Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population

Abstract

The objective of this study was to compare the efficacy and tolerability of palonosetron and granisetron in a Chinese population receiving highly emetogenic cisplatin-based chemotherapy or moderately emetogenic chemotherapy. Patients were stratified by chemotherapy with cisplatin (yes/no) and then randomly assigned to receive either palonosetron (0.25 mg i.v.) in the first cycle followed by granisetron (3 mg i.v.) in the second cycle or vice versa. The primary efficacy endpoint was the proportion of patients with complete response 0-24 h post-chemotherapy administration. The proportions of patients with complete response 24-120 and 0-120 h following chemotherapy were also compared. Of the 144 patients randomized, 36 (25%) received 60-80 mg/m(2) cisplatin; 66 of 72 patients in the palonosetron to granisetron group and 56 of 72 patients in the granisetron to palonosetron group completed treatment with both antiemetics. The efficacy and safety analyses included 128 palonosetron treatments and 138 granisetron treatments. Palonosetron consistently produced numerically higher complete response rates than granisetron in the acute phase (0-24 h, 71.09 vs. 65.22%), the delayed phase (24-120 h, 60.16 vs. 55.80%), and overall (0-120 h, 53.13 vs. 50.00%) though the differences were not significant. Both palonosetron and granisetron were well tolerated. Palonosetron was well tolerated and effective in preventing acute and delayed chemotherapy-induced nausea and vomiting in a Chinese population. When used as monotherapy, 0.25-mg palonosetron was not inferior to 3-mg granisetron for preventing vomiting following highly or moderately emetogenic chemotherapy.

Impact of initiating antiemetic prophylaxis with palonosetron versus ondansetron on risk of uncontrolled chemotherapy-induced nausea and vomiting in patients with lung cancer receiving multi-day chemotherapy

“…Palonosetron, which has pharmacologic and pharmacokinetic advantages over ondansetron with respect to its receptor-binding affinity and half-life [10,12] that appear to translate into significantly improved efficacy in preventing delayed CINV [13,14], is the only 5-HT 3 RA that has been granted US Food and Drug Administration approval for preventing delayed CINV. Positive clinical trial experiences in preventing both acute and delayed CINV have been described for palonosetron alone or with dexamethasone (± other agents) [15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. In contrast to other 5-HT 3 receptor antagonists, palonosetron exhibits allosteric receptor binding with positive cooperativity and triggers internalization of cell surface serotonin receptor sites [32,33].…”

Efficacy, Safety and Quality of Life Outcomes of Palonosetron, Ramosetron and Granisetron as a Part of Antiemetic Therapy in Prevention of Chemotherapy Induced Nausea and Vomiting- A Randomised Comparative Trial

“…11,14 In a study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in Chinese population, palonosetron consistently produced numerically higher complete response rates than granisetron in the acute phase and delayed phase, though the differences were not significant. 15 In a comparative study of antiemetics for the prevention of postoperative nausea and vomiting after laparoscopic gynaecologic surgery, the number of complete responders at 48 h after the surgery was maximum for ramosetron, though the differences between the groups were not statistically significant. 16 In all the three groups, the complete response rates in the acute phase were seen to be better as compared to the respective complete response rates in the delayed phase in the terms of proportions.…”

“…17 Some comparative trials have also corroborated these findings. 14,15 Chemotherapeutic agents release 5-HT from enterochromaffin cells which activate 5-HT3 receptors on visceral afferent fibres to induce emesis. 5-HT3 receptor antagonists block the activity of 5-HT3 receptors in gut as well as in area postrema, CTZ and vomiting centre.…”

Effectiveness of antiemetics in control of antineoplastic chemotherapy-induced emesis at home

“…(1) In cancer chemotherapy, the drugs used are potent inducers of nausea and vomiting, which represent the most uncomfortable and stressful adverse effects in view of the patients themselves. (2) Several drugs are used in the prevention and treatment of chemotherapy-induced emesis.…”

“…Antagonists of serotonin receptors (5-HT3) such as ondansetron and granisetron are widely prescribed in hospitals, outpatient clinics and for use at home. (1) However, despite proven efficacy, the 5-HT3 antagonists do not show satisfactory results in about 20 to 30% of patients in antiemetic treatment. (3) In this context, the use of corticosteroids associated with the 5-HT3 antagonist is recommended, in view of greater efficacy in the control of emesis.…”