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

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 I inoperable NSCLC?

Key Facts

Study Design

randomised controlled trial

Study aims:

To compare event free survival following hypo fractionated radiotherapy with and without weekly gemcitabine.

Number of Patients:

111

72 patients stage 1, 39 hilar node involvement. Most patients did not have PET scans.

Reported outcome(s):

Progression free survival. Toxicity.

Results of outcome(s):

Event free survival at 5 years 20% radiotherapy, 31% combined modality (p=0.72), overall survival 20% and 33% (p= 0.87). Adverse events more frequent in combined modality arm. (P<0.01).

Comments on results:

Underpowered. 2 patients died of accelerated ILD. In combined arm.

Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias

Low risk of bias

Comments: Although randomised, trial was closed early and is underpowered.

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?

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?

Inadequate or not reported

Size of effect

2	Reason for decision: Primary endpoint of a survival benefit was not met, but toxicity differences favour radiotherapy alone.

Relevance of evidence

1	Additional comments: No survival benefit from the addition of low dose gemcitabine to radical radiotherapy. Significantly more adverse events in patients randomised to gemcitabine.

Result of appraisal

Included