Fosaprepitant safe and effective for chemo-induced nausea in kids

Last Updated: 2018-06-07

By Rob Goodier

NEW YORK (Reuters Health) - Intravenous fosaprepitant is safe for children and effective at reducing chemotherapy-induced vomiting, according to results from a phase 3 trial.

"Based on our study, fosaprepitant should become the standard of care for preventing vomiting in children receiving chemotherapy," Dr. Venkatraman Radhakrishnan of the Cancer Institute in Chennai, India, told Reuters Health by email.

The findings were presented June 2 at the American Society of Clinical Oncology's annual conference in Chicago.

Dr. Radhakrishnan and colleagues enrolled 135 pediatric patients ages 1-12 years who were undergoing chemotherapy and randomly assigned them to receive an injection of fosaprepitant (3 mg/kg) or placebo. Both groups received ondansetron (0.15 mg/kg) and dexamethasone (0.075 mg/kg).

The treatment arm achieved complete response, defined as no vomiting, at significantly higher rates in all three time periods studied.

In the acute phase, at 0-24 hours after administration of the drug, the treatment arm had an 84% complete-response rate, compared to 57% with placebo. In the delayed phase, from 25-120 hours, 79% of the treatment arm had a complete response, compared to 51%. Overall, the response rate was 69% with fosaprepitant versus 42% with placebo (P=0.0014).

Three patients in the treatment arm (4%) and 14 in the placebo arm (21%) needed rescue antiemetics (P=0.004).

The researchers say they found no "fosaprepitant related grade 3-4 adverse events."

As a prodrug, fosaprepitant is converted in the body into aprepitant, an anti-emetic compound that blocks the neurokinin-1 receptor. Aprepitant (Emend, Merck & Co.) is also administered for nausea linked to chemotherapy. As an oral pill, however, Dr. Radhakrishnan believes it may be hard for children to swallow, whereas the injectable fosaprepitant may be easier and requires only a single dose.

"Fosaprepitant is also useful in children who are vomiting and therefore will not be able to retain aprepitant," the researchers write in their abstract.

The U.S. Food and Drug Administration has approved oral aprepitant and injectable fosaprepitant for children and adults. Merck markets the latter formulation as Emend for Injection in the U.S. and as Ivemend in the U.K.

The researchers report no conflicts of interest.

SOURCE: https://bit.ly/2sDY1GF

ASCO 2018.