Authors: Meiri, Eyal¹; Jhangiani, Haresh²; Vredenburgh, James J.³; Barbato, Luigi M.⁴; Carter, Frederick J.⁴; Yang, Hwa-Ming⁴; Baranowski, Vickie⁴

Source: Current Medical Research and Opinion, Volume 23, Number 3, March 2007 , pp. 533-543(11)

Publisher: Informa Healthcare

Abstract:

Objective: To compare the efficacy and tolerability of dronabinol, ondansetron, or the combination for delayed chemotherapy-induced nausea and vomiting (CINV) in a 5-day, double-blind, placebo-controlled study.

Research design and methods: Patients receiving moderately to highly emetogenic chemotherapy received dexamethasone (20 mg PO), ondansetron (16 mg IV) and either placebo or dronabinol (2.5 mg) prechemotherapy on day 1. Patients randomized to active treatment (dronabinol and/or ondansetron) also received dronabinol (2.5 mg) after chemotherapy on day 1. On day 2, fixed doses of placebo, dronabinol (10 mg), ondansetron (16 mg), or combination therapy were administered. On days 3-5, patients received placebo, flexible doses of dronabinol (10-20 mg), ondansetron (8-16 mg), or dronabinol and ondansetron (10-20 mg dronabinol, 8-16 mg ondansetron).

Main outcome measures: Total response (TR = nausea intensity <5 mm on visual analog scale, no vomiting/retching, no rescue antiemetic), nausea (occurrence and intensity) and vomiting/retching episodes.

Results: Sixty-four patients were randomized; 61 analyzed for efficacy. TR was similar with dronabinol (54%), ondansetron (58%), and combination therapy (47%) versus placebo (20%). Nausea absence was significantly greater in active treatment groups (dronabinol, 71%; ondansetron, 64%; combination therapy, 53%) versus placebo (15%; p < 0.05 vs. placebo for all). Nausea intensity and vomiting/retching were lowest in patients treated with dronabinol. Active treatments were well tolerated. The low number of patients due to slow enrollment limits the interpretation of these data.

Conclusions: Dronabinol or ondansetron was similarly effective for the treatment of CINV. Combination therapy with dronabinol and ondansetron was not more effective than either agent alone. Active treatments were well tolerated.

Keywords: CHEMOTHERAPY; CINV; DRONABINOL; ONDANSETRON

Document Type: Research article

DOI: http://dx.doi.org/10.1185/030079907X167525

Affiliations: 1: Bethesda Memorial Hospital, Comprehensive Cancer Care Center, Boynton Beach, FL, USA 2: Compassionate Cancer Care, Pacific Coast Hem/Onc Medical Group, Fountain Valley, CA, USA 3: Duke University Medical Center, Duke Brain Tumor Center, Durham, NC, USA 4: Solvay Pharmaceuticals, Inc., Neuroscience Department, Marietta, GA, USA

Publication date: 2007-03-01

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