Back to Search
Start Over
Double-blind, randomised, controlled study of the efficacy and tolerability of palonosetron plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy.
- Source :
-
Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2010 May; Vol. 21 (5), pp. 1083-8. Date of Electronic Publication: 2010 Jan 15. - Publication Year :
- 2010
-
Abstract
- Background: To reduce side-effects of corticosteroid-containing antiemetic regimens, tailoring antiemetic schedules to specific requirements of different patients could be of benefit. We evaluated the possibility to reduce the total dose of corticosteroids when palonosetron, a long-acting second-generation 5-hydroxytryptamine-3 (5-HT(3)) receptor antagonist, is used.<br />Materials and Methods: Double-blind, multicentre, noninferiority study of chemotherapy-naive breast cancer patients receiving 0.25 mg palonosetron and 8 mg dexamethasone on day 1, randomly assigned to receive placebo (n = 151) or 4 mg b.i.d. dexamethasone (n = 149) on days 2 and 3. Primary end point was complete response (CR) rate (no emesis, no rescue medication) in the overall (days 1-5) period. Secondary end points were CR rates in the acute (day 1) and delayed (days 2-5) periods, rates of no emesis and no nausea and impact on daily functioning (Functional Living Index-Emesis).<br />Results: Noninferiority between the two treatments was demonstrated by similar CR rates (P = 0.487) in the overall period. Most parameters showed that palonosetron and dexamethasone on day 1 only offer chemotherapy-induced nausea and vomiting protection similar to multiple-day dexamethasone administration.<br />Conclusion: In patients treated with a single injection of palonosetron on day 1, reducing dexamethasone is an option that is not associated with significant reduction in antiemetic control during the 5-day period or an impact on patient functioning.
- Subjects :
- Adolescent
Adult
Aged
Aged, 80 and over
Breast Neoplasms pathology
Child
Double-Blind Method
Drug Therapy, Combination
Female
Humans
Maximum Tolerated Dose
Middle Aged
Nausea chemically induced
Palonosetron
Placebos
Prognosis
Prospective Studies
Serotonin Antagonists therapeutic use
Survival Rate
Vomiting chemically induced
Young Adult
Antiemetics therapeutic use
Antineoplastic Combined Chemotherapy Protocols adverse effects
Breast Neoplasms drug therapy
Dexamethasone therapeutic use
Isoquinolines therapeutic use
Nausea prevention & control
Quinuclidines therapeutic use
Vomiting prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 1569-8041
- Volume :
- 21
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Annals of oncology : official journal of the European Society for Medical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 20080830
- Full Text :
- https://doi.org/10.1093/annonc/mdp584