Critical appraisal:Price A, Yellowlees A, Keerie C, Russell S, Faivre-Finn C, Gilligan D, et al 2012
Critical Appraisal
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.
Key Facts
randomised controlled trial
To compare event free survival following hypo fractionated radiotherapy with and without weekly gemcitabine.
111
Progression free survival. Toxicity.
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).
Underpowered. 2 patients died of accelerated ILD. In combined arm.
no
Evidence ratings
II
Low risk of bias | Comments: Although randomised, trial was closed early and is underpowered. |
2 | Reason for decision: Primary endpoint of a survival benefit was not met, but toxicity differences favour radiotherapy alone. |
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. |
- 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
Section below only relevant for Cancer Council Project Officer
Underpowered study showing no survival benefit for low dose gemcitabine added to radical radiotherapy, but greater frequency of adverse events.