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I. Fernandez



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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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      P3.11-052 - Phase II study of intermittent erlotinib (E) plus carboplatin (C), paclitaxel (P) and bevacizumab (B) as frontline treatment of patients (pts) with advanced non-squamous non-small cell lung cancer (nsNSCLC): AVAFAST Study. (ID 1432)

      09:30 - 09:30  |  Author(s): I. Fernandez

      • Abstract

      Background
      To improve outcomes of nsNSCLC, investigators have empirically combined targeted therapies with conventional platinum-based regimens. The potential for combining E with cytotoxic drugs was initially investigated in two randomized phase III trials. Data from this studies showed that simultaneous EGFR-TKI/platinum combination resulted in antagonism in NSCLC. First-line sequential administration of E with chemotherapy in several studies, particularly the FAST-ACT trial, has demonstrated promising results in patients with nsNSCLC. The aim of this study is to combine E with C/P + B as per a sequential schedule in order to avoid the potential cell cycle-based antagonism between E and chemotherapy. In this study B has been added to the chemotherapy regimen since the addition of B has demonstrated improvement in response and survival, and should be considered as the most efficacious treatment for patients with nsNSCLC.

      Methods
      AVAFAST is an ongoing, open-label, multicenter, phase II study in chemo-naïve pts diagnosed with unresectable advanced, metastatic or recurrent nsNSCLC. Elegible pts also have 1 unidimensionally measurable lesion according to RECIST; age ≥ 18 years; ECOG PS ≤ 1; adequate hematological, renal and liver function; treated brain metastasis and signed informed consent. Radiological evidence of tumor invasion of major blood vessels, EGFR-mutation-positive disease, hemoptysis grade ≥2, significant cardiovascular disease or uncontrolled hypertension are exclusion criteria. Pts receive sequential combination of C (6 AUC), P (175mg/m2), B (7,5 mg/kg) on day 1, and intermittent E (150 mg) from day 5 to18 up to 4 cycles of 21 days. Pts who had not progressed after 4 cycles continue to receive B (7,5mg/kg) on day 1 until progression of disease or unacceptable toxicity. Non Progression Rate (NPR) at 12 weeks is used as the primary efficacy endpoint. Secondary endpoints include ORR, DCR, NPR at 24 weeks, PFS, OS, Safety profile and Quality of Life. 35 of planned 64 patients have been enrolled.

      Results
      not applicable

      Conclusion
      not applicable