Critical appraisal:Mocellin S, Lens MB, Pasquali S, Pilati P, Chiarion Sileni V 2013

From Cancer Guidelines Wiki

Critical Appraisal

Article being appraised

Mocellin S, Lens MB, Pasquali S, Pilati P, Chiarion Sileni V. Interferon alpha for the adjuvant treatment of cutaneous melanoma. Cochrane Database Syst Rev 2013 Jun 18;6:CD008955 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23775773.


Applicable clinical question

Key Facts

Study Design

systematic review — The literature search yielded 644 papers, from which 18 randomised controlled trials were included. All but one study (a phase II RCT) were phase III RCTs.

18 studies included in descriptive synthesis of which: - 17 studies were included in quantitative synthesis (meta-analysis) for DFS, and - 15 studies were included in quantitative synthesis (meta-analysis) for OS (2 studies did not address overall survival as end point).

Study aims:

To summarise the evidence on interferon, comparing interferon treatment versus any other comparator than interferon in participants with high risk cutaneous melanoma.

All included studies investigated the impact of interferon alpha on disease free survival and overall survival of people with cutaneous melanoma after surgery. Sixteen out of 18 trials compared interferon to obsrvation, while 2 trials compared interferon to the GMK antimelanoma vaccine.

Number of Patients:

10,499

Sample sizes ranged between 96 and 1388 participants.
Reported outcome(s):

Disease free survival (DFS) and overall survival (OS) were the primary outcomes.
The main outcome measure was the hazard ratio (HR), which is the ratio of the risk of the event occurring in the treatment arm (adjuvant interferon) compared to the control arm (no adjuvant interferon).

Results of outcome(s):

The meta-analysis of 17 RCTs showed a significant risk reduction (17%) for disease free survival, in participants undergoing postoperative interferon compared to those undergoing observation (15 trials) or other adjuvant therapy (HR= 0.83, 95%CI 0.78-0.87, P < 0.00001).

The meta-analysis of 15 RCTs showed a significant risk reduction (9%) for overall survival in participants undergoing postoperative interferon compared to those unferoing observation (14 trials) or other adjuvant therapy (HR= 0.91; 95%CI 0.85-0.97; P= 0.003).

There was no significant between-study heterogeneity for either disease free survival (I squared statistic= 16%, Q-test P= 0.27) or overall survival (I squared statistic= 6%; Q-test P= 0.38).

Includes an economic evaluation

no

Evidence ratings

Level of evidence

I

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?
Yes
If there was heterogeneity, were sources of heterogeneity explored?
Yes
Result of appraisal

Jutta's tick icon.png Included




Completed by

Tamsin Parrish


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


Article
Mocellin S, Lens MB, Pasquali S, Pilati P, Chiarion Sileni V. Interferon alpha for the adjuvant treatment of cutaneous melanoma. Cochrane Database Syst Rev 2013 Jun 18;6:CD008955 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23775773.
Assigned to
User:Tamsin.parrish
Topic area
Guidelines:Melanoma
Clinical question
Form
Form:Critical appraisal


Section below only relevant for Cancer Council Project Officer

Edit appraisal assignment