Radiotherapy versus imiquimod for complex lentigo maligna: A phase 3 randomized clinical trial - 17/10/25
, Serigne N. Lo, PhD a, b, Gerald B. Fogarty, PhD c, Jonathan Stretch, MD a, b, Wei Wang, MBBS b, d, Pablo Fernandez-Penas, PhD b, e, Richard C.W. Martin, MB ChB f, Matthew Foote, MBBS g, H. Peter Soyer, PhD h, i, Jeremy Ruben, MBBS j, k, Victoria Mar, PhD k, l, Lilian Rocha, PhD m, Cyro Festa-Neto, PhD m, Chris Wratten, MBBS n, o, Sam Hogarth, PhD p, Helena Collgros, MD q, Amanda Glanz, PhD b, q, Bruna Melhoranse Gouveia, PhD a, b, Richard A. Scolyer, MD a, b, r, s, Madeleine T. King, PhD t, Pascale Guitera, PhD a, b, qAbstract |
Background |
For patients with lentigo maligna who are not suitable for surgery, radiotherapy, or topical imiquimod are alternative nonsurgical treatments.
Objective |
This trial aimed to assess the efficacy, safety, and patient-reported health-related quality of life (HRQL).
Methods |
A multiinstitutional, phase 3, randomized trial conducted between August 2015 and November 2021. Patients were randomized to radiotherapy or imiquimod. The primary end point was treatment failure at 24 months. Secondary end points 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 6 in the imiquimod group at 24 months (Odd ratios, 2.35; 95% CI, 0.82-6.75; P = .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 lentigo maligna. Neither have negative impacts on HRQL at 24 months.
Le texte complet de cet article est disponible en PDF.Key words : imiquimod, lentigo maligna, melanoma in situ, radiotherapy
Abbreviation used : CTV, EQ-5D-5L, HRQL, LM, MID, OR, RCM, RT, VAS
Plan
| Funding sources: The authors would like to acknowledge funding support from the Australian Government, Cancer Australia and the Royal Australia and New Zealand College of Radiologists (Faculty of Radiation Oncology). |
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| Presented at the oral presentation at the American Society of Clinical Oncology 2024. |
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| Patient consent: All patients provided a written consent to participate in the trial. |
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| IRB approval status: The trial was approved by the Sydney Local Health District Ethics Committee (2019/ETH12644), as well as by institutional review boards at each site. |
Vol 93 - N° 5
P. 1251-1260 - novembre 2025 Retour au numéro
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