OLANZAPINE VERSUS APREPITANT IN PATIENTS RECEIVING HIGH-EMETOGENIC CHEMOTHERAPY: INTERIM ANALYSIS OF RANDOMIZED PHASE II TRIAL
Authors: A.A. Rumyantsev, E.V. Glazkova, R.Yu. Nasyrova, E.O. Ignatova, L.V. Chitia, A.S. Popova, Kh.Kh. Elsnukaeva, I.A. Pokataev, A.S. Tyulyandina, M.B. Stenina, M.A. Frolova, A.A. Bulanov, V.Yu. Fedyanin, O.V. Sekhina, A.A. Tryakin, S.A. Tjulandin
Rationale: optimal management of chemotherapy-induced nausea and vomiting (CINV) remains challenging. Olanzapine might provide several benefits over aprepitant which is current standard of care – particularly in terms of nausea control and cost effectiveness. However, undesired sedation associated with recommended doses of olanzapine precludes its wide use in oncology practice.
Aim of the study: to develop effective, low-toxic and affordable regimen for CINV prophylaxis to be used in daily oncology practice.
Material and methods: this was randomized phase II single center study aimed to compare olanzapine and aprepitant in CINV prophylaxis during high emetogenic chemotherapy (HEC). Key inclusion criteria were: chemo- and radio-therapy naive patients, planned administration of HEC (cisplatin, carboplatin AUC≥4, doxorubicin etc). Patients were randomized in 1:1 ratio in the following arms: olanzapine 5 QD day 0-4 or aprepitant 125 mg day 1, 80 mg day 2, 3. All patients received standard therapy with ondansetron and dexamethasone. Primary endpoint was complete nausea control (absence of nausea and no use of rescue medication) during 0–120 hours after chemotherapy. Nausea was assessed using MASCC Antiemesis Tool. Interim analysis was scheduled after enrollment of 49 patients.
Results: on the time of analysis we enrolled 49 patients. The groups were well balanced. The proportion of patients with no chemotherapy-induced nausea was numerically greater with olanzapine than with aprepitant (45,5% and 25,9%; p=0,228). Complete response was achieved in 63,6% and 48,1% patients, respectively (p=0,241). No differences in rates of undesired sedations were detected.
Conclusion: our data suggests superiority of low-dose olanzapine regimen in terms of nausea control and supports the continuation of this study.