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A randomized, multicenter study comparing the efficacy and tolerability of tropisetron, a new 5-HT3 receptor antagonist, with a metoclopramide-containing antiemetic cocktail in the prevention of cisplatin-induced emesis

Sorbe, B G ; Högberg, T LU ; Glimelius, B ; Schmidt, M ; Wernstedt, L ; Hansen, O ; Sörensen, B T ; Räisänen, I ; van Oosterom, A T and de Bruijn, K M (1994) In Cancer 73(2). p.54-445
Abstract

BACKGROUND: Chemotherapy-induced emesis is one of the most disturbing side effects in cancer therapy. Thus, antiemetic treatment is a mandatory adjunct in emetogenic chemotherapy.

METHODS: Tropisetron (Navoban, Sandoz Pharma Ltd., Basel, Switzerland), a new 5-HT3 receptor antagonist, was compared in a randomized multicenter trial with a high-dose metoclopramide-dexamethasone cocktail for the prevention of nausea and emesis during cisplatin-containing chemotherapy. Two hundred fifty-nine chemotherapy-naive patients were included and followed during two consecutive courses. The main cancer types were gynecologic tumors, followed by lung cancer, head and neck cancer, and bladder cancer. The cisplatin dose usually was in the range of... (More)

BACKGROUND: Chemotherapy-induced emesis is one of the most disturbing side effects in cancer therapy. Thus, antiemetic treatment is a mandatory adjunct in emetogenic chemotherapy.

METHODS: Tropisetron (Navoban, Sandoz Pharma Ltd., Basel, Switzerland), a new 5-HT3 receptor antagonist, was compared in a randomized multicenter trial with a high-dose metoclopramide-dexamethasone cocktail for the prevention of nausea and emesis during cisplatin-containing chemotherapy. Two hundred fifty-nine chemotherapy-naive patients were included and followed during two consecutive courses. The main cancer types were gynecologic tumors, followed by lung cancer, head and neck cancer, and bladder cancer. The cisplatin dose usually was in the range of 50-89 mg/m2. The efficacy and quality of life assessments and the safety recordings were done during the first 6 days of both courses of chemotherapy.

RESULTS: Acute vomiting was prevented in 63-64% of patients by both antiemetic regimens. The total rate of control of vomiting increased from 63% on day 1 to 93% on day 6 in the group receiving tropisetron. Acute nausea was prevented in 40% of the patients with tropisetron monotherapy and in 61% of patients receiving the antiemetic cocktail. With regard to delayed nausea, there were no significant differences between the two antiemetic regimens. Mild headache and constipation were more frequently associated with tropisetron, and extra-pyramidal side effects and sedation were associated with the antiemetic cocktail.

CONCLUSIONS: Tropisetron was easier to administer and better tolerated than the cocktail, and it seems to be a highly efficacious and safe new antiemetic drug.

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Contribution to journal
publication status
published
subject
keywords
Adult, Aged, Aged, 80 and over, Antiemetics/adverse effects, Cisplatin/adverse effects, Female, Humans, Indoles/adverse effects, Male, Metoclopramide/adverse effects, Middle Aged, Nausea/chemically induced, Neoplasms/drug therapy, Quality of Life, Tropisetron, Vomiting/chemically induced
in
Cancer
volume
73
issue
2
pages
10 pages
publisher
John Wiley and Sons
external identifiers
  • pmid:8293412
ISSN
0008-543X
DOI
10.1002/1097-0142(19940115)73:2<445::aid-cncr2820730233>3.0.co;2-4
language
English
LU publication?
no
id
fe38bd4e-6192-4357-bbfe-584a4e5be0d5
date added to LUP
2019-09-20 08:09:59
date last changed
2020-12-19 04:03:09
@article{fe38bd4e-6192-4357-bbfe-584a4e5be0d5,
  abstract     = {<p>BACKGROUND: Chemotherapy-induced emesis is one of the most disturbing side effects in cancer therapy. Thus, antiemetic treatment is a mandatory adjunct in emetogenic chemotherapy.</p><p>METHODS: Tropisetron (Navoban, Sandoz Pharma Ltd., Basel, Switzerland), a new 5-HT3 receptor antagonist, was compared in a randomized multicenter trial with a high-dose metoclopramide-dexamethasone cocktail for the prevention of nausea and emesis during cisplatin-containing chemotherapy. Two hundred fifty-nine chemotherapy-naive patients were included and followed during two consecutive courses. The main cancer types were gynecologic tumors, followed by lung cancer, head and neck cancer, and bladder cancer. The cisplatin dose usually was in the range of 50-89 mg/m2. The efficacy and quality of life assessments and the safety recordings were done during the first 6 days of both courses of chemotherapy.</p><p>RESULTS: Acute vomiting was prevented in 63-64% of patients by both antiemetic regimens. The total rate of control of vomiting increased from 63% on day 1 to 93% on day 6 in the group receiving tropisetron. Acute nausea was prevented in 40% of the patients with tropisetron monotherapy and in 61% of patients receiving the antiemetic cocktail. With regard to delayed nausea, there were no significant differences between the two antiemetic regimens. Mild headache and constipation were more frequently associated with tropisetron, and extra-pyramidal side effects and sedation were associated with the antiemetic cocktail.</p><p>CONCLUSIONS: Tropisetron was easier to administer and better tolerated than the cocktail, and it seems to be a highly efficacious and safe new antiemetic drug.</p>},
  author       = {Sorbe, B G and Högberg, T and Glimelius, B and Schmidt, M and Wernstedt, L and Hansen, O and Sörensen, B T and Räisänen, I and van Oosterom, A T and de Bruijn, K M},
  issn         = {0008-543X},
  language     = {eng},
  month        = {01},
  number       = {2},
  pages        = {54--445},
  publisher    = {John Wiley and Sons},
  series       = {Cancer},
  title        = {A randomized, multicenter study comparing the efficacy and tolerability of tropisetron, a new 5-HT3 receptor antagonist, with a metoclopramide-containing antiemetic cocktail in the prevention of cisplatin-induced emesis},
  url          = {http://dx.doi.org/10.1002/1097-0142(19940115)73:2<445::aid-cncr2820730233>3.0.co;2-4},
  doi          = {10.1002/1097-0142(19940115)73:2<445::aid-cncr2820730233>3.0.co;2-4},
  volume       = {73},
  year         = {1994},
}