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

Steven M. Grunberg, Janusz Rolski, J. Strausz, Zeba Aziz, Stephen Lane, Mark W. Russo, Paul Wissel, Mary Guckert, Oliver Wright, Jørn Herrstedt

Research output: Contribution to journalArticle

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Abstract

Background: Chemotherapy-induced nausea and vomiting (CINV) remains a clinical management problem after treatment with highly emetogenic chemotherapy (HEC). We therefore designed and carried out a multicentre, randomised, double-blind, placebo-controlled trial to assess whether a three-drug antiemetic regimen of ondansetron, dexamethasone, and the neurokinin-1-receptor antagonist casopitant mesylate was able to prevent acute and delayed CINV events in patients naive to chemotherapy with a malignant solid tumour who were scheduled to receive cisplatin-based HEC regimens. Methods: The study was done between Nov 6, 2006, and Oct 9, 2007, in 77 participating centres in 22 countries. All 810 patients enrolled in the trial received dexamethasone and ondansetron. Patients were randomly assigned to also receive placebo (n=269), single oral dose of casopitant mesylate (150 mg oral, n=271), or 3-day intravenous plus oral casopitant mesylate (90 mg intravenous 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 patients during the study period. The primary endpoint was the proportion of patients 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 patients who received placebo or study drug and HEC (n=265 control, n=266 single-dose oral casopitant mesylate, n=269 3-day intravenous and oral casopitant mesylate). Safety was reported in 802 patients who received either placebo or study medication. This study is registered with ClinicalTrials.gov, NCT00431236. Findings: Significantly more patients in each casopitant group achieved complete response in cycle 1 of HEC treatment than did those in the control group (175 [66%] patients in the control group, 228 [86%] in the single-dose oral casopitant mesylate group [p

Original languageEnglish
Pages (from-to)549-558
Number of pages10
JournalThe Lancet Oncology
Volume10
Issue number6
DOIs
Publication statusPublished - Jun 2009

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Neurokinin-1 Receptor Antagonists
Nausea
Cisplatin
Vomiting
Placebos
Safety
Drug Therapy
Ondansetron
Dexamethasone
casopitant
Control Groups
Antiemetics
Random Allocation
Telephone

ASJC Scopus subject areas

  • Oncology

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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. / Grunberg, Steven M.; Rolski, Janusz; Strausz, J.; Aziz, Zeba; Lane, Stephen; Russo, Mark W.; Wissel, Paul; Guckert, Mary; Wright, Oliver; Herrstedt, Jørn.

In: The Lancet Oncology, Vol. 10, No. 6, 06.2009, p. 549-558.

Research output: Contribution to journalArticle

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abstract = "Background: Chemotherapy-induced nausea and vomiting (CINV) remains a clinical management problem after treatment with highly emetogenic chemotherapy (HEC). We therefore designed and carried out a multicentre, randomised, double-blind, placebo-controlled trial to assess whether a three-drug antiemetic regimen of ondansetron, dexamethasone, and the neurokinin-1-receptor antagonist casopitant mesylate was able to prevent acute and delayed CINV events in patients naive to chemotherapy with a malignant solid tumour who were scheduled to receive cisplatin-based HEC regimens. Methods: The study was done between Nov 6, 2006, and Oct 9, 2007, in 77 participating centres in 22 countries. All 810 patients enrolled in the trial received dexamethasone and ondansetron. Patients were randomly assigned to also receive placebo (n=269), single oral dose of casopitant mesylate (150 mg oral, n=271), or 3-day intravenous plus oral casopitant mesylate (90 mg intravenous 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 patients during the study period. The primary endpoint was the proportion of patients 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 patients who received placebo or study drug and HEC (n=265 control, n=266 single-dose oral casopitant mesylate, n=269 3-day intravenous and oral casopitant mesylate). Safety was reported in 802 patients who received either placebo or study medication. This study is registered with ClinicalTrials.gov, NCT00431236. Findings: Significantly more patients in each casopitant group achieved complete response in cycle 1 of HEC treatment than did those in the control group (175 [66{\%}] patients in the control group, 228 [86{\%}] in the single-dose oral casopitant mesylate group [p",
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AU - Grunberg, Steven M.

AU - Rolski, Janusz

AU - Strausz, J.

AU - Aziz, Zeba

AU - Lane, Stephen

AU - Russo, Mark W.

AU - Wissel, Paul

AU - Guckert, Mary

AU - Wright, Oliver

AU - Herrstedt, Jørn

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