Abstract P3-15-02: A prospective, open label, non-comparative trial to determine the incidence of chemotherapy-induced nausea and vomiting associated with the docetaxel-cyclophosphamide regimen in early breast cancer patients. Results from the GEICAM 2009-02 study

Abstract

Abstract Background: Docetaxel-Cyclophosphamide (TC) has become a common chemotherapy regimen for moderate-high risk Early Breast Cancer (EBC) patients. The incidence of chemotherapy induced nausea and vomiting (CINV) with TC together with an adequate standard anti-emetic therapy with 5-HT3 antagonist and corticosteroids are unknown. This study investigates the incidence of emesis control (complete response), defined as no vomiting (any grade of NCI CTCAE version 4.0) and no use of rescue treatment within 120 hours after the first cycle of TC. Secondary objective evaluates the efficacy of Aprepitant in non-responding patients. Methods: EBC patients with no prior moderate-high risk CINV were included. Patients received Docetaxel 75 mg/m2 plus Cyclophosphamide 600 mg/m2 IV every three weeks. Antiemetic treatment consisted of oral Dexamethasone (D) 8 mg (at night) on day 0; oral D 8 mg x 3 (in the morning, 1 hour before chemotherapy and at night) plus 5-HT3 antagonists on day 1; and oral D 8 mg x 2 (in the morning and at night) on days 2 and 3. Non-responding patients (vomiting or need of rescue therapy in the first cycle) were offered participation in the efficacy phase (Aprepitant 125mg day 1 and 80 mg days 2 and 3 added to the standard antiemetic therapy in cycle 2). In addition to the standard NCI-CTCAE adverse event collection, a patient´s diary (from day 1 to 6) and the FLIE (Functional Living Index-Emesis questionnaire) were used. Assuming a 25% (+/- 6%) of patients resistant to standard antiemetic therapy, 212 patients were estimated. Results: From May-11 to March-13, 212 EBC patients were included. Median age was 57 years (range 34-82), 29.3% were premenopausal. Twenty-seven patients were excluded from the main analysis because of major protocol violations (25) or consent withdrawal (2). Twenty-four patients (13%; IC95%: 8.2 – 17.8) did not respond to standard antiemetics and entered the efficacy phase with Aprepitant. From these 24 patients, 14 (56%; IC95%: 36.5 – 75.5) achieved a complete response on cycle 2. No adverse events related to Aprepitant were observed. Conclusions: Proper use of standard antiemetic therapy for early breast cancer patients treated with TC provides a high control rate (87%). Among no responding patients, about half of them were rescued with Aprepitant. Identification of the non-responding patients could lead to a better antiemetic control with Aprepitant from the first cycle. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-15-02.