Combination Antiemetic Regimen Proves 90% Effective in Italian Study

January 1, 1995

LISBON, Portugal--Combining granisetron (Kytril), a 5-HT3 antagonist, with high and repeated doses of dexamethasone yields superior protection against nausea and vomiting than either agent alone in cancer patients receiving moderately emetogenic antineoplastic agents, Dr. Maurizio Tonato reported on behalf of the Italian Group for Antiemetic Research.

LISBON, Portugal--Combining granisetron (Kytril), a 5-HT3 antagonist,with high and repeated doses of dexamethasone yields superiorprotection against nausea and vomiting than either agent alonein cancer patients receiving moderately emetogenic antineoplasticagents, Dr. Maurizio Tonato reported on behalf of the ItalianGroup for Antiemetic Research.

This 13-month trial recruited more than 400 consecutive patientsin 27 Italian centers who had been treated with one or more ofthe following cytotoxic drugs: cyclophosphamide, 600 to 1,000mg/m²; doxorubicin,equal to or more than 50 mg/m²; epirubicin,equal to or more than 75 mg/m²; or carboplatin, equal toor more than 300 mg/m², said Dr. Tonato at the congress ofthe European Society of Medical Oncology.

On their first day of chemotherapy, these subjects were randomizedto receive either granisetron, 3 mg IV 20 minutes prior to thestart of chemotherapy, or dexamethasone, 8 mg IV 15 minutes beforechemotherapy, and four oral doses of 4 mg each, or the same dosingschedules of the two drugs in combination.

More than 90% of patients receiving combination antiemetic therapyexperienced no vomiting whatsoever during the first 24 hours afterchemotherapy, compared with roughly 70% of subjects treated witheither single-drug regimen.

Both dexamethasone alone and in combination with granisetron weresuperior to granisetron alone in controlling delayed emesis, with80% of patients remaining free of vomiting and 50% free of nauseaon the second to the fifth day following chemotherapy when patientsreceived no antiemetic prophylaxis.

All three regimens were equally well tolerated. The most commoncomplaints were constipation and hot flushes in patients randomizedto the combination regimen, and pyrosis in those receiving dexamethasonealone.