Wong_2006
Supportive Therapie · Version 2.1
|
Referenz (Autor, Jahr, Journal) |
Studientyp Mono- vs. Multizentrisch, Verblindung, Randomisierung, Arme, Fallzahl n, Land, Zeitraum
|
Patienten-merkmale Indikation, Alter, Geschlecht (m/w) |
Intervention Fallzahl n, Beschreibung der präventiven bzw. therapeutischen Maßnahme |
Kontrolle Fallzahl n, Beschreibung der präventiven Maßnahme bzw. therapeutischen Maßnahme |
Zielgrößen Primärer Endpunkt Sekundäre(r) Endpunkt(e) |
Primärer Endpunkt Angaben für Intervention vs. Kontrolle |
Sekundäre(r) Endpunkt(e) Angaben für Intervention vs. Kontrolle |
Finanzierung |
Evidenzstufe Bei Abwertung: Angabe von Gründen Bewertung des Autors |
|
Wong
2006
J Clin Oncol |
multicenter, placebo-controlled, double-blind, randomized trial
n = 211
Canada
05/2001 – 01/2004 |
radiotherapy field: whole abdomen and pelvis, partial abdomen and pelvis, and partial abdomen
Ondansetron + Dexamethasone (days 1-5) N = 101 Median age, years: 50.7y Male: Female: 58:43
Ondansetron + Placebo (days 1-5) N = 103 Median age, years: 51.2 Male: Female: 59:44 |
ondansetron 8 mg p.o. 2x/d (fractions 1 to 5)
+
dexamethasone 4 mg 1/d (fractions 1 to 5)
rescue pack: prochloperazine 10 mg tid orally (fractions 1 to 5) and ondansetron 8 mg tid (fractions 6 to 15)
|
ondansetron 8 mg p.o. 2x/d (fractions 1 to 5)
+
Placebo
rescue pack: prochloperazine 10 mg tid orally (fractions 1 to 5) and ondansetron 8 mg tid (fractions 6 to 15)
|
primary endpoint: Complete control of nausea
Complete control of vomiting
complete control of nausea and complete control of vomiting during fractions 1 to 5
secondary endpoints: complete control of nausea and complete control of vomiting during fractions 1 to 15 average nausea score use of rescue medications toxicities QOL |
Ondansetron + Dexamethasone (days 1-5) vs. Ondansetron + Placebo (days 1-5)
Complete control of emesis: 79/101, 78% (95% CI 71-86) vs. 73/102, 71% (95% CI 63-80); p=0.14 Partial control of emesis or better 92/101, 91% (95% CI 85-97) vs. 88/102, 86% (95% CI 80-93); p=0.13 Complete control of nausea: 50/101, 50% (95% CI 40-59) vs. 39/102, 38% (95% CI 29-48); p=0.06 no use of rescue medications (prochloperazine): 91/101, 90% vs. 88/103 85% ; p=0.2 |
Ondansetron + Dexamethasone (days 1-15) vs. Ondansetron + Placebo (days 1-15)
complete protection against emesis: 23% vs. 12%; P=0.02 average nausea score: 0.28 vs. 0.39; P= 0.03 less use of rescue medications: 71% vs. 82%; P=0.09 partial or better control of emesis: 70% vs. 65%; P=0.19 complete control of nausea: 15% vs. 9%; P=0.14
fractions 5 to 15 appetite (P=0.005) global QOL (P=0.08) nausea and vomiting (P=0.06) effect on sleep (P=0.013) constipation (P=0.07) |
Joseph Pater Research Funds GlaxoSmithKline (C) ≥ $100,000 |
1b
funded by pharmaceutical industry
"The addition of dexamethasone to ondansetron as prophylaxis provides a modest improvement in protection against RIE during moderately emetogenic fractionated radiotherapy. It is a potentially useful addition to 5-hydroxytryptamine-3 receptor antagonists in this setting." |