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Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 8049
© 2004 American Society of Clinical Oncology
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Abstract

Palonosetron (PALO) versus ondanestron/dolasetron (OND/DOL) in preventing chemotherapy-induced nausea and vomiting (CINV) in elderly patients: Combined results from 2 phase III trials

M. S. Aapro and A. Macciocchi

Clinique de Genolier, Genolier, Switzerland; Helsinn Healthcare, Lugano, Switzerland

8049

Background: The majority of cancer patients (pts) are elderly (age ≥ 65 yrs) with age-related increases in mortality, comorbidity, and potential for treatment complications. Therefore, simple, convenient treatment regimens are desirable in this population. PALO is a pharmacologically distinct 5-HT3 receptor antagonist which offers multiday prevention of CINV with a single 0.25-mg IV dose. To assess efficacy/safety of PALO in elderly pts, a retrospective subset analysis of randomized studies (N = 754) in pts receiving moderately emetogenic CT was conducted. Methods: The subset consisted of pts (n = 165) ≥ 65 yrs in the pooled data from 2 phase III, multicenter, randomized, double-blind trials comparing single IV doses of PALO 0.25 mg, OND 32 mg, or DOL 100 mg. Concomitant dexamethasone was administered in 3% of pts. Endpoints included complete response rates (CR: no emetic episodes [EE] & no rescue therapy) and % of pts with no EE through 5 days post-CT. Results: A greater proportion of PALO-treated pts had a CR or were emesis-free compared with those treated with OND/DOL during the 5 days post-CT.



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*P = 0.01 Pts in the PALO group experienced a longer time to treatment failure than pts in the OND/DOL group (P = 0.01). Fewer PALO-treated pts experienced the most common adverse events of constipation (9.8% vs 13.5%) and headache (6.1% vs 12.4%) compared with OND/DOL-treated pts; cardiac adverse events were similar and infrequent (<3%) in both groups. The adverse event profile was similar to that seen in the pts < 65 yrs. Conclusions: A single dose of PALO was more effective than OND/DOL in preventing CINV over 5 days post-CT in elderly patients. PALO's longer half-life and improved control make it a more convenient and appropriate 5-HT3 receptor antagonist for use in elderly cancer patients receiving emetogenic CT.


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Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration
Helsinn Healthcare Helsinn Healthcare Helsinn Healthcare Helsinn Healthcare

Abstract presentation from the 2004 ASCO Annual Meeting




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Copyright © 2004 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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