Palonosetron compared to ondansetron in the prevention of chemotherapy-induced nausea and vomiting: Activity, safety, and cost-effectiveness evaluation

Abstract

e20573 Background: Chemotherapy(CT)-induced nausea and vomiting (CINV) are common adverse effects in cancer patients. The control of CINV is a relevant objective for the patient's quality of life and also aims to optimize cancer treatment. 5-HT3- receptor antagonists (RAs) are commonly used to prevent CINV. Palonosetron, the only second generation 5-HT3-RA, has a significantly longer half-life and a higher binding activity than the first generation of 5-HT3RAs. Methods: To evaluate the activity, safety and farmacoeconomic profile of palonosetron compared to ondansetron as antiemetic prophylaxis for highly (HEC) or moderately (MEC) emetogenic chemotherapy, 235 consecutive chemo-naïve patients (pts) were assigned (1:1) to receive palonosetron 250 mcg i.v. plus dexamethasone 8 mg i.v. 30 min before CT on day 1 (Group A) or ondansetron 8 mg i.v. plus dexamethasone 8 mg i.v. on day 1, followed by 8 mg os twice daily over 3 days (Group B). Results: The 2 treatment groups were comparable with respect to tumour type (breast 52%, lung 20%, colorectal cancer 11%, ovarian 8%, head & neck 5%, other 4%) and emetogenic potential of CT (HEC in 78 pts, AC-based chemotherapy in 123, MEC in 35). FLIE questionnaires were completed on days 2–5. Complete response (CR) rate for the acute period was 82% in pts given HEC in group A versus 63.2% in group B, 93.4 % versus 80.6% in pts given AC and 100% versus 94.4% in pts given MEC. For the delayed period: 74.4% in group A versus 63.2% in group B for pts receiving HEC, 90.2% versus 71% in pts given AC and 94% versus 88.9% in pts given MEC. FLIE analysis showed a reduced impact of CINV on daily life in group A (p<0.05). The pharmacoeconomic evaluation showed favourable cost effectiveness profiles for palonosetron, with a saving of about 50% per cycle/per patient over ondansetron. A not significant reduced incidence of headache and constipation was observed in group A. Conclusions: Palonosetron was effective in preventing CINV following HEC, AC and MEC in both acute and delayed phases, as well as being cost effective. The CR rates were maintained throughout subsequent cycles of CT, with a significant positive impact on daily functioning and quality of life. No significant financial relationships to disclose.