Triple antiemetic therapy, such as a 5-HT3 receptor antagonist (5H3-RA), aprepitant and dexamethasone, is recommended for the prophylaxis of highly emetogenic chemotherapy induced nausea and vomiting in patients with breast cancer. In the present study, we aimed to verify whether adding metoclopramide to the triplet antiemetic therapy is superior to the triplet antiemetic therapy in preventing CINV in patients with breast cancer.
A single-blind, randomized trial was performed on ninety-seven patients who received HEC among chemotherapy-naive patients with breast cancer. The visual analogue scale (VAS) utilized to detect nausea, and FLIE was used in order to determine its impact on the patients’ quality of life. The patients were randomized to arm A(n:48, dexamethasone and 5HT3RA on day 1, aprepitant on day 1-3, and metoclopramide on days 1-5) and arm B (n:49, dexamethasone and 5HT3RA on day 1and aprepitant on day 1-3). The primary endpoint was complete response (CR) (no nausea, no vomiting, and no rescue medication) during the overall phase (days 1–5).
The demographic and clinical features such as age, educational background, height and weight measurements were similar in both groups. The CR was found in twenty patients (45.8%) of the forty-eight patients in the arm A, while it was found in thirteen patients (26.5%) of the forty-nine patients in the arm B (p:0.038).The mean total FLIE score was 31.31 (SD: 20.5) in arm A, which was42.29 (SD: 26.4) in arm B (p:0.045).
A triple or quadruple antiemetic combination is proposed to alleviate CINV for female patients with breast cancer treated with HEC. In patients receiving anthracycline-based chemotherapy, quadruple antiemetic therapy with dexamethasone, aprepitant, palonosetron and metoclorpropamide is associated with a significant CR and clinically relevant improvement in FLIE score, compared to dexamethasone, aprepitant and palonosetron. Therefore, a quadruple antiemetic combination including metpamid might be a treatment option for patients receiving highly emetogenic chemotherapy.
Clinical trial identification
Legal entity responsible for the study
Izmir Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey.
Has not received any funding.
All authors have declared no conflicts of interest.