Pablo Balado-Simó, Marc Hernández-Santacana, Daniel Morgado-Carrasco
{"title":"Long-Term Outcomes of Topical 5% Imiquimod Treatment for Lentigo Maligna: A Systematic Review.","authors":"Pablo Balado-Simó, Marc Hernández-Santacana, Daniel Morgado-Carrasco","doi":"10.1007/s13555-025-01552-6","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Lentigo maligna (LM) is a melanoma in situ frequently located on sun-exposed areas. While surgery is the standard of care, topical 5% imiquimod has emerged as a non-invasive alternative for patients unsuitable for surgery. However, existing literature often lacks long-term follow-up. This systematic review aims to assess the long-term effectiveness and safety of imiquimod in LM, focusing on studies with ≥ 48 months of follow-up.</p><p><strong>Methods: </strong>A comprehensive search was conducted in MEDLINE (PubMed) and the Cochrane Library up to July 2025. Inclusion criteria comprised original studies reporting on LM treated with 5% imiquimod with ≥ 48 months of follow-up.</p><p><strong>Results: </strong>Six studies (422 patients) met the inclusion criteria: one prospective and five retrospective studies. Median follow-up ranged from 49 to 205 months. Clinical clearance rates varied between 63.6% and 97.1%, with recurrence rates ranging from 0% to 20.7%. Histological clearance was inconsistently confirmed. Progression to lentigo maligna melanoma (LMM) was infrequent (9/422). One retrospective study (n = 111) reported melanoma-specific survival at 10 years as 100% (95% CI 90.5-100%). The presence of a robust local inflammatory response was consistently associated with improved outcomes. Adverse effects were mostly mild and self-limiting. Overall evidence certainty was moderate to low.</p><p><strong>Discussion: </strong>This review provides evidence that 5% imiquimod may offer durable responses for LM, particularly in patients who develop a marked inflammatory reaction. Nevertheless, recurrence and occasional progression to LMM underscore the need for long-term monitoring, ideally combining clinical, dermoscopic and histological assessment. Lack of standardized treatment protocols and heterogeneous definitions of response limit comparability between studies.</p><p><strong>Conclusion: </strong>Topical 5% imiquimod may be a viable long-term treatment option for selected patients with LM, although the evidence is scarce and mostly of low quality. A strong local inflammatory response appears predictive of clinical success. Given the potential for late recurrence and risk of progression to LMM, long-term structured follow-up is essential. Future prospective studies with uniform protocols are warranted.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2000,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13555-025-01552-6","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Lentigo maligna (LM) is a melanoma in situ frequently located on sun-exposed areas. While surgery is the standard of care, topical 5% imiquimod has emerged as a non-invasive alternative for patients unsuitable for surgery. However, existing literature often lacks long-term follow-up. This systematic review aims to assess the long-term effectiveness and safety of imiquimod in LM, focusing on studies with ≥ 48 months of follow-up.
Methods: A comprehensive search was conducted in MEDLINE (PubMed) and the Cochrane Library up to July 2025. Inclusion criteria comprised original studies reporting on LM treated with 5% imiquimod with ≥ 48 months of follow-up.
Results: Six studies (422 patients) met the inclusion criteria: one prospective and five retrospective studies. Median follow-up ranged from 49 to 205 months. Clinical clearance rates varied between 63.6% and 97.1%, with recurrence rates ranging from 0% to 20.7%. Histological clearance was inconsistently confirmed. Progression to lentigo maligna melanoma (LMM) was infrequent (9/422). One retrospective study (n = 111) reported melanoma-specific survival at 10 years as 100% (95% CI 90.5-100%). The presence of a robust local inflammatory response was consistently associated with improved outcomes. Adverse effects were mostly mild and self-limiting. Overall evidence certainty was moderate to low.
Discussion: This review provides evidence that 5% imiquimod may offer durable responses for LM, particularly in patients who develop a marked inflammatory reaction. Nevertheless, recurrence and occasional progression to LMM underscore the need for long-term monitoring, ideally combining clinical, dermoscopic and histological assessment. Lack of standardized treatment protocols and heterogeneous definitions of response limit comparability between studies.
Conclusion: Topical 5% imiquimod may be a viable long-term treatment option for selected patients with LM, although the evidence is scarce and mostly of low quality. A strong local inflammatory response appears predictive of clinical success. Given the potential for late recurrence and risk of progression to LMM, long-term structured follow-up is essential. Future prospective studies with uniform protocols are warranted.
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
