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Benjamin P Levy



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    MTE18 - Case-Based Management of Patients with Inadequate Tissue for Molecular Tests (Ticketed Session) (ID 828)

    • Event: WCLC 2018
    • Type: Meet the Expert Session
    • Track: Advanced NSCLC
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 07:00 - 08:00, Room 201 F
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      MTE18.01 - Case-Based Management of Patients with Inadequate Tissue for Molecular Tests (ID 11577)

      07:00 - 08:00  |  Presenting Author(s): Benjamin P Levy

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    P1.13 - Targeted Therapy (Not CME Accredited Session) (ID 945)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.13-30 - Neutrophil-to-Lymphocyte Ratio as a Prognostic Factor and its Relationship to NSCLC Patient Outcomes in the REVEL Trial (ID 13126)

      16:45 - 18:00  |  Author(s): Benjamin P Levy

      • Abstract
      • Slides

      Background

      Neutrophil-to-lymphocyte ratio (NLR) reflects underlying levels of systemic inflammation and has prognostic importance in solid tumors. Higher baseline NLR is an independent negative prognostic factor in advanced non–small cell lung cancer (NSCLC) and may indicate more aggressive disease. An exploratory analysis from REVEL demonstrated benefits of ramucirumab(RAM)/docetaxel(DOC) in NSCLC patients with rapidly progressing and refractory disease. We investigated the relationship between pretreatment NLR, prognosis and response to RAM/DOC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Pretreatment NLR was analyzed by dividing absolute neutrophil count by absolute lymphocyte count from peripheral blood. Multiple NLR cutoffs ≥4 were evaluated for prognostic significance by analyzing overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). Kaplan-Meier analysis and Cox proportional hazards regression model were used for analyzing OS and PFS, and Cochran-Mantel-Haenszel test for ORR.

      4c3880bb027f159e801041b1021e88e8 Result

      Pretreatment NLR was determined for 1224 REVEL patients (n=611 RAM/DOC, n=613 placebo [PBO]/DOC), among whom 51%, 40%, and 32% had NLR ≥4, 5, and 6, respectively. Baseline characteristics were balanced between arms in NLR subgroups and the REVEL intent-to-treat (ITT) population. Patients with higher NLR values had worse OS, PFS, and ORR compared to the ITT population. For all NLR cutoff values, OS, PFS and ORR were improved in patients treated with RAM/DOC compared to patients receiving PBO/DOC (Table). Efficacy and safety outcomes across high NLR subgroups were consistent with those in the ITT population.

      table 1.jpg

      8eea62084ca7e541d918e823422bd82e Conclusion

      In this exploratory analysis of REVEL, higher pretreatment NLR was an independent prognostic factor indicating poorer survival outcomes. Treatment benefit with RAM/DOC was preserved in patients with elevated NLR and was consistent with REVEL ITT results. NLR is an inexpensive and reproducible blood test and may provide a simple way to identify patients with more aggressive disease who can benefit from treatment with RAM/DOC in second-line NSCLC.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.01 - Advanced NSCLC (Not CME Accredited Session) (ID 967)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.01-70 - Meta-Analysis of Metformin in Combination with Platinum Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer (ID 12602)

      12:00 - 13:30  |  Author(s): Benjamin P Levy

      • Abstract
      • Slides

      Background

      Metformin has been shown to have a variety of insulin-dependent and –independent antitumor effects, primarily through cellular growth inhibition via the AMP-activated protein kinase (AMPK) pathway and the IGF1-insulin axis. Two prospective trials evaluating metformin with platinum doublet chemotherapy +/- bevacizumab have demonstrated competitive outcomes in non-diabetic, chemotherapy-naïve advanced non-small cell lung cancer (NSCLC) patients. Outcomes in KRAS-mutated NSCLC, an area of interest due to potential co-occurring LKB1 mutations, an AMPK pathway upstream kinase, is currently unknown.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This meta-analysis is of two phase II study treatment arms (NCT02019979, NCT01578551), evaluating the use of concurrent metformin and platinum-based doublet chemotherapy +/- bevacizumab. Patient’s demographic, molecular and adverse event (AE) profiles were summarized with descriptive statistics. Kaplan-Meier curves for progression free survival (PFS) and overall survival (OS) were generated for all patients, as well as known KRAS and EGFR mutation subsets.

      4c3880bb027f159e801041b1021e88e8 Result

      33 non-squamous NSCLC patients were treated; 60% were female and the median age was 64 (Range: 37-77). The most common AE was neutropenia (Grade 3-4: 30%). No patients required study treatment cessation due to metformin-related toxicity. Across all patients, mPFS was 6 months (95% CI: 1.36-7.96); mOS was 14.83 months (95% CI: 8.25-19.99). In KRAS-mutated patients (n=13), mPFS was 7.21 months; mOS was 17.46 months. In EGFR-mutated patients (n=7), mPFS was 6.57 months; mOS was 13.25 months.overall survival.jpg

      8eea62084ca7e541d918e823422bd82e Conclusion

      Combination metformin and chemotherapy +/- bevacizumab was safe and well-tolerated in advanced, chemotherapy-naïve non-squamous NSCLC across two phase II clinical trials. Metformin appeared particularly effective in KRAS-mutated NSCLC. Data for LKB1 status was unknown for a majority of patients, but may be an important co-mechanism for benefit. Metformin appeared to underperform in the EGFR subset, perhaps due to lack of TKI use. Given the tolerability, low cost and activity observed in NSCLC, further investigation into metformin’s antitumor effects in molecularly defined subsets is needed.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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