Olanzapine versus aprepitant in the prevention of chemotherapy induced nausea and vomiting (CINV) in breast cancer patients.

Abstract

e21670 Background: Olanzapine has been shown to be a safe and effective agent for the prevention of CINV. This study aims to compare olanzapine with aprepitant in the prevention of CINV. Methods: This study included breast cancer patients receiving doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 chemotherapy. Female patient; age, ≥ 18; chemotherapy naïve; no nausea/ vomiting in the past 24 hours were included. Patients with seizure disorder, brain metastasis, prior use of antipsychotic agents and hypersensitivity to olanzapine were excluded. Patients were randomized into two groups. Olanzapine group received tab olanzapine 10 mg on day 1 to 3. Aprepitant group received tab.aprepitant 125mg on day 1 and 80mg on days 2-3. Both groups received inj palnosteron 0.25mg, inj dexamethasone 8mg on day 1. Use of rescue therapy for nausea or vomiting was permitted. The primary end point of the study was complete response (CR) for nausea that is no nausea in the acute (within 24 hours), delayed (days 2-5), and overall periods (0-120 hours). 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 84 patients (42 in each arm) were evaluated and consented for the study. The median age 48 years; range 29-80; ECOG PS - 0, 1. CR for nausea was 84% for the acute period , 58% for the delayed period and 56% for the overall period for the olanzapine group. CR for nausea in aprepitant group was 69% acute period, 55% delayed period, and 55% for the overall period. CR for vomiting was 91% acute; 74% delayed; 70% overall period for olanzapine group. CR for vomiting in aprepitant group was 91% acute; 83% delayed; 83% overall period. There were no Grade 3 /4 toxicities. Conclusions: Olanzapine is better in the prevention of nausea. However aprepitant is better in the prevention of vomiting. Combination of these two agents needs to be studied in future studies.

Olanzapine for the prophylaxis and rescue of chemotherapy-induced nausea and vomiting: a systematic review, meta-analysis, cumulative meta-analysis and fragility assessment of the literature

“…Three studies reported on olanzapine for the rescue of breakthrough CINV [ 42 – 44 ]; 22 studies reported on olanzapine in the prophylactic setting [ 45 – 66 ]. Only seven studies (one reporting on rescue of breakthrough CINV, and six reporting on prophylactic CINV) had no corresponding full-text articles [ 42 , 48 , 53 , 55 , 56 , 60 , 61 ]. One study reported on olanzapine for children [ 48 ].…”

“…Among the adult prophylactic studies, 15 reported exclusively on HEC patients [ 46 , 49 – 52 , 55 , 56 , 58 , 60 – 66 ], three exclusively on MEC patients [ 53 , 57 , 59 ], and three on a patient population that consists of both HEC and MEC patients [ 45 , 47 , 54 ]. Eight studies compared olanzapine to a double-blind placebo-controlled regimen [ 47 , 52 , 59 , 62 – 66 ] and thirteen used an opened controlled study design—nine studies used a control arm with antiemetics different from the antiemetics in the investigational (olanzapine-containing) arm [ 46 , 49 , 51 , 53 , 55 , 56 , 58 , 60 , 61 ] and four used a control arm with the same antiemetics as in the investigational (olanzapine-containing) arm except for olanzapine [ 45 , 50 , 54 , 57 ]. 17 adult prophylactic studies used 10 mg doses of olanzapine [ 45 , 46 , 49 – 59 , 61 , 62 , 65 , 66 ], and 3 studies used 5 mg [ 47 , 60 , 63 ]; 1 used a mix of 5 mg and 10 mg [ 64 ] (Table 1 ).…”