title: Comparison of three tropisetron-containing antiemetic regimens in the prophylaxis of acute and delayed chemotherapy-induced emesis and nausea.
abstract: There is still controversy as to what constitutes the optimal therapy for acute and delayed chemotherapy-induced emesis and nausea. We conducted a three-armed randomized multi-centre study in 193 chemotherapy-naive patients receiving highly emetogenic chemotherapy inducing both acute and delayed symptoms (cisplatin > or = 50 mg/m2, carboplatin > or = 300 mg/m2, cyclophosphamide > or = 750 mg/m2, ifosfamide > or = 1.5 g/m2 on day 1). Group A: 1 x 5 mg tropisetron i.v. on day 1 + 2, then 10 mg p.o. (oral dose now recommended: 5 mg); group B: tropisetron as for A+dexamethasone, 20 mg i.v., on days 1 + 2, then 4 mg i.v./p.o.; group C: tropisetron as for A+metoclopramide, 20 mg i.v. +2 x 10 mg p.o. on day 1, then 3 x 10 mg p.o. Treatment was continued for at least 2 days after the end of chemotherapy. Tropisetron+dexamethasone was significantly superior to tropisetron alone both for acute (P = 0.0064) and delayed (P = 0.0053) emesis. Complete control of acute and delayed emesis (nausea) was achieved in 80% (75%) and 53% (46%) in group A, 97% (90%) and 80% (58%) in group B, and 86% (80%) and 49% (45%) in group C. Patients completely asymptomatic during the whole cycle accounted for 26% of those in group A, 49% in group B and 28% in group C. The most frequent adverse events were constipation (16.6%), headache (7.3%) and tiredness (7.3%). Once-daily tropisetron+dexamethasone over several days is well tolerated and is a simple means of achieving further significant improvement in the efficacy of tropisetron against acute and delayed symptoms.
authors.affiliation: Department of Dermatology, University of Bonn, Germany. DrSDrechs@aol.com
authors.forename: S
authors.initials: S
authors.lastname: Drechsler
authors.forename: U
authors.initials: U
authors.lastname: Bruntsch
authors.forename: J
authors.initials: J
authors.lastname: Eggert
authors.forename: J
authors.initials: J
authors.lastname: Grote-Kiehn
authors.forename: H
authors.initials: H
authors.lastname: Gosse
authors.forename: M
authors.initials: M
authors.lastname: Bangerter
authors.forename: D
authors.initials: D
authors.lastname: Ukena
authors.forename: C
authors.initials: C
authors.lastname: Oehm
authors.forename: J
authors.initials: J
authors.lastname: Mezger
authors.forename: L
authors.initials: L
authors.lastname: Faerber
authors.forename: W
authors.initials: W
authors.lastname: Imhoff
authors.forename: M
authors.initials: M
authors.lastname: Untch
authors.forename: W M
authors.initials: WM
authors.lastname: Gallmeier
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D003907:Dexamethasone / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage*; D008297:Male; D008787:Metoclopramide / Q000008:administration & dosage*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy*; D011788:Quality of Life; D016896:Treatment Outcome; D000077526:Tropisetron; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D007211:Indoles; D000077526:Tropisetron; D003907:Dexamethasone; D008787:Metoclopramide