University of Auckland, Auckland, New Zealand.
Auckland City Hospital, Auckland, New Zealand.
Target Oncol. 2017 Oct;12(5):663-675. doi: 10.1007/s11523-017-0515-4.
Since 2013, clinical practice guidelines recommend EGFR mutation testing of non-squamous NSCLC to select advanced-stage patients for first-line treatment using EGFR-TKIs.
We aimed to determine population-based trends in the real-world uptake and impact in routine practice of these recently updated testing guidelines.
A population-based observational study was conducted of notifications to the New Zealand Cancer Registry of patients eligible for EGFR testing diagnosed in northern New Zealand between January 2010 and April 2014. The main study variable was EGFR mutation testing. Main outcome measures (overall survival and dispensing of EGFR-TKIs) were extracted from prospectively archived electronic databases until October 2015.
The population-based cohort of 1857 patients had an average age of 70 years. Most had adenocarcinoma and metastatic disease at diagnosis. EGFR testing was undertaken in 500 patients (27%) with mutations detected in 109 patients (22%). EGFR testing increased during the period of study from <5% to 67% of patients (P < 0.0001). Full uptake of testing by all eligible patients was limited by a lack of availability of specimens for testing and variable testing referral practices. The proportion of patients treated with EGFR-TKIs decreased during the same time period, both among untested patients (from 12.2% to 2.8% (P < 0.0001)) and in the population as a whole (from 13.7% to 10.6% (P < 0.05)). EGFR testing was associated with prolonged overall survival (Adjusted HR = 0.76 (95% CI, 0.65-0.89) Log-rank P < 0.0001) due at least in part to the much longer overall survival achieved by mutation-positive patients, of whom 79% received EGFR-TKIs. Compared to untested EGFR-TKI-treated patients, mutation-positive EGFR-TKI-treated patients received EGFR-TKIs for longer, and survived longer both from the start of EGFR-TKI treatment and date of their diagnosis.
In this real world setting, high uptake of EGFR testing was achieved and associated with major changes in EGFR-TKI prescribing and improved health outcomes. Modifiable factors determined testing uptake. Study registration ACTRN12615000998549.
自 2013 年以来，临床实践指南建议对非鳞状非小细胞肺癌进行 EGFR 突变检测，以选择晚期患者进行一线治疗，使用 EGFR-TKIs。
我们旨在确定这些最近更新的检测指南在常规实践中的实际应用率及其影响。
对 2010 年 1 月至 2014 年 4 月期间在新西兰北部被诊断患有符合 EGFR 检测条件的非小细胞肺癌的患者，进行了一项基于人群的观察性研究。主要研究变量是 EGFR 突变检测。主要观察指标（总生存期和 EGFR-TKIs 的配给）从前瞻性存档的电子数据库中提取，直到 2015 年 10 月。
基于人群的 1857 例患者队列的平均年龄为 70 岁。大多数患者在诊断时患有腺癌和转移性疾病。对 500 例患者进行了 EGFR 检测（27%），其中 109 例患者（22%）检测出突变。在研究期间，EGFR 检测的应用率从<5%增加到 67%（P<0.0001）。由于缺乏用于检测的标本和可变的检测转诊实践，所有符合条件的患者全面接受检测的比例受到限制。在此期间，未接受检测的患者（从 12.2%降至 2.8%（P<0.0001））和整个人群中（从 13.7%降至 10.6%（P<0.05））接受 EGFR-TKI 治疗的患者比例均有所下降。EGFR 检测与延长总生存期相关（调整后的 HR=0.76（95%CI，0.65-0.89）Log-rank P<0.0001），这至少部分归因于突变阳性患者的总生存期明显延长，其中 79%接受了 EGFR-TKI。与未接受 EGFR-TKI 治疗的患者相比，突变阳性的 EGFR-TKI 治疗患者接受 EGFR-TKI 的时间更长，并且从开始接受 EGFR-TKI 治疗和诊断日期开始，他们的生存期也更长。
在这种真实环境下，EGFR 检测的高应用率得以实现，并与 EGFR-TKI 处方的重大变化和改善的健康结果相关。可改变的因素决定了检测的应用率。研究注册 ACTRN12615000998549。
