Quality of life (QOL) for breast cancer patients receiving aprepitant versus placebo for prevention of chemotherapy induced nausea and vomiting

Abstract

20549 Background: A Phase III randomized, double-blind placebo controlled trial was done to determine if there is a favourable QOL outcome for patients receiving aprepitant for the prevention of chemotherapy-induced nausea and vomiting (adriamycin 60 mg/m2 + cyclophosphamide 600 mg/m2). Methods: 80 breast cancer patients were entered with 40 in the study treatment arm (aprepitant 125mg; ondansetron 8mg x 2 doses; dexamethasone 20mg on day 1 and aprepitant 80mg QD day 2–3) and 40 patients in the control arm (ondansetron 8mg x 2 doses; dexamethasone 12mg on day 1, and ondansetron 8mg every 12 hours on days 2–3). The QLQ-C30 and FLIE were completed prior to chemotherapy and at the end of day 5. A change score from baseline to day 5 was used in the analysis. Results: The average nausea scores captured by 100 mm visual analog scale between placebo and aprepitant arms were not significant (16.5 vs. 12.8, p=0.554). However, in cycle 1 the QLQ-C30 NV subscale (40.3 vs 20.4, p=0.0066) and appetite loss (57.4 vs 33.3, p=0.0023) were significantly different in favour of aprepitant arm. There were no significant difference with respect to global QOL (-19.9 vs -12.2, p=0.1633). The FLIE nausea subscale (40.1 vs 30.6, p=0.3214) were not significant, but FLIE vomiting subscale (30.4 vs 3.1, p=0.0001) and FLIE overall score (35.3 vs 16.8, p=0.0289) were significant in favour of study treatment. For cycles 2 and 3, we have 36 and 38 patients in the control and study treatment arms respectively. Similar results were found in the FLIE subscales and overall score. Conclusions: There is a significant benefit for the study treatment with respect to QLQ-C30 QOL NV subscale, which is a combined measure on nausea and vomiting. FLIE overall score is an aggregate measurement of 18 items and reflects a significant benefit in favour of aprepitant arm. The majority of treatment effect was due to FLIE vomiting subscale but not FLIE nausea subscale reflecting that aprepitant may provide better control to vomiting than nausea. Study supported by Merck Sharp & Dohme (Asia) Ltd. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Merck Sharp & Dohme (Asia) Ltd.