1204 Preventing nausea and vomiting during days 2–7 following high dose cisplatin chemotherapy (HDCP)

The combination of dexamethasone (D) and granisetron (G), a selective 5HT3, receptor antagonist, has greatly reduced the incidence of emesis and nausea in the first 24 hours after HDCP (≥50mg/m2). How best to control emesis after this time remains a key problem in patient management. Our double-blind multicentre trial addressed the issue by detertnining whether the addition of G to D enhanced the efficacy of D alone in controlling emesis beyond 24 hours. Prior to chemotherapy, 434 randomized patients (pts) received G 3mg IV and D 10mg IV and G 1mg PO at +6 and +12 hours. Beginning day 2, 218 pts received G 1mg PO and D 8mg PO bid for 6 days (group (gp) 1) and 216 pts received D 8mg PO bid for 6 days (gp 2). Pts completed a self report diary daily in which the number of emetic episodes were recorded. A 100mm visual analogue scale (VAS) was used to assess nausea severity. An intent to treat analysis on all evaluable pts was perfortned. Baseline characteristics were similar for both groups. The proportion of pts who did not vomit in the first 24 hours was 47% in gp 1 and 44% in gp 2. Over the 7 day period the proportion of pts who had no emesis, no rescue medication and who completed the diary was 38% in gp 1 and 35% in gp 2, a difference of 3% (P=0.532; 95% CI –6% to 12%). The proportion of pts with nausea severity scores ≤5mm for the complete 7 day period was 28% in gp 1 and 25% in gp 2, a difference of 3% (95% CI, –6% to II %). We conclude that the effectiveness of D is not augmented by the addition of G and D is as effective as the combination of D and G during days 2–7 following HDCP.