Critical appraisal:Andrews DW, Scott CB, Sperduto PW, Flanders AE, Gaspar LE, Schell MC, et al 2004 2

Critical Appraisal

Article being appraised

Andrews DW, Scott CB, Sperduto PW, Flanders AE, Gaspar LE, Schell MC, et al. Whole brain radiation therapy with or without stereotactic radiosurgery boost for patients with one to three brain metastases: phase III results of the RTOG 9508 randomised trial. Lancet 2004 May 22;363(9422):1665-72 Available from: http://www.ncbi.nlm.nih.gov/pubmed/15158627.

Applicable clinical question

What is the clinical benefit of radiotherapy to the brain for patients with inoperable brain metastases from NSCLC?

Key Facts

Study Design

randomised controlled trial

Number of Patients:

331

Includes an economic evaluation

no

Evidence ratings

Level of evidence

II

Risk of bias

Low risk of bias

Comments: Large RCT, central randomisation, stratified for prognostic factors,19% in SRS arm did not receive SRS but ITT analysis, adequate FU

Size of effect

1

Reason for decision: RCT of WBRT (37.5/15) +/- SRS boost of 18-24Gy in patients with up to 3 brain metastases. No difference in survival or intracranial progression or neurological deaths overall. SRS group had sig better PS and reduced steroid use following treatment. In subgroup analysis, patients with solitary inoperable met had improvement in survival from median 4.9m to 6.5m.

Relevance of evidence

1	Additional comments: Endpoint was survival. Also looked at local control, patient performance status, steroid use and mental state - all patient relevant outcomes.Approx 2/3rd of patients had lung primary.

Result of appraisal

Included