To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Casopitant Effective for Chemotherapy-Related Nausea and Vomiting: Presented at ASCO URL: http://www.pslgroup.com/dg/222A9E.htm Doctor's Guide June 1, 2008
By Bruce Sylvester CHICAGO -- June 1, 2008 -- Patients receiving the investigative neurokinin-1 antagonist casopitant along with ondansetron/dexamethasone (OND/DEX) chemotherapy have achieved meaningful reductions in treatment-related nausea and vomiting, researchers reported at the American Society of Clinical Oncology (ASCO) 44th Annual Meeting. "If you add casopitant, the patients do better, and we can give the drug effectively once for each cycle of chemotherapy," noted lead investigator Steven Grunberg, MD, University of Vermont College of Medicine, Burlington, Vermont, speaking here on May 30. "We saw no new adverse events emerge in this study." Dr. Grunberg stated that, in a prior phase 2, dose-ranging trial, casopitant plus OND/DEX demonstrated efficacy for reducing chemotherapy-induced nausea and vomiting among patients receiving moderately emetogenic chemotherapy (MEC). In this phase 3 trial, the investigators evaluated 3 dosing regimens of casopitant for chemotherapy patients also being treated with anthracycline and cyclophosphamide (AC)-based MEC. The investigators enrolled 1,933 subjects with breast cancer in the multinational, double-blind, active-controlled trial. All subjects received DEX 8 mg intravenously (IV) on day 1 plus OND 8 mg orally twice daily on days 1 to 3. The researchers randomised subjects to 1 of 4 cohorts: a control group receiving no additional therapy (n = 483); a group receiving a single 150-mg casopitant oral regimen on day 1 (n = 483); a group receiving a 3-day oral casopitant regimen with 150 mg orally on day 1 and 50 mg orally on days 2 and 3 (n = 483); or a group receiving a 3-day IV/oral casopitant regimen with 90 mg IV on day 1 and 50 mg orally on days 2 and 3 (n = 484). Actively treated subjects remained on casopitant therapy for up to 4 cycles of chemotherapy. The primary endpoint of the study was complete response (CR) -- no vomiting, retching, or rescue medications in the first 120 hours after each cycle of an AC-based MEC regimen. In both the single oral-dosing cohort and in the 3-day oral-regimen cohort, 73% of the subjects achieved statistically significant improvement (P < .0001) in overall CR rates over 5 days, compared to 59% in the control group. In the 3-day IV/oral-regimen cohort, the subjects achieved a statistically significant 74% overall CR rate compared to the control group (P < .0001). The investigators reported that the observed clinical benefit in the actively treated groups was maintained throughout the repeated cycles of MEC. Casopitant was generally well tolerated, with adverse events (such as neutropenia, alopecia, fatigue, leukopenia, and constipation) being similar across study groups. The authors concluded that "the reduction in chemotherapy-induced nausea and vomiting events achieved by the addition of casopitant as a standard 2-drug prophylactic regimen establishes casopitant as a valuable component of antiemetic therapy." Funding for this study was provided by GlaxoSmithKline. [Presentation title: Phase III Results of a Novel Oral Neurokinin-1 (NK-1) Receptor Antagonist, Casopitant: Single Oral and 3-day Oral Dosing Regimens for Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients (pts) Receiving Moderately Emetogenic Chemotherapy (MEC). Abstract 9540] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.