Abstract: Objective To evaluate the antiemetic efficacy and safety of single and multipleday dosing of palonosetron in patients receiving chemotherapy.
MethodsA total of 451 patients were randomized to receive a single intravenous dose of palonosetron 025 mg 30 min before chemotherapy on day 1（group A， n=232）， or palonosetron 025 mg once daily 30 min before chemotherapy on days 1，3 and 5（group B， n=219）. In group B， patients that received chemotherapy less than 2 days， and who were without vomiting and nausea occurred on the fourth day after chemotherapy， were not received palonosetron on day 5. The clinical effects and adverse reaction were analyzed between two groups.
ResultsThe complete remission（CR） rates for emesis and nausea in the whole chemotherapy course of group B was 52.97％，higher than 38.36％ of group A（P=0.002）. The CR rates for acute emesis and nausea were 5819％ for group A and 62.56％ for group B（P=0.340）， which demonstrated no statistical difference. Comparisons of CR rates for delayed emesis and nausea yielded statistical difference between group A and group B（46.98％ vs.65.30％， P＜0.001）. There was no statistical difference in CR rates for acute emesis between group A and group B（86.64％ vs.87.21％， P=0.860）. CR rates for emesis were significantly higher for group B than group A during the delayed period （89.95％ vs.71.12％， P＜0.001）. There was no statistical difference in CR rates for acute nausea between group A and group B（58.19％ vs.62.56％， P=0.340）. CR rates for nausea were significantly higher for group B than group A during the delayed period （66.21％ vs.51.72％， P=0.0018）.The rate of rescue treatment for group B was lower than group A（11.42％ vs.19.83％， P=0.014）. There was no statistical difference in incidence of adverse reactions between group A and group B（8.19％ vs.10.05％， P=0.390）. Conclusion Multipleday dosing of palonosetron is superior to a single dose of palonosetron in the prevention of delayed emesis and nausea. There is no statistical difference in incidence of adverse reactions between the two groups.