| Autor: |
Wymenga, ANM, vanderGraaf, WTA, Wils, JA, vanHeukelom, LS, vanderLinden, GHM, DullemondWestland, AC, Nooy, M, vanderHeul, C, deBruijn, KM, deVries, EGE |
| Přispěvatelé: |
Guided Treatment in Optimal Selected Cancer Patients (GUTS) |
| Jazyk: |
angličtina |
| Rok vydání: |
1996 |
| Předmět: |
|
| Zdroj: |
Annals of Oncology, 7(5), 505-510. Oxford University Press |
| ISSN: |
0923-7534 |
| Popis: |
Background: This study compares efficacy safety and tolerability of 2 and 5 mg tropisetron in prevention of nausea and vomiting induced by low-dose cisplatin- or non-cisplatin-containing chemotherapy. Patients and methods: 152 chemotherapy-naive cancer patients were randomized in a double-blind manner to receive 2 or 5 mg tropisetron intravenously day 1 and orally days 2-6. Primary efficacy criteria were control of acute (day 1) and delayed (days 26) vomiting and nausea. Secondary efficacy criteria included overall control (days 1-6) and control of vomiting and nausea by chemotherapy regimen. Safety and tolerability were evaluated clinically, biochemically and by the patient's diary. Only the first cycle was evaluated. Results: 124 of the 144 intention-to-treat patients were evaluable. There was a better total control (no events) of acute vomiting in the 5 mg (73%) than in the 2 mg group (55%, P = 0.02). Total control (less than or equal to 15 minutes) of acute nausea was obtained in 70% of the 5 mg group and in 51% of the 2 mg (P = 0.03). No differences were observed for total control of delayed nausea or vomiting and for the overall outcome of nausea. Less vomiting (days 1-6) occurred in the 5 mg than in the 2 mg group. Efficacy rates ranged widely between chemotherapy regimens, independent of the tropisetron dose groups. There occurred more headache in the 5-mg group (P |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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