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)

  • 17566

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    P2.03a-010 - A Randomized Phase II Study of Platinum-Based Chemotherapy +/- Metformin in Chemotherapy-Naïve Advanced Non-Squamous NSCLC (ID 5185)

    14:30 - 14:30  |  Author(s): X. Zhou
    • Abstract

    Background:
    Lung cancer is the number one cause of cancer-related death. 80% of patients present with advanced disease, and first line standard of care is multi-agent chemotherapy; however, overall 2-year survival is only 15%. Metformin, a well-tolerated oral biguanide used in diabetes, is thought to have anti-cancer effects via a variety of proposed mechanisms.
    
    Methods:
    This is a single-arm study with a randomized control arm for reference to expected 1-year progression-free survival (PFS), the primary endpoint, defined as the proportion of patients alive without disease progression at 1 year of treatment. Non-diabetic, chemotherapy-naïve patients with advanced non-squamous NSCLC were randomized 3:1 to Arm A:Arm B. (NCT01578551) Arm A consisted of standard doses of paclitaxel, carboplatin, bevacizumab (PCB) and metformin (M; 1,000 mg PO BID) x 4-6 cycles, followed by bevacizumab (B) + M until disease progression. Arm B consisted of standard doses of PCB x 4-6 cycles, followed by B until disease progression.
    
    Results:
    The study enrolled 19 patients to Arm A and 6 patients to Arm B. 37% of Arm A patients and 33% of Arm B patients were male. Median age was 58 years (range: 37-64) in Arm A and 64 years (range: 55-70) in Arm B. One-year PFS for Arm A was 0.47 (95% CI: 0.25, 0.88). The 95% CI lower bound exceeded 15%, the hypothesized 1-year PFS without metformin. All Arm B patients either progressed or were off study treatment prior to 1 year. Median PFS (Figure) was statistically significantly better for Arm A patients (9.6 months; 95% CI: 7.3 months, Not Reached (NR)) than Arm B patients (6.7 months; 95% CI: 4.4 months, NR). Figure 1
    
    
    
    Conclusion:
    The addition of metformin to standard first-line PCB was well-tolerated and significantly improves PFS in chemotherapy-naïve advanced non-squamous NSCLC patients. Further study of the addition of metformin to treatment in NSCLC patients is needed.