Patients with breakthrough chemotherapy-induced nausea and vomiting (CINV) can gain superior relief from olanzapine (Zyprexa), a drug approved by the US Food and Drug Administration as an antipsychotic, compared with standard antiemetic therapy with metoclopramide. The results from this phase 3 study address an important unmet need for patients who experience these side effects despite being given standard antiemetic therapy.
“Breakthrough CINV usually occurs on day 2 through 4 after chemotherapy, despite guideline-directed prophylaxis. This study found that olanzapine is significantly better than metoclopramide in controlling CINV in this group of patients,” stated lead author Rudolph Navari, MD, PhD, of the University of Indiana in Indianapolis.
Olanzapine achieved superior emesis control at 72 hours: 71% of those receiving olanzapine had no emesis versus 32% of those treated with metoclopramide (P <.01). Patients treated with olanzapine also had significantly im proved control of nausea: 67% of the olanzapine group versus 24% of the metoclopramide group had complete control of nausea (P <.01).
No patient experienced any grade 3 or 4 toxicity, and no central nervous system adverse events were seen in this shortterm study comparing the 2 drugs. Olanzapine is known to have several adverse effects when used as long-term antipsychotic therapy, but Navari emphasized that these effects were not seen with short-term administration of the drug.
“This is the first study to show a treatment is effective in breakthrough CINV,” Navari stated.
The study included 205 chemotherapy-naive patients receiving highly emetogenic chemotherapy who were given standard drugs to control CINV. Of these, 80 experienced breakthrough CINV on standard therapy and were randomized 1:1 to olanzapine 10 mg orally daily for 3 days versus metoclopramide 10 mg TID for 3 days. Patients with breakthrough CINV were ob - served for 72 hours and were asked to fill out a daily diary.
Incoming American Society of Clinical Oncology President Sandra Swain, MD, said, “This study was a reminder that in the era of precision medicine, we still need to improve the patient experience. CINV can be quite limiting. Patients don’t eat and they can be tired. Olanzapine is another tool we now have to treat this side effect.”
Navari RM, Nagy CK, Gray SE. The use of olanzapine versus metoclopramide for the treatment of breakthrough chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy. Presented at: 2012 Annual Meeting of the American Society of Clinical Oncology; June 2012; Chicago, IL. Abstract 9064.