1097-0142/asset/cover.gif?v=1&s=a7299bc18f075294c232ade468773cd0672bd470 "Cancer")
Dr. Eisenberg has participated in clinical trials and received consulting fees and honoraria from Helsinn Healthcare SA (Lugano, Switzerland), MGI Pharma (Bloomington, Minnesota), GlaxoSmithKline (Research Triangle Park, North Carolina), Merck (Whitehouse Station, New Jersey), Roche (Basel, Switzerland), and Aventis Pharmaceuticals (Bridgewater, New Jersey). Dr. Cartmell is a clinical investigator for MGI Pharma. Dr. Macciocchi is an employee of Helsinn Healthcare SA. Dr. Grunberg is a consultant to Helsinn Healthcare SA and has received honoraria from MGI Pharma.
1097-0142/asset/olbannerleft.gif?v=1&s=ca681f5719430b26e1bc15e9ea4c9fc0a7110104)
1097-0142/asset/olbannerright.gif?v=1&s=8142566facf7e76aef9be6c51162a2e920b3b9f9)
Original Article
You have full text access to this OnlineOpen article
Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist
Results of a Phase III, single-dose trial versus dolasetron
Article first published online: 16 OCT 2003
DOI: 10.1002/cncr.11817
Copyright © 2003 American Cancer Society
Additional Information
How to Cite
Eisenberg, P., Figueroa-Vadillo, J., Zamora, R., Charu, V., Hajdenberg, J., Cartmell, A., Macciocchi, A. and Grunberg, S. (2003), Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist. Cancer, 98: 2473–2482. doi: 10.1002/cncr.11817
Publication History
- Issue published online: 17 NOV 2003
- Article first published online: 16 OCT 2003
- Manuscript Accepted: 1 SEP 2003
- Manuscript Revised: 11 AUG 2003
- Manuscript Received: 5 MAY 2003
Funded by
- Helsinn Healthcare SA
- Abstract
- Article
- References
- Cited By
Keywords:
- palonosetron;
- 5-HT3 receptor antagonist;
- antiemetic;
- chemotherapy-induced nausea and vomiting;
- dolasetron
Abstract
BACKGROUND
Palonosetron, a highly selective and potent 5-HT3 receptor antagonist with a strong binding affinity and a long plasma elimination half-life (approximately 40 hours), has shown efficacy in Phase II trials in preventing chemotherapy-induced nausea and vomiting (CINV) resulting from highly emetogenic chemotherapy. The current Phase III trial evaluated the efficacy and safety of palonosetron in preventing acute and delayed CINV after moderately emetogenic chemotherapy.
METHODS
In the current study, 592 patients were randomized to receive a single, intravenous dose of palonosetron 0.25 mg, palonosetron 0.75 mg, or dolasetron 100 mg, 30 minutes before receiving moderately emetogenic chemotherapy. The primary efficacy endpoint was the proportion of patients with a complete response (CR; defined as no emetic episodes and no rescue medication) during the first 24 hours after chemotherapy. Secondary endpoints included assessment of prevention of delayed emesis (2–5 days postchemotherapy).
RESULTS
In the current study, 569 patients received study medication and were included in the intent-to-treat efficacy analyses. CR rates during the first 24 hours were 63.0% for palonosetron 0.25 mg, 57.1% for palonosetron 0.75 mg, and 52.9% for dolasetron 100 mg. CR rates during the delayed period (24–120 hours after chemotherapy) were superior for palonosetron compared with dolasetron. Adverse events (AEs) were mostly mild to moderate and not related to study medication, with similar incidences among groups. There were no serious drug-related AEs.
CONCLUSIONS
A single dose of palonosetron is as effective as a single dose of dolasetron in preventing acute CINV and superior to dolasetron in preventing delayed CINV after moderately emetogenic chemotherapy, with a comparable safety profile for all treatment groups. Cancer 2003. © 2003 American Cancer Society.