A DOUBLE-BLIND, RANDOMIZED, PARALLEL STUDY OF IV DOLASETRON MESILATE VERSUS IV METOCLOPRAMIDE IN PATIENTS RECEIVING MODERATELY EMETOGENIC CHEMOTHERAPY

Background - This 24-hour trial compared two single-doses IV dolasetro n mesilate (DM) with IV metoclopramide (MTC) for prevention of emesis induced by moderately emetogenic chemotherapy. Methods - In this doubl e-blind, double-dummy, multicenter study, cancer patients (pts) strati fied by gender and prior chemotherapy received MTC 3 mg/kg continuous infusion for 8 hours after a 2 mg/kg loading dose, or IV DM 1.2 or 1.8 mg/kg, 30 minutes before chemotherapy (primarily doxorubicin, epirubi cin, and cyclophosphamide). Results - 309 pts were randomized, For the overall patient population, complete response (CR: 0 emetic episodes [EE] and no rescue medication [RM]) and complete -plus- major response (CMR: 0-2 EE, no RM) rates were not statistically significant (p>.05) between treatments: 53%, 56%, and 64% for CR; and 63%, 74%, and 77% f or CMR with MTC, DM 1.2 mg/kg and 1.8 mg/kg, respectively, Subgroup an alyses showed DM 1.2 and 1.8 mg/kg were superior to MTC for CMR in fem ales overall (55%, 72%, and 77%, respectively) and in chemotherapy-non naive females (46%, 74%, and 72%) (p<.05). No significant differences were noted between the 1.8 and 1.2 mg/kg DM doses, Higher incidence o f diarrhea was reported in the MTC-treated group, There was a higher i ncidence of mild to moderate headache with DM than with MTC (16% vs, 4 %) but no extrapyramidal disorder (1 pt with MTC). Conclusions - The t hree treatments exhibited equal efficacy in the overall population. In subgroups of females and chemotherapy-non naive females, DM was signi ficantly more effective than MTC.