Abstract
Purpose
Nausea and vomiting are among the most feared complications of chemotherapy reported by patients. The objective of this study was to establish the overall complete response (CR; no emesis or use of rescue medication 0–120 h after chemotherapy) with either ondansetron- or palonosetron-containing antiemetic regimens in patients receiving highly emetogenic chemotherapy (HEC).
Methods
This was a prospective, open-label, randomized, single-center, pilot study that enrolled patients receiving their first cycle of HEC. Patients were randomized to receive either palonosetron 0.25 mg IV (PAD) or ondansetron 24 mg orally (OAD) on day 1 prior to HEC. All patients received oral aprepitant 125 mg on day 1, then 80 mg on days 2 and 3, and oral dexamethasone 12 mg on day 1, then 8 mg on days 2, 3, and 4. Descriptive statistics were used to summarize the data.
Results
A total of 40 patients were enrolled, 20 in each arm. All patients were female, and 39 received doxorubicin/cyclophosphamide chemotherapy for breast cancer. For the primary endpoint, 65 % (95 % CI, 40.8–84.6 %) of patients in the PAD arm and 40 % (95 % CI, 19.1–63.9 %) of patients in the OAD arm achieved an overall CR.
Conclusions
While CR rates for aprepitant and dexamethasone plus palonosetron or ondansetron-containing regimens have been published previously, this is the first documentation of CR rates with these regimens in the same patient population. These results may be used to design a larger, adequately powered, prospective study comparing these regimens.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
de Boer-Dennert M, de Wit R, Schmitz PI, Djontono J, v.Beurden V, Stoter G et al (1997) Patient perceptions of the side-effects of chemotherapy: the influence of 5HT3 antagonists. Br J Cancer 76:1055–1061
Li Q, Roddy JVF, Berger M (2009) Palonosetron hydrochloride in the treatment of chemotherapy-induced nausea and vomiting. Clin Med Ther 1:1145–1158
National Comprehensive Cancer Network (2012) Clinical practice guidelines in oncology: antiemesis; V.1.2012. http://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf. Accessed 1 July 2012
Ruhlmann C, Herrstedt J (2010) Palonosetron hydrochloride for the prevention of chemotherapy-induced nausea and vomiting. Expert Rev Anticancer Ther 10:137–148
Basch E, Prestrud AA, Hesketh PJ, Kris MG, Feyer PC, Somerfield MR et al (2011) Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 29:4189–4198
Hesketh PJ (2008) Chemotherapy-induced nausea and vomiting. N Engl J Med 358:2482–2494
Zofran® tablets (package insert). Research Triangle Park, NC: GlaxoSmithKline; May 2010
Kytril® tablets and oral solution (package insert). Nutley, NJ: Roche Laboratories, Inc; March 2010
Anzemet® tablets (package insert). Bridgewater, NJ: Sanofi-Aventis U.S. LLC; October 2009
Aloxi® injection for intravenous use (package insert). Albuquerque, NM: Catalent Pharma Solutions; February 2008
Rojas C, Li Y, Zhang J, Stathis M, Alt J, Thomas AG et al (2010) The antiemetic 5-HT3 receptor antagonist palonosetron inhibits substance P-mediated responses in vitro and in vivo. J Pharmacol Exp Ther 335:362–368
Basch E, Prestrud AA, Hesketh PJ, Kris MG, Feyer PC, Somerfield MR et al (2011) Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol 4189–4198
Saito M, Aogi K, Sekine I, Yoshizawa H, Yanagita Y, Sakai H et al (2009) Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial. Lancet Oncol 10:115–124
Aapro MS, Grunberg SM, Manikhas GM, Olivares G, Suarez T, Tjulandin SA et al (2006) A phase III, double-blind, randomized trial of palonosetron compared with ondansetron in preventing chemotherapy-induced nausea and vomiting following highly emetogenic chemotherapy. Ann Oncol 17:1441–1449
National Comprehensive Cancer Network (2010) Clinical practice guidelines in oncology: antiemesis; V.1.2010. http://www.nccn.org. Accessed 1 September 2010
Oken MM, Creech H, Tormey DC, Horton J, Davis TE, McFadden ET et al (1982) Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649–655
Funding
There has been no funding provided to this research study.
Conflict of interest
The authors have no conflicts of interest to disclose.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Wenzell, C.M., Berger, M.J., Blazer, M.A. et al. Pilot study on the efficacy of an ondansetron- versus palonosetron-containing antiemetic regimen prior to highly emetogenic chemotherapy. Support Care Cancer 21, 2845–2851 (2013). https://doi.org/10.1007/s00520-013-1865-9
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00520-013-1865-9