Angela M Hong, Serigne N Lo, Gerald B Fogarty, Jonathan Stretch, Wei Wang, Pablo Fernandez-Penas, Richard Cw Martin, Matthew Foote, H Peter Soyer, Jeremy Ruben, Victoria Mar, Lilian Rocha, Cyro Festa-Neto, Chris Wratten, Sam Hogarth, Helena Collgros, Amanda Glanz, Bruna Melhoranse Gouveia, Richard A Scolyer, Madeleine T King, Pascale Guitera
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Primary endpoint was treatment failure at 24 months. Secondary endpoints included response at 6 months, development of invasive disease, toxicity and HRQL.</p><p><strong>Results: </strong>Between August 2015 and November 2021, 126 patients were randomized. The response rate was 95% at 6 months in both groups. The treatment failure rates were low with 12 failures in the radiotherapy group and six in the imiquimod group at 24 months (OR 2.35, 95% CI 0.82-6.75, p=0.11). Both were well tolerated with mainly grade 1 and 2 acute skin toxicity with no significant differences between groups in skin symptoms or HRQL at long-term. Patients had significantly better emotional scores after treatment than at baseline in both groups. The trial is underpowered due to early cessation of recruitment.</p><p><strong>Conclusions: </strong>Both radiotherapy and imiquimod are efficient and well-tolerated treatments for LM. 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引用次数: 0
摘要
背景：对于不适合手术治疗的恶性黄斑患者，放疗或局部咪喹莫特是可选择的非手术治疗方法。目的：本试验旨在评估疗效、安全性和患者报告的健康相关生活质量（HRQL）。方法：2015年8月至2021年11月进行的一项多机构、3期随机试验。患者随机接受放疗或咪喹莫特治疗。主要终点是24个月时治疗失败。次要终点包括6个月时的缓解、侵袭性疾病的发展、毒性和HRQL。结果：2015年8月至2021年11月，126例患者被随机分组。两组患者6个月时的有效率均为95%。治疗失败率较低，24个月放疗组有12例失败，咪喹莫特组有6例失败（OR 2.35, 95% CI 0.82-6.75, p=0.11）。两组患者均耐受良好，主要为1级和2级急性皮肤毒性，两组间长期皮肤症状或HRQL无显著差异。两组患者治疗后的情绪评分均明显优于基线水平。由于提前停止招募，该试验的动力不足。结论：放疗和咪喹莫特都是治疗LM的有效且耐受性良好的方法。在24个月时对HRQL均无负面影响。
Radiotherapy Versus Imiquimod for Complex Lentigo Maligna: a Phase 3 Randomized Clinical Trial.
Background: For patients with lentigo maligna who are not suitable for surgery, radiotherapy or topical imiquimod are alternative non-surgical treatments.
Objective: This trial aimed to assess the efficacy, safety and patient-reported health-related quality of life (HRQL).
Methods: A multi-institutional, phase 3 randomized trial conducted between August 2015 and November 2021. Patients were randomized to radiotherapy or imiquimod. Primary endpoint was treatment failure at 24 months. Secondary endpoints included response at 6 months, development of invasive disease, toxicity and HRQL.
Results: Between August 2015 and November 2021, 126 patients were randomized. The response rate was 95% at 6 months in both groups. The treatment failure rates were low with 12 failures in the radiotherapy group and six in the imiquimod group at 24 months (OR 2.35, 95% CI 0.82-6.75, p=0.11). Both were well tolerated with mainly grade 1 and 2 acute skin toxicity with no significant differences between groups in skin symptoms or HRQL at long-term. Patients had significantly better emotional scores after treatment than at baseline in both groups. The trial is underpowered due to early cessation of recruitment.
Conclusions: Both radiotherapy and imiquimod are efficient and well-tolerated treatments for LM. Neither have negative impacts on HRQL at 24 months.
期刊介绍：
The Journal of the American Academy of Dermatology (JAAD) is the official scientific publication of the American Academy of Dermatology (AAD). Its primary goal is to cater to the educational requirements of the dermatology community. Being the top journal in the field, JAAD publishes original articles that have undergone peer review. These articles primarily focus on clinical, investigative, and population-based studies related to dermatology. Another key area of emphasis is research on healthcare delivery and quality of care. JAAD also highlights high-quality, cost-effective, and innovative treatments within the field. In addition to this, the journal covers new diagnostic techniques and various other topics relevant to the prevention, diagnosis, and treatment of skin, hair, and nail disorders.
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