Author of

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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)

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    P2.01-088 - <em>nab</em>-Paclitaxel + Carboplatin for Elderly Patients with Advanced NSCLC (ABOUND.70+) (ID 1084)

    09:30 - 17:00  |  Author(s): W. Skinner
    • Abstract
    • Slides

    Background:
    Treatment of elderly patients with non-small cell lung cancer (NSCLC) is challenging due to comorbidities and reduced tolerability; as a result, these patients often receive suboptimal treatment. In addition, 5-year survival rates are lower in elderly than in younger patients with NSCLC. In a multicenter phase III trial, first-line treatment with nab-paclitaxel plus carboplatin (nab-P/C) significantly increased median overall survival (OS) vs solvent-based paclitaxel plus C in a subset of patients ≥ 70 years of age with advanced NSCLC (19.9 vs 10.4 months; HR 0.583; P = 0.009; Socinski et al. Ann Oncol. 2013;24:314-321). However, 55% of elderly patients treated with nab-P/C required dose reductions and 84% had dose delays, primarily due to adverse events, including myelosuppression. In the open-label, multicenter phase IV ABOUND.70+ trial, the safety and efficacy of 2 different schedules of first-line nab-P/C treatment will be evaluated prospectively in elderly patients with advanced NSCLC.
    
    Methods:
    Approximately 284 patients with NSCLC ≥ 70 years of age who are not candidates for curative surgery or radiation therapy will be randomized 1:1 to nab-P 100 mg/m[2] intravenously (IV; 30-minute infusion) on days 1, 8, and 15 plus C AUC 6 on day 1 every 21 days or the same nab-P/C dose every 21 days followed by a 1-week break. Key eligibility criteria include histologically/cytologically confirmed locally advanced or metastatic NSCLC, no prior chemotherapy for metastatic disease, ECOG performance status ≤ 1, adequate organ function, no active brain metastases, and absence of preexisting peripheral neuropathy (PN) grade > 2. Patients will be stratified by ECOG performance status (0 vs 1) and histology (squamous vs nonsquamous). ClinicalTrials.gov identifier NCT02151149.

    Key Endpoints
    Primary	Percentage of patients developing either PN grade ≥ 2 or myelosuppression grade ≥ 3
    Secondary	Safety Progression-free survival OS Overall response rate
    Exploratory[a]	Healthcare resource utilization throughout the study Changes in quality of life

    [a] Additional exploratory endpoints may be defined in the statistical analysis plan if applicable.
    
    Results:
    TPS Abstract Section NA
    
    Conclusion:
    TPS Abstract Section NA
    
    

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