Critical appraisal:Gojkovič-Horvat A, Jančar B, Blas M, Zumer B, Karner K, Hočevar M, et al 2012

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Critical Appraisal

Article being appraised

Gojkovič-Horvat A, Jančar B, Blas M, Zumer B, Karner K, Hočevar M, et al. Adjuvant radiotherapy for palpable melanoma metastases to the groin: when to irradiate? Int J Radiat Oncol Biol Phys 2012 May 1;83(1):310-6 Available from: http://www.ncbi.nlm.nih.gov/pubmed/22035662.


Applicable clinical question

Key Facts

Study Design

cohort study

Study aims:

To review experience with postoperative radiotherapy in patients with melanoma metastases to the groin at the Institute of Oncology Ljubljana, Slovenia, and to identify subgroups that would benefit most from combined therapy.

Number of Patients:

101

64 patients underwent nodal surgery alone
37 patients underwent nodal surgery plus adjuvant radiotherapy
Reported outcome(s):

overall survival
systemic metastases rates
distant metastasis-free survival
regional recurrence
regional control rates

Results of outcome(s):

2Y OS: 56% (95%CI 44-68%) vs 56% (95%CI 39-72%), p=0.813; nodal surgery alone vs nodal surgery plus adjuvant radiotherapy

SYSTEMIC METASTASES RATES: 65.5% (95%CI 52.7-77.1%) vs 64.9% (95%CI 47.5-79.8%), p=NR; nodal surgery alone vs nodal surgery plus adjuvant radiotherapy

DISTANT METASTASIS-FREE SURVIVAL: 48% (95%CI 35-61%) vs 47% (95%CI 30-63%), p=0.899; nodal surgery alone vs nodal surgery plus adjuvant radiotherapy

REGIONAL RECURRENCE: 21.2% (95%CI 12.1-33.0%) vs 13.5% (95%CI 4.5-28.8%), p=0.431; nodal surgery alone vs nodal surgery plus adjuvant radiotherapy
-sub-analysis
OS: in nodal surgery alone group, difference in OS between those with regional recurrence and those without was not significant, p=0.714. in nodal surgery plus adjuvant radiotherapy group, difference in OS between those with regional recurrence and those without was not significant, p=0.661.

2Y REGIONAL CONTROL RATES: 86% (95%CI 76-95%) vs 91%(95%CI 81-100), p=0.395; nodal surgery alone vs nodal surgery plus adjuvant radiotherapy

Comments on results:

toxicity outcomes reported but not extracted from study

Includes an economic evaluation

no

Evidence ratings

Level of evidence

III-2

Risk of bias
Moderate risk of bias Comments: representative cohort, comparable baseline, objective measures used

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
Size of effect
4 Reason for decision: Please replace this text and briefly describe the reasons for your rating
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

Cecilia Taing


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Article
Gojkovič-Horvat A, Jančar B, Blas M, Zumer B, Karner K, Hočevar M, et al. Adjuvant radiotherapy for palpable melanoma metastases to the groin: when to irradiate? Int J Radiat Oncol Biol Phys 2012 May 1;83(1):310-6 Available from: http://www.ncbi.nlm.nih.gov/pubmed/22035662.
Assigned to
User:Cecilia.taing
Topic area
Guidelines:Melanoma
Clinical question
Form
Form:Critical appraisal


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