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Erschienen in: Supportive Care in Cancer 11/2007

01.11.2007 | Original Article

Palonosetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy for germ cell cancer

verfasst von: Lawrence H. Einhorn, Mary J. Brames, Robert Dreicer, Craig R. Nichols, Michael T. Cullen Jr., Joseph Bubalo

Erschienen in: Supportive Care in Cancer | Ausgabe 11/2007

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Abstract

Goals of work

The aims of this study were to assess the safety and antiemetic efficacy of multiple-day dosing of palonosetron plus dexamethasone in patients receiving highly emetogenic multiple-day cisplatin-based chemotherapy for germ cell tumors.

Materials and methods

Forty-one men undergoing 5-day cisplatin-based chemotherapy for testicular cancer received palonosetron 0.25 mg IV once daily 30 min before chemotherapy on days 1, 3, and 5 plus IV dexamethasone 20 mg before chemotherapy on days 1 and 2, and 8 mg PO bid on days 6 and 7 and 4 mg bid on day 8. Safety and efficacy were assessed in 24-h intervals for 9 days. Efficacy endpoints included emesis, intensity of nausea and its interference with patient functioning, and rescue antiemetic use. A subset of patients (n = 11) was studied for electrocardiograph effects and pharmacokinetic evaluation.

Main results

This multiple-day antiemetic regimen was safe, with headache and constipation the most common treatment-related adverse events, mostly mild. Neither adverse events nor electrocardiographic changes appeared to increase in frequency, duration, or intensity over time despite a 1.42-fold systemic accumulation of palonosetron with repeated doses. The majority of patients had no emesis at any time throughout days 1–5 (51%) or days 6–9 (83%), had no moderate-to-severe nausea, and did not require rescue medication. Most patients reported that nausea had no significant effect on daily functioning on days 1–4 (72%) and days 5–9 (85%).

Conclusions

Palonosetron on days 1, 3, and 5, along with a regimen of dexamethasone, was safe and well tolerated and effectively controlled both nausea and emesis in patients undergoing 5-day cisplatin-based chemotherapy for testicular cancer.
Fußnoten
1
Kytril® (2005) (granisetron hydrochloride) Injection. Prescribing information. Roche Laboratories, Inc. Nutley, NJ, USA November 2005.
 
2
Zofran® (2006) (ondansetron hydrochloride) Injection. Prescribing information. GlaxoSmithKline, Research Triangle Park, NC, USA. February 2006.
 
3
Anzemet® (2006) Injection (dolasetron meselate injection). Prescribing information. Sanofi-Aventis US, L.L.C., Bridgewater, NJ, USA, June 2006.
 
4
Aloxi® (palonosetron HCl) injection. Prescribing information. Helsinn Birex Pharmaceuticals Ltd., Damastown, Dublin, Republic of Ireland: 2005; MGI PHARMA, INC., Bloomington, MN, USA, January 2006.
 
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Metadaten
Titel
Palonosetron plus dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy for germ cell cancer
verfasst von
Lawrence H. Einhorn
Mary J. Brames
Robert Dreicer
Craig R. Nichols
Michael T. Cullen Jr.
Joseph Bubalo
Publikationsdatum
01.11.2007
Verlag
Springer-Verlag
Erschienen in
Supportive Care in Cancer / Ausgabe 11/2007
Print ISSN: 0941-4355
Elektronische ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-007-0255-6

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