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

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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

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.

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

Jutta's tick icon.png Included



Comments

Underpowered study showing no survival benefit for low dose gemcitabine added to radical radiotherapy, but greater frequency of adverse events.

Completed by

Professor David Ball MB BS, MD, FRANCZR


Jutta's tick icon.png 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 I inoperable
Clinical question
Form
Form:Critical appraisal


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