本帖最后由 keketunxi 于 2017-12-2 15:16 编辑
NCCN指南最近期更新总结 （2017年11月27日）
来自Targeted Oncology
http://www.targetedonc.com/news/ ... ines-for-egfr-nsclc
最关键的部分是说osimertinib (9291)现在推荐作为一线靶向药使用。此推荐基于今年夏天发布的临床试验结果，相对于标准疗法（一线一代靶向药吉非替尼［易瑞沙］厄落替尼［特罗凯］和二代靶向药阿法替尼[Gilotrif])，一线直接用9291达到18.9个月的中位无进展期，比标准疗法的10.2个月明显增长。除无进展期更长以外，osimertinib毒性更小，对脑转移控制更好。一线使用osimertinib相对标准一代靶向药疗法对疾病进展及死亡有54%的减少。目前对于osimertinib一线抗药的原理还在研究，产生抗药后化疗是目前标准办法。
Notable Updates in NCCN Guidelines for EGFR+ NSCLC
Among the notable updates in the National Comprehensive Cancer Network's (NCCN) recently released treatment guidelines for non–small cell cancer1 (NSCLC) is the category 2A recommendation to give osimertinib (Tagrisso), a third-generation irreversible EGFR inhibitor designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, in the first-line setting for patients whose disease is EGFR mutant, explains Suresh A. Ramalingam, MD.
Osimertinib was also given a category 1 recommendation as a subsequent therapy after patients progressed on treatment with standard EGFR tyrosine kinase inhibitors (TKIs) erlotinib (Tarceva), gefitinib (Iressa), and afatinib (Gilotrif). The FDA granted a breakthrough therapy designation to a supplemental biologics license application for osimertinib as a frontline treatment for patients with metastatic EGFR-mutation–positive NSCLC in October 2017. The application was based on findings from the double-blind, phase III FLAURA trial, in which frontline osimertinib was associated with a 54% reduction in the risk of progression or death compared with standard therapy.
Additional data showed that the median progression-free survival (PFS) was 10.2 months (95% CI, 9.6-11.1) for standard therapy and 18.9 months (95% CI, 12.5-21.4) with osimertinib (HR, 0.46; 95% CI, 0.37-0.57; P <.0001). Though overall survival data remain immature, there is an encouraging trend that favors osimertinib.
Moreover, the phase III findings of the AURA3 trial demonstrated a benefit with osimertinib in patients with T790M-positive NSCLC who also had central nervous system (CNS) metastases and progressed on first-line therapy with an EGFR TKI.3 In the subset analysis of patients with CNS metastases in AURA3, the overall response rate was 70% with osimertinib versus 31% for patients treated with platinum-based doublet chemotherapy (odds ratio, 5.13; 95% CI, 1.44-20.64; P = .015).
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