Lymph-node field relapse

 Eligible population
o 54 of 217 (adjuvant + observation) patients had lymph-node field
relapse as first relapse
o 20/109 lymph-node field relapsed (adjuvant) vs. 34/108 (observation)
[HR 0.56, 95% CI 0.32-0.98; p=.041]
o Cumulative incidence of lymph-node relapse at 3 years was 19%
adjuvant [95% CI 11-27] vs. 31% observation [95% CI 20-40]
o Time to distant relapse (as a first relapse) did not differ significantly
[HR 1.06 95% CI 0.72-1.57; p=.77]
o Time to any distant relapse was almost identical between the groups
[HR 1.00, 0.71-1.41; p=.8]
 Intention to treat population
o 62 of 248 patients (adjuvant + observation) had lymph-node field
relapse as first relapse
o 20/122 lymph-node field relapsed (adjuvant) vs. 42/126 (observation)
Similar significant statistics
[HR 0.47, 95% CI 0.28-0.81; p=.005]
 Higher risk of lymph-node field relapse in observation group than
radiotherapy group was consistent across all nodal sites
[data not shown]

Survival
 Eligible population
o 23 patients in eligible observation group who had isolated lymph-node
field relapse as first relapse -> 18 received salvage therapy -> 7 patients
have died
o Survival from first relapse in all eligible patients who relapsed at any
site was 44% (95% CI 36-53) at 1 year, 24% (17-34) at 2 years, and 18%
(11-27) at 3 years;
median survival was 10 months (IQR 7-13)
o 142/217 patients relapsed with melanoma (69 adjuvant, 73
observation)
o Relapse-free survival was not significantly different between adjuvant
vs. observation group
[HR 0.91, 95% CI 0.65-1.26; p=.56]
 o Median recurrence-free survival was 15 months (95% CI 11-27) in the
adjuvant vs. 14 months (95% CI 9-23) in the observation group
o Median overall survival was 32 months for adjuvant (95% CI 20-not yet
reached) and 47 months in the observation group (95% CI 30-not yet
reached)
o Overall deaths were not statistically significant between the two
groups and included 59/109 in the adjuvant vs. 47/108 in the
observation group
[HR 1.37, 95% CI 0.94-2.01; p=.12]

Toxicity
 Most common early surgery adverse events were seroma formation in the
groin or axilla; infection; nerve damage; wound necrosis; local pain
 Most common early radiotherapy adverse events were radiation dermatitis
and pain

Prognosis
 Extranodal spread was the only independent risk factor for lymph-node field
relapse
[HR 1.77 per degree of spread, 95% CI 1.26-2.49; p=.001]
 Extranodal spread [HR 1.66 per degree of spread, 95% CI 1.30-2.13; p=.0001]
and number of positive nodes (1 vs. 2-3 vs. 4+) [HR 1.45, 95% CI 1.13-1.86;
p=.004]
were independently predictive of poor overall survival
 Treatment group adjusting for these two factors was not significantly
related to survival
[HR 1.36, 95% CI 0.92-2.0; p=.12]