Author of

• 25938

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  P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall

  • 26924

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    P2.01-119 - Phase III Randomized Trial of Palonosetron and Dexamethasone with Aprepitant to Prevent Full Dose Single-Day Cisplatin-Based CINV in Lung Cancer (ID 12316)

    16:45 - 18:00  |  Author(s): Fang Wu
    • Abstract

    Background
    

    This study aimed to determine the efficacy and safety of aprepitant, palonosetron and dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV) in patients with locally advanced or metastatic lung cancer receiving full dose single-day cisplatin-based combination chemotherapy.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    Patients diagnosed with locally advanced or metastatic lung cancer received full dose single-day cisplatin-based chemotherapy were randomized (1:1) to aprepitant plus palonosetron and dexamethasone, or placebo plus palonosetron and dexamethasone. Primary endpoint was complete response (CR; no vomiting/retching and no use of rescue medication) of nausea and vomiting in the overall period (0-120 h) in first cycle. The secondary endpoints were the proportion of nausea and vomiting, who received rescue antiemetic medication with metoclopramide, the response of cross over patients and safety were also evaluated.

    4c3880bb027f159e801041b1021e88e8 Result
    

    244 patients were randomized. There was no difference between two groups with personal characteristics. The aprepitant significantly improved CR for vomiting in the overall period (92.6% vs. 79.93%, p<0.01), rather than nausea-free (75.4% vs.71.3%, p＞0.05) in first cycle. The percentage of patients who received rescue antiemetic medication was decreased for aprepitant group (14.8% vs. 37.1%, p<0.001). Patients without using aprepitant suffered with nausea and vomiting in cycle 1 were crossed over to aprepitant group (N=32), the rate of nausea and vomiting in cycle 2 were decreased to 37.5% (p<0.05) and 25% (p<0.05) respectively. There was no drug related i ntolerance side effects.

    Primary and secondary endpoints

    aprepitant placebo CR for vomiting 92.60% 79.93% nausea-free 75.40% 71.30% received rescue antiemetic medication 14.80% 37.10%

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    Aprepitant plus palonosetron and dexamethasone proved to be effective and well-tolerated in preventing CINV for full dose single-day cisplatin-based combination chemotherapy.

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