Critical appraisal:Prens SP, van der Ploeg AP, van Akkooi AC, van Montfort CA, van Geel AN, de Wilt JH, et al 2011

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Critical Appraisal

Article being appraised

Prens SP, van der Ploeg AP, van Akkooi AC, van Montfort CA, van Geel AN, de Wilt JH, et al. Outcome after therapeutic lymph node dissection in patients with unknown primary melanoma site. Ann Surg Oncol 2011 Dec;18(13):3586-92 Available from: http://www.ncbi.nlm.nih.gov/pubmed/21611857.


Applicable clinical question

Key Facts

Study Design

cohort study

Study aims:

To evaluate the incidence and outcome of melanoma of unknown primary site (MUP) after therapeutic lymph node dissection (TLND) of palpable nodal melanoma metastasis.

Number of Patients:

342

47 MUP, 295 MKP (melanoma known primary)
Reported outcome(s):

Disease free survival
Overall survival

Results of outcome(s):

Univariate analyses= factors statistically significantly affected DFS: site of dissection, number of positive nodes, node positive ratio, ECE. Multivariate analyses for DFS showed 3 significant prognostic factors: N2 (P = 0.04), N3 (P<0.001) and ECE (P = 0.004). As for OS, ulceration, site of dissection, node positive ratio, number of positive nodes, ECE and MUP were statistically significant prognostic factors. Ulceration was not known for MUP patients and not included in multivariate analyses. Multivariate analysis for OS revealed 2 highly significant factors associated with worse prognosis: the presence of ECE and N3 status (both P<0.001). 2 factors were associated with significant better prognosis: MUP (P = 0.03) and neck dissections (P = 0.04). The estimated 5-year DFS rates for ECE were an estimated 12% when present and 26% when absent (P<0.001). For nodal status, 5-year DFS rates were 31%, 17% and 9% for the respective N1, N2 and N3 categories (P<0.001). The 5-year DFS rate for MKP patients was 21%, while the 5-year DFS rate for MUP patients was 25% (P = 0.619). Absence of ECE demonstrated a 5-year OS of 36% compared to 15% when present (P<0.001). The estimated 5-year OS rates for the different categories of nodal status (N1, N2 and N3) were 36%, 30% and 16%, respectively (P<0.001). The 5-year estimated Kaplan–Meier OS rate for MUP versus MKP showed a trend toward a better survival for MUP at 43% vs. 27% for MKP, respectively (P = 0.06)

Includes an economic evaluation

no

Evidence ratings

Level of evidence

III-2

Risk of bias
Moderate risk of bias Comments: Please replace this text and include any additional comments in regards to your quality rating

Risk of bias assessment: cohort study

Subject selection
"New technology" group
Selected group
Comparison group
Selected group
Comparability of groups on demographic characteristics and clinical features
Not comparable but adjusted analysis used
Measurement of outcomes
Outcome measures blind to technology used
No, but objective measures used
Same method of measurement used across comparison groups
Yes
Completeness of follow-up
Was follow-up complete and were all patients included in the analysis?
Yes (follow-up >95%) or survival analysis using all patients


Relevance of evidence
1 Additional comments: Please replace this text and briefly describe the reasons for your rating
Result of appraisal

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Completed by

Jackie Buck


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Article
Prens SP, van der Ploeg AP, van Akkooi AC, van Montfort CA, van Geel AN, de Wilt JH, et al. Outcome after therapeutic lymph node dissection in patients with unknown primary melanoma site. Ann Surg Oncol 2011 Dec;18(13):3586-92 Available from: http://www.ncbi.nlm.nih.gov/pubmed/21611857.
Assigned to
User:Jackie.buck
Topic area
Guidelines:Melanoma
Clinical question
Form
Form:Critical appraisal


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