The 6-year follow-up of the phase III ANZMTG 01.02/TROG 02.01 trial, reported in The Lancet Oncology by Henderson et al, showed that adjuvant lymph-node field radiotherapy in melanoma patients with high risk of lymph-node field recurrence reduced the rate of recurrence but did not improve overall survival compared with observation. The findings are similar to an earlier report from the trial.
The study enrolled 217 evaluable patients from sites in Australia, New Zealand, the Netherlands, and Brazil who had undergone lymphadenectomy for palpable lymph-node field relapse and were at high risk of recurrence. Patients were randomly assigned between March 2003 and November 2007 to adjuvant radiotherapy consisting of 48 Gy in 20 fractions given over a maximum of 30 days (n = 109) or observation (n = 108).
Relapse and Survival
Median follow-up was 73 months. Relapse occurred in 21% of patients in the adjuvant radiotherapy group vs 36% in the observation group (adjusted hazard ratio [HR] = 0.52, P = .023). Five-year overall survival was 40% vs 45% (HR = 1.27, P = .21), and no difference in relapse-free survival was observed (HR = 0.89, P = .51).
Long-term toxic effects from radiotherapy were common, consisting mostly of pain and fibrosis of the skin or subcutaneous tissue; grade 3 or 4 effects occurred in 22% (20% grade 3), with the most common affecting skin (10%) and subcutaneous tissue (7%). At 5 years, the radiotherapy group had significantly increased lower limb (P = .014) but not upper limb volume compared with the observation group.
The investigators concluded: “Long-term follow-up supports our previous findings. Adjuvant radiotherapy could be useful for patients for whom lymph-node field control is a major issue, but entry to an adjuvant systemic therapy trial might be a preferable first option. Alternatively, observation, reserving surgery and radiotherapy for a further recurrence, might be an acceptable strategy.”
Michael A. Henderson, MD, of Peter MacCallum Cancer Centre, East Melbourne, is the corresponding author for the Lancet Oncology article.
The study was funded by the National Health and Medical Research Council of Australia, Cancer Council Australia, Melanoma Institute Australia, and the Cancer Council South Australia. For full disclosures of the study authors, visit www.thelancet.com/journals/lanonc.
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