COMPARABLE SAFETY AND ANTIEMETIC EFFICACY OF A BRIEF (30-SECOND BOLUS) INTRAVENOUS GRANISETRON INFUSION AND A STANDARD (15-MINUTE) INTRAVENOUS ONDANSETRON INFUSION IN BREAST-CANCER PATIENTS RECEIVING MODERATELY EMETOGENIC CHEMOTHERAPY

PURPOSE For patients receiving chemotherapy optimization of antiemetic therapy in terms of safety of administration, efficacy, cost, and con venience remains a subject of intense clinical research. In this study , we evaluated and compared tile safety and antiemetic efficacy of a s ingle 30-second intravenous bolus infusion of granisetron with those o f a standard 15-minute intravenous infusion of ondansetron in chemothe rapy-naive breast cancer patients receiving moderately emetogenic chem otherapy. PATIENTS AND MATERIALS This was a randomized, double-blind, double-dummy, multicenter crossover study of 623 chemotherapy-naive pa tients (two male, 621 female) receiving moderately emetogenic chemothe rapy (cyclophosphamide plus doxorubicin, with or without 5-fluorouraci l) for breast cancer, Patients were assigned randomly to receive eithe r granisetron or ondansetron in cycle 1 and the other agent in cycle 2 . Granisetron (10 mu g/kg) was administered as a 30-second intravenous bolus infusion within 5 minutes before the start of chemotherapy and ondansetron (32 mg) was administered as a 15-minute intravenous infusi on beginning 30 minutes before the starr of chemotherapy. A total of 5 73 patients received the two planned chemotherapy cycles. Safety asses sment nas based on the type and frequency of adverse experiences repor ted by the patient at 24 and 48 hours after chemotherapy began, Effica cy assessments included the occurrence of nausea or emesis and the pro portion of patients who achieved total emetic control at 24 and 48 hou rs after chemotherapy. RESULTS Similar proportions of patients in both treatment groups remained free of emesis at the 24-hour assessment pe riod (58.6% and 62.7% of granisetron- and ondansetron-treated patients , respectively) and at 48 hours (42.2% and 45.0% for granisetron vs on dansetron) in both cycles, The proportions of granisetron- and ondanse tron-treated patients who remained nausea-free for the first 24 hours after treatment in both cycles were 44.0% and 48.5%, respectively, and at 48 hours were 26.7% and 32.0%, respectively, Statistical analysis demonstrated no significant treatment-by-cycle interaction. The 30-sec ond granisetron infusion and the 15-minute ondansetron infusion were w ell tolerated. However, administration of ondansetron as a 15-minute i ntravenous infusion produced abnormal vision (6.28%) in significantly more patients than granisetron (0.35%), DISCUSSION These two intraveno us 5-hydroxytryptamine(3)-receptor antagonist antiemetics were similar ly effective in controlling acute nausea and emesis during two cycles of moderately emetogenic chemotherapy. Granisetron (30 seconds) and th e longer infusion of ondansetron (15 minutes) were well tolerated; how ever, ondansetron was associated with a greater proportion of patients reporting abnormal vision Granisetron administered as a 30-second bol us infusion allows a considerably shorter waiting time between the end of the antiemetic infusion and the initiation of chemotherapy, This s horter administration time may enhance patient convenience and provide r efficiency.