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Y. Liu



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    P2.11 - Poster Session 2 - NSCLC Novel Therapies (ID 209)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P2.11-002 - A Prospective, Open-labeled, Randomized, Multicenter Phase II Study to Evaluate Efficacy and Safety of Erlotinib vs NP Chemotherapy as Adjuvant Therapy in Post Radical Operation stage IIIA NSCLC Patients With EGFR 19 or 21 Exon Mutation (EVAN, ML28280, NCT01683175) (ID 316)

      09:30 - 09:30  |  Author(s): Y. Liu

      • Abstract

      Background
      Stage IIIA NSCLC represents a relatively heterogeneous group, which the relative roles of treatment modalities are not clearly defined. Adjuvant chemotherapy remains the most important treatment for stage IIIA NSCLC after radical operation, but the drug-related toxicities limit its use and benefits for patients. The tyrosine-kinase inhibitor might provide a promising treatment for NSCLC patients with EGFR19 or 21 exon mutation. In the OPTIMAL study comparing first-line erlotinib with carboplatin/gemcitabine in advanced NSCLC patients with EGFR activating mutations, the primary analysis showed significantly prolonged progressive free survival in erlotinib treatment in comparison to carboplatin/gemcitabine (p<0.0001). The aim of this study is to investigate the efficacy and safety of erlotinib in comparison to vinorelbin plus cisplatin (NP) chemotherapy as adjuvant therapy in post radical operation stage IIIA NSCLC patients with EGFR19 or 21 exon mutation to explore a new treatment strategy for this subset.

      Methods
      The study was designed as a prospective, open-labeled, randomized, multicenter phase II clinical trial. Patients aged between 18 and 75 with ECOG PS 0–1 IIIA NSCLC confirmed by histopathology or cytology after radical operation and with EGFR exon 19 deletion mutation or exon 21 L858R single base substitution were enrolled (n=94). Within 4 weeks post radical surgery, the enrolled patients would randomly allocated for adjuvant therapy, receiving either erlotinib (n=47) 150mg/day for 2 years or NP (n=47) chemotherapy (vinorelbine 25mg/m2 on day 1, 8 and cisplatinum 75mg/m2 on day 1 of a 3-week schedule ) for 4 cycles. Duration of trial recruitment is estimated to 18 months. Primary endpoint is 2-year disease free survival rate (DFSR). Secondary endpoints are disease free survival (DFS), 3-year and 5-year overall survival (OS), Quality of Life (QOL) and Safety. Biomarker profile will be the exploratory research. Patients after surgery and therapy will receive long-term follow-up including chest and abdominal CT scan every 3 months, brain MRI every 6 months and bone scan every 12 months for up to 2 years.

      Results
      Current recruitment: twenty-five patients have been enrolled since FPI in August, 2012.

      Conclusion
      Adjuvant erlotinib therapy in IIIA-N2 NSCLC with EGFR activating mutation is a promising strategy.

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    P3.07 - Poster Session 3 - Surgery (ID 193)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Surgery
    • Presentations: 1
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      P3.07-026 - A non-interventional study on EGFR mutation status and clinical outcomes of Chinese patients with completely resected lung adenocarcinoma (ICAN study) (ID 2187)

      09:30 - 09:30  |  Author(s): Y. Liu

      • Abstract

      Background
      ICAN study (NCT01106781) investigated EGFR mutation status, clinical outcomes and recurrent risk factors in Chinese lung adenocarcinoma (ADC) patients after complete resection. Here we report analysis results for the profile of surgery, adjuvant therapy and 2-year disease free survival (DFS) rate in the real-world practice.

      Methods
      Patients were aged ≥18 years, with histological diagnosed lung ADC, and received surgical complete resection. Tumor sample EGFR mutation status was determined according to clinical routine practice. All eligible patients would be followed up to collect the clinical information and the outcomes till 3 years after operation.

      Results
      Of 571 patients from 26 sites, 315 (55.2%) patients were EGFR mutation positive. The most common mutations were exon19 deletion and L858R mutation found in 140 (24.52%) and 132 (22.59%) patients respectively. There were 50.79% of patients who received adjuvant therapy, in which 45.37% received chemotherapy, 4.55% received radiotherapy and 1.93% received TKI therapy, respectively. The 2-year DFS rate was 68.83%. There was statistically significant difference of 2-year DFS among the patients with different postoperative pathologic stage (P <0.0001). There was no statistically significant difference of 2-year DFS among the patients with age, gender, smoking history and EGFR mutation status. Operation method and adjuvant therapy correlated significantly with 2-year DFS, but was not significant when adjusted for postoperative pathologic stage.

      Conclusion
      The overall EGFR mutation positive rate in operable Chinese ADC was 55.2%. 2-year DFS rate was 68.83%. Postoperative pathologic stage had a statistically significant association with 2-year DFS, while age, gender, smoking history and EGFR mutation status didn’t show statistically significant association.