular, spindle cell, pagetoid, infiltrating, centrofacial keratoacanthoma,
single cell, clear cell, lymphoepithelial, sarcomatoid, breslow depth 2 mm or greater. c For participant calculations, histopathologic subtype of first BCC or SCC was used.
d
Fisher’s exact test used in lieu of chi-2 for first-year SCC calculation p-values.
This is an open access article under the CC BY-NC license. www.medicaljournals.se/acta
Journal Compilation © 2019 Acta Dermato-Venereologica.
doi: 10.2340/00015555-3176
Acta Derm Venereol 2019; 99: 707–708