BOSTON—A single dose of a new long-acting 5-HT3 receptor antagonist called palonosetron(Drug information on palonosetron) matched the effectiveness of a single dose of dolasetron(Drug information on dolasetron) (Anzemet) against acute emesis and was more effective against delayed emesis in a phase III clinical trial conducted in patients receiving moderately emetogenic chemotherapy.
Steven M. Grunberg, MD, professor of medicine and pharmacology, University of Vermont, Burlington, reported the results in a late program addition at the 14th International Meeting of the Multinational Association for Supportive Care in Cancer (MASCC) and International Association for Oral Oncology.
MGI PHARMA Inc. of Minneapolis and its Swiss partner Helsinn Healthcare SA announced that they plan to submit a new drug application for palonosetron to the US Food and Drug Administration in the third quarter of this year.
According to MGI PHARMA, palonosetron has a stronger receptor binding affinity than the three widely used antiemetic agents: dolasetron, granisetron(Drug information on granisetron) (Kytril), and ondansetron(Drug information on ondansetron) (Zofran). It has a 40-hour plasma half-life, which is significantly longer than the half-lives of the other agents and might make it more useful against delayed emesis. "When we find a family of compounds that are very similar, any small differences may lead to the next advance in antiemetic care," Dr. Grunberg said.
The lead consultant for the palonosetron project, Dr. Grunberg reported that 569 patients participated in the trial at 40 sites in the United States and 20 in Mexico. All had histologically confirmed cancer; 380 had not had chemotherapy before, and 467 were female. The most common regimens were carboplatin (Paraplatin), cisplatin(Drug information on cisplatin) (Platinol) at doses up to 50 mg/m², cyclophosphamide(Drug information on cyclophosphamide) up to 1,500 mg/m², and more than 25 mg/m² of doxorubicin(Drug information on doxorubicin).
Although 5-HT3 antagonists are usually given just prior to chemotherapy and then as needed following chemotherapy, patients in this study received only one dose of palonosetron, 0.25 mg or 0.75 mg, or dolasetron, 100 mg, intravenously 30 minutes before chemotherapy. A complete response was defined as no vomiting and no need for a rescue medication.
Primary Endpoint Met
