Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated with Moderately Emetogenic (MEC) Chemotherapy in Patients with Breast Cancer.

Abstract

Abstract Purpose: Aprepitant was shown previously to be effective for prevention of CINV associated with MEC in breast cancer patients. A recent study (PN130) assessed aprepitant in patients with a variety of tumor types receiving a broad range of MEC regimens. A post-hoc subgroup analysis of patients with breast cancer was performed and results (nominal p-values) are reported.Methods: This randomized, gender-stratified, double-blind trial enrolled patients with confirmed malignancies, naïve to HEC or MEC agents, who received at least one MEC agent. Patients received an aprepitant triple-therapy regimen (aprepitant 125 mg PO day 1 and 80 mg PO days 2-3, ondansetron 8 mg PO bid day 1, and dexamethasone 12 mg PO day 1) or an active control regimen (ondansetron 8 mg PO bid days 1-3 and dexamethasone 20 mg PO day 1). Primary and key secondary efficacy endpoints were proportions of patients with No Vomiting and Complete Response (no vomiting/no rescue medication use) respectively, during the overall phase (120 hours post-chemotherapy). Treatment group comparisons were based on a logistic regression model with terms for treatment, region, and gender.Results: Of 832 patients in the modified intent to treat population analyzed, 53% (n=439) had breast cancer. In the overall phase, significantly more patients in the aprepitant group achieved No Vomiting and Complete Response both overall and in the subgroup of patients with breast cancer (Table 1). The magnitude of the treatment group differences were similar to the differences observed in the entire study population. Similar trends were seen in the acute and delayed phase in both the overall population and the subgroup of patients with breast cancer. Results for additional endpoints are consistent with the data presented here. Adverse events were generally similar in the aprepitant and control groups. Aprepitant, n/m (%)Active control, n/m (%)No vomitingAll tumors324/425 (76.2)*252/406 (62.1) Breast cancer152/219 (69.4)*116/220 (52.7)Complete responseAll tumors292/425 (68.7)*229/407 (56.3) Breast cancer139/219 (63.5)*102/220 (46.4)n/m = patients with favorable response/patients included in subgroup; * p-value < 0.001Conclusions: The aprepitant regimen provided superior efficacy over the control regimen for prevention of CINV for all patients receiving MEC. The benefit of aprepitant triple therapy in patients with breast cancer in this trial is in agreement with the results of a previous large-scale trial of aprepitant in this population. Control of CINV in breast cancer patients in this trial was consistently lower than in the overall population for all endpoints, demonstrating the importance of CINV prophylaxis in women with breast cancer undergoing MEC. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 1116.