Critical appraisal:Xing Y, Badgwell BD, Ross MI, Gershenwald JE, Lee JE, Mansfield PF, et al 2009

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Critical Appraisal

Article being appraised

Xing Y, Badgwell BD, Ross MI, Gershenwald JE, Lee JE, Mansfield PF, et al. Lymph node ratio predicts disease-specific survival in melanoma patients. Cancer 2009 Jun 1;115(11):2505-13 Available from: http://www.ncbi.nlm.nih.gov/pubmed/19309746.


Applicable clinical question

Key Facts

Study Design

cohort study

Study aims:

The objectives of this analysis were to compare various measures associated with lymph node (LN) dissection and to identify threshold values associated with disease-specific survival (DSS) outcomes in patients with melanoma.

Number of Patients:

2348

Reported outcome(s):

Removed lymph nodes
LN ratio thresholds and DSS
Prognotic factors

Results of outcome(s):

Median of 1 positive LN removed from patients who underwent neck, axillary and inguinal LND (P < .001). Fewer negative LNs (median, 9; interquartile range [IQR], 5 to 14) and total LNs (median, 11; IQR, 7 to 16) were removed from patients who underwent inguinal LND than from patients who underwent neck and axillary LND. Median LN ratio was higher in inguinal LND patients than in neck and axillary LND patients (0.15 v 0.09 and 0.08, respectively; P<.001).

Cox multivariate analyses: increasing LN ratio was an adverse prognostic factor for DSS for all LND regions (data not shown). Total LNs removed and number of negative LNs removed were not significantly associated with DSS
LN ratio thresholds were 0.07, 0.13, and 0.18 for neck, axillary, and inguinal regions, corresponding to 15, 8, and 6 LNs removed per positive node. 5-year DSS rates: 64% vs 36% for neck LND, 70% vs 51% for axillary LND, and 70% vs 45% for inguinal LND (P < .001)

After adjustment for age, sex, year of diagnosis, SEER region, Clark level, primary tumor (T) stage, histologic subtype, and the presence/absence of primary tumor ulceration, patients who had a LN ratio less than the threshold had a 50% reduction in the risk of disease-specific death compared with patients who had a LN ratio at or above the threshold (P <.001). Specifically, the HR was 0.53 (95% CI, 0.40 to 0.71) in the neck, 0.52 (95% CI, 0.42 to 0.65) in the axillary, and 0.47 (95% CI, 0.36 to 0.61) in the inguinal LND groups for patients who met LN ratio threshold. In the axillary LND group, nodular melanoma (HR, 1.40; 95% CI, 1.02 to 1.94; P = .04) was a poor prognostic factor for DSS; Clark levels IV and V (HR, 1.56; 95% CI, 1.0 to 2.43; P = .05) and primary tumor ulceration (HR, 1.44; 95% CI, 1.07 to 1.94; P = .016) were adverse prognostic factor for DSS in the inguinal LND group.

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 risk of bias rating

Risk of bias assessment: cohort study

Subject selection
"New technology" group
Representative of eligible patients.
Comparison group
Representative of eligible patients
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
Xing Y, Badgwell BD, Ross MI, Gershenwald JE, Lee JE, Mansfield PF, et al. Lymph node ratio predicts disease-specific survival in melanoma patients. Cancer 2009 Jun 1;115(11):2505-13 Available from: http://www.ncbi.nlm.nih.gov/pubmed/19309746.
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Form:Critical appraisal


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