Yeo, W., Mo, F.K., Suen, J.J., Ho, W.M., Chan, S.L., Lau, W., … Zee, B. (2009). A randomized study of aprepitant, ondansetron and dexamethasone for chemotherapy-induced nausea and vomiting in Chinese breast cancer patients receiving moderately emetogenic chemotherapy. Breast Cancer Research and Treatment, 113, 529–535. 

To compare the efficacy of an aprepitant-based antiemetic regimen and a standard antiemetic regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) in Chinese patients with breast cancer receiving a first cycle of moderately emetogenic chemotherapy (MEC) and to compare patient-reported quality of life (QOL) among all patients

Chemotherapy naïve patients with breast cancer receiving adjuvant AC chemotherapy were assigned to either an aprepitant-based regimen (day 1: 125 mg aprepitant, 8 mg ondansetron, and 12 mg dexamethasone before chemotherapy and 8 mg ondansetron 8 hours later; days 2-3: 80 mg aprepitant four times a day) or a control arm (day 1: 8 mg ondansetron and 20 mg dexamethasone before chemotherapy and 8 mg ondansetron 8 hours later; days 2-3: 8 mg ondansetron twice daily).

• The sample consisted of 124 participants.
• Mean age (range) for the aprepitant group was 46.5 years (32–66 years) and, for the control group, 48.5 years (26–68 years).
• All of the patients were female (100%).
• Diagnoses were 94% invasive ductal carcinoma, 1.6% invasive lobular carcinoma, and 5% other.
• Cancer stages were 22% stage I, 50% stage II, 18% stage IIIa, and 9% stage IIIb.
• Patients had to be ethnic Chinese females older than 18 years with a life expectancy of four months or more and a Karnofsky score of 60 or more.
• Both groups had slight differences in history of motion sickness and vomiting during pregnancy.

The study was conducted at a single site in China.

All study participants were in active treatment.

This was a randomized, double-blind placebo-controlled study.

• Patient diaries were used to monitor the antiemetic efficacy for 120 hours following chemotherapy infusion. Vomiting episodes and the use of rescue therapy were recorded on days 1–6, and daily nausea ratings (based on a visual analogue scale [VAS]) were recorded on days 2–6.
• The Functional Living Index, an emesis questionnaire (Chinese version), was completed immediately after the patients completed the diary on day 6. It contained nine items in both the nausea and vomiting domains.
• Adverse events were collected according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTAE).
• Data on nausea, vomiting, and the use of rescue medication were collected with self-report diaries, and patient QOL assessment was self-administered.

• In the overall timeframe (0–120 hours) in cycle 1, no significant differences in symptoms were found.
• The requirement of rescue medication appeared to be less in the aprepitant group than the control group (11% versus 20%; p = 0.06).
• No significant difference was found in the median time to first vomiting and nausea domain.
• Both treatment arms were generally well tolerated.

The addition of aprepitant to ondansetron and dexamethasone for CINV did not have a definitive superiority over the existing regimen in Chinese patients with breast cancer; however the addition of aprepitant reduced the requirement of rescue medication and resulted in significantly better QOL.

• Cultural and traditional Chinese medicine influences may have influenced the study outcomes.
• No reporting was given on of how often patients needed to take the rescue therapy, metoclopramide, which may have influenced outcomes.
• Limited generalizability of study findings exists because of the homogenous sample population.
• The standard “control” regimen only included dexamethasone on day 1.

The addition of aprepitant to ondansetron and dexamethasone for CINV in Chinese patients with breast cancer receiving MEC may have some effect in improving QOL and reducing the requirement for rescue medication.