Triplet aprepitant/ dexamethasone/ondansetron versus doublet dexamethasone/ ondansetron for prevention of moderately emetogenic chemotherapy: A placebo-controlled, double-blind, randomized clinical trial of efficacy

• Autores: Morteza Tabatabaeefar, Jouybari Ali Yaghoubi, Ahmad R Mafi, Shaghayegh Kamian, Mania Rajabzadeh Kheradmardi, Alireza Khajavi
• Localización: European journal of clinical pharmacy: atención farmacéutica, ISSN 2385-409X, Vol. 23, Nº. 2, 2021, págs. 89-97
• Idioma: inglés
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• Resumen

  • Background: This randomized, placebo-controlled, double-blind study aimed to evaluate the efficacy of adding aprepitant to standard antiemetic regimens for the prevention of chemotherapy-induced nausea and vomiting (CINV) caused by moderately emetogenic chemotherapy (MEC) regimens.

    Method: One hundred and sixty eligible patients who were scheduled to receive MEC regimens for the first time were randomized to receive either triplet (aprepitant, dexamethasone, ondansetron) or doublet (dexamethasone, ondansetron and placebo) anti-emetic medications. The primary endpoint was to determine the proportion of patients who experienced CINV within 120 hours after the chemotherapy commencement. Secondary endpoints were complete response (CR) of overall phase (OP), correlation between CR of the OP with the CR of acute phase, and the effect of aprepitant on subsequent cycle of chemotherapy.

    Results: There was a trend towards decreasing nausea from 13% to 5% (p = 0.12), and vomiting from 8% to 1% (p = 0.084). Moreover, aprepitant increased CR rates from 91% to 98% in the overall phase (p = 0.08). For the second cycle of chemotherapy in which all patients received the standard anti-emesis protocol (the doublet) the rate of CR in OP was correlated with aprepitant use in the first cycle of chemotherapy (p = 0.01).

    Conclusion: In patients receiving MEC regimens, aprepitant decreased nausea and vomiting and increased complete response rates on different phases of the first cycles of treatment, although these differences did not reach statistical significance. However, using aprepitant in the first cycle significantly increased overall phase complete response rate of the second cycle of treatment