吉非替尼在表皮生长因子受体激活突变阳性非小细胞肺癌中的疗效：外显子19缺失与外显子21突变有何不同？
Efficacy of gefitinib in epidermal growth factor receptor-activating mutation-positive nonsmall cell lung cancer: Does exon 19 deletion differ from exon 21 mutation?
作者信息
Joshi Amit, Patil Vijay, Noronha Vanita, Chougule Anuradha, Bhattacharjee Atanu, Kumar Rajiv, Goud Supriya, More Sucheta, Ramaswamy Anant, Karpe Ashay, Pande Nikhil, Chandrasekharan Arun, Goel Alok, Talreja Vikas, Mahajan Abhishek, Janu Amit, Purandare Nilendu, Prabhash Kumar
机构信息
Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
Department of Biometrics, Chiltern International Limited, Bengaluru, Karnataka, India.
出版信息
Lung India. 2018 Jan-Feb;35(1):27-30. doi: 10.4103/lungindia.lungindia_201_17.
BACKGROUND
This study was designed to evaluate the differential effect of epidermal growth factor receptor (EGFR) mutation status (exon 19 vs. 21) on progression-free survival (PFS) and overall survival (OS) in treatment-naïve advanced EGFR mutation-positive nonsmall cell lung cancer (NSCLC) treated with gefitinib as first-line agent.
METHODS
This was a post hoc analysis of EGFR-mutated (exon 19 and 21) advanced-stage (Stage IIIB or IV), chemotherapy-naive NSCLC patients treated with gefitinib as first line in a phase 3 randomized study. Patients were treated with gefitinib 250 mg daily. Patients underwent axial imaging for response assessment on D42, D84, D126, and subsequently every 2 months till progression. Responding or stable patients were treated until progression or unacceptable toxicity. SPSS was used for statistical analysis. Kaplan-Meier method was used for survival estimation and log-rank test for comparison. Cox proportion hazard model was used for multivariate analysis.
RESULTS
One hundred and forty-one patients were eligible for analysis, of which 78 were males and 63 were females. A total of 127 patients (90.1%) were ECOG 0-1 while 14 patients (9.1%) were ECOG >1. Exon 21 mutation was present in 65 patients (46.1%) and exon 19 mutation in 76 patients (53.9%). One hundred and thirty-three of 141 patients were evaluable for response. Response rate of patients having exon 19 mutation was 72.9% (51 patients, n = 70) while it was 55.6% in patients having exon 21 mutation (35 patients, n = 63) (P = 0.046). Median PFS in exon 19-mutated patients was 9.3 months (95% confidence interval [CI] 6.832-11.768) compared to 7.8 months (95% CI 5.543-10.0) (P = 0.699) in exon 21-mutated patients. The median OS in exon 19-mutated patients was 19.8 months (95% CI 16.8-22.7), and it was 16.5 months (95% CI 10.9-22.1) in exon 21-mutated patients (P = 0.215).
CONCLUSION
There were no differential outcomes in the Indian patients of advanced-stage NSCLC with exon 19 and 21 EGFR mutations treated with gefitinib.
背景
本研究旨在评估表皮生长因子受体（EGFR）突变状态（外显子19与外显子21）对初治的晚期EGFR突变阳性非小细胞肺癌（NSCLC）患者使用吉非替尼作为一线治疗药物时的无进展生存期（PFS）和总生存期（OS）的差异影响。
方法
这是一项对在一项3期随机研究中使用吉非替尼作为一线治疗的EGFR突变（外显子19和21）的晚期（IIIB期或IV期）、未接受过化疗的NSCLC患者进行的事后分析。患者每日接受250 mg吉非替尼治疗。患者在第42天、第84天、第126天接受轴向成像以评估反应，随后每2个月进行一次直至疾病进展。反应良好或病情稳定的患者持续治疗直至疾病进展或出现不可接受的毒性。使用SPSS进行统计分析。采用Kaplan-Meier方法进行生存估计，采用对数秩检验进行比较。采用Cox比例风险模型进行多变量分析。
结果
141例患者符合分析条件，其中男性78例，女性63例。共有127例患者（90.1%）ECOG评分为0 - 1，14例患者（9.1%）ECOG评分>1。65例患者（46.1%）存在外显子21突变，76例患者（53.9%）存在外显子19突变。141例患者中有133例可评估反应。外显子19突变患者的反应率为72.9%（51例，n = 70），而外显子21突变患者的反应率为55.6%（35例，n = 63）（P = 0.046）。外显子19突变患者的中位PFS为9.3个月（95%置信区间[CI] 6.832 - 11.768），相比之下，外显子21突变患者的中位PFS为7.8个月（95% CI 5.543 - 10.0）（P = 0.699）。外显子19突变患者的中位OS为19.8个月（95% CI 16.8 - 22.7），外显子21突变患者的中位OS为16.5个月（95% CI 10.9 - 22.1）（P = 0.215）。
结论
在印度晚期NSCLC患者中，使用吉非替尼治疗外显子19和21 EGFR突变患者的结局无差异。
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