Author of

• 11745

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

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 2
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11747

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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): L. Zhang
    • 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.

  • 11761

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    P2.11-016 - A Comparative Analysis of EGFR Mutation Status in Association with the Efficacy of TKI in Combination with WBRT/SRS/Surgery plus chemotherapy in Brain Metastasis from Non-small Cell Lung Cancer (ID 1579)

    09:30 - 09:30  |  Author(s): L. Zhang
    • Abstract

    Background
    The outcomes of brain metastasis (BM) from non-small cell lung cancer (NSCLC) remain poor even with optimized option of stereotacic radiosurgery (SRS), whole brain radiotherapy (WBRT), surgery, chemotherapy or a combination. We purposed to identify the efficacy of tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR) using with conventional therapy on BM patients from NSCLC and clarify the association between treatment outcome and EGFR gene mutation status.

    Methods
    Totally 282 cases treated basically with conventional therapy alone or in addition to TKI were enrolled in our study from 2003-2012. Among these patients, 178 cases were treated with conventional therapy (Non-TKI group) and 104 cases were treated with TKI plus conventional therapy (TKI group). EGFR mutation analysis was performed in 107 patients with tissue samples.

    Results
    With a median follow-up of 28 months (range, 22-34 months), the median overall survival (MOS), median progression-free survival of intracranial disease (MPFSI), and median progression-free survival for extracranial disease (MPFSE) in TKI group was 31.9, 19.8, and 19.6 months compared with 17.0 (P<0.0001), 12.0 (P<0.0001), and 12.3 (P<0.0001) months in Non-TKI group, respectively. Within TKI group, patients harboring EGFR mutation had longer time of 20.4 months to extracranial disease progression than 14.1 months in EGFR negative patients (P=0.032). In additional, EGFR positive patients had nonsignificant but potential improvements of 37 and 22.7 months for MOS and MPFSI compared with 23.4 and 16.9 months in EGFR negative patients (P=0.094, P=0.382 respectively).

    Conclusion
    Administration of TKI agents with conventional therapy might be benefit for patients with BMs from NSCLC on MOS, MPFSI and MPFSE compared with conventional therapy. Patients harboring EGFR mutation not only had significant improvement for PFSE with TKI plus conventional treatment compared with EGFR negative patients, but also non-significantly better outcome of OS and PFSI as well.