A phase three clinical trial directed by Rudolph M. Navari, director of the University of Notre Dame’s Walther Cancer Institute, demonstrated that a novel combination of drugs appears to be very successful in preventing chemotherapy-induced nausea and vomiting.
Navari points out that chemotherapy-induced nausea and vomiting is associated with a significant deterioration in the quality of life of cancer patients and is perceived by patients as a major adverse effect of chemotherapy.
In the study, a combination of the drugs olanzapine, palonosetron and dexamethasone was compared to a combination of the drugs aprepitant, palonosetron and dexamethasone in controlling both acute and delayed chemotherapy-induced nausea and vomiting in 61 patients.
In previous studies, Navari and researchers working with him have shown that olanzapine was highly effective in controlling chemotherapy’s most common side effects.
The new study demonstrated that nausea was better controlled with the olanzapine regimen in the initial 24 hours after chemotherapy (acute phase) and during days two to five post-chemotherapy (delayed phase).
Olanzapine, which carries the brand name Zyprexa, has been used since the 1990s to treat schizophrenia and other psychoses.
“What distinguishes the olanzapine regimen is the ability to drop out the steroids after chemo,” said Steven D. Passik, associate attending psychologist at Memorial Sloan-Kettering Cancer Center and associate professor of psychology in psychiatry at Weill Cornell Medical College. “Not only was the regimen better for controlling nausea, but the ability to do so without having to give steroids is important. A lot of patients are sensitive to steroids — causing insomnia, agitation and a ‘crash’ for some patients when they are stopped after several days.
“I think the study shows that this can be an alternative regimen that can be used right off the bat, or for patients who have demonstrated problems with steroids in previous cycles. Many patients and oncologists would like to avoid steroids for any number of reasons and this regimen is a safe and effective alternative,” he said.
Navari, who also is director and assistant dean of the Indiana University School of Medicine South Bend, presented the study findings at the Annual International American Society of Clinical Oncology Meeting held June 5 to 8 in Chicago. Notre Dame undergraduates Sarah E. Gray and Andrew Kerr contributed to the study.
The study was funded by the National Cancer Inistitute.
Contact: Rudolph M. Navari, 574-631-3793, rnavari@nd.edu