Critical appraisal:Rotolo F, Dunant A, Le Chevalier T, Pignon JP, Arriagada R, IALT Collaborative Group 2014 1

This appraisal has been completed.

Article

Rotolo F, Dunant A, Le Chevalier T, Pignon JP, Arriagada R, IALT Collaborative Group. Adjuvant cisplatin-based chemotherapy in nonsmall-cell lung cancer: new insights into the effect on failure type via a multistate approach. Ann Oncol 2014 Nov;25(11):2162-6 Available from: http://www.ncbi.nlm.nih.gov/pubmed/25193990.

Assigned to

User:Shawgi.sukumaran

Topic area

Guidelines:Lung cancer/Treatment/Non-small-cell stage II operable

Clinical question

• What is the role of chemotherapy after surgery in the treatment of operable stage II NSCLC?

Form

Form:Critical appraisal

Study design

randomised controlled trial

Level of Evidence

II

Section below only relevant for Cancer Council Project Officer

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Critical Appraisal

Article being appraised

Rotolo F, Dunant A, Le Chevalier T, Pignon JP, Arriagada R, IALT Collaborative Group. Adjuvant cisplatin-based chemotherapy in nonsmall-cell lung cancer: new insights into the effect on failure type via a multistate approach. Ann Oncol 2014 Nov;25(11):2162-6 Available from: http://www.ncbi.nlm.nih.gov/pubmed/25193990.

Applicable clinical question

• What is the role of chemotherapy after surgery in the treatment of operable stage II NSCLC?

Key Facts

Study Design

randomised controlled trial

Study aims:

This study aimed to look at long term mortality data from subjects on the IALT study

Number of Patients:

1687

Reported outcome(s):

it reports that long term non-cancer mortality was higher in patients who received chemotherapy arm compared to the control

Results of outcome(s):

Hazard Ratio of non cancer mortality in the Treated arm compared to controls HR 3.6 (95% CI 2.2-5.9, P<0.001)

Comments on results:

The conclusion were based on a small total number of events

Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

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

Show/Hide Risk of bias assessment

Risk of bias assessment: randomised controlled trial

Was the trial double-blinded?

Outcomes not blinded, substantial side-effects, or not reported.

Was the treatment allocation schedule concealed?

No concealment or unclear (e.g. no approach described, open randomisation lists, person doing recruitment tossing a coin).

Were all randomised participants included in the analysis?

No exclusions or survival analysis used with all subjects included (>95% follow-up for all groups).

The field below is not considered when calculating the risk of bias rating

How was the allocation schedule generated?

Adequate (e.g. random number table, computer random generator, coin tossing, card shuffling)

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

Included

Comments

Long term side effects including the potential increased mortality risks should be taken into consideration while making clinical decisions regarding adjuvant chemotherapy

Completed by

Dr Shawgi Sukumaran