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|Title:||Adjuvant lymph-node field radiotherapy versus observation only in patients with melanoma at high risk of further lymph-node field relapse after lymphadenectomy (ANZMTG 01.02/TROG 02.01): 6-year follow-up of a phase 3, randomised controlled trial|
Di Iulio, J.
|Citation:||The Lancet Oncology, 2015; 16(9):1049-1060|
|Michael A Henderson, Bryan H Burmeister, Jill Ainslie, Richard Fisher, Juliana Di Iulio, B Mark Smithers, Angela Hong, Kerwin Shannon, Richard A Scolyer, Scott Carruthers, Brendon J Coventry, Scott Babington, Joao Duprat, Harald J Hoekstra, John F Thompson|
|Abstract:||Background: Adjuvant radiotherapy is recommended for patients with melanoma after lymphadenectomy. We previously showed this treatment reduced risk of repeat lymph-node fi eld cancer in patients with a high risk of recurrence but had no eff ect on overall survival. H ere, we aim to update the relapse and survival data from that trial and assess quality of life and toxic eff ects. Methods: In the ANZMTG 01.02/TROG 02.01 randomised controlled trial, we enrolled patients who had undergone lymphadenectomy for a palpable lymph-node fi eld relapse and were at high risk of recurrence at 16 hospitals (11 in Australia, three in N ew Zealand, one in Netherlands, and one in Brazil). We randomly assigned patients (1:1) to adjuvant radiotherapy (48 Gy in 20 fractions, given over a maximum of 30 days) or observation, stratifi ed by institution, areas of lymph-node fi eld (parotid and cervical, axilla, or groin), number of involved nodes (≤3 vs >3), maximum involved node diameter (≤4 cm vs >4 cm), and extent of extracapsular extension (none, limited, or extensive). Participants, those giving treatment, and those assessing outcomes were not masked to treatment allocation, but participants were unaware of each other’s treatment allocation. In this follow-up, we assessed outcomes every 3 months from randomisation for the fi rst 2 years, then every 6 months up to 5 years, then annually. The primary endpoint was lymph-node fi eld relapse as a fi rst relapse, assessed in patients without major eligibility infringements (determined by an independent data monitoring committee). We assessed late adverse eff ects (occurring >90 days after surgery or start of radiotherapy) with standard criteria in the as-treated population. This study is registered with ClinicalTrials.gov, number NCT00287196. Findings: Between March 21, 2003, and Nov 15, 2007, we randomly assigned 123 patients to adjuvant radiotherapy (109 eligible for effi cacy assessments) and 127 to observation (108 eligible). The fi nal follow-up date was N ov 15, 2011. Median follow-up was 73 months (IQR 61–91). 23 (21%) relapses occurred in the adjuvant radiotherapy group compared with 39 (36%) in the observation group (adjusted hazard ratio [HR] 0·52 [95% CI 0·31–0·88], p=0·023). Overall survival (HR 1·27 [95% CI 0·89–1·79], p=0·21) and relapse-free survival (0·89 [0·65–1·22], p=0·51) did not diff er between groups. Minor , long-term toxic eff ects from radiotherapy (predominantly pain, and fi brosis of the skin or subcutaneous tissue) were common, and 20 (22%) of 90 patients receiving adjuvant radiotherapy developed grade 3–4 toxic eff ects. 18 (20%) of 90 patients had grade 3 toxic eff ects, mainly aff ecting skin (nine [10%] patients) and subcutaneous tissue (six [7%] patients). Over 5 years, a signifi cant increase in lower limb volumes was noted after adjuvant radiotherapy (mean volume ratio 15·0%) compared with observation (7·7%; diff erence 7·3% [95% CI 1·5–13·1], p=0·014). No signifi cant diff erences in upper limb volume were noted between groups. Interpretation: Long-term follow-up supports our previous fi ndings. Adjuvant radiotherapy could be useful for patients for whom lymph-node fi eld control is a major issue, but entry to an adjuvant systemic therapy trial might be a preferable fi rst option. Alternatively, observation, reserving surgery and radiotherapy for a further recurrence, might be an acceptable strategy. Funding: National Health and Medical Research Council of Australia, Cancer Council Australia, Melanoma Institute Australia, and the Cancer Council South Australia.|
|Rights:||Copyright © 2015 Elsevier Ltd. All rights reserved.|
|Appears in Collections:||Medicine publications|
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