Author of

• 17556

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  P2.03a - Poster Session with Presenters Present (ID 464)

  • Event: WCLC 2016
  • Type: Poster Presenters Present
  • Track: Advanced NSCLC
  • Presentations: 1
  • Moderators:
  • Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)

  • 17602

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    P2.03a-046 - Safety and Efficacy Results From ABOUND.70+: nab-Paclitaxel/Carboplatin in Elderly Patients With Advanced NSCLC (ID 4630)

    14:30 - 14:30  |  Author(s): A. Sanford
    • Abstract

    Background:
    Treatment of elderly patients with NSCLC is challenging given comorbidities and reduced tolerability. First-line nab-paclitaxel/carboplatin significantly increased median OS vs paclitaxel/carboplatin in a subset of patients ≥70 years with advanced NSCLC in a phase III trial. Here we report pooled interim safety and efficacy results from the ongoing ABOUND.70+ trial evaluating 2 schedules of first-line nab-paclitaxel/carboplatin in elderly patients with advanced NSCLC.
    
    Methods:
    Patients ≥70 years with histologically/cytologically confirmed locally advanced/metastatic NSCLC received (1:1) first-line nab-paclitaxel 100 mg/m[2] qw + carboplatin AUC 6 q3w (arm A) or the same nab-paclitaxel/carboplatin dose q3w followed by a 1-week break (arm B). Stratification factors: ECOG PS (0 vs 1) and histology (squamous vs nonsquamous). Primary endpoint: percentage of patients with grade ≥2 peripheral neuropathy (PN) or grade ≥3 myelosuppression AEs. Key secondary endpoints: PFS, OS, and ORR.
    
    Results:
    As of 5/20/2016, 124/128 randomized patients were treated. Median age was 76 years, 30% were ≥80 years, 58% were male, and 86% were white. Majority of patients (70%) had ECOG PS 1, stage IV disease (82%), and nonsquamous histology (59%). Overall, 91 (73%) patients experienced grade ≥2 PN or grade ≥3 myelosuppression AEs (primary endpoint). Grade ≥2 PN was reported in 34%, and grade ≥3 neutropenia, anemia, thrombocytopenia in 52%, 21% and 21%, respectively. Interim efficacy analysis demonstrated a median PFS of 6.2 months and a median OS of 14.6 months. ORR (unconfirmed) was 43% (95% CI, 34.3-52.0), with 1 complete response; 32% had a best response of stable disease, 6% had progressive disease, and response data are pending for 19% of patients. QoL measured by LCSS and EQ-5D-5L remained stable or improved through 4 cycles.
    
    Conclusion:
    This interim analysis from ABOUND.70+ demonstrated promising activity and tolerability of nab-paclitaxel/carboplatin regimens in elderly patients with advanced NSCLC similar to prior phase III data. NCT02151149 Figure 1