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    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.
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    Affiliation
    Department of Dermatology, Barts Health NHS Trust, London, UK.
    Issue Date
    2022
    
    Metadata
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    Abstract
    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 Dermatology
    URI
    http://hdl.handle.net/10541/625400
    DOI
    10.1111/bjd.20974
    PubMed ID
    34988975
    Additional Links
    https://dx.doi.org/10.1111/bjd.20974
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1111/bjd.20974
    Scopus Count
    Collections
    All Paterson Institute for Cancer Research

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