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A comparison of the safety and efficacy of ondansetron versus granisetron as prophylaxis against chemo/ radiotherapy-induced nausea and vomiting in bone marrow transplantation patients. A double-blinded, randomized, prospective, pilot study

Department of Bone Marrow Transplantation, Hadassah University Hospital, 91120 Jerusalem, Israel

Yosef Kupaluchnik, MD

Department of Bone Marrow Transplantation, Hadassah University Hospital, 91120 Jerusalem, Israel

Pavlos Drakos, MD

Department of Bone Marrow Transplantation, Hadassah University Hospital, 91120 Jerusalem, Israel

Arnon Nagler, MD

Department of Bone Marrow Transplantation, Hadassah University Hospital, 91120 Jerusalem, Israel

Yaakov Cass, Msc MRPharmS

Ministry of Health, Central Region, Israel

Introduction. Nausea and vomiting (N&V) are well known and distressing side effects of chemoradio therapy. Conditioning protocols for patients undergo ing bone marrow transplantation (BMT) consist of highly emetogenic high-dose chemotherapy with or without total body irradiation (TBI). The 5HT₃ (sero tonin receptor) antagonists heralded a marked im provement in controlling chemotherapy-induced N&V. Ondansetron and granisetron have been avail able for some time with limited information available concerning their pharmacological and pharmacoeco nomic differences and patient acceptability.

Patients and Methods. This pilot study initiated comparison of the two drugs and evaluated the antiemetic efficacy and safety of a single daily dose of ondansetron, 16 mg, plus dexamethasone, 10 mg, compared to granisetron, 3 mg, plus dexamethasone, 10 mg, in patients receiving high dose chemotherapy (±TBI), prior to BMT. The 12-month pilot study was double-blinded, randomized, and prospective. A non- homogenous cohort of 23 patients (10 receiving ondansetron and 13 granisetron) were enrolled.

Results. No significant differences in the efficacy of the two protocols were observed. In each arm about 50% of the patients had a complete response, and a similar number had a major response.

Side Effects. The most common adverse events reported during the study included diarrhea and head ache. No patients were withdrawn due to side effects.

Conclusions. Our preliminary findings suggest that both of these two antiemetic protocols are safe and similarly effective in preventing chemotherapy-induced emesis in patients receiving BMT conditioning.

Discussion. Further evaluation in a multicenter study should now be made to compare efficacy, safety, cost-effectiveness, and quality of life parame ters of these two drugs.

Key Words: Antiemetics • ondansetron; granisetron • BMT • 5HT3 antagonists.

Journal of Oncology Pharmacy Practice, Vol. 3, No. 1, 13-17 (1997)
DOI: 10.1177/107815529700300102


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