Combination Antiemetic Regimen Proves 90% Effective in Italian Study

LISBON, Portugal--Combining granisetron(Drug information on granisetron) (Kytril), a 5-HT3 antagonist, with high and repeated doses of dexamethasone(Drug information on 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.

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

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

More than 90% of patients receiving combination antiemetic therapy experienced no vomiting whatsoever during the first 24 hours after chemotherapy, compared with roughly 70% of subjects treated with either single-drug regimen.

Both dexamethasone alone and in combination with granisetron were superior to granisetron alone in controlling delayed emesis, with 80% of patients remaining free of vomiting and 50% free of nausea on the second to the fifth day following chemotherapy when patients received no antiemetic prophylaxis.

All three regimens were equally well tolerated. The most common complaints were constipation and hot flushes in patients randomized to the combination regimen, and pyrosis in those receiving dexamethasone alone.