MRC Clinical Trials Unit, London, UK.
Clin Oncol (R Coll Radiol). 2013 Mar;25(3):e23-30. doi: 10.1016/j.clon.2012.11.002. Epub 2012 Dec 2.
Over 30% of patients with non-small cell lung cancer (NSCLC) develop brain metastases. If inoperable, optimal supportive care (OSC), including steroids, and whole brain radiotherapy (WBRT) are generally considered to be standard care, although there is no randomised evidence demonstrating that the addition of WBRT to OSC improves survival or quality of life.
QUARTZ is a randomised, non-inferiority, phase III trial comparing OSC + WBRT versus OSC in patients with inoperable brain metastases from NSCLC. The primary outcome measure is quality-adjusted life years (QALYs). QUARTZ was threatened with both loss of funding and early closure due to poor accrual. A lack of preliminary randomised data supporting the trial's hypotheses was thought to underlie the poor accrual, so, with no knowledge of the data, the independent trial steering committee agreed to the unusual step of releasing interim data.
Between March 2007 and April 2010, 151 (of the planned 534) patients were randomised (75 OSC + WBRT, 76 OSC). Participants' baseline demographics included median age 67 years (interquartile range 62-73), 60% male, 50% with a Karnofsky performance status <70; steroid usage was similar in the two groups; 64/75 (85%) received WBRT (20 Gy in five fractions). Median survival was: OSC + WBRT 49 days (95% confidence interval 39-61), OSC 51 days (95% confidence interval 27-57) - hazard ratio 1.11 (95% confidence interval 0.80-1.53) in favour of WBRT. Quality of life assessed using EQ-5D showed no evidence of a difference. The estimated mean QALYs was: OSC + WBRT 31 days and OSC 30 days, difference -1 day (95% confidence interval -12.0 to +13.2 days).
These interim data indicate no early evidence of detriment to quality of life, overall survival or QALYs for patients allocated to OSC alone. They provide key information for discussing the trial with patients and strengthen the argument for continuing QUARTZ to definitively answer this important clinical question.
超过 30%的非小细胞肺癌（NSCLC）患者会发展为脑转移。如果无法手术，最佳支持治疗（OSC），包括类固醇和全脑放疗（WBRT）通常被认为是标准治疗，尽管没有随机证据表明 WBRT 联合 OSC 治疗可提高生存率或生活质量。
QUARTZ 是一项随机、非劣效性、III 期试验，比较了无法手术的 NSCLC 脑转移患者接受 OSC+WBRT 与 OSC 的疗效。主要终点是生活质量调整生命年（QALYs）。QUARTZ 由于入组人数少而面临资金损失和提前关闭的威胁。研究人员认为，缺乏支持试验假设的初步随机数据是入组人数少的原因，因此，在不了解数据的情况下，独立的试验指导委员会同意采取不同寻常的步骤发布中期数据。
2007 年 3 月至 2010 年 4 月，共有 151 例（计划入组 534 例）患者被随机分配（OSC+WBRT 组 75 例，OSC 组 76 例）。参与者的基线人口统计学特征包括中位年龄 67 岁（四分位间距 62-73 岁），60%为男性，50%的 Karnofsky 表现状态<70；两组的类固醇使用率相似；64/75（85%）例接受 WBRT（20Gy 分 5 次）。中位生存期为：OSC+WBRT 组 49 天（95%置信区间 39-61），OSC 组 51 天（95%置信区间 27-57）-WBRT 组的风险比为 1.11（95%置信区间 0.80-1.53）。使用 EQ-5D 评估的生活质量未见差异。估计的平均 QALYs 为：OSC+WBRT 组 31 天，OSC 组 30 天，差值-1 天（95%置信区间-12.0 至+13.2 天）。
这些中期数据表明，单独接受 OSC 治疗的患者的生活质量、总生存期或 QALYs 没有早期证据表明受损。这些数据为与患者讨论试验提供了关键信息，并为继续进行 QUARTZ 以最终回答这一重要临床问题提供了支持。
