論文No2490
EGFR exon 20 insertion mutations in Chinese advanced non-small cell lung cancer patients: Molecular heterogeneity and treatment outcome from nationwide real-world study
Guangjian Yang, Jun Li, Haiyan Xu, Yaning Yang, Lu Yang, Fei Xu, Bing Xia, Viola W. Zhu, Misako Nagasaka, Yan Yang, Yapin Li, Weini Qiu, Jianming Ying, Sai-Hong Ignatius Ou, Yan Wang
LUNG CANCER, VOLUME 145, P186-194, JULY 01, 2020.
＜目的＞
中国人の非小細胞肺がん(NSCLC)患者でEGFR exon 20挿入(EX20ins)変異のある群で、
リアルワールドでの治療パターン、予後を検討した。
＜方法＞
中国人のNSCLCでEGFR ex20ins変異のある患者のリアルワールドでの治療予後を、
異なった施設のカルテとweb患者質問票を用いて後ろ向きに解析した。
＜結果＞
2018年3月17日から2018年12月20日までで、
165名の進行NSCLCでEGFR ex20insのある患者が中国の26の地域、99の病院から登録され解析された。
39名の異なったEGFR ex20insの分子パターンが同定され、V769_D770insASVが最も多かった(23.0%)。
ベースラインの診断時に23.0%の患者に中枢神経(CNS)転移が起こっていた。
PFS中央値は最初にプラチナベースの化学療法を受けた群(6.4 m; 95 % CI: 5.7–7.1)が
全世代のEGFR-TKI治療を受けた群(2.9 m; 95 %CI: 1.5–4.3; P < 0.001)あるいは
第一世代EGFR-TKI治療を受けた群(2.0 m; 95 %CI: 0.2–3.8; P < 0.001)よりも有意に長かった。
PFS中央値はセカンドラインで化学療法を受けた群(4.0 m; 95 %CI: 3.2–4.8)の方が
セカンドラインでEGFR-TKI治療を受けた群(2.0 m; 95 %CI: 1.1–2.9; P = 0.342)よるも数字上長かった。
CNS転移のある患者は1st lineで化学療法を受けた群(3.6 m; 95 %CI: 0–8.0 vs. 6.5 m; 95 %CI: 4.9–8.1; P = 0.645)
あるいは1st line EGFR-TKIを受けた群(2.0 m; 95 %CI: 0.8–3.2 vs. 2.9 m; 95 %CI: 2.1–3.7; P = 0.058)でも
CNS転移がない群よりもPFSが数字上短かった。
＜感想＞
EGFR exon20挿入変異のある患者ではEGFR-TKIよりも化学療法の方がPFSが良好だったようです。
Objectives
To describe the treatment patterns and outcomes of Chinese non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor ( EGFR) exon 20 insertion (ex20ins) mutations in real-world as EGFR ex20ins consist of a diverse group of mutations with limited information on the clinical outcome of these patients treated with chemotherapy or EGFR tyrosine kinase inhibitors (TKIs).
Materials and methods
Real-world treatment outcomes of Chinese NSCLC patients harboring EGFR ex20ins were retrospectively analyzed based on medical records at different institutions and detailed web-based patient questionnaires.
Results
Between March 17, 2018 and December 20, 2018, 165 advanced EGFR ex20ins NSCLC patients treated in 99 hospitals from 26 different regions in China were analyzed. Thirty-nine different molecular variants of EGFR ex20ins were identified with V769_D770insASV being the most common (23.0 %). Central nervous system (CNS) metastasis occurred in 23.0 % of patients at the time of baseline diagnosis. Median progression-free survival (PFS) was significantly longer in patients who received first-line platinum-based chemotherapy (6.4 m; 95 % CI: 5.7–7.1) than all-generation EGFR TKIs (2.9 m; 95 %CI: 1.5–4.3; P < 0.001) or 1st-generation EGFR TKIs (2.0 m; 95 %CI: 0.2–3.8; P < 0.001). Median PFS was numerically longer in patients who received second-line chemotherapy (4.0 m; 95 %CI: 3.2–4.8) than those received second-line EGFR TKIs (2.0 m; 95 %CI: 1.1–2.9; P = 0.342). Patients with CNS metastasis had numerically shorter median PFS than those without CNS metastasis when treated with 1st-line chemotherapy (3.6 m; 95 %CI: 0–8.0 vs. 6.5 m; 95 %CI: 4.9–8.1; P = 0.645) or 1st-line EGFR TKIs (2.0 m; 95 %CI: 0.8–3.2 vs. 2.9 m; 95 %CI: 2.1–3.7; P = 0.058).
Conclusion
Chemotherapy is superior to current approved EGFR TKIs as 1st- or 2nd-line treatment of EGFR ex20ins mutations. CNS metastasis conferred numerically shorter PFS with chemotherapy or EGFR TKIs treatment. Targeted agent against EGFR ex20ins with CNS activity is urgently needed.