Wenzell, C.M., Berger, M.J., Blazer, M.A., Crawford, B.S., Griffith, N.L., Wesolowski, R., . . . Layman, R.M. (2013). Pilot study on the efficacy of an ondansetron- versus palonosetron-containing antiemetic regimen prior to highly emetogenic chemotherapy. Supportive Care in Cancer, 21, 2845–2851.
To compare the effect of single-day ondansetron use versus palonosetron in combination with aprepitant and dexamethasone
Patients were stratified into cisplatin and noncisplatin chemotherapy groups and then randomized. On day 1 prior to highly emetogenic chemotherapy (HEC), patients in group 1 received palonosetron at 0.25 mg IV. Group 2 received ondansetron at 24 mg orally 30 minutes before chemotherapy. Both groups received oral aprepitant at 125 mg on day 1 (60 minutes prior to chemotherapy) then 80 mg on days 2 and 3, and oral dexamethasone at 12 mg on day 1 then 8 mg on days 2, 3, and 4. Data were recorded on days 1–6 following chemotherapy administration.
Prospective, open-label, randomized pilot study
Thirteen patients (65%) in the palonosetron arm and eight patients (40%) in the ondansetron arm achieved an overall complete response (CR). In the acute setting, 11 patients (55%) in the ondansetron group and 15 (75%) in the palonosetron group achieved a CR. In the delayed setting, nine patients (45%) in the ondansetron group and 13 (65%) in the palonosetron group achieved a CR. In the ondansetron group, 11 patients reported the use of rescue antiemetics, and in the palonosetron group, seven patients reported antiemetic use (in both acute and delayed time periods). Few patients experienced episodes of retching or vomiting. Seven patients in the ondansetron group and eight in the palonosetron group reported acute nausea. Delayed nausea was reported by 11 patients in the ondansetron group and 12 in palonosetron group.
This pilot study demonstrated a consistently higher rates of CR and lower rates of vomiting and retching in the palonosetron group although there was no statistically significant difference.
Take caution before interpreting the results of this study because it did not use the most robust research design (i.e., randomization, blinding, placebo-control) to detect the drug's efficacy. This study highlighted the need to conduct a large, adequately powered study.