University of Birmingham Effect of topical imiquimod as primary treatment for lentigo maligna - the LIMIT-1 study Marsden, Jerry R; Fox, Richard; Boota, N; Wheatley, Keith; Billingham, Lucinda; Steven, Neil; Group, The NCRI Skin Cancer Clinical Studies; Group, UK Dermatology Clinical Trials Network and the LIMIT-1 Collaborative DOI: 10.1111/bjd.15112 License: Other (please specify with Rights Statement) Document Version Peer reviewed version Citation for published version (Harvard): Marsden, JR, Fox, R, Boota, N, Wheatley, K, Billingham, L, Steven, N, Group, TNCRISCCS & Group, UKDCTNATLIMITC 2017, 'Effect of topical imiquimod as primary treatment for lentigo maligna - the LIMIT-1 study', British Journal of Dermatology, vol. 176, no. 5, pp. 1148-1154. https://doi.org/10.1111/bjd.15112 Link to publication on Research at Birmingham portal Publisher Rights Statement: This is the peer reviewed version of the following article: Effect of topical imiquimod as primary treatment for lentigo maligna – the LIMIT-1 study, which has been published in final form at 10.1111/bjd.15112. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving. General rights Unless a licence is specified above, all rights (including copyright and moral rights) in this document are retained by the authors and/or the copyright holders. The express permission of the copyright holder must be obtained for any use of this material other than for purposes permitted by law. • Users may freely distribute the URL that is used to identify this publication. • Users may download and/or print one copy of the publication from the University of Birmingham research portal for the purpose of private study or non-commercial research. • User may use extracts from the document in line with the concept of ‘fair dealing’ under the Copyright, Designs and Patents Act 1988 (?) • Users may not further distribute the material nor use it for the purposes of commercial gain. Where a licence is displayed above, please note the terms and conditions of the licence govern your use of this document. When citing, please reference the published version. Take down policy While the University of Birmingham exercises care and attention in making items available there are rare occasions when an item has been uploaded in error or has been deemed to be commercially or otherwise sensitive. If you believe that this is the case for this document, please contact [email protected] providing details and we will remove access to the work immediately and investigate. Download date: 07. Mar. 2021
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University of Birmingham
Effect of topical imiquimod as primary treatment forlentigo maligna - the LIMIT-1 studyMarsden, Jerry R; Fox, Richard; Boota, N; Wheatley, Keith; Billingham, Lucinda; Steven, Neil;Group, The NCRI Skin Cancer Clinical Studies; Group, UK Dermatology Clinical TrialsNetwork and the LIMIT-1 CollaborativeDOI:10.1111/bjd.15112
License:Other (please specify with Rights Statement)
Document VersionPeer reviewed version
Citation for published version (Harvard):Marsden, JR, Fox, R, Boota, N, Wheatley, K, Billingham, L, Steven, N, Group, TNCRISCCS & Group,UKDCTNATLIMITC 2017, 'Effect of topical imiquimod as primary treatment for lentigo maligna - the LIMIT-1study', British Journal of Dermatology, vol. 176, no. 5, pp. 1148-1154. https://doi.org/10.1111/bjd.15112
Link to publication on Research at Birmingham portal
Publisher Rights Statement:This is the peer reviewed version of the following article: Effect of topical imiquimod as primary treatment for lentigo maligna – the LIMIT-1study, which has been published in final form at 10.1111/bjd.15112. This article may be used for non-commercial purposes in accordancewith Wiley Terms and Conditions for Self-Archiving.
General rightsUnless a licence is specified above, all rights (including copyright and moral rights) in this document are retained by the authors and/or thecopyright holders. The express permission of the copyright holder must be obtained for any use of this material other than for purposespermitted by law.
•Users may freely distribute the URL that is used to identify this publication.•Users may download and/or print one copy of the publication from the University of Birmingham research portal for the purpose of privatestudy or non-commercial research.•User may use extracts from the document in line with the concept of ‘fair dealing’ under the Copyright, Designs and Patents Act 1988 (?)•Users may not further distribute the material nor use it for the purposes of commercial gain.
Where a licence is displayed above, please note the terms and conditions of the licence govern your use of this document.
When citing, please reference the published version.
Take down policyWhile the University of Birmingham exercises care and attention in making items available there are rare occasions when an item has beenuploaded in error or has been deemed to be commercially or otherwise sensitive.
If you believe that this is the case for this document, please contact [email protected] providing details and we will remove access tothe work immediately and investigate.
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Patients with clinical diagnosis of LM
Histological confirmation of LM
Consent
Screen for eligibility
Week 1-12 imiquimod treatment. Daily diaries of adverse events and compliance,
and weekly acceptability.
Week 22-24 Clinical assessment of response.
Biopsies from normal skin, residual pigmentation and new pigmentation.
Surgical excision of entire mapped lesion.
Assess pathological response in biopsies and surgical specimen. Report to local
investigator.
Week 36 – complete survey of patient’s treatment preference
MAP 1: Draw round perimeter of lesion. Tattoo edge at 4 compass points. Trace on transparent sheet
MAP 2: Use tattoos and map 1 to define pre-treatment lesion. Draw round new pigmentation. Add 5mm margin to define excision area. Trace onto transparent sheet
CENTRAL PATHOLOGICAL REVIEW: Single H&E section of pre and post--treatment biopsy and 2mm sections through whole surgical specimen and post treatment biopsies.
IMIQUIMOD TREATMENT: Apply to visible skin + 2cm margin normal skin, wash off after 8 hours (overnight) 5 days/week. Escalate to 7 days/week if well tolerated. De-escalate to 3 days/week for intolerable inflammatory reactions. Suspend for 7 days at dermatologist’s discretion for poor tolerance.
Identified 157
Enrolled 30 a, b
Treated 29 c
Continued on-trial 28 d
Surgical excision 27 f
Completed questionnaire 16 g
Blood sample
Blood sample
Dose intensity e
median 87%, IQR 71-111%, range 33-137%
Figure 1. Trial design and recruitment.
The sample size was constituted 28 patients evaluated on an intention to treat basis and 27 treated
patients with post-treatment surgical specimens: (a) 75 patients were ineligible, most commonly
because LM size <10mm, invasive or recurrent disease, not on head or neck, LM histology not