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Medline ® Abstract for Reference 2

of 'Systemic therapy for advanced non-small cell lung cancer with an activating mutation in the epidermal growth factor receptor'

A prospective, molecular epidemiology study of EGFR mutations in Asian patients with advanced non-small-cell lung cancer of adenocarcinoma histology (PIONEER).
Shi Y, Au JS, Thongprasert S, Srinivasan S, Tsai CM, Khoa MT, Heeroma K, Itoh Y, Cornelio G, Yang PC
J Thorac Oncol. 2014;9(2):154.
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.
*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.