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C. Lanzarotti



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    MA 08 - Supportive Care and Communication (ID 669)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Nursing/Palliative Care/Ethics
    • Presentations: 1
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      MA 08.02 - Efficacy of Single-Dose NEPA versus 3-Day Aprepitant Regimen for Prevention of CINV: A Phase 3 Lung Cancer Subset Analysis (ID 8460)

      11:00 - 12:30  |  Author(s): C. Lanzarotti

      • Abstract
      • Presentation
      • Slides

      Background:
      Cisplatin, a systemic treatment component for many lung cancer types, is highly emetogenic (HEC). The guideline-recommended antiemetic combination for patients receiving HEC includes a NK~1~ receptor antagonist (NK~1~RA), a 5-HT~3~RA, and dexamethasone (DEX). NEPA is the first oral fixed combination of an NK~1~RA (netupitant) and a 5-HT~3~RA (palonosetron). The approval of oral NEPA was based on studies demonstrating superior prevention of chemotherapy-induced nausea and vomiting (CINV) over oral palonosetron; an intravenous formulation of NEPA is under FDA evaluation. A new Phase 3 study in Asia has reached its primary objective: a single day oral dose of NEPA is non-inferior to a 3-day regimen of aprepitant (APR) and granisetron (GRAN) [both combined with DEX] in preventing CINV in patients receiving cisplatin. This post-hoc analysis explores the efficacy of NEPA vs APR/GRAN within the lung cancer subset of that study.

      Method:
      Chemotherapy-naïve lung cancer patients in this double-blind, parallel group study received either a single oral dose of NEPA prior to cisplatin-based HEC or a 3-day regimen of APR/GRAN, both with oral DEX on days 1-4. Efficacy endpoints were complete response (CR: no emesis/no rescue medication), no emesis, and no significant nausea (<25 mm on 100 mm visual analog scale) during the acute (0-24h), delayed (25-120h) and overall (0-120h) phases post-chemotherapy. The risk difference for NEPA – APR/GRAN and associated 95% confidence intervals (CIs) were analyzed for each endpoint using the Cochran-Mantel-Haenszel test.

      Result:
      542 (65%) of the 828 patients had lung cancer. Mean age was 56.1; 73% males. Response rates were comparable for both arms during the acute phase, and favored NEPA in delayed phase (Table). Figure 1



      Conclusion:
      As a fixed oral combination of an NK~1~RA and 5HT~3~RA in a single capsule/cycle, NEPA offers a convenient and effective prophylactic antiemetic in lung cancer patients receiving cisplatin-based HEC regimens.

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