Llombart-Cussac, A., Ramos, M., Dalmau, E., Garcia-Saenz, J.A., Gonzalez-Farre, X., Murillo, L., . . . Jara-Sanchez, C. (2016). Incidence of chemotherapy-induced nausea and vomiting associated with docetaxel and cyclophosphamide in early breast cancer patients and aprepitant efficacy as salvage therapy. Results from the Spanish Breast Cancer Group/2009-02 study. European Journal of Cancer, 58, 122–129.

To investigate the incidence of CINV among chemotherapy naïve patients with breast cancer receiving docetaxel-cyclophosphamide chemotherapy regimen (MEC). To investigate the prophylactic efficacy of aprepitant on CINV for the patients who experienced CINV in their first chemotherapy cycle

Phase 1: involved 212 breast cancer naïve patients receiving TC and detected the incidence of CINV. Antiemetic therapy on the first cycle consisted of dexamethasone 8 mg (x 3) for day 1 and then dexamethasone 8 mg (x 2) on days 2 and 3 plus 5-hydroxytryptamine (5-HT₃) antagonists (gransetron 1 mg [x 2], or tropisetron 5 mg [x 1]) on day 1. Patient also received 8 mg dexamethasone on day 0. 

Phase 2: for the patient who experienced vomiting and requested rescue antiemetic in the first 120 hours were involved during their second chemotherapy cycle. Patients received same antiemetic regimen prescribed in cycle 1 in addition to aprepitatnt 125 mg orally (x 1) on day 1, and aprepitant 80 mg and dexamethasone 4 mg (x 2) in days 2 and 3 Patients’ diaries and Functional Living Index Emesis (FLIE) questionnaires were collected in cycles 1 and 2.

• N = 185 patient in the observational phase; 32 patient in the efficacy phase (24 evaluable)  
• AGE: Median = 57 years (range = 34-82)
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Stage I to III breast cancer, chemotherapy naive patients, receiving T-75 mg/m² and C-600 mg/m²
• OTHER KEY SAMPLE CHARACTERISTICS: No anticipatory nausea and vomiting, no radiotherapy, no receiving systemic cortisone, had Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1; and had a life expectancy ≥ 4 months and adequate bone marrow, liver, and renal functions

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: 12 sites in Spain

PHASE OF CARE: Active anti-tumor treatment

Open-label, non-comparative, observational clinical trial

FLIE questionnaire on day 1 before chemotherapy and day 6. Patient diary for nausea and vomiting episodes and severity (VAS) and need of rescue antiemetics day 1-6.

On cycle 1, 87% achieved a complete response (no vomiting and no rescue antiemetic). On cycle 2, 23 patients reached a CR (52.2%). The absence of CR significant affected the patients QOL on cycle 1 (p = 0.0124) and 2 (p = 0.0059). No AEs related to aprepitant were observed in cycle 2.

Antiemetic guidelines of dexamethasone for 3 d plus 5-hydroxytryptamine (5-HT₃) antagonists on day 1 is associated with low incidence of CINV for patient receiving MEC. Aprepitant is effective as a secondary treatment line for patients who do not response to the first-line antiemetic.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)

Even with the use of standard antiemetics (steroid, %HT3 RAs) with patient receiving MEC, some patients still experience CINV. Failing to be free of nausea and vomiting negatively affect patients’ quality of life and therefore required additional therapy (aprepitant).