Research in context
Evidence before this study
We did a systematic search of the Cochrane, PubMed, and Medline databases with the terms “melanoma”, “regional recurrence”, and “lymph-node field recurrence”, and the date restrictions 1970–2014. Only retrospective studies were available, and suggested that radiotherapy reduces lymph-node field recurrence but without an effect on survival. No reliable information on quality of life or toxicity of treatment was identified.
Added value of this study
To the best of our knowledge, our study is the first completed randomised trial with the primary endpoint of lymph-node field relapse. We report the final results from a trial of radiotherapy versus observation for patients with melanoma at high risk of further lymph-node field relapse after lymphadenectomy. The risk of lymph-node field relapse is significantly reduced, but overall survival is not altered. Patients in the observation group who developed an isolated lymph-node field relapse given surgery and or radiotherapy achieved similar outcomes to patients randomly assigned to radiotherapy. The addition of radiotherapy after lymphadenectomy had negligible effect on quality of life but specific lymph-node field symptoms were more common in patients receiving radiotherapy. Tissue fibrosis was the most common side-effect of radiotherapy and was usually minor in severity. Limb volumes slightly increased after radiotherapy more than after surgery but this was only significant in the lower limbs.
Implications of all the available evidence
Patients at high risk of lymph-node field (and distant) recurrence should be considered for adjuvant systemic therapy studies. Alternatively, adjuvant radiotherapy could be considered, although close observation might be a reasonable option reserving further surgery and radiotherapy if an isolated lymph-node field relapse occurs.