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Adding Zyprexa to ondansetron cut nausea and vomiting safely in abdominal/pelvic radiation with low-emetogenic capecitabine.
Adding Zyprexa to ondansetron cut nausea and vomiting safely in abdominal/pelvic radiation with low-emetogenic capecitabine.
Among patients receiving abdominal/pelvic radiotherapy or concurrent chemoradiation with low-emetogenic oral capecitabine, the addition of Zyprexa (olanzapine) to standard antiemetics may safely and effectively prevent radiation-induced nausea and vomiting (RINV), according to data from a phase 3 placebo-controlled trial presented at 2025 ASCO Annual Meeting.
Safety data from the trial revealed that among patients assigned to receive 5 mg of Zyprexa (148 patients) versus placebo (153 patients), nausea occurred in 14.2% and 83.6%, respectively. Additionally, the incidence of grade 2 (moderate) or greater nausea was 67.3% versus 7.4% with placebo versus olanzapine.
Additionally, vomiting was also reduced with olanzapine; 25.5% of the placebo group and 4.1% of the experimental group experienced any-grade vomiting. Furthermore, the incidence of grade 2 or higher vomiting was 7.8% versus 1.3% in each respective arm. Further data showed that the addition of Zyprexa also reduced the total number of vomiting episodes among patients receiving radiotherapy, with 16.3% of the standard group experiencing 1 to 15 episodes versus 2% of the experimental group; 9.2% versus 2% of each arm experienced more than 15 episodes.
The incidence of grade 2 or higher nausea was also significantly lower for patients across a variety of cancer types. In patients with endometrial cancer, 85.7% of the placebo group and 2.8% of the experimental group experienced grade 2 or higher nausea. The respective rates for endometrial, stomach/pancreatic, and prostate cancers were 92.9% versus 0%, 100% versus 40%, and 19.1% versus 8.7%.
Radiation-induced nausea and vomiting (RINV): nausea and vomiting caused by radiation therapy, particularly in abdominal or pelvic areas.
Antiemetics: medications used to prevent or treat nausea and vomiting.
Quality of life (QOL): a measure of a patient's overall well-being and ability to perform daily activities.
“The addition of 5 mg Zyprexa to standard ondansetron therapy is found to be safe and effective for preventing nausea and vomiting in patients receiving abdominal/pelvic radiation therapy, and those undergoing concurrent chemoradiation with low-emetogenic oral capecitabine,” Meenu Vijayan, MPharm, assistant professor at the Amrita School of Pharmacy, said in the presentation. “Our study was a single-center study. Future studies involving multiple centers and a large number of patients are recommended to corroborate our findings.”
Patients 18 years or older who were receiving abdominal/pelvic radiotherapy and were previously radiotherapy naïve were randomly assigned to receive 4 milligrams of twice daily ondansetron (Zofran) and either 5 mg of oral daily Zyprexa or matching placebo. The study assessed efficacy and safety using the Common Terminology Criteria for Adverse Events (CTCAE) scale, including a nausea and vomiting diary, as well as anxiety and depression using the Hamilton Rating Scale, and quality of life (QOL) using the EORTC QLQ C30 questionnaire.
Patients in the standard and experimental groups, respectively, had a mean age of 63.82 versus 62.32, 58.2% versus 62.8% were males, and 67.3% versus 70.3% had comorbidities. Furthermore, 18.3% versus 19.6% had a history of smoking, 24.8% versus 23% had a history of alcohol, and 50.3% versus 54.7% had a family history of cancer in respective groups. In total, 56.9% versus 53.4% of each group received concurrent capecitabine and 30.7% versus 31.1% received hormone therapy.
The most common cancer types in the standard and experimental groups included rectal cancer (50.3% versus 48.6%), prostate cancer (30.7% versus 31.1%), and endometrial cancer (9.2% versus 9.5%). The most common type of radiotherapy was image-guided radiation therapy (88.9% versus 83.1%) and the most common radiotherapy site was the pelvic area (91.5% versus 93.2%). Patients in each group received a mean dose of 222.58 Gy/day versus 222.01 Gy/day, with a mean duration of 23.67 days versus 23.76 days.
Additional findings from the trial revealed that treatment with Zyprexa reduced mean anxiety scores versus placebo. A similar trend was observed for mean depression scores. Additionally, mean changes in QOL score in the functional scale from baseline to radiotherapy universally favored the experimental, particularly for emotional functioning. This trend was observed in the symptom scale as well, with significant improvements noted in nausea/vomiting, insomnia, and loss of appetite.
“Phase 3 randomized placebo-controlled trial on repurposing Zyprexa for prevention of radiotherapy-induced nausea and vomiting (RINV)” by Dr. M. Vijayan, et al., Journal of Clinical Oncology.
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