A phase II trial of olanzapine, dexamethasone, and palonosetron for the prevention of chemotherapy-induced nausea and vomiting: a Hoosier oncology group study
- 1.6k Downloads
The purpose of this study is to determine the control of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC) with the combined use of palonosetron and olanzapine, and dexamethasone with the dexamethasone given on day 1 only.
Materials and methods
Forty chemotherapy-naive patients received on the day of chemotherapy, day 1, an anti-emetic regimen consisting of dexamethasone, palonosetron, and olanzapine. Patients continued olanzapine for days 2–4 after chemotherapy administration. Patients recorded daily episodes of emesis, daily symptoms utilizing the M.D. Anderson Symptom Inventory, and the utilization of rescue therapy.
For the first cycle of chemotherapy, the complete response (no emesis, no rescue) for the acute period (24 h post-chemotherapy) was 100%, the delayed period (days 2–5 post-chemotherapy) 75%, and the overall period (0 120 h post-chemotherapy) 75% in 8 patients receiving HEC and was 97, 75, and 72% in 32 patients receiving MEC. Patients with no nausea for the acute period was 100%, the delayed period 50%, and the overall period 50% in 8 patients receiving HEC and was 100, 78, and 78% in 32 patients receiving MEC.
The complete response and control of nausea in subsequent cycles of chemotherapy were not significantly different from cycle one.
Olanzapine combined with a single dose of dexamethasone and a single dose of palonosetron was very effective in controlling acute and delayed CINV in patients receiving both HEC and MEC.
KeywordsOlanzapine Palonosetron Dexamethasone Chemotherapy Anti-emetic therapy Delayed emesis
This study was supported by the Walther Cancer Institute, MGI Pharma, and Eli Lilly.
- 7.Eisenberg P, Figueroa-Vadillo J, Zamora R et al (2003) Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5HT3 receptor antagonist: results of a phase III, single dose trial versus dolasetron. Cancer 98:2473–2482PubMedCrossRefGoogle Scholar
- 11.Gralla R, Lichinitser M, Van der Vegt S et al (2003) Palonosetron improves prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy: results of a double-blind randomized phase II trial comparing single does of palonosetron with ondansetron. Ann Oncol 14:1570–1577PubMedCrossRefGoogle Scholar
- 13.Hale AS (1997) Olanzapine. Br J Hosp Med 58:443–445Google Scholar
- 14.Hesketh PJ, Grunberg SM, Gralla RJ et al (2003) The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: A multinational, randomized, double-blind placebo-controlled trial in patients receiving high-dose cisplatin-the Aprepitant Protocol 052 Study group. J Clin Oncol 21:4112–4119PubMedCrossRefGoogle Scholar
- 15.Mantovani G, Maccio A, Aslexandro B et al (1996) Comparison of granisetron versus ondansetron versus tropisetron in the prophylaxis of acute nausea and vomiting induced by cisplatin for the treatment of head and neck cancer; a randomized controlled trial. Cancer 77:941–948PubMedCrossRefGoogle Scholar
- 25.Red Book Annual Drug Topic (2006) Medical Economics Company, Montvale, NJ, pp 239–243Google Scholar