A prospective, molecular epidemiology study of EGFR mutations in Asian patients with advanced non-small-cell lung cancer of adenocarcinoma histology (PIONEER).
A prospective, molecular epidemiology study of EGFR mutations in Asian patients with advanced non-small-cell lung cancer of adenocarcinoma histology (PIONEER).
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亚洲晚期非小细胞腺癌组织学肺癌患者 EGFR 突变的前瞻性分子流行病学研究 (PIONEER)。
DOI：
10.1097/jto.0000000000000033
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发表时间：
2014-02
期刊：
影响因子：
--
通讯作者：
Yang PC
中科院分区：
文献类型：
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作者：
Shi Y;Au JS;Thongprasert S;Srinivasan S;Tsai CM;Khoa MT;Heeroma K;Itoh Y;Cornelio G;Yang PC
PIONEER（NCT 01185314）是一项在亚洲新诊断的晚期肺腺癌患者中进行的表皮生长因子受体（EGFR）突变的前瞻性、多国、流行病学研究。合格患者（年龄≥20岁）患有未经治疗的IIIB/IV期腺癌。确定肿瘤样本（活检、手术标本或细胞学）的EGFR突变状态（主要终点：阳性、阴性或未确定）（Scorpion扩增难治性突变系统）。计算EGFR突变频率，并在人口统计学和临床亚组之间进行比较。在来自7个亚洲地区的1482例患者中，43.4%的患者为女性，中位年龄为60岁（范围：17-94岁），52.6%的患者从不吸烟。1450例患者（97.8%）的肿瘤EGFR突变状态可评价（746例[51.4%]阳性; 704例[48.6%]阴性）。国家、性别、种族、吸烟状况、包-年（所有p < 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。突变频率在女性中为61.1%，男性中为44.0%;印度患者（22.2%）低于其他地区（47.2%-64.2%）;在从不吸烟者中最高（60.7%）;随着包年数的增加而降低（>0-10包年，57.9%; >50包年，31.4%）（性别趋势相似）。种族（p < 0.001）和包年（p < 0.001）与突变频率有统计学意义的相关性（多变量分析）;性别在调整吸烟状况后没有显著性。PIONEER是第一项证实亚洲腺癌患者肿瘤中EGFR突变频率较高（总体为51.4%）的前瞻性研究。与白色人群相比，在人口统计学/临床亚组中观察到的高突变频率表明，应考虑对亚洲人群中的所有IIIB/IV期腺癌患者进行突变检测，即使是男性和经常吸烟者。
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. 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. 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. 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.