Researchers from Japan have reported that the combination of Aloxi® (palonosetron) and dexamethasone was as effective as Kytril® (granisetron) and dexamethasone for prevention of acute chemotherapy-induced nausea and vomiting (CINC) but was superior for prevention of delayed CINC. The details of this study appeared in the February 2009 issue of Lancet Oncology.[1]
Aloxi was approved by the U.S. Food and Drug Administration (FDA) in 2003 for the prevention of acute and delayed CINC. Aloxi is the first and only 5-HT3 receptor antagonist to be indicated for the prevention of delayed CINV. Kytril is a serotonin 5-HT receptor antagonist used to prevent CINV; it was approved by the FDA in 1994.
The current study involved 1,143 patients receiving highly emetic chemotherapy in 75 institutions in Japan. Patients were randomly allocated to receive Aloxi or Kytrel in conjunction with dexamethasone. The following table summarizes the main findings of this trial.
Table 1: Aloxi Versus Kytril in Prevention of CINC
| Aloxi | Kytril |
Complete Acute Response | 75.3% | 73.3% |
Delayed Complete Response | 56.8% | 44.5% |
Constipation | 17.4% | 15.7% |
Aspartate Aminotransferase Elevation | 4.3% | 6.0% |
Alainine Aminotransferase Elevation | 2.9% | 5.9% |
These researchers concluded: “When administered with dexamethasone before highly emetogenic chemotherapy, palonosetron exerts efficacy against chemotherapy-induced nausea and vomiting, which is non-inferior to that of granisetron in the acute phase and better than that of granisetron in the delayed phase, with a comparable safety profile for the two treatments.”
Comments: These data confirm the relative effectiveness of Aloxi to prevent delayed CINV.
Reference:
[1] Saito M, Aogi K, Sekine I, et al. Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomized, comparative phase III trial. Lancet Oncology. 2009;10:115-124.
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