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Efficacy and safety of anti-PD-1 immunotherapy in patients with advanced Non Small Cell Lung Cancer with BRAF, HER2 or MET mutation or RET-translocation. GFPC 01-2018.
Journal of Thoracic Oncology ( IF 20.4 ) Pub Date : 2020-04-01 , DOI: 10.1016/j.jtho.2019.12.129
Florian Guisier 1 , Catherine Dubos-Arvis 2 , Florent Viñas 3 , Helene Doubre 4 , Charles Ricordel 5 , Stanislas Ropert 6 , Henri Janicot 7 , Marie Bernardi 8 , Pierre Fournel 9 , Régine Lamy 10 , Maurice Pérol 11 , Jerome Dauba 12 , Gilles Gonzales 13 , Lionel Falchero 14 , Chantal Decroisette 15 , Pascal Assouline 16 , Christos Chouaid 3 , Olivier Bylicki 17
Affiliation  

INTRODUCTION Immune-checkpoint inhibitor (ICI) efficacy in patients with non-small cell lung cancer (NSCLC) harboring molecular alterations remains poorly elucidated. This study was undertaken to determine ICI efficacy against BRAF/HER2/MET/RET-NSCLC in a real-world setting. METHODS In this retrospective, multicenter study in ICI-treated BRAF-, HER2-, MET- or RET-NSCLCs, we analyzed clinical characteristics and outcomes: ICI-treatment duration, progression-free survival (PFS), objective response rate, duration of response (DoR), and overall survival (OS). RESULTS 107 NSCLC patients (mean age, 65.5 years) were included from 21 centers: 37% never-smokers, 54% male and 93% with adenocarcinoma. Among them, 44 had BRAF- mutation (V600: 26), 23 HER2 mutation, 30 MET mutation and 9 RET translocation. PDL1 status was known for 45 patients: ≥1% in 34. Before ICI, patients had received a median of one treatment line. Median DoR, PFS and OS were 15.4 (95%CI, 12.6 - NR) months, 4.7 (95%CI, 2.3-7.4) months and 16.2 (95%CI, 12.0 - 24.0) months for the entire cohort, respectively. Response rate for BRAF-V600, BRAF-nonV600, HER2, MET and RET-altered NSCLC was 26%, 33%, 27%, 38% and 38%, respectively. For PDL1 negative and positive patients, PFS was 3.0 (95%CI, 1.2 - NR) and 4.3 (95%CI, 2.1 - 8.5) months, respectively, and OS was 13.3 (95%CI, 4.1 - NR) and 35.2 (95%CI, 9.0 - 35.2) months, respectively. Toxicities were reported in 28 (26%) patients including 11 (10%) grade ≥3. CONCLUSION In this real-world setting, ICI efficacy against BRAF-, HER2-, MET- or RET-NSCLC patients appeared close to that observed in unselected NSCLC patients. Large prospective studies on these patient subsets are needed.

中文翻译:

抗 PD-1 免疫疗法对 BR​​AF、HER2 或 MET 突变或 RET 易位晚期非小细胞肺癌患者的疗效和安全性。GPC 01-2018。

引言 免疫检查点抑制剂 (ICI) 对具有分子改变的非小细胞肺癌 (NSCLC) 患者的疗效仍不清楚。本研究旨在确定 ICI 在真实环境中对 BRAF/HER2/MET/RET-NSCLC 的疗效。方法 在这项针对 ICI 治疗的 BRAF-、HER2-、MET- 或 RET-NSCLC 的回顾性多中心研究中,我们分析了临床特征和结果:ICI 治疗持续时间、无进展生存期 (PFS)、客观缓解率、持续时间反应(DoR)和总生存期(OS)。结果 包括来自 21 个中心的 107 名 NSCLC 患者(平均年龄 65.5 岁):37% 从不吸烟,54% 男性和 93% 患有腺癌。其中BRAF-突变44例(V600:26),HER2突变23例,MET突变30例,RET易位9例。45 名患者的 PDL1 状态已知:34 名患者的 PDL1 状态≥1%。在 ICI 之前,患者接受了中位数的一条治疗线。整个队列的中位 DoR、PFS 和 OS 分别为 15.4 (95%CI, 12.6 - NR) 个月、4.7 (95%CI, 2.3-7.4) 个月和 16.2 (95%CI, 12.0 - 24.0) 个月。BRAF-V600、BRAF-nonV600、HER2、MET 和 RET 改变的 NSCLC 的反应率分别为 26%、33%、27%、38% 和 38%。对于 PDL1 阴性和阳性患者,PFS 分别为 3.0(95%CI,1.2 - NR)和 4.3(95%CI,2.1 - 8.5)个月,OS 为 13.3(95%CI,4.1 - NR)和 35.2( 95% CI, 9.0 - 35.2) 个月,分别。28 名 (26%) 患者报告了毒性,包括 11 名 (10%) ≥3 级。结论 在这个真实世界的环境中,ICI 对 BRAF-、HER2-、MET- 或 RET-NSCLC 患者的疗效与在未选择的 NSCLC 患者中观察到的疗效接近。需要对这些患者亚群进行大型前瞻性研究。
更新日期:2020-04-01
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