Olanzapine is more effective than placebo, in combination with a 5-HT3-receptor antagonist and an NK1-receptor antagonist, in preventing nausea in patients undergoing chemotherapy, according to investigators.
“This large, randomized, double-blind, placebo-controlled, phase III trial showed that it is more effective to combine olanzapine than placebo with an NK1-receptor antagonist, a 5-HT3–receptor antagonist, and dexamethasone for the prevention of nausea and vomiting in patients who have not received previous chemotherapy but are currently receiving highly emetogenic chemotherapy,” reported Rudolph Navari, MD, PhD, of the World Health Organization, Geneva, and his associates (N Engl J Med. 2016;375:134-42).
©monkeybusinessimages/ thinkstockphotos.com
©monkeybusinessimages/thinkstockphotos.com
Patients were randomized to receive olanzapine or the placebo, along with a 5-HT3-receptor antagonist (either palonosetron intravenously, granisetron intravenously or orally, or ondansetron intravenously or orally) and an NK1-receptor antagonist (fosaprepitant intravenously or aprepitant orally). The olanzapine (n = 192) and placebo (n = 188) groups were balanced with respect to age, race, sex, and chemotherapy administered.
Patients kept daily records of nausea and episodes of vomiting. The proportion of patients who reported no nausea or who experienced no clinically significant nausea was significantly greater in the olanzapine group than in the placebo group (37% vs. 22%, P = .002 and 67% vs. 49%, P = .001).
Patients receiving olanzapine had significantly increased sedation (severe in 5%) on day 2 compared with baseline, Dr. Navari and his associates reported. The sedation resolved on days 3, 4, and 5 even though patients continued to receive the drug on days 3 and 4. No patients discontinued the study because of sedation.
The National Cancer Institute funded the study. One investigator reported receiving financial support from Merck and Co. The other investigators reported having no disclosures.
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