Li_2017

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

Li

 

2017

 

Ann Palliat Med

 

Sicher et al. 1968

Stryker et al. 1979

Lucraft et al. 1982

Collis et al. 1991

Priestman et al. 1993

Spitzer et al. 1994

Prentice et al. 1995

Bey et al. 1996

Franzén et al. 1996

Aass et al. 1997

Khoo et al. 1997

Sykes et al. 1997

Kirkbride et al. 2000

Spitzer et al. 2000

Lanciano et al. 2001

Martin et al. 2002

Wong et al. 2006

systematic review and meta-analysis of randomized controlled trials

 

17 RCTs

 

literature search

Ovid MEDLINE: 1946 -09/2015

EMBASE: 1947 -09/2015

Cochrane CENTRAL: until 09/2015

 

China, Canada

patients receiving radiotherapy to abdomen/pelvis, including total body irradiation (TBI).

5HT3 RA

 

 

 

 

 

 

 

 

 

 

 

 

5HT3 RA and dexamethasone

 

dexamethasone

 

placebo

 

dopamine receptor antagonist

 

rescue therapy

 

chlorpromazine plus dexamethasone

 

5HT3 RA plus placebo

 

 

placebo

 

Primary endpoints: complete control of nausea and complete control of vomiting during acute and delayed phases

 

Secondary endpoints: use of rescue medication, quality of life (QoL) and incidence of adverse events

5HT3 RA versus placebo

complete control of vomiting: OR 0.49; 95% CI: 0.33–0.72

complete control of nausea: OR 0.43; 95% CI: 0.26–0.70

 

5HT3RA versus dopamine receptor antagonist

Complete control of vomiting: OR 0.17; 95% CI: 0.05–0.58

complete control of nausea: OR 0.46; 95% CI: 0.24–0.88

 

 

5HT3 RA plus dexamethasone versus 5HT3 RA plus placebo

 

Wong et al

 

fractions 1–5: complete

control of nausea: 50% vs. 38%, P=0.06

control of vomiting: 78% vs. 71%, P=0.14

 

fractions 1–15: complete

control of vomiting: 23% vs. 12%, P=0.02

requiring rescue medication

Aass et al.

tropisetron vs. metoclopramide: 18.2% vs. 25%, P value NR

Wong et al.

Ondansetron + dexamethasone:70% vs. 80%, P=0.09

Kirkbride et al.

dexamethasone vs. placebo group: 29% vs. 43%, P=0.125

Spitzer et al.

TBI - ondansetron vs. placebo: 40% vs. 0%, P value NR

Prentice et al.

TBI - granisetron group vs. combination therapy of metoclopramide, dexamethasone and lorazepam: 46.7% vs. 93.3%, P=0.05

QoL

Franzén et al. EORTC QLQ-C30

ondansetron vs. placebo: better functioning, global QoL and lower symptom levels at week 2

Wong et al. (30) EORTC QLQ-C30

ondansetron  + dexamethasone: significant benefits in appetite, nausea and vomiting and a trend favouring global QoL improvement; marginally worse outcomes in sleep and constipation scales.

Sykes et al. (26) Functional Living Index Cancer (FLIC) and Functional Living Index Emesis (ELIE)

no difference for the FLIC questionnaire, FLIE: difference in favour of the ondansetron vs. chlorpromazine plus dexamethasone

Kirkbride et al. (27) EORTC QLQ-C30

no difference in global QoL

dexamethasone vs. placebo: better scores in the domains of nausea/vomiting and appetite but a lower score in the domain of sleep

Bratty Family Fund, Michael and Karyn Goldstein Cancer Research Fund, Joey and Mary Furfari Cancer Research Fund, Pulenzas Cancer Research Fund, Joseph and Silvana Melara Cancer Research Fund, and Ofelia Cancer Research Fund.

1

only puplished papers were included
only english writen papers
heterogeneity among the RCTs
small sample size of the included studies
no detailed information about the bias of the included studies

 

"5HT3 RAs are more effective than other antiemetics for prophylaxis of RINV in patients receiving radiotherapy to abdomen/pelvis and TBI. Future RCTs should investigate the efficacy of newer agents such as substance P neurokinin 1 receptor antagonists in addition to 5HT3 RAs in prophylaxis of RINV during both acute and delayed phases."