Efficacy and tolerability of tropisetron and dexamethasone in the control of nausea and vomiting induced by cisplatin.
A multicentre study was performed at four oncology centres in Sweden, in 160 chemotherapy-naive women, primarily with ovarian or endometrial carcinomas. Abdominal surgery preceded chemotherapy in 146 (91%) women, and another 39 (24%) women had a history of radiotherapy. The chemotherapy regimens contained cisplatin (50-100 mg/m2), in combination with a variety of other agents. In Course 1, all patients received tropisetron (5 mg i.v. Day 1; 5 mg p.o. Days 2-6) and 84% of patients achieved total or partial control of vomiting; 95% of patients achieved total or partial control of nausea during the first 24 hours. Vomiting was least successfully controlled on Day 2 (73% total or partial control) and Days 2-4 for the control of nausea (81, 83, 88% total or partial control, respectively). Patients with partial response in Course 1 (39% of patients) were randomized to addition of dexamethasone or placebo in Course 2. In Course 2, tropisetron plus dexamethasone (Group B2) prevented acute vomiting in 75% of patients, compared with 40% of patients receiving tropisetron plus placebo (Group B1). Over the entire 6 days, there was no vomiting at all in 54% and 20% of B2 and B1 patients, respectively. In Course 2, acute nausea was prevented in 75% of patients (receiving B1) and in 37% of patients (receiving B2). For nausea, over the complete 6 days, the figures were 64% and 3% (p < 0.001). This indicated that patients with incomplete control of emesis in Course 1 benefited from the addition of dexamethasone, provided that it was added for each of the 6 days studied.(ABSTRACT TRUNCATED AT 250 WORDS)
Schmidt
M
M
Department of Gynecological Oncology, University Hospital, Uppsala, Sweden.
Sorbe
B
B
Högberg
T
T
Himmelmann
A
A
Räisänen
I
I
Stockmeyer
M
M
de Bruijn
K M
KM
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000008:administration & dosage / Q000627:therapeutic use*; D002945:Cisplatin / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D012702:Serotonin Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000077526:Tropisetron; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
D000932:Antiemetics; D007211:Indoles; D012702:Serotonin Antagonists; D000077526:Tropisetron; D003907:Dexamethasone; D002945:Cisplatin