Abstract
Keratinocyte carcinoma (KC) is the most common cancer in the United States, with no proven means for prevention other than systemic retinoids, which have significant toxicity, and sunscreen. Topical tretinoin has been used for KC chemoprevention, although this use is unproven. Hence, we conducted the randomized Veterans Affairs Topical Tretinoin Chemoprevention Trial of high-dose topical tretinoin for KC prevention. We randomized 1,131 patients to topical 0.1% tretinoin or a matching vehicle control for 1.5-5.5 years. The primary outcomes were time to development of new basal cell carcinoma (BCC) and new invasive squamous cell carcinoma (SCC) on the face or ears. The effects were not significant (P0.3 for BCC and P0.4 for SCC). The proportions of the tretinoin and control groups who developed a BCC at 5 years were 53 and 54% and an invasive SCC at 5 years were 28 and 31%. These differences (95% confidence intervals) were: for BCC, 1.0% (6.5, 8.6%); for SCC, 3.6% (3.1, 10.3%). No differences were observed in any cancer-related end points or in actinic keratosis counts. The only quality of life difference was worse symptoms in the tretinoin group at 12 months after randomization. This trial in high-risk patients demonstrates that high-dose topical tretinoin is ineffective at reducing risk of KCs.
| Original language | English |
|---|---|
| Pages (from-to) | 1583-1590 |
| Number of pages | 8 |
| Journal | Journal of Investigative Dermatology |
| Volume | 132 |
| Issue number | 6 |
| DOIs | |
| State | Published - Jun 1 2012 |
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ASJC Scopus subject areas
- Dermatology
- Biochemistry
- Cell Biology
- Molecular Biology
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Tretinoin and the prevention of keratinocyte carcinoma (basal and squamous cell carcinoma of the skin) : A veterans affairs randomized chemoprevention trial. / Weinstock, Martin A.; Bingham, Stephen F.; Digiovanna, John J.; Rizzo, Amilcar E.; Marcolivio, Kim; Hall, Russell; Eilers, David; Naylor, Mark; Kirsner, Robert; Kalivas, James; Cole, Gary; Vertrees, Julia E.
In: Journal of Investigative Dermatology, Vol. 132, No. 6, 01.06.2012, p. 1583-1590.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Tretinoin and the prevention of keratinocyte carcinoma (basal and squamous cell carcinoma of the skin)
T2 - A veterans affairs randomized chemoprevention trial
AU - Weinstock, Martin A.
AU - Bingham, Stephen F.
AU - Digiovanna, John J.
AU - Rizzo, Amilcar E.
AU - Marcolivio, Kim
AU - Hall, Russell
AU - Eilers, David
AU - Naylor, Mark
AU - Kirsner, Robert
AU - Kalivas, James
AU - Cole, Gary
AU - Vertrees, Julia E.
PY - 2012/6/1
Y1 - 2012/6/1
N2 - Keratinocyte carcinoma (KC) is the most common cancer in the United States, with no proven means for prevention other than systemic retinoids, which have significant toxicity, and sunscreen. Topical tretinoin has been used for KC chemoprevention, although this use is unproven. Hence, we conducted the randomized Veterans Affairs Topical Tretinoin Chemoprevention Trial of high-dose topical tretinoin for KC prevention. We randomized 1,131 patients to topical 0.1% tretinoin or a matching vehicle control for 1.5-5.5 years. The primary outcomes were time to development of new basal cell carcinoma (BCC) and new invasive squamous cell carcinoma (SCC) on the face or ears. The effects were not significant (P0.3 for BCC and P0.4 for SCC). The proportions of the tretinoin and control groups who developed a BCC at 5 years were 53 and 54% and an invasive SCC at 5 years were 28 and 31%. These differences (95% confidence intervals) were: for BCC, 1.0% (6.5, 8.6%); for SCC, 3.6% (3.1, 10.3%). No differences were observed in any cancer-related end points or in actinic keratosis counts. The only quality of life difference was worse symptoms in the tretinoin group at 12 months after randomization. This trial in high-risk patients demonstrates that high-dose topical tretinoin is ineffective at reducing risk of KCs.
AB - Keratinocyte carcinoma (KC) is the most common cancer in the United States, with no proven means for prevention other than systemic retinoids, which have significant toxicity, and sunscreen. Topical tretinoin has been used for KC chemoprevention, although this use is unproven. Hence, we conducted the randomized Veterans Affairs Topical Tretinoin Chemoprevention Trial of high-dose topical tretinoin for KC prevention. We randomized 1,131 patients to topical 0.1% tretinoin or a matching vehicle control for 1.5-5.5 years. The primary outcomes were time to development of new basal cell carcinoma (BCC) and new invasive squamous cell carcinoma (SCC) on the face or ears. The effects were not significant (P0.3 for BCC and P0.4 for SCC). The proportions of the tretinoin and control groups who developed a BCC at 5 years were 53 and 54% and an invasive SCC at 5 years were 28 and 31%. These differences (95% confidence intervals) were: for BCC, 1.0% (6.5, 8.6%); for SCC, 3.6% (3.1, 10.3%). No differences were observed in any cancer-related end points or in actinic keratosis counts. The only quality of life difference was worse symptoms in the tretinoin group at 12 months after randomization. This trial in high-risk patients demonstrates that high-dose topical tretinoin is ineffective at reducing risk of KCs.
UR - http://www.scopus.com/inward/record.url?scp=84861188451&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84861188451&partnerID=8YFLogxK
U2 - 10.1038/jid.2011.483
DO - 10.1038/jid.2011.483
M3 - Article
C2 - 22318383
AN - SCOPUS:84861188451
VL - 132
SP - 1583
EP - 1590
JO - Journal of Investigative Dermatology
JF - Journal of Investigative Dermatology
SN - 0022-202X
IS - 6
ER -