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N. Li



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    P1.22 - Poster Session 1 - Epidemiology, Etiology (ID 166)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Prevention & Epidemiology
    • Presentations: 1
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      P1.22-005 - A Prospective, Molecular Epidemiological Study of EGFR Mutations in Asian Patients with Advanced Non-Small-Cell Lung Cancer with Adenocarcinoma Histology (PIONEER study) - China Subset Analysis (ID 2241)

      09:30 - 09:30  |  Author(s): N. Li

      • Abstract

      Background
      PIONEER (A molecular ePIdemiOlogy study in Asian patients with advanced NSCLC of adEno histology to assess EGFR mutation status; NCT01185314) was a multinational prospective epidemiological study planned to investigate EGFR mutation frequency in patients from Asia with newly diagnosed advanced lung adenocarcinoma (ADC) and the influence of demographic and clinical factors on EGFR mutation frequency. Here we report analysis results for the subset of patients from China.

      Methods
      Patients were aged ≥20 years, with treatment naïve stage IIIB/IV lung ADC. The primary objective was assessment of overall EGFR mutation frequency. The secondary endpoints included investigation of the correlation between EGFR mutation status and demographic and clinical factors and attrition rates of EGFR mutation testing. The acquisition, preparation, and processing of tumor material was performed in line with the routine clinical practice of the participating hospital laboratories. Tumor EGFR mutation status was determined in central labs using amplification refractory mutation system (ARMS)-based EGFR mutation detection kit (Scorpion ARMS IVD2, Qiagen, Crawley, UK). 29 mutations were detectable by this method across Exons 18, 19, 20, and 21.

      Results
      747 patients were registered in 17 investigational sites in China (50.4% of the overall study population). 46.9% of the patients were female, mean age was 58 years (range 17-83), and 56.4% were never-smokers. 72.4% (541/747) of the samples used for mutation testing were primary tumor. Sample locations include lung (73.5%), local lymph nodes (10.3%), distant lymph nodes (6.3%), pleural effusion (2.5%), pleura (2.0%), and others. sample types include image-guided core biopsy (29.7%), bronchoscopic biopsy (24.1%), incisional biopsy(12.7%), cytology and others. The median time interval taken from order to report of mutation test was 16 days with a range from 3 days to 62 days. EGFR mutation status was successfully evaluated in 741 patients: 372 (50.2%) were mutation positive, 369 (49.8%) were mutation negative. Smoking status and pack years had a statistically significant association with presence of EGFR mutation, but even in regular smokers, the mutation frequency was 35.3%. 12 patients provided both histology and cytology samples. Among these 11 had concordant EGFR mutations status and 1 had mutation results that did not match.

      Conclusion
      Locations and types of the samples used for EGFR mutation testing were various in clinical practice. The overall EGFR mutation frequency in clinically unselected Chinese ADC was 50.2%. Smoking status and pack years had a statistically significant association with presence of EGFR mutation.

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    P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.11-005 - Randomized, open-label, multi-center study of Gefitinib dose-escalation (500mg/d versus 250mg/d) in advanced NSCLC patient achieved Stable Disease (SD) after one-month Gefitinib treatment (ID 784)

      09:30 - 09:30  |  Author(s): N. Li

      • Abstract

      Background
      Some retrospective studies revealed that higher drug exposure of EGFR-TKIs was associated with better clinical outcome, especially in EGFR mutation-negative patients (pts). This randomized, open-label, multi-center study try to confirm whether dose-escalation of gefitinib would improve effect and survivals.

      Methods
      Key eligibility criteria of this study include: ECOG PS 0-2, stage IIIB/IV NSCLC all histologies, progression after previous platinum-based chemotherapy, SD after one-month treatment of standard dose gefitinib (250mg/d). Patients were randomized (1:1) to received either higher dose (500mg/d, H group) or continue standard dose (250mg/d, S group) of gefitinib untill progression or toxicities. The primary end-point was objective response rate (ORR), and secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety. The sample size was determined based on the assumption that H group was superior to S group in ORR (15% vs 5%, a one-sided alpha of 0.1, 1 - beta = 0.8) and 50 pts per arm was needed. Paired plasma was collected for detection of gefitinib concentration with high-performance liquid chromatographic method with tandem mass spectrometric (LC–MS/MS) method in consented patients at baseline (randomization, D1) and first evaluation (D60). (NCT01017679)

      Results
      From May 2009 to Jan 2012, 466 pts treated with gefitinib were included in this study. Among these pts, 155 achieved SD after one-month gefitinib treatment and 96 pts were randomly assigned to H group (48 pts) or S group (48 pts), respectively. Baseline factors including age (55.5 vs 57.5 years), gender (M/F: 24/24 vs 19/29), histology (adenocarcinoma/others: 44/4 vs 41/7), smoking status (Y/N: 18/30 vs 15/33) and EGFR mutantion rate (20% vs 31%) were balanced between two arms. ORR were same (12.5%) in two groups (p=1.000); median PFS were 159 days (H group) vs 187 days (S group, p=0.077); and median OS were 411 days (H group) vs 743 days (S group, p=0.098), respectivedly. Significantly more grade 3/4 acne-like rash was seen in H group (14.6% vs 0%, p=0.012). PFS was significantly longer in EGFR mutation pts than wild type pts (344 d vs 135 d, p =0.001 ). Plasma gefitinib concentration increased significantly in the H group (n=12, D1 vs D60: 217.02 ng/ml vs 397.25 ng/ml, p=0.017) while it remained stable in S group (n=7, 312.59 ng/ml vs 310.33 ng/ml, p=0.972). However the gefitinib concentration increase did not translate to survival improvement.

      Conclusion
      Gefitinib 500mg/d did not confer a response or survival advantage over gefitinib 250mg/d in patients achieved SD with one-month gefitinib treatment. EGFR mutation remained predictive for PFS with gefitinib.