Real-world effectiveness and safety of ondansetron oral soluble film for the prevention of chemotherapy-induced nausea and vomiting.

Abstract

e24079 Background: Chemotherapy-induced nausea and vomiting (CINV) are significant adverse effects that compromise patient adherence and quality of life. Ondansetron oral soluble film is a rapidly absorbed formulation that may improve patient convenience and antiemetic adherence. This study aimed to evaluate the real-world effectiveness and safety of ondansetron oral soluble film for CINV prevention. Methods: This multi-center, real-world study included patients undergoing chemotherapy who received ondansetron oral soluble film for at least three days. Dosing was determined based on clinical practice guidelines. For high emetic risk chemotherapy, patients received 24 mg ondansetron oral soluble film (administered as 8 mg per dose, three times) orally, starting 30 minutes before chemotherapy. For moderate emetic risk chemotherapy, patients received 8 mg ondansetron oral soluble film twice daily: the first dose 30 minutes before chemotherapy and the second dose eight hours later. Patients continued taking 8 mg ondansetron oral soluble film twice daily for 1-2 days after completing chemotherapy. The primary outcomes were the incidence and severity of nausea and vomiting within 24 hours post-chemotherapy. Results: A total of 988 patients were included, with a median age of 63 years (interquartile range: 54-70). The majority were male (59.8%). The Eastern Cooperative Oncology Group performance status was 0 or 1 in 68.0% of patients. A history of tobacco and alcohol use was reported by 26.2% of patients. The most common tumor types were lung cancer (23.5%) and esophageal cancer (7.5%). Chemotherapy regimens with moderate and high emetic risk accounted for 50.4% and 27.0% of treatments, respectively. Only 2.8% of patients underwent combined radiotherapy. Motion sickness and anxiety were each reported in 0.6% of patients. Within the first 24 hours post-chemotherapy, 62.2% of patients experienced no nausea, 28.1% reported mild nausea, 6.9% moderate nausea, and 0.7% severe nausea. Regarding vomiting, 80.4% of patients reported no episodes, 13.1% had 1-2 episodes, 3.2% had 3-5 episodes, and 0.3% experienced ≥6 episodes. A total of 15.6% of patients reported at least one treatment-related adverse event, with the most being fatigue (6.1%), constipation (4.4%), dizziness (4.4%), and dry mouth (4.3%). Conclusions: Ondansetron oral soluble film demonstrated robust effectiveness in controlling CINV, with over 80% of patients reporting no vomiting within the first 24 hours of chemotherapy. The majority of patients tolerated the treatment well, with mild and manageable adverse events. These findings support the use of ondansetron oral soluble film as an effective and convenient option for CINV prevention in clinical practice.