Topical Treatment of Melanoma In Situ, Lentigo Maligna, and Lentigo Maligna Melanoma with Imiquimod Cream: A Systematic Review of the Literature,Dermatology and Therapy

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Topical Treatment of Melanoma In Situ, Lentigo Maligna, and Lentigo Maligna Melanoma with Imiquimod Cream: A Systematic Review of the Literature
Dermatology and Therapy ( IF 3.5 ) Pub Date : 2023-08-24 , DOI: 10.1007/s13555-023-00993-1
Silvia Vaienti ₁ , Paolo Calzari ₂ , Gianluca Nazzaro ₃

Affiliation

Introduction

The classical management of melanoma is surgery, but this can be challenging because of several factors, such as age, body area, lesion size, among others. Topical imiquimod may be a therapeutic option for the treatment of melanoma in situ and lentigo maligna melanoma due to its efficacy, tolerability, and non-invasiveness. The purpose of this systematic review is to assemble current evidence on the treatment of non-metastatic melanoma with topical imiquimod.

Methods

The PubMed/MEDLINE and Cochrane Library databases were searched as the primary sources using the main search terms “imiquimod” combined with “lentigo maligna” and “melanoma” with the command “AND.” Articles were identified, screened, and extracted for relevant data, following the PRISMA guidelines.

Results

A total of 87 studies covering 1803 lesions treated with imiquimod cream were identified and included in this sytematic review. Forty-nine studies were case reports, 16 were retrospective analyses, 3 were open label trials, six were case series; one study was a controlled randomized trial, one was a randomized trial, and one was a single-arm phase III trial. Because of the high number of low-evidence studies, the overall risk of bias resulted high. In 55 studies, imiquimod 5% was used in monotherapy as the primary treatment; only in one study was imiquimod 3.75% introduced. In most cases, the topical treatment was applied once daily, with the exception of nine cases where an increased daily dosage was prescribed. The total duration of the treatment regimen was extremely variable and depended on body area and tolerability, with differences among patients of the same study. In six studies, imiquimod was used as neoadjuvant therapy before the surgical excision, and in 11 studies it was used after surgery as complementary or adjuvant therapy. In total, 1133 of the 1803 (62.8%) lesions were reported to be cleared after the treatment, taking into account that not all of the patients completed the treatment. Of these 1133 lesions, histological clearance was achieved in 645 (56.9%) lesions and clinical clearance only was achieved in 490 (43.2%) lesions; relapse occurred in 107 lesions.

Conclusions

The heterogeneity of the studies included in this systematic review precludes the drawing of any relevant conclusions regarding the application of imiquimod. Its efficacy in melanoma in situ and lentigo maligna melanoma has been demonstrated, but further evidence from controlled studies concerning the modalities is missing.

中文翻译：

用咪喹莫特乳膏局部治疗原位黑色素瘤、恶性雀斑样痣和恶性雀斑样痣黑色素瘤：文献的系统回顾

介绍

黑色素瘤的经典治疗方法是手术，但由于年龄、身体面积、病变大小等多种因素，这可能具有挑战性。由于其功效、耐受性和非侵入性，外用咪喹莫特可能成为治疗原位黑色素瘤和恶性雀斑样黑色素瘤的一种治疗选择。本系统评价的目的是收集有关局部用咪喹莫特治疗非转移性黑色素瘤的当前证据。

方法

使用主要搜索词“咪喹莫特”结合“恶性雀斑样痣”和“黑色素瘤”以及命令“AND”，对 PubMed/MEDLINE 和 Cochrane 图书馆数据库作为主要来源进行搜索。遵循 PRISMA 指南对文章进行识别、筛选和提取相关数据。

结果

本次系统评价共确定了 87 项研究，涵盖 1803 个用咪喹莫特乳膏治疗的病变。 49 项研究为病例报告，16 项为回顾性分析，3 项为开放标签试验，6 项为病例系列研究；一项研究是对照随机试验，一项是随机试验，一项是单臂 III 期试验。由于大量低证据研究，总体偏倚风险很高。在 55 项研究中，5% 咪喹莫特作为单一疗法作为主要治疗；仅在一项研究中引入了 3.75% 的咪喹莫特。在大多数情况下，局部治疗每天一次，但有九个案例除外，规定每日剂量增加。治疗方案的总持续时间变化很大，取决于身体面积和耐受性，同一研究的患者之间存在差异。在 6 项研究中，咪喹莫特在手术切除前用作新辅助治疗，在 11 项研究中，咪喹莫特在手术后用作补充或辅助治疗。考虑到并非所有患者都完成了治疗，总共 1803 个病灶中有 1133 个（62.8%）在治疗后被清除。在这1133个病灶中，645个（56.9%）病灶实现了组织学清除，而仅490个（43.2%）病灶实现了临床清除； 107个病灶出现复发。