A randomized, controlled trial comparing olanzapine with a standard antiemetic regimen resulted in more patients achieving no vomiting and no rescue medication during the acute, delayed and overall periods.
Results from the PRaCTiCE trial published in the Journal of Clinical Oncology demonstrated that Zyprexa (olanzapine), a second-generation atypical antipsychotic agent, improved nausea and vomiting in children undergoing their first cycle of highly emetogenic (likely to cause nausea/vomiting) chemotherapy.
“The use of this drug with cancer chemotherapy would prevent this dreaded side effect and thereby the quality of life of parent and patients receiving highly emetogenic chemotherapy would improve,” said Dr. Sameer Bakhshi, professor in the department of medical oncology at All India Institute of Medical Sciences in New Delhi, in an interview with CURE®. “Notably, the cost of this drug is also minimal.”
The authors conducted an open-label, parallel-group, randomized, controlled trial of 240 children aged 5 to 18 years with cancer from a tertiary care hospital in New Delhi. All children were had not received chemotherapy before, and were scheduled to undergo their first cycle of highly emetogenic chemotherapy.
“Nausea and vomiting is one of the most dreaded side effects of cancer chemotherapy, and with the current armamentarium of drugs, 45% to 60% of children would be free of vomiting,” said Bakhshi.“This implies that still 40% to 50% of patients would vomit after receiving high emetogenic chemotherapy. Hence, there was a need to find a drug which could reduce this side effect.”
Children were assigned to receive Zyprexa (120 patients; median age, 13 years; 69% boys), administered once per day during the chemotherapy block and for 3 days after completion, or to the control arm (120 patients; median age, 11 years; 76% boys). The assigned treatment was administered by the investigator during the chemotherapy block, and the parent or guardian administered Zyprexa after the block was completed. Both groups received an antiemetic regimen, which included a combination of dexamethasone, ondansetron and aprepitant.
Authors compared complete response in the treatment and control groups during the acute, delayed and overall assessment periods. Complete response was defined as no vomiting episodes and no rescue medication use. The secondary objective included a comparison of patients without nausea during the three periods. Authors also evaluated safety in both groups.
A modified intention-to-treat analysis to assess efficacy included 231 patients, of whom 115 were in the treatment group and 116 were in the control. For this analysis, authors focused on patients who received chemotherapy, received at least one dose of the antiemetic regimen and had at least one outcome after treatment.
More patients assigned Zyprexa achieved complete response compared with the control group during the acute period (78% vs. 59%), delayed period (74% vs. 47%) and overall period (64% vs. 38%). The treatment group also had a higher proportion of patients without nausea vs. the control group during the acute period (74% vs. 52%), delayed period (74% vs. 47%) and overall period (64% vs. 37%).
Grade 1/2 somnolence, or sleepiness, was higher in patients assigned Zyprexa compared with control (35% vs. 11%), although there were no reports of grade 3/4 somnolence.
“Although with this drug, we have reached almost 70% to 75% patients who are free of vomiting with cancer therapy, the goal is 100%, and so more drugs are needed to further decrease this side effect,” said Bakhshi .
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