Whole brain radiotherapy for brain metastases from non-small lung cancer: Quality of life (QoL) and overall survival (OS) results from the UK Medical Research Council QUARTZ randomised clinical trial (ISRCTN 3826061).

8005 Background: Brain metastases affect up to 40% of patients with non-small cell lung cancer (NSCLC), and for inoperable cases whole brain radiotherapy (WBRT) and dexamethasone is standard treatment. However there are no randomised clinical trials to show whether WBRT improves either QoL or survival. Methods: A phase III randomised non-inferiority trial with a primary outcome measure of quality adjusted life years (QALYs). Patients with brain metastases from NSCLC (not suitable for resection or stereotactic radiotherapy) were randomly allocated to either optimal supportive care, including dexamethasone, plus WBRT 20 Gy/5f (OSC+WBRT) or OSC alone. QALYs were generated from OS and patients’ weekly completion of the EQ-5D questionnaire. OSC alone was considered non-inferior to OSC+WBRT if not greater than 7 QALY days worse (80% power and a 1-sided 5% significance level required 534 patients.) Secondary outcome measures include sub-group analyses to identify/validate predictive classifications. Results: Fro...