Critical appraisal:Price A, Yellowlees A, Keerie C, Russell S, Faivre-Finn C, Gilligan D, et al 2012 2

Critical Appraisal

Article being appraised

Price A, Yellowlees A, Keerie C, Russell S, Faivre-Finn C, Gilligan D, et al. Radical radiotherapy with or without gemcitabine in patients with early stage medically inoperable non-small cell lung cancer. Lung Cancer 2012 Sep;77(3):532-6 Available from: http://www.ncbi.nlm.nih.gov/pubmed/22672970.

Applicable clinical question

What is the best practice radiotherapy approach in patients with stage II inoperable NSCLC?

Key Facts

Study Design

randomised controlled trial

Number of Patients:

111

Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias

Low risk of bias

Comments: Well conducted but underpowered study

Show/Hide Risk of bias assessment

Risk of bias assessment: randomised controlled trial

Was the trial double-blinded?

Trial was double-blinded but may have limitations (eg method of blinding inappropriate, tablet vs injection with no double-dummy, different treatment schedules, side-effects may unblind)

or
single-blinded (eg outcomes assessed blind, objective outcomes, no revealing side-effects).

Was the treatment allocation schedule concealed?

Adequately concealed (e.g. central randomisation, numbered or coded bottles, drugs prepared by pharmacy).

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?

No response

Size of effect

2	Reason for decision: Significantly fewer adverse events in radiotherapy only arm.

Relevance of evidence

1	Additional comments: No survival benefit for the addition of gemcitabine to radical radiotherapy. Significantly more adverse events in gemcitabine arm.

Result of appraisal

Included

Comments

No evidence for a benefit of concomitant low dose gemcitabine in patients having radical radiotherapy for stage I and II NSCLC, and evidence of increased adverse events.

Completed by

Professor David Ball MB BS, MD, FRANCZR

This appraisal has been completed.

Article: Price A, Yellowlees A, Keerie C, Russell S, Faivre-Finn C, Gilligan D, et al. Radical radiotherapy with or without gemcitabine in patients with early stage medically inoperable non-small cell lung cancer. Lung Cancer 2012 Sep;77(3):532-6 Available from: http://www.ncbi.nlm.nih.gov/pubmed/22672970.

Assigned to

User:David.ball

Topic area

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

Clinical question

What is the best practice radiotherapy approach in patients with stage II inoperable NSCLC?

Form: Form:Critical appraisal

Section below only relevant for Cancer Council Project Officer

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