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 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.