Meeting: 2009 ASCO Annual Meeting
Title: A randomized pilot study comparing aprepitant to olanzapine for treatment of chemotherapy-induced nausea and vomiting.


Background: Chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC) is prevalent. The NK1 antagonist, aprepitant (APR), has been shown to decrease CINV and with increased use, cost of supportive care is rising. Recent studies have shown that olanzapine (OLN) is safe and effective for CINV when used in combination with dexamethasone and palonosetron. We conducted a randomized, double-blind, placebo controlled pilot study to evaluate the use of OLN compared to APR for prevention of CINV in patients receiving HEC. Methods: Chemotherapy nave patients receiving HEC were randomized to an APR containing arm or an OLN containing arm [see Table] for the first 2 cycles of treatment. Patients recorded episodes of emesis and use of rescue meds using a daily diary and symptoms using the M.D. Anderson Symptom Inventory(MDASI). 18 patients consented to the protocol and 17/18 (OLN=8, APR=9) patients were evaluable (1 lost daily diary) with a median age 60 (range 24-71) 11/18 were females. Results: Chemo regimens for OLN group included (AC=50%, cisplatin=25%, ABVD=25%, and ifos=25%) and for APR (AC=55%, cisplatin=33%, and ABVD=11%) For both cycles (C1+C2) the complete response (CR=no emesis, no rescue) during the anticipatory period (D-2, D-1) was 87.5% in the OLN group compared to 77.8% in the APR group. Acute period (D1) CR rates were 75% in OLN vs. 44% in the APR group. Delayed (D2-4) CR rates were 62.5% in OLN vs. 55.6% in the APR group. Rates of nausea (score 1 on scale of 0-10, MDASI) were 25% OLN vs. 22.2% APR for anticipatory period, 62.5% OLN vs. 44.4% APR for acute period, and 62.5% OLN vs. 66.7% APR for delayed period. There were no grade 3 /4 toxicities. Conclusions: OLN containing antiemetic regimens were well tolerated and offered similar efficacy as APR containing regimens in preventing CINV in patients receiving HEC. Larger studies are needed to evaluate non-inferiority and potential cost savings of OLN containing regimens. Treatment arms D-2D-1D1D2D3D4 Standard armPlaceboPlaceboAprepitant 125mg po Decadron 12mg IV Palonosetron .25mg IVAprepitant 80mg po Decadron 4mg po bidAprepitant 80mg po Decadron 4mg po bidPlacebo Decadron 4mg po bid Experimental armOlanzapine 5mg poOlanzapine 5mg poOlanzapine 10mg po Decadron 12mg IV Palonosetron .25mg IVOlanzapine 10mg po Decadron 4mg po bidOlanzapine 10mg po Decadron 4mg po bidOlanzapine 10mg po Decadron 4mg po bidTreatment medications were blinded from patients and providers using black gel capsules