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X. Li



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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): X. Li

      • 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.