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Casopitant mesylate reduced nausea, vomiting with cisplatin-based chemotherapy

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A combination of casopitant mesylate, dexamethasone and ondansetron reduced chemotherapy-induced nausea and vomiting in patients assigned to cisplatin-based highly emetogenic chemotherapy better than dexamethasone and ondansetron alone.

In a study funded by GlaxoSmithKline, researchers at 77 participating sites in 22 countries recruited patients who were chemotherapy-naive and scheduled to receive at least 70 mg/m² IV cisplatin as treatment for a malignant solid tumor. All patients in the intent-to-treat population (n=800) were assigned to dexamethasone and ondansetron; 266 patients were assigned to also receive single-dose 150-mg oral casopitant mesylate and 269 were assigned to three-day IV plus oral casopitant mesylate. Another 265 patients were assigned to placebo.

In the single-dose oral group, 85.7% of patients achieved the primary endpoint of complete response (no vomiting or use of rescue medications during the first 120 hours) compared with 79.6% of patients in the three-day IV plus oral group and 66% of patients in the placebo group.

Overall, 77.8% of patients assigned to oral casopitant mesylate reported no significant nausea (OR=1.6; 95% CI, 0.98-2.44) compared with 76.2% (OR=1.4; 95% CI, 0.91-2.22) for the IV group and 69.4% for the control group. No nausea was reported overall for 56.8% of patients assigned to oral casopitant mesylate and for 54.6% assigned to IV casopitant mesylate compared with 45.7% of patients assigned to placebo.

More than 73% of patients assigned to oral casopitant mesylate reported having complete protection (OR=1.8; 95% CI, 1.21-2.82) compared with 69.1% for IV casopitant mesylate (OR=1.5; 95% CI, 0.99-2.26) and 60% for the placebo group.

Almost 89% of patients assigned to the oral drug reported no vomiting (OR=3.8; 95% CI, 2.2-6.25) compared with 82.5% for the IV group (OR=2.3; 95% CI, 1.43-3.70) and 67.5% for the control group.

Grunberg SM. Lancet. 2009;doi:10.1016/S1470-2045(09)70109-3.