Topical treatment of actinic keratoses in organ transplant recipients: a feasibility study for SPOT (Squamous cell carcinoma Prevention in Organ transplant recipients using Topical treatments)
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Authors
Zeeshaan-Ul, H.Ahmed, I.
Matin, R. N.
Homer, V.
Lear, J. T.
Ismail, F.
Whitmarsh, T.
Green, Adèle C
Thomson, J.
Milligan, A.
Hogan, S.
Van-de-Velde, V.
Mitchell-Worsford, L.
Kentley, J.
Gaunt, C.
Jefferson-Hulme, Y.
Bowden, S. J.
Gaunt, P.
Wheatley, K.
Proby, C. M.
Harwood, C. A.
Affiliation
Department of Dermatology, Barts Health NHS Trust, London, UK.Issue Date
2022
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Show full item recordAbstract
Background: The risk of cutaneous squamous cell carcinoma (cSCC) is significantly increased in organ transplant recipients (OTRs). Clearance of actinic keratoses (AKs) is generally regarded as a surrogate biomarker for cSCC prevention. OTR-cSCC chemoprevention with topical AK treatments has not been investigated in randomized controlled trials (RCTs), although there is evidence that 5% 5-fluorouracil (5-FU) may be chemoprotective in immunocompetent patients. Objectives: To assess the feasibility, activity and evaluation outcomes relevant to the design of a future phase III RCT of topical cSCC chemoprevention in OTRs. Methods: OTRs with 10 or more AKs in predefined areas were randomized 1 : 1 : 1 to topical 5-FU, 5% imiquimod (IMIQ) or sunscreen (sun-protective factor 30+) in a phase II, open-label RCT over 15 months. Feasibility outcomes included proportions of eligible OTRs randomized, completing treatment and willing to be re-treated. AK activity [AK clearance, new AK development, patient-centred outcomes (toxicity, health-related quality of life, HRQoL)] and evaluation methodology (clinical vs. photographic) were assessed. Results: Forty OTRs with 903 AKs were randomized. All feasibility outcomes were met (56% of eligible OTRs were randomized; 89% completed treatment; 81% were willing to be re-treated). AK activity analyses found 5-FU and IMIQ were superior to sunscreen for AK clearance and prevention of new AKs. 5-FU was more effective than IMIQ in AK clearance and prevention in exploratory analyses. Although toxicity was greater with 5-FU, HRQoL outcomes were similar. Conclusions: Trials of topical AK treatments in OTRs for cSCC chemoprevention are feasible and AK activity results support further investigation of 5-FU-based treatments in future phase III trials.Citation
Hasan Z, Ahmed I, Matin RN, Homer V, Lear JT, Ismail F, et al. Topical treatment of actinic keratoses in organ transplant recipients: a feasibility study for <scp>SPOT</scp> (Squamous cell carcinoma Prevention in Organ transplant recipients using Topical treatments). British Journal of Dermatology. Wiley; 2022.Journal
British Journal of DermatologyDOI
10.1111/bjd.20974PubMed ID
34988975Additional Links
https://dx.doi.org/10.1111/bjd.20974Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1111/bjd.20974