Author of

• 18374

  +

  P3.02b - Poster Session with Presenters Present (ID 494)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 18435

    +

    P3.02b-061 - A Phase II Study of Nab-Paclitaxel (Nab-P) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR Mutations (ID 4337)

    14:30 - 14:30  |  Author(s): S. Lee
    • Abstract

    Background:
    Patients with NSCLC harboring a sensitizing EGFR mutation have effective targeted therapy options initially but most patients eventually need to receive cytotoxic chemotherapy. We previously reported our institutional experience with taxane based therapy in this patient population and this provided the rationale for the currently ongoing phase II study (NCT01620190).
    
    Methods:
    Patients with EGFR mutation positive NSCLC who were refractory to tyrosine kinase inhibitor (TKI) therapy and chemotherapy naive received nab-P at 125mg/m2 on days 1, 8 and 15 in a 28-day cycle. The primary endpoint was response rate which was assessed using RECIST v1.1.
    
    Results:
    As of data cut-off of March 14 2016, 22 patients were enrolled and received therapy (19 evaluable, 2 not yet evaluable, 1 patient excluded due to not being eligible). Median age was 65 (range 54-77), 75% of patients were women, 40% did not have a smoking history and majority (65%) of patients had an ECOG performance status of 1. Tumor histology consisted mostly of adenocarcinoma (90%); 55% of patients harbored exon 21 L858R and 45% harbored exon deletion 19 mutations. Confirmed partial response was documented in 8 of 19 (42%) patients with a median duration of response of 4.3 months (range 3.3-9.5) and stable disease was documented in 4 of 19 (21%) patients with a disease control rate of 63%. Median progression free survival was 4.4 months (95% CI 1.8-5.5 months). The most common grade 3 treatment-related adverse events (AE) were peripheral neuropathy (10%), fatigue (10%) and neutropenia (15%). There were no treatment-related grade 4 AEs.
    
    Conclusion:
    Single agent nab-P has promising activity in patients with EGFR mutation positive NSCLC. The AE profile was consistent with previously reported AEs in the literature. Accrual of patients continues and updated data will be presented Figure 1