A phase II randomised study to evaluate the efficacy of aprepitant plus palonosetron for preventing delayed-phase CINV associated with TC therapy in gynaecological cancer

INTERVENTION: control group (standard antiemetic therapy:0.75 mg palonosetron administered intravenously on day 1 and 6 mg dexamethasone administered intravenously on day 1 and 4 mg dexamethasone administered orally on days 2 and 3). aprepitant group (oral administration of 125 mg aprepitant 90 minutes before administration of the chemotherapy drug on day 1 and of 80 mg on days 2 and 3 and 0.75 mg palonosetron administered intravenously on day 1 and 6 mg dexamethasone administered intravenously on day 1 and 4 mg dexamethasone administered orally on days 2 and 3) CONDITION: gynaecological cancer PRIMARY OUTCOME: complete response (CR, defined as complete absence of emetic events) in the delayed phase INCLUSION CRITERIA: 20 years of age with gynaecological cancer who were scheduled to receive single‐day chemotherapy with a carboplatin target area under the concentration curve of 5, and paclitaxel at 175 mg/m2. All patients had an Eastern Cooperative Oncology Group performance status of 0‐2, adequate renal function, adequate hepatic function, and adequate marrow function. All patients provided written informed consent for their participation in the study.