Critical appraisal:Tzellos T, Kyrgidis A, Mocellin S, Chan AW, Pilati P, Apalla Z 2014

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Critical Appraisal

Article being appraised

Tzellos T, Kyrgidis A, Mocellin S, Chan AW, Pilati P, Apalla Z. Interventions for melanoma in situ, including lentigo maligna. Cochrane Database Syst Rev 2014 Dec 19;12:CD010308 Available from: http://www.ncbi.nlm.nih.gov/pubmed/25526608.


Applicable clinical question

Key Facts

Study Design

systematic review — One randomised controlled trial was included. This study involved the non-surgical treatment of 90 people with LM.

Study aims:

To assess the effects of all available interventions, surgical and non-surgical, for the treatment of melanoma in situ, including lentigo maligna.

Number of Patients:

90

One study: 44 were treated with imiquimod cream plus tazarotene gel, and 46 treated with imiquimod cream for 3 months.
Reported outcome(s):

Primary Outcomes:
- Histologic or clinical complete response rate
- Total number of acute and short-term (up to 1 year) treatment-related adverse events

Secondary Outcomes:
- Clinical or histological local recurrence rate
- Time to complete histologic and clinical clearance, and local recurrence
- Incidence of distal metastases
- Progression to invasive melanoma
- Short-, medium-, and long-term participant satisfaction
- Treatment-related quality of lide
- Discontinuation of treatment rate because of harms
- Inflammatory response

Results of outcome(s):

Primary outcomes:
Histological or clinical complete response was measured at 5 months in 29/44 participants (66%) treated with imiquimod plus tazarotene (combination therapy) and 27/46 participants (59%) treated with imiquimod (monotherapy).
The difference was not statistically significant: risk ratio (RR)= 1.12; 95% CI 0.81-1.55; P= 0.48.

Secondary outcomes: Recurrence and inflammation
After a mean follow-up of 42 months, no local recurrences were observed among complete responders. Difference in overall inflammation score between two groups was significant, with a mean difference of 0.6; 95% CI 0.2-1.0; P= 0.004, and the mean overall inflammation score being significantly higher in the combination group.

Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias
Low 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: systematic review

Studies included in the review
Was an adequate search strategy used?
Very thorough – included appropriate search terms and databases
Were the inclusion criteria appropriate and applied in an unbiased way?
Yes – pre-specified inclusion criteria applied independently by two people
Were the studies assessed for quality (relating to the minimisation of biases)?
Yes – appropriate quality issues were assessed independently by two people
Were the characteristics and results of individual studies appropriately summarised?
Yes – summary descriptive tables of subjects, interventions, outcomes etc are provided and estimates of treatment effect displayed
The following questions are only relevant for systematic reviews that pooled data
Were the methods used for pooling the data appropriate?
No response
If there was heterogeneity, were sources of heterogeneity explored?
No response
Result of appraisal

Jutta's tick icon.png Included




Completed by

Tamsin Parrish


Jutta's tick icon.png This appraisal has been completed.


Article
Tzellos T, Kyrgidis A, Mocellin S, Chan AW, Pilati P, Apalla Z. Interventions for melanoma in situ, including lentigo maligna. Cochrane Database Syst Rev 2014 Dec 19;12:CD010308 Available from: http://www.ncbi.nlm.nih.gov/pubmed/25526608.
Assigned to
User:Tamsin.parrish
Topic area
Guidelines:Melanoma
Clinical question
Form
Form:Critical appraisal


Section below only relevant for Cancer Council Project Officer

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