Critical appraisal:Hughes MC, Wright A, Barbour A, Thomas J, Smithers BM, Green AC, et al 2013

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Critical Appraisal

Article being appraised

Hughes MC, Wright A, Barbour A, Thomas J, Smithers BM, Green AC, et al. Patients undergoing lymphadenectomy for stage III melanomas of known or unknown primary site do not differ in outcome. Int J Cancer 2013 Dec 15;133(12):3000-7 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23754707.


Applicable clinical question

Key Facts

Study Design

cohort study

Study aims:

to compare outcomes of those with MUPs versus MKPs with palpable lymph node invasion, after staging with modern imaging technology.

Number of Patients:

485

403 (83%) had a MKP and 82 (17%) had MUP
Reported outcome(s):

Risk of disease recurrence
Risk of death due to Melanoma

Results of outcome(s):

Disease recurrence was identified in 212 cases overall (43.7%), 181 MKPs and 31 MUPs. Localrecurrence in 23 (10.8%) (10.5 MUP vs. 12.9% MKP, p = 0.69). Median,time to recurrence for 181 MKPs was 7.4 months (IQR 5 8.3, range: 0.4–103.1 months) and for 31 MUPs, 7.7 months (IQR 5 10.8, range: 1.4–31.1 months). 209 (43.1%) died during follow-up with melanoma as cause of death in 199 patients (172 MKPs and 27 MUPs). Median time to death for MKPs was 13.9 months (IQR 5 18.5, range: 0.4–90.5 months) as compared to 16.5 (IQR 5 14.4) months for MUPs (range, 3.9–41.8).
17 MUP and 25% MKP risk of recurrence and melanoma-specific death (non-significant).
Increasing number of positive nodes, the presence of micro- or gross extra-capsular extension, Stage IIIC staging and the presence of a post-surgery seroma requiring intervention were all positively associated with recurrence. After full adjustment, the difference in risk of disease recurrence between MUPs and MKPs (adjusted HR: 0.81; 95% confidence interval [CI]: [0.55, 1.19], p = 0.28).
Five-year adjusted recurrence-free survival 50% MUPs vs 44% MKPs. Adjusted analysis restricted to groups of MUPs and MKPs with only 1, 2–3 or >4 nodes produced similar results.
Melanoma-specific mortality, age at LND of 75+ years, increasing number of positive nodes, the presence of micro- or gross extra-capsular extension, Stage IIIC disease and post-surgery seroma were positively associated with melanoma death.
Risk of death due to melanoma- Adjusted for risk factors (adjusted HR: 0.88 95% CI [0.58, 1.33], p = 0.54).
Five-year adjusted melanoma specific survival and overall survival were 58% MUPs vs 49% MKP (adjusted HR 5 0.86 [0.58, 1.28], p = 0.47). Adjusted analysis restricted to groups of MUPs and MKPs with only 1, 2–3 or >4 nodes produced similar results.

Comments on results:

Groin dissection as well as increasing number of harvested nodes became significantly associated with recurrence only after adjustment for the above major risk factors (not included in final model)

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
Hughes MC, Wright A, Barbour A, Thomas J, Smithers BM, Green AC, et al. Patients undergoing lymphadenectomy for stage III melanomas of known or unknown primary site do not differ in outcome. Int J Cancer 2013 Dec 15;133(12):3000-7 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23754707.
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