Olanzapine versus aprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV): A randomized phase III trial.

Abstract

9020 Background: Olanzapine (OLN) has been shown to be a safe and effective agent for the prevention of CINV. In combination with other antiemetics, aprepitant (APR) has been approved for the prevention of acute and delayed CINV in patients receiving highly emetogenic chemotherapy (HEC). Methods: A phase III trial was performed for the prevention of CINV in chemotherapy naïve patients receiving HEC (cisplatin, ≥70 mg/m2 or doxorubicin, ≥50 mg/m2) comparing OLN to APR in combination with palonosetron (PALO) and dexamethasone (DEX). The OLN regimen was 10 mg of oral OLN, 0.25 mg of intravenous (IV) PALO, and DEX 20 mg IV on the day of chemotherapy, day 1, and 10 mg/day of oral OLN alone on days 2-4 after chemotherapy. The APR regimen was 125 mg of oral APR, 0.25 mg IV PALO, and 12 mg IV DEX, day 1, and 80 mg oral APR, 4 mg DEX BID, days 2-3. Fifty patients (median age 58 yrs, range 39-81; 29 females; ECOG PS 0,1) consented to the protocol and all were evaluable. Results: Complete response (CR) (no emesis, no rescue) was 100% for the acute period (24 h post-chemotherapy), 75% for the delayed period (days 2-5 post-chemotherapy), and 75% for the overall period (0-120 h) for 27 patients receiving the OLN regimen. CR was 87% for the acute period, 70% for the delayed period, and 70% for the overall period in 23 patients receiving the APR regimen. Patients without nausea (0, scale 0-10, M.D. Anderson Symptom Inventory) was: OLN: 88%, acute; 65%, delayed; and 65%, overall; APR: 88%, acute; 38%, delayed; and 38% overall. There were no Grade 3 or 4 toxicities. CR and control of nausea in subsequent cycles of chemotherapy (45 patients, cycle 2; 41 patients cycle 3; 33 patients, cycle 4) were equal to or greater than cycle one for both regimens. Conclusions: OLN was comparable to APR in the control of CINV in patients receiving HEC. Nausea was better controlled with OLN. No significant financial relationships to disclose.