Ikari, Y., Ogata, K., Nakashima, Y., Sato, E., Masaki, M., Katsuya, H., . . . Tamura, K. (2014). Safety and pharmacokinetic evaluation of repeated intravenous administration of palonosetron 0.75 mg in patients receiving highly or moderately emetogenic chemotherapy. Supportive Care in Cancer, 22, 1959–1964.
To evaluate the safety, efficacy, and pharmacokinetics of repeated doses of palonosetron 0.75 mg on days 1 and 3 in Japanese patients who received highly emetogenic chemotherapy (HEC)
Prospective pharmacologic safety and efficacy clinical trial
The pharmacokinetic results are not included here as they were specific to pharmacists. The main treatment-related adverse effects were constipation (77%), diarrhea (15.4%), and pain (7.7%). CR was achieved by 96.2% of patients in the acute phase. In the delayed phase, the CR rate was 76.9 %, and the CP rate was 61.5%. The percentage of patients without nausea in the acute phase was 80.8% and 53.8% in the delayed phase.
Repeated treatment with palonosetron was safe and well tolerated by patients who received HEC or MEC.
In this study, patients with cancer receiving HEC or MEC often experienced delayed nausea despite booster doses of palonosetron 0.75 mg IV on day 3. One of the common adverse effects of this drug was constipation.