Dexamethasone and supportive care with or without whole brain radiotherapy in treating patients with non-small cell lung cancer with brain metastases unsuitable for resection or stereotactic radiotherapy (QUARTZ): results from a phase 3, non-inferiority, randomised trial

作者：P. Mulvenna, Matthew Guy Nankivell, Rachael Barton, Corinne Faivre Finn, Paula Wilson, Elaine McColl, BARBARA J. MOORE, Iona Brisbane, David Ardron, Tanya R Holt, Sally Morgan, Caroline Guat Lay Lee, Kathryn J Waite, N. Bayman, Cheryl Pugh, Benjamin Sydes, Richard J. Stephens, Mahesh Parmar, Ruth Elizabeth Langley · 发表于：The Lancet · 年份：2016 · DOI：10.1016/s0140-6736(16)30825-x · 被引用次数：731 · 研究领域：Brain Metastases and Treatment、Lung Cancer Research Studies、Lung Cancer Treatments and Mutations

BACKGROUND: Whole brain radiotherapy (WBRT) and dexamethasone are widely used to treat brain metastases from non-small cell lung cancer (NSCLC), although there have been no randomised clinical trials showing that WBRT improves either quality of life or overall survival. Even after treatment with WBRT, the prognosis of this patient group is poor. We aimed to establish whether WBRT could be omitted without a significant effect on survival or quality of life. METHODS: The Quality of Life after Treatment for Brain Metastases (QUARTZ) study is a non-inferiority, phase 3 randomised trial done at 69 UK and three Australian centres. NSCLC patients with brain metastases unsuitable for surgical resection or stereotactic radiotherapy were randomly assigned (1:1) to optimal supportive care (OSC) including dexamethasone plus WBRT (20 Gy in five daily fractions) or OSC alone (including dexamethasone). The dose of dexamethasone was determined by the patients' symptoms and titrated downwards if symptoms improved. Allocation to treatment group was done by a phone call from the hospital to the Medical Research Council Clinical Trials Unit at University College London using a minimisation programme with a random element and stratification by centre, Karnofsky Performance Status (KPS), gender, status of brain metastases, and the status of primary lung cancer. The primary outcome measure was quality-adjusted life-years (QALYs). QALYs were generated from overall survival and patients' weekly compl...