Efficacy of ondansentron treatment for acute emesis with different dosing schedules 8 vs 32 mg. A randomized study

The aim of the present randomized study was to evaluate which dose of Ondan sentron (OND) (32 8 mg) is appropriate for the antiemetic treatment of a un iform group of patients (pts) with Non Cell Lung Cancer (NSCLC) who were tr eated with Cisplatin (CDDP) 100 mg/m(2) in combination with other less emet ogenic drugs. One hundred and ten patients, with histologically confirmed N SCLC entered this randomized study. They were between 50 - 70 years old, wi th no previous Chemotherapy, with a PS (Karnofsky) >60%. They were randomiz ed into two groups; Group A: OND as a 32 mg dose the first 24 hours, follow ed by 8 mg every 8 hrs for the following four days, combined with dexametha sone, 8 mg i.v. the first day, and 8 mg p.o., in the morning, the following three days. Group B: OND as a 8 mg dose every day for 4 days, combined wit h dexamethasone 8 mg i.v. and 8 mg p.o. the following three days. In this r andomized study, of the 110 patients who entered, 106 were evaluable. Clini cal parameters were similar between the examined groups. A higher number of patients of Group A presented complete response (P 0.0001), compared to pa tients of Group B who failed (P 0.004), during the first 24 hours. In the 3 days that followed, a higher number of pts of Group A presented complete r esponse to the antiemetic therapy(P 0.001, P 0.0001), while Group B failed( P 0.007, P 0.001, P 0.019), or presented minor response (P 0.0001, P 0.004) . Patients who had no antiemetic response needed additional therapy and wer e excluded from the evaluatio (13 pts of Group B). Retches (P 0.0001, P 0.0 05), and nausea(P 0.0001, P were also frequent in Group B. We concluded tha t reduced OND doses (8 mg) are inadequate in the prevention of emesis after high dose CDDP (100 mg/m(2))) and should be avoided.