Critical appraisal:Spillane AJ, Pasquali S, Haydu LE, Thompson JF 2014

Critical Appraisal

Article being appraised

Spillane AJ, Pasquali S, Haydu LE, Thompson JF. Patterns of recurrence and survival after lymphadenectomy in melanoma patients: clarifying the effects of timing of surgery and lymph node tumor burden. Ann Surg Oncol 2014 Jan;21(1):292-9 Available from: http://www.ncbi.nlm.nih.gov/pubmed/24052314.

Applicable clinical question

Should all patients with a positive sentinel lymph node biopsy have a complete node dissection?

Key Facts

Study Design

case series

Study aims:

To investigate whether lymphadenectomy at different times in the course of disease progression influences Disease-free survival (DFS), post recurrence survival and overall survival (OS).

Number of Patients:

1704

502 patients underwent immediate completion lymphadenectomy (ICL) after postitive sentinel node biopsy (SNB), 214 had delayed completion lymphadenectomy (DCL) for regional recurrence after positive SLB with no ICL or after an earlier false-negative SNB, 709 had no SNB and later required delayed therapeutic lymphadenectomy (DTL) for clinically evident metastases, and 279 had immediate therapeutic lymphadenectomy (ITL) for clinically positive LNs at primary melanoma diagnosis.

Reported outcome(s):

Disease-free survival (DFS)
Post Recurrence Survival (PRS)
Overall Survival (OS)

Results of outcome(s):

DFS was significantly different among the four patient groups (p<0.001). Median DFS times for ICL, DCL, DTL, and ITL groups were 68 (95% CI not reached), 48 (95% CI 39-56), 82 (95 % CI 66-97), and 16 months (95% CI 14-19), respectively.
DFS after 5 years was significantly different when comparing the ICL (n=113) and DTL (n=283) groups (p=0.005).
Overall, the PRS in those who had relapse after CLND was 9 months (95% CI 7-10).
In patients with first relapse as local/in-transit, nodal and distant relapse, median PRS was 18 (95% CI 14-21), 18 (95% CI 11-24) and 7 (95% CI 6-8) months, respectively (p<0.001).
Patients in the ICL group had a significantly longer PRS than patients in the other clinical scenarios (log rank test, p < 0.001). PRS times for ICL, DCL, DTL and ITL groups were 14 (95% CI 9.6-18.4), 8 (95% CI 6.3-9.7), 9 (95% CI 7.2-10.7), and 9 (95% CI 6.7-11.3) months, respectively.
Overall there were 675 deaths de to melanoma (39.6%), and the median survival from the time of primary melanoma diagnosis for all patients was 91.7 months (95% CI 80.7-102.9). OS was significantly different across clinical scenarios (p< 0.001). Median survival for patients in ICL group was not reached, while for DCL, DTL and ITL groups it was 71.1 (95% CI 45.8-96.4), 101.3 (95% CI 86.1-116.0), and 29.2 (95% CI 22.7-35.8) months, respectively.
OS after 5 years was significantly different when comparing the ICL (n=141) and DTL (n=332) groups (p=0.012).

Includes an economic evaluation

no