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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 : The Lancet Oncology
The Lancet Oncology - Online First, 05/12/09

Grunberg SM et al. - In a trial to assess whether a 3-drug antiemetic regimen of ondansetron, dexamethasone, and casopitant mesylate was able to prevent acute and delayed chemotherapy-induced nausea and vomiting (CINV) events in pts naive to chemotherapy with a malignant solid tumour who were scheduled to receive cisplatin-based highly emetogenic chemotherapy (HEC) regimens, it was concluded that a 3-drug regimen including a single oral dose or 3-day intravenous (IV) plus oral regimen of casopitant mesylate plus dexamethasone and ondansetron significantly reduced CINV events in pts receiving HEC vs a 2-drug regimen of dexamethasone and ondansetron.

Methods

All 810 pts enrolled in the trial received dexamethasone and ondansetron.
Pts were randomly assigned to also receive placebo (n=269), single oral dose of casopitant mesylate (150 mg oral, n=271), or 3-day IV plus oral casopitant mesylate (90 mg IV on day 1 plus 50 mg oral on days 2 and 3, n=270).
Randomisation was done using a central telephone system at the study level, because some centres were expected to recruit only a few pts during the study period.
Primary endpoint was the proportion of pts achieving complete response (no vomiting, retching, or use of rescue medications) in the first 120 h after receiving HEC.
Efficacy analysis was done on the modified intention-to-treat population (n=800), which included all pts who received placebo or study drug and HEC (n=265 control, n=266 single-dose oral casopitant mesylate, n=269 3-day IV and oral casopitant mesylate).
Safety was reported in 802 pts who received either placebo or study medication.

Results

Significantly more pts in each casopitant group achieved complete response in cycle 1 of HEC treatment than did those in the control group (175 [66%] pts control group, 228 [86%] in single-dose oral casopitant mesylate group, and 214 [80%] in 3-day IV plus oral casopitant mesylate group).
Improvement was sustained over multiple cycles of HEC.
Adverse events occurred in 205 (77%) pts in the single-dose oral casopitant mesylate group and 203 (75%) pts in the 3-day IV and oral casopitant mesylate group vs 194 (73%) pts in the control group.
The most common serious adverse events were neutropenia (n=5 [3%] in control group, n=3 [1%] in single-dose oral casopitant mesylate group, and n=11 [4%] in 3-day IV plus oral casopitant mesylate group), febrile neutropenia (n=1 [<1%] in control group, n=4 [1%] in single-dose oral casopitant mesylate group, and n=6 [2%] in 3-day IV plus oral casopitant mesylate group), and dehydration (n=4 [2%] in the control group, n=2 [<1%] in single-dose oral casopitant mesylate group, and n=1 [<1%] in 3-day IV plus oral casopitant mesylate group).

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