不常见EGFR突变的靶向治疗,693例患者的结果发表于JTO

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  Afatinib治疗不常见EGFR突变的非小细胞肺癌693例
  结论
  Afatinib在NSCLC中具有抗主要罕见和复合EGFR突变的临床活性。
  它还具有广泛的抗其他不常见的EGFR突变和一些外显子20插入突变的活性。
  这些数据支持在这些罕见EGFR突变患者中使用afatinib。
  Afatinib has clinical activity in NSCLC against major uncommon and compound EGFR mutations. It also has broad activity against other uncommon EGFR mutations and some exon 20 insertions. The data support the use of afatinib in these settings.
  背景
  关于表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKIs)对非小细胞肺癌(NSCLC)患者EGFR基因突变的疗效,现有的临床资料有限。
  这项联合分析评估了693例在随机临床试验、对比研究和扩大应用范围研究中、IIIb期临床试验、非介入性试验和病例系列/研究中治疗的具有罕见EGFR突变的肿瘤患者的afatinib活性。
  Limited clinical data are available regarding the efficacy of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) in patients with non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations. This pooled analysis assessed the activity of afatinib in 693 patients with tumors harboring uncommon EGFR mutations treated in randomized clinical trials, compassionate-use and expanded-access programs, phase IIIb trials, non-interventional trials and case series/studies.
  方法
  患者有不常见的EGFR突变,分为:
  i)T790M;
  ii)外显子20插入;
  iii)“主要”不常见突变(G719X、L861Q和S768I,除了T790M和/或外显子20插入外,有或无任何其他突变);
  i v)复合突变;
  v)“其他”不常见突变。
  主要终点是总有效率(ORR)、反应持续时间(DoR)和治疗失败时间(TTF)。
  Patients had uncommon EGFR mutations categorized as: i) T790M; ii) exon 20 insertions; iii) ‘major’ uncommon mutations (G719X, L861Q and S768I, with or without any other mutation except T790M and/or an exon 20 insertion); iv) compound mutations and v) ‘other’ uncommon mutations. Key endpoints were overall response rate (ORR), duration of response (DoR) and time to treatment failure (TTF).
  结果
  在EGFR-TKI初治患者(n=315)中,afatinib对主要的不常见突变(中位TTF 10.8个月;95%CI:8.1-16.6;ORR 60.0%)、复合突变(14.7个月;95%CI:6.8-18.5;77.1%)、其他不常见突变(4.5个月;95%CI:2.9-9.7;65.2%)和一些外显子20插入(4.2个月;95%CI:2.8-5.3,24.3%)有活性。
  中位DoR分别为17.1、16.6、9.0和11.9个月。
  EGFR-TKI经治的患者(n=378)也观察到afatinib的活性。
  同时,我们创建了一个可搜索的数据库,这些结果均可通过基因型检索。
  In EGFR-TKI naïve patients (n=315), afatinib demonstrated activity against major uncommon mutations (median TTF 10.8 months; 95% CI: 8.1–16.6; ORR 60.0%), compound mutations (14.7 months; 95% CI: 6.8–18.5; 77.1%), other uncommon mutations (4.5 months; 95% CI: 2.9–9.7; 65.2%), and some exon 20 insertions (4.2 months; 95% CI: 2.8–5.3; 24.3%). Median DoR was 17.1, 16.6, 9.0 and 11.9 months, respectively. Activity of afatinib was also observed in EGFR-TKI pretreated patients (n=378). A searchable database of these outcomes by individual genotype was generated.
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