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).
Authors
Ahmed, Ikhlaaq
Matin, Rubeta N
Homer, Victoria
Lear, John T
Ismail, Ferina
Whitmarsh, Tristan
Thomson, Jason
Milligan, Alan
Hogan, Sarah
Van-de-Velde, Vanessa
Mitchell-Worsford, Liza
Gaunt, Claire
Jefferson-Hulme, Yolande
Bowden, Sarah J
Gaunt, Piers
Wheatley, Keith
Harwood, Catherine A
Publication Date
2022-01-05Journal Title
Br J Dermatol
ISSN
0007-0963
Publisher
Wiley
Language
en
Type
Article
This Version
AO
VoR
Metadata
Show full item recordCitation
Hasan, Z., Ahmed, I., Matin, R. N., Homer, V., Lear, J. T., Ismail, F., Whitmarsh, T., et al. (2022). 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).. Br J Dermatol https://doi.org/10.1111/bjd.20974
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.
Keywords
Clinical trial
Sponsorship
Research for Patient Benefit programme (PB‐PG‐0110‐21244)
Identifiers
bjd20974, bjd-2021-2213.r1
External DOI: https://doi.org/10.1111/bjd.20974
This record's URL: https://www.repository.cam.ac.uk/handle/1810/338072
Rights
Licence:
http://creativecommons.org/licenses/by-nc/4.0/
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