Little Benefit Reported With WBRT in NSCLC Patients With Brain Metastases Unsuitable for Resection or Stereotactic Radiotherapy
In a UK-based phase III noninferiority trial (QUARTZ) reported in The Lancet, Mulvenna et al found that use of whole-brain radiotherapy in addition to optimal supportive care including dexamethasone was associated with little additional benefit in non–small cell lung cancer (NSCLC) patients with brain metastases unsuitable for surgical resection or stereotactic radiotherapy.
Study Details
In the trial, 538 patients from 69 UK and 3 Australian centers were randomized between March 2007 and August 2014 to receive optimal supportive care including dexamethasone plus whole-brain radiotherapy given at 20 Gy in 5 daily fractions (n = 269) or optimal supportive care alone including dexamethasone (n = 269). The dexamethasone dose was determined by patient symptoms.
The primary outcome measure was quality-adjusted life-years (QALYs) in the intent-to-treat population, derived from overall survival and weekly completion of the EQ-5D (EurolQol 5 dimension) questionnaire. Noninferiority of optimal supportive care alone was met if it was associated with QALYs of no more than 7 QALY days worse than whole-brain radiotherapy plus optimal supportive care. Patients had a median age of 66 years.
QALY and Survival
Whole-brain radiotherapy was associated with a significantly higher incidence of drowsiness, hair loss, nausea, and dry/itchy scalp, with no difference in the incidence of serious adverse events between the two groups. No significant differences were found between the whole-brain radiotherapy and optimal supportive care alone groups for overall survival (hazard ratio = 1.06, P = .8084; median = 9.2 vs 8.5 weeks), overall quality of life, or dexamethasone use. Mean QALYs were 46.4 days vs 41.7 days; the difference was 4.7 days (90% confidence interval of –12.7 to 3.3), meeting the noninferiority criterion.
The investigators concluded: “Although the primary outcome measure result includes the prespecified non-inferiority margin, the combination of the small difference in QALYs and the absence of a difference in survival and quality of life between the two groups suggests that [whole-brain radiotherapy] provides little additional clinically significant benefit for this patient group.”
The study was funded by Cancer Research UK, Medical Research Council Clinical Trials Unit at the University College London, and the National Health and Medical Research Council in Australia.
Ruth Langley, PhD, of the Medical Research Council Clinical Trials Unit at the University College London, is the corresponding author of The Lancet article.
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