Annals of Oncology Advance Access originally published online on June 9, 2006
Annals of Oncology 2006 17(9):1441-1449; doi:10.1093/annonc/mdl137
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© 2006 European Society for Medical Oncology
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A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy
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
Correspondence to: Dr A. Macciocchi, c/o Gaia Piraccini, Helsinn Healthcare, SA via Pian Scairolo 9, 6912 Pazzallo (Lugano), Switzerland. Tel: +41-91-985 21 21; Fax: +41-91-993 21 22; E-mail: gpi{at}helsinn.com
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.
Key words: chemotherapy-induced nausea and vomiting, emesis, 5-HT3 receptor antagonist, highly emetogenic chemotherapy, palonosetron
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