Researchers involved in an international randomized study have reported that cancer patients receiving Rezonic™ (casopitant) in addition to Zofran® (ondansetron) and dexamethasone have better control of chemotherapy-induced nausea and vomiting (CINV) than patients receiving only Zofran and dexamethasone. The details of this study appeared in an early online publication on May 11, 2009 in Lancet Oncology.[1]
Rezonic is a new oral and parenteral neurokinin 1 (NK-1) antagonist that has been in clinical trials for prevention of CINV since 2005. However, this drug is not yet approved for this purpose by the U.S. Food and Drug Administration. Most studies of Rezonic have involved combinations of agents (usually Zofran and dexamethasone).[2] Previous studies have suggested that the addition of Rezonic to Zofran and dexamethasone increases the complete response rate from 70% to 80% following moderately emetogenic chemotherapy and from 60% to 80% following highly emetogenic chemotherapy (HEC). The major effect of Rezonic in previous studies has been a decrease in incidence and severity of delayed nausea and vomiting.
The current study was carried out in 77 centers in 22 countries. All 810 patients in this trial were receiving multiple cycles of cisplatin-based HEC. All patients received Zofran and dexamethasone and were randomly allocated to receive: 1) placebo, 2) a single oral dose of Rezonic, or 3) 3 days of intravenous plus oral Rezonic. The following table summarizes the main findings of this trial:
Table 1: Placebo, Single-dose Rezonic, and Three-day Rezonic for Control of Nausea and Vomiting
| Placebo | Single-dose Rezonic | 3-day Rezonic |
Number of Patients | 269 | 271 | 270 |
Complete Response-Cycle 1 HEC | 66% | 86% | 80% |
Adverse Events | 73% | 77% | 75% |
| | | |
The better control of nausea and vomiting extended over all cycles of chemotherapy. These authors concluded: “A three-drug regimen including a single oral dose or 3-day intravenous plus oral regimen of casopitant mesylate plus dexamethasone and ondansetron significantly reduced CINV events in patients receiving HEC compared with a two-drug regimen of dexamethasone and ondansetron.”
Comments: It is of interest that a single dose of oral Rezonic appeared to be as effective as a three-day regimen.
References:
[1] Grunberg SM, Rolski J, Strauss J, et al. Efficacy and safety of casopitant mesylate, a neurokinin 1 (NK1)-receptor antagonist, in prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy: a randomised, double-blind, placebo-controlled trial. Lancet Oncology [early online publication]. May 8, 2009.
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