Combination of olanzapine and aprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients.

Abstract

11577 Background: Olanzapine and Aprepitant have been shown to be a safe and effective agent for the prevention of CINV. This study aims to compare Olanzapine, Aprepitant and their combination in the prevention of CINV. Methods: Prospective randomized controlled study in breast cancer patients receiving doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 chemotherapy. Female patient; age, ≥ 18; chemotherapy naïve; were included. Patients with seizure disorder, brain metastasis were excluded. Olanzapine group received Tablet Olanzapine 10 mg on day 1 to 3. Aprepitant group received Tablet. Aprepitant 125mg on day 1, 80mg on days 2-3. The combination group received Aprepitant 125mg on day 1, 80mg on days 2-3 and Olanzapine 10mg on day 1. All groups received Palnosteron 0.25mg and Dexamethasone 8mg on day 1. The primary end point of the study was complete response (CR) for nausea that is no nausea in the acute, delayed and overall periods. Secondary endpoint was CR for vomiting and no use of rescue drugs in all periods. Beginning with the first day of chemotherapy and daily through day 5, patients were asked to record daily episodes of nausea using a visual analogue scale from 0 to 10, with 0 indicating no nausea and 10 indicating a maximal level of nausea. They were asked to record daily episodes of vomiting (number and time) and the utilization of rescue therapy. Results: A total of 141 patients were evaluated and consented for the study. The median age was 47 years; range 29-80; CR for nausea in the acute period (within 24 hours) was 83%, 63.8% and 78.7% (p=0.078); for the delayed period (days 2-5) 59.6%, 55.3% and 63.8% (p=0.702); for the overall period (0-120 hours) 57.4%, 53.2% and 59.6% (p=0.817) for the Olanzapine, Aprepitant and combination arm respectively. CR for vomiting in the acute period was 91.5%, 91.5% and 97.9.7% (p=0.344); for the delayed period 74.5%, 85.1% and 97.9% (p=0.005); for the overall period 70.2%, 85.1% and 97.9% (p=0.001) for the Olanzapine, Aprepitant and combination arm respectively. There were no Grade 3/4 toxicities. Conclusions: The combination strategy shows trend towards better prevention of CINV. Clinical trial information: CTRI/2017/12/010864.