Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy

Abstract

Purpose

Dexamethasone, plus a 5-HT3 receptor antagonist and an NK-1 receptor antagonist are recommended for controlling the chemotherapy-induced nausea and vomiting (CINV) of highly emetogenic chemotherapy. Several days of dexamethasone are effective for CINV; however, dexamethasone also has side effects. The purpose of this trial was to investigate whether the use of a second-generation 5-HT3 receptor antagonist and an NK-1 receptor antagonist could allow a reduced dose of dexamethasone for breast cancer patients receiving highly emetogenic chemotherapy.

Methods

Eighty breast cancer patients who received an anthracycline-cyclophosphamide combination regimen were enrolled. The patients were randomized to arm A (dexamethasone days 1–3) and arm B (dexamethasone day 1). The primary endpoint was complete response (CR) (no emetic episodes and no rescue medication) during the overall phase (days 1–5). The secondary endpoints were the CR during the delayed phase (days 2–5), complete control (CC) (no emetic episodes, no rescue medication, and no more than mild nausea) during the overall phase, and the safety of this antiemetic therapy.

Results

There were no significant differences in the rates of CR and CC between arm A and B as follows: CR overall phase—arm A: 82.9 %, 90 % confidence interval [CI] 71.3–90.5 % vs arm B: 82.1 %, 90 % CI 70.0–90.0 %; p = 1.00; CR delayed phase—arm A: 87.8 %, 90 % CI 77.0–93.9 % vs arm B: 94.9 %, 90 % CI 85.6–98.3 %; p = 0.43; CC overall phase—arm A: 48.8 %, 90 % CI 36.4–61.3 % vs arm B: 61.5 %, 90 % CI 48.4–73.2 %; p = 0.27. There were very few adverse events and no severe adverse events associated with this antiemetic therapy.

Conclusions

The results suggest that the antiemetic effect provided by dexamethasone administered for 3 days can be obtained by dexamethasone administered for 1 day.