Single-dose anti-emetic reduces chemotherapy-induced nausea

Last Updated: 2015-06-04

By Rob Goodier

NEW YORK (Reuters Health) - A single IV dose of fosaprepitant helped reduce chemotherapy-induced nausea and vomiting in a new phase III trial.

Adding the neurokinin-1 (NK1) receptor antagonist to ondansetron and dexamethasone produced a roughly 10% better response compared to the two other drugs alone among patients on moderately emetogenic chemotherapy, according to findings presented May 30 in a poster at the American Society of Clinical Oncology meeting in Chicago.

"The agent is very active in the delayed phase, which is often underdiagnosed," Dr. Bernardo Rapoport, of the Medical Oncology Centre of Rosebank in Johannesburg, South Africa, who gave the presentation, told Reuters Health by email.

In the delayed phase, 25 to 120 hours after treatment, most patients are away from the clinic and can fail to adhere to regimens of oral anti-emetics. As a single dose, however, fosaprepitant would not have adherence problems.

The double-blind, parallel group trial included 1,000 patients, all of whom received 8 mg oral ondansetron and 20 mg dexamethasone before their chemotherapy. Ondansetron, a serotonin (5-HT3) receptor agonist, reduces nausea and vomiting in the acute phase 0-24 hours after chemotherapy, and dexamethasone aids the 5-HT3 regimen.

The patients were then randomized to receive either 150 mg IV fosaprepitant before their first dose of chemotherapy, or a saline infusion.

The control group continued to take oral ondansetron eight hours after the first dose and then every 12 hours on days two and three. The treatment group, on the other hand, did not take any further anti-emetic medication.

Nearly 79% of the treatment group achieved the trial's primary endpoint of no vomiting and no need for rescue medication, compared to 68.5% of the control group.

The difference of 10.4% is statistically significant (p<0.001), the researchers say.

"It's good level-one data to support what most of us are doing already," Dr. Jyoti Patel, associate professor of medicine at Northwestern University in Chicago, who was not involved in the research, told Reuters Health by email.

Three of the nine authors have financial relationships with Merck, which markets fosaprepitant as Emend.

SOURCE: http://bit.ly/1H5mYfT

Am Soc Clin Oncol 2015.