A double-blind, randomised, parallel study comparing intravenous dolasetron plus dexamethasone and intravenous dolasetron alone for the management offractionated cisplatin-related nausea and vomiting

Fractionated cisplatin-containing regimens are routinely used for chemother apy in certain types of cancer. Dolasetron has been shown to be effective i n preventing acute emesis related to high-dose cisplatin chemotherapy over 24 h; its effectiveness has not been evaluated in fractionated cisplatin-co ntaining chemotherapy, This trial was designed to assess the efficacy of do lasetron alone or dolasetron plus dexamethasone in preventing nausea and vo miting related to fractionated cisplatin chemotherapy, The patients were 21 0 cancer in-patients, who were randomised to receive 100 mg dolasetron i.v. or 100 mg dolasetron i.v. plus 20 mg dexamethasone before chemotherapy pri marily with cisplatin (15-50 mg/m(2)) infused over less than or equal to 4h for at least 2 but not more than 5 consecutive days, Dolasetron was admini stered to all patients 30 min before cisplatin, Dexamethasone was administe red in double-blind fashion 5 min before cisplatin. Efficacy was measured a t hour 24 of each study day using complete response (no vomiting and no res cue medication) and maximum severity of nausea, self-assessed by patients u sing a 100mm visual analogue scale. Most (198) of the patients completed th e study and were evaluable. Overall complete response rates were significan tly higher in the dolasetron plus dexamethasone group than in the dolasetro n only group (72.9% vs 40.8%, respectively; P < 0.0001). Complete response rates on each study day were also significantly higher with dolasetron plus dexamethasone than with dolasetron alone (P < 0.029), with an attenuated e fficacy in the delayed phase in both groups. Chi-square test and logistic r egression applied to daily response rates indicated a significant influence of treatment (day 1: P=0.0002, day 2: P < 0.0001, day 3: P = 0.0007, day 4 : P = 0.0007, day 5: P = 0.029). Treatment and duration of chemotherapy exe rted the only statistically significant subgroup effects on complete respon se (P < 0.0001), Both treatments were administered safely. As seen with oth er 5-HT3 receptor antagonist antiemetics, the addition of dexamethasone to dolasetron significantly increases effectiveness in preventing nausea and v omiting related to fractionated cisplatin chemotherapy. Both dolasetron and dolasetron plus dexamethasone were well tolerated.