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P. Yu



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    P1.10 - Poster Session 1 - Chemotherapy (ID 204)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.10-055 - Treatment rationale and study design for an open-label randomized phase II trial of gemcitabine and cisplatin with or without bevacizumab in EGFR wild-type non-squamous non-small-cell lung cancer (ID 207)

      09:30 - 16:30  |  Author(s): P. Yu

      • Abstract

      Background
      EGFR wild-type non-squamous non-small-cell lung cancer (NSCLC) accounted for the majority of lung cancer patients, but the outcome of its first-line treatment was not satisfactory. INNOVATION study provided a new therapy perspective for those patients. EGFR wild-type subgroup analysis of this study revealed gemcitabine/cisplatin first-line chemotherapy plus bevacizumab showed significant advantage compare with gemcitabine/cisplatin alone (PFS 8.4m vs. 3.4m, OS 18.0 vs. 10.3m), which suggested that gemcitabine/cisplatin plus bevacizumab may be the preferred first-line therapy for EGFR wild-type non-squamous NSCLC. However, no other prospective trail has been preceded to confirm this conclusion in patients with EGFR wild-type non-squamous NSCLC. As a new type of anti-tumor angiogenesis monoclonal antibody, bevacizumab precisely targets VEGF to inhibit angiogenesis for continuous tumor control. We conduct this randomized phase II trial to investigate if gemcitabine/cisplatin first-line chemotherapy plus bevacizumab is a better treatment for advanced non-squamous NSCLC patients without EGFR mutations. This study will also explore plasma biomarkers of bevacizumab efficacy.

      Methods
      This is an open-label randomized (1:1) 2-arm phase II study. Stage IIIB/IV EGFR wild-type non-squamous NSCLC with performance status (PS) 0 or 1 will be included; patients who have received prior chemotherapy or radiotherapy will be excluded. Patients (N=40) will receive (1:1) gemcitabine/cisplatin orgemcitabine/cisplatinplus bevacizumab (chemotherapy up to 6 cycles) until disease progression, unacceptable toxicity, patient/physician decision to discontinue, or death. Patients in the control arm receive first-line gemcitabine/cisplatin (gemcitabine 1250mg/m[2] IV D1 and D8 plus cisplatin 75mg/m[2] IV D1, every 21-day cycle). Patients in the experimental arm receive gemcitabine/cisplatin plus bevacizumab (7.5 mg/kg IV D1, every 21-day cycle). At the time point of start of chemotherapy and six weeks after chemotherapy, peripheral blood of patients from both arms will be collected to detect plasma VEGF, VEGFR and VEGFR-2 level by ELISA. The primary endpoint is progression-free survival (PFS). Secondary endpoints include response rate, disease control rate, safety of bevacizumab and quality of life. Exploratory objective is biomarker analysis. Recruitment began in February 2013; the estimated final data collection for the primary endpoint is Aug 2014. Further details can be found on ClinicalTrials.gov (NCT01623102).

      Results
      not applicable

      Conclusion
      not applicable

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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 - 16:30  |  Author(s): P. Yu

      • 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.