THE ANTIEMETIC EFFICACY AND SAFETY OF GRANISETRON COMPARED WITH METOCLOPRAMIDE PLUS DEXAMETHASONE IN PATIENTS RECEIVING FRACTIONATED CHEMOTHERAPY OVER 5 DAYS

The antiemetic efficacy and safety of granisetron (40 mug/kg), a selec tive and potent 5-hydroxytryptamine (serotonin) antagonist, was compar ed with that of metoclopramide (7 mg/kg) plus dexamethasone (12 mg) in patients receiving fractionated chemotherapy. Patients receiving cisp latin at doses of at least 15 mg/m2 or etoposide at least 120 mg/m2 or ifosfamide at least 1.2 g/m2 on each of 5 consecutive days were eligi ble. A total of 143 patients received granisetron and 141 received the comparator regimen. The 5-day complete response rate (no vomiting, no worse than mild nausea) for granisetron (46.8%) was equivalent to tha t for metoclopramide plus dexamethasone (43.9%). The overall 5-day res ponse profile was superior for granisetron (P = 0.013) because of fewe r failures in this group. The overall incidence of adverse experiences was significantly lower in the granisetron group (60.8% versus 77.3%, P = 0.003). Headache and constipation, more prevalent in the graniset ron group, are recognized side-effects of serotonin antagonists. Extra pyramidal syndrome, not seen in any granisetron patients, occurred in 20.6% of comparator patients (P<0.0001). The majority of granisetron p atients only required a single prophylactic dose of the drug on each t reatment day (at least 82%). In conclusion, granisetron showed at leas t equivalent efficacy to metoclopramide plus dexamethasone in patients receiving 5-day fractionated chemotherapy. In addition it offered a s imple and convenient dosing regimen and a safer side-effect profile.