未经评估:以前,我们建立了一个数据库,该数据库包含接受阿法替尼治疗的693例NSCLC和罕见EGFR突变患者.这里,我们提供了超过1000名患者的更新,有更多关于特定突变的数据。
UNASSIGNED:患者从BoehringerIngelheim开发的前瞻性数据库和文献综述中确定。突变被归类为T790M阳性,外显子20插入,主要不常见(G719X,L861Q,S768I)和\'其他\'。分别分析具有复合突变(≥2个EGFR突变)的患者。关键终点是治疗失败时间(TTF)和客观缓解率(ORR)。
未经批准:纳入1023例患者,587例患者接受EGFRTKI治疗,425例接受EGFRTKI治疗。突变类别的分布为:主要不常见(41.4%);外显子20插入(22.3%);T790M(20.3%);和“其他”(15.9%);38.6%具有复合突变。总的来说,中位TTF(TKI初始/预处理)为10.7个月和4.5个月.ORR分别为49.8%和26.8%,分别。在TKI患者中,阿法替尼表现出对主要罕见突变的活性(中位TTF:12.6个月;ORR:59.0%),其他突变(中位TTF:10.7个月;ORR:63.9%),包括对E709X(11.4个月;84.6%)和L747X(14.7个月;80.0%)的强活性,和复合突变(11.5个月;63.9%)。虽然样本量很小,针对残基A763,M766,N771和V769的特定外显子20插入以及针对奥希替尼抗性突变的显着活性(G724S,L718X,C797S)。
UNASSIGNED:阿法替尼应被视为主要不常见NSCLC患者的一线治疗选择。化合物,\'其他\'(包括E709X和L747X)和一些特定的外显子20插入突变。针对奥希替尼耐药性EGFR突变观察到中等活性。
UNASSIGNED: Previously, we developed a database of 693 patients with NSCLC and uncommon EGFR mutations treated with afatinib. Here, we provide an update of >1000 patients, with more data on specific mutations.
UNASSIGNED: Patients were identified from a prospective database developed by Boehringer Ingelheim and via literature review. Mutations were categorized as T790M-positive, exon 20 insertions, major uncommon (G719X, L861Q, S768I) and \'others\'. Patients with compound mutations (≥2 EGFR mutations) were analyzed separately. Key endpoints were time to treatment failure (TTF) and objective response rate (ORR).
UNASSIGNED: Of 1023 patients included, 587 patients were EGFR TKI-naïve and 425 were EGFR TKI-pretreated. The distribution of mutation categories was: major uncommon (41.4%); exon 20 insertions (22.3%); T790M (20.3%); and \'others\' (15.9%); 38.6% had compound mutations. Overall, median TTF (TKI naïve/pretreated) was 10.7 and 4.5 months. ORR was 49.8% and 26.8%, respectively. In TKI-naïve patients, afatinib demonstrated activity against major uncommon mutations (median TTF: 12.6 months; ORR: 59.0%), \'other\' mutations (median TTF: 10.7 months; ORR: 63.9%) including strong activity against E709X (11.4 months; 84.6%) and L747X (14.7 months; 80.0%), and compound mutations (11.5 months; 63.9%). Although sample sizes were small, notable activity was observed against specific exon 20 insertions at residues A763, M766, N771, and V769, and against osimertinib resistance mutations (G724S, L718X, C797S).
UNASSIGNED: Afatinib should be considered as a first-line treatment option for NSCLC patients with major uncommon, compound, \'other\' (including E709X and L747X) and some specific exon 20 insertion mutations. Moderate activity was seen against osimertinib resistance EGFR mutations.