Author of

• 14306

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  P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)

  • Event: WCLC 2015
  • Type: Poster
  • Track: Treatment of Advanced Diseases - NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)

  • 14401

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    P2.01-095 - <em>nab</em>-Paclitaxel/Carboplatin Followed By <em>nab</em>-Paclitaxel for NSCLC PS 2 (ABOUND.PS2) (ID 955)

    09:30 - 09:30  |  Author(s): H. Ali
    • Abstract
    • Slides

    Background:
    Many patients with advanced non-small cell lung cancer (NSCLC) often present with poor performance status (PS), and there is no clear consensus on how best to treat these patients. Despite an increased risk of toxicity resulting from standard chemotherapy, patients with NSCLC and a poor PS can clinically benefit from platinum-doublet therapy. In a multicenter phase III trial, first-line treatment with nab-paclitaxel plus carboplatin (nab-P/C) in patients with NSCLC and an ECOG PS 0-1 significantly improved the overall response rate (ORR) compared with solvent-based paclitaxel plus C (33% vs 25%; P = 0.005; Socinski et al. J Clin Oncol. 2012;30:2055-2062). In the single-arm, open-label, multicenter phase II ABOUND.PS2 study, the safety and efficacy of first-line nab-P/C followed by nab-P monotherapy will be evaluated in patients with locally advanced/metastatic NSCLC and an ECOG PS of 2.
    
    Methods:
    During the induction part of the study, approximately 50 patients will be treated with 4 cycles of nab-P 100 mg/m[2] intravenously (IV; 30-minute infusion) on days 1 and 8 plus C AUC 5 IV on day 1 every 21 days. Patients without disease progression may proceed to the monotherapy part of the study in which they will continue to receive nab-P 100 mg/m[2] IV (30-minute infusion) on days 1 and 8 every 21 days until progression or unacceptable toxicity. Key eligibility criteria include histologically/cytologically confirmed stage IIIB/IV NSCLC, no prior chemotherapy for metastatic disease, ECOG PS of 2, adequate organ function, no active brain metastases, and preexisting peripheral neuropathy grade < 2. ClinicalTrials.gov number NCT02289456.

    Key Endpoints
    Primary	The percentage of patients who discontinue treatment during the induction part due to treatment-emergent adverse events
    Secondary	Safety Progression-free survival Disease control rate Overall survival ORR
    Exploratory	Healthcare resource utilization throughout the study Changes in physician-reported ECOG PS and patient-reported quality of life Summary of Charlson Co-Morbidity Index at baseline Correlation between patient- and physician-reported ECOG PS during treatment Correlation between patient- and physician-reported Karnofsky PS at baseline

    
    
    Results:
    This is a TPS abstract Results = NA
    
    Conclusion:
    This is a TPS abstract Results = NA
    
    

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