Comparison of three tropisetron-containing antiemetic regimens in the prophylaxis of acute and delayed chemotherapy-induced emesis and nausea |
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| Authors: | S Drechsler U Bruntsch J Eggert J Grote-Kiehn H Gosse M Bangerter D Ukena C Oehm J Mezger L Faerber W Imhoff M Untch W M Gallmeier |
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| Institution: | (1) Department of Dermatology, University of Bonn, Robert-Koch-Strasse 25, D-53105 Bonn, Germany Tel./Fax: (49) 228–26 54 49; e-mail: DrSDrechs@aol.com, DE;(2) 5th Medical Department, City Hospital, Nuremberg, Germany, DE;(3) Department of Internal Medicine (Cancer Research), West German Cancer Center Essen, University of Essen, Essen, Germany, DE;(4) 2nd Medical Department, St. Johannes-Hospital, Duisburg, Germany, DE;(5) Robert-Koch-Klinik, Leipzig, Germany, DE;(6) Department of Hematology/Oncology, University of Ulm, Ulm, Germany, DE;(7) Department of Internal Medicine (Pneumonology), University of Homburg/Saar, Homburg/Saar, Germany, DE;(8) Lungenfachklinik Beelitz, Beelitz, Germany, DE;(9) Department of General Internal Medicine, University of Bonn, Bonn, Germany, DE;(10) Department of Clinical Research, Novartis Pharma GmbH, Nuremberg, Germany, DE;(11) Department of Obstetrics and Gynaecology, Klinikum Grosshadern, Ludwig Maximilians University, Munich, Germany, DE |
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| 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 ≥50 mg/m2, carboplatin ≥300 mg/m2, cyclophosphamide ≥750 mg/m2, ifosfamide ≥1.5 g/m2 on day 1). Group A: 1×5 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.+2×10 mg p.o. on day 1, then 3×10 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. |
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| Keywords: | Tropisetron Dexamethasone Metoclopramide Acute emesis Delayed emesis |
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