Critical appraisal:Henderson MA, Burmeister BH, Ainslie J, Fisher R, Di Iulio J, Smithers BM, et al 2015 4
Critical Appraisal
Henderson MA, Burmeister BH, Ainslie J, Fisher R, Di Iulio J, Smithers BM, et al. 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. Lancet Oncol 2015 Jul 20 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26206146.
Key Facts
randomised controlled trial - Cochrane tool
To provide updated follow-up analyses of lymph-node field relapse, relapse-free survival, and overall survival, and reports late toxic effects(occurring more than 90 days after surgery or initiation of radiotherapy), lymphoedema, and quality of life data for the first time.
250
intention to treat population = 248
126 in observation group
122 in adjuvant radiotherapy group
eligible population = 217
109 in adjuvant radiotherapy group
lymph-node relapse
overall survival
relapse-free survival
ELIGIBLE POPULATION RESULTS -
LYMPH-NODE RELAPSE: after 3y, 2 patients in the observation group had a lymph-node field relapse.
patients in the observation group had more frequent first relapses in the lymph-node field than patients in the adjuvant radiotherapy arm (HR 0.52, 95%CI 0.31-0.88), p=0.23, adjusted for lymph-node field region
lymph-node field relapse at any time was also more common in the observation group HR 0.54 (95%CI 0.33-0.89), p=0.021
5-year cumulative incidence of lymph-node field relapse as a site of first relapse was 18% (95%CI 11-26) vs 33% (95%CI 24-42); difference: 15% (95%CI 3.5-27), p=0.011.
5-year cumulative incidence for isolated lymph-node field relapse as a site of first relapse was 8.3% (95%CI 3.0-13.5) for adjuvant radiotherapy and 23% (95%CI 15-31) for observation; difference 15% (95%CI 5.4-4.25), p=0.002. Multivariate analysis results for treatment arm is as follows: HR 0.49 (95%CI 0.28-0.85), p=0.011
RISK OF DISTANT RELAPSE: comparison between radiotherapy and observation only
- any relapse: HR 1.07 (95%CI 0.77-1.50), p=0.73
- first relapse: HR 1.12 (95%CI 0.77-1.50), p=0.56
- relapse-free survival: HR 0.89 (95%CI 0.65-1.22), p=0.51
- overall survival: HR 1.27 (95%CI 0.89-1.79), p=0.21
5-Y SURVIVAL: 40% (95% CI 31-50%) vs 45% (95%CI 36-55); HR 1.27 (95%CI 0.89-1.79), p=0.21
eligible population extracted
intention to treat population results reported but not extracted from study
Quality of life outcomes were reported but not extracted from study
no
Evidence ratings
II
Unclear risk of bias | Comments: outcomes not blinded, randomisation concealed, elgible population reported in this paper |
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- Article
- Henderson MA, Burmeister BH, Ainslie J, Fisher R, Di Iulio J, Smithers BM, et al. 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. Lancet Oncol 2015 Jul 20 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26206146.
- Assigned to
- User:Cecilia.taing
- Topic area
- Guidelines:Melanoma
- Clinical question
Section below only relevant for Cancer Council Project Officer