一项针对亚洲晚期非小细胞肺癌腺癌组织学患者中表皮生长因子受体突变的前瞻性分子流行病学研究（PIONEER）。

A prospective, molecular epidemiology study of EGFR mutations in Asian patients with advanced non-small-cell lung cancer of adenocarcinoma histology (PIONEER).

机构信息

*Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China; †Department of Clinical Oncology, Queen Elizabeth Hospital, Kowloon, Hong Kong; ‡Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital; Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand; §Medical Oncology Department, Apollo Speciality Hospital, Anna Salai, Chennai, India; ‖Chest Department, Taipei Veteran's General Hospital, Taipei, Taiwan; ¶Nuclear Medicine and Oncology Center, Bach Mai Hospital, Hanoi, Vietnam; #Medical Department, AstraZeneca, Singapore; **Clinical Science Division, AstraZeneca, Osaka, Japan; ††St. Peregrine Oncology Unit, San Juan De Dios Hospital, Pasay City, Philippines; and ‡‡Department of Internal Medicine, National Taiwan University College of Medicine, National Taiwan University, Taipei, Taiwan.

出版信息

J Thorac Oncol. 2014 Feb;9(2):154-62. doi: 10.1097/JTO.0000000000000033.

DOI:10.1097/JTO.0000000000000033

PMID:24419411

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4132036/

Abstract

INTRODUCTION

PIONEER (NCT01185314) was a prospective, multinational, epidemiological study of epidermal growth factor receptor (EGFR) mutations in patients from Asia with newly diagnosed advanced lung adenocarcinoma.

METHODS

Eligible patients (aged ≥20 years) had untreated stage IIIB/IV adenocarcinoma. The EGFR mutation status (primary end point: positive, negative, or undetermined) of tumor samples (biopsy, surgical specimen, or cytology) was determined (Scorpion amplification refractory mutation system). EGFR mutation frequency was calculated and compared between demographic and clinical subgroups.

RESULTS

Of 1482 patients from seven Asian regions, 43.4% of patients were female, median age was 60 years (range, 17-94), and 52.6% of patients were never-smokers. EGFR mutation status was evaluable in tumors from 1450 patients (97.8%) (746 [51.4%] positive; 704 [48.6%] negative). Country, sex, ethnicity, smoking status, pack-years (all p < 0.001), disease stage (p = 0.009), and histology type (p = 0.016) correlated significantly with EGFR mutation frequency. Mutation frequency was 61.1% in females, 44.0% in males; lower in patients from India (22.2%) compared with other areas (47.2%-64.2%); highest among never-smokers (60.7%); and decreased as pack-year number increased (>0-10 pack-years, 57.9%; >50 pack-years, 31.4%) (similar trend by sex). Ethnic group (p < 0.001) and pack-years (p < 0.001) had statistically significant associations with mutation frequency (multivariate analysis); sex was not significant when adjusted for smoking status.

CONCLUSION

PIONEER is the first prospective study to confirm high EGFR mutation frequency (51.4% overall) in tumors from Asian patients with adenocarcinoma. The observed high mutation frequency in demographic/clinical subgroups compared with white populations suggests that mutation testing should be considered for all patients with stage IIIB/IV adenocarcinoma, even males and regular smokers, among Asian populations.

摘要

简介

PIONEER（NCT01185314）是一项在亚洲新诊断为晚期肺腺癌的患者中进行的关于表皮生长因子受体（EGFR）突变的前瞻性、多国家、流行病学研究。

方法

符合条件的患者（年龄≥20 岁）患有未经治疗的 IIIB/IV 期腺癌。肿瘤样本（活检、手术标本或细胞学）的 EGFR 突变状态（主要终点：阳性、阴性或不确定）由（Scorpion 扩增耐药突变系统）确定。计算并比较了人口统计学和临床亚组之间的 EGFR 突变频率。

结果

来自七个亚洲地区的 1482 名患者中，43.4%为女性，中位年龄为 60 岁（范围 17-94 岁），52.6%为从不吸烟者。1450 名患者的肿瘤 EGFR 突变状态可评估（97.8%）（746[51.4%]阳性；704[48.6%]阴性）。国家、性别、种族、吸烟状况、吸烟年数（均<0.001）、疾病分期（p=0.009）和组织学类型（p=0.016）与 EGFR 突变频率显著相关。女性的突变频率为 61.1%，男性为 44.0%；与其他地区（47.2%-64.2%）相比，来自印度的患者（22.2%）较低；从不吸烟者最高（60.7%）；吸烟年数增加时，突变频率降低（>0-10 吸烟年数，57.9%；>50 吸烟年数，31.4%）（按性别有类似趋势）。种族群体（<0.001）和吸烟年数（<0.001）与突变频率具有统计学显著关联（多变量分析）；调整吸烟状况后，性别无显著意义。