• Eur. J. Cancer · Jul 2003

    Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial

    Functional relevance of antiemetic control. Experience using the FLIE questionnaire in a randomised study of the NK-1 antagonist aprepitant.

    • A R Martin, A D Carides, J D Pearson, K Horgan, M Elmer, C Schmidt, B Cai, S P Chawla, and S M Grunberg.
    • Merck Research Labs, 10 Sentry Parkway, Blue Bell, PA 19422, USA. allison_martin@merck.com
    • Eur. J. Cancer. 2003 Jul 1; 39 (10): 1395-401.

    AbstractLittle information exists on the functional impact of effective antiemetic protection. In the present study, the Functional Living Index-Emesis (FLIE), was used to assess patient-reported impact of chemotherapy-induced nausea and vomiting (CINV) after administration of a new NK-1 receptor antagonist (aprepitant). Cisplatin-treated patients in a double-blind randomised trial received either aprepitant+dexamethasone+ondansetron on day 1 and aprepitant+dexamethasone on days 2-5 or standard antiemetic therapy (dexamethasone and ondansetron on day 1 and dexamethasone on days 2-5). Emetic events, nausea ratings and rescue medications were recorded in a 5-day diary and the FLIE was completed on day 6. Compared with standard therapy, significantly more patients treated with the high dose aprepitant regimen achieved a Complete Response (71 vs 44%, P<0.001) and also reported no impact on daily life as indicated by the FLIE total score (84 vs 66%, P<0.01). Use of the FLIE demonstrated that improved control of emesis was highly effective in reducing the impact of CINV on patients' daily lives.

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