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Annals of Oncology Advance Access published online on June 9, 2006
Annals of Oncology, doi:10.1093/annonc/mdl137
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© 2006 European Society for Medical Oncology
Received May 3, 2006
Accepted May 10, 2006

original article

A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy

M. S. Aapro 1, S. M. Grunberg 2, G. M. Manikhas 3, G. Olivares 4, T. Suarez 5, S. A. Tjulandin 6, L. F. Bertoli 7, F. Yunus 8, B. Morrica 9, F. Lordick 10, and A. Macciocchi 11 *

1 IMO, Clinique de Genolier, Genolier, Vaud, Switzerland
2 University of Vermont, Burlington, Vermont, USA
3 St. Petersburg Oncology Center, St. Petersburg, Russia
4 Centro Medico La Raza, IMSS, Mexico City, Mexico
5 Centro Anticanceroso de Mérida, Merida, Yucatan, Mexico
6 Russian Oncology Center n.a. Blokhin, Moscow, Russia
7 Southern Hematology and Oncology, Birmingham, Alabama, USA
8 The Boston Cancer Center Group, Memphis, Tennessee, USA
9 Presidio Ospedaliero di Cremona, Cremona, Italy
10 Klinikum rechts der Isar, Technische Universität München, Munich, Germany
11 Helsinn Healthcare, SA, Lugano, Switzerland

* To whom correspondence should be addressed.
A. Macciocchi, E-mail: gpi{at}helsinn.com


  Abstract

Background: This pivotal phase III trial evaluated the efficacy and safety of palonosetron in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) following highly emetogenic chemotherapy (HEC).

Patients and methods: Patients were randomized to a single intravenous dose of palonosetron 0.25 mg or 0.75 mg, or ondansetron 32 mg prior to HEC. Dexamethasone pre-treatment (with stratification) was used at investigator discretion. The primary efficacy endpoint was the proportion of patients with complete response (CR) during the first 24 h post-chemotherapy (acute phase).

Results: In the intent-to-treat analysis (n = 667), palonosetron 0.25 mg and 0.75 mg were at least as effective as ondansetron in preventing acute CINV (59.2%, 65.5%, and 57.0% CR rates, respectively); CR rates were slightly higher with palonosetron than ondansetron during the delayed (24-120 h) and overall (0-120 h) phases. Two thirds of patients (n = 447) received concomitant dexamethasone. Patients pre-treated with palonosetron 0.25 mg plus dexamethasone had significantly higher CR rates than those receiving ondansetron plus dexamethasone during the delayed (42.0% versus 28.6%) and overall (40.7% versus 25.2%) phases. Palonosetron and ondansetron were well tolerated.

Conclusions: Single-dose palonosetron was as effective as ondansetron in preventing acute CINV following HEC, and with dexamethasone pre-treatment, its effectiveness was significantly increased over ondansetron throughout the 5-day post-chemotherapy period.

Keywords: chemotherapy-induced nausea and vomiting; emesis; 5-HT3 receptor antagonist; highly emetogenic chemotherapy; palonosetron.
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