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news.Palonosetron, a second generation 5-HT3 receptor antagonist, patients undergoing multiday-HDT and ASCT
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Helsinn has provided new positive data presented at the ECCO-ESMO joint European oncology conference in Berlin, for palonosetron. Palonosetron, a second generation 5-HT3 receptor antagonist, which improves emesis and nausea control in patients undergoing multiday-high dose chemotherapy (HDT) and autologous stem cell transplantation (ASCT).
Moreover the results also demonstrates, the addition of a second palonosetron dose 48 hours after the first one significantly reduces the detrimental impact of nausea on daily activities.
A total of 60 patients with diagnosis of lymphoma, myeloma, sarcoma, acute leukemia, and breast cancer were enrolled in the trial. They were all receiving multiday chemotherapy regimens. The first cohort (30 patients) received a single dose of palonosetron (0.25mg iv) plus dexamethasone (8mg) half an hour before starting HDT, the second cohort (30 patients) received a second dose of palonosetron plus dexamethasone after 48 hours.
The results showed no significant differences between the two groups as to acute CINV evaluation, since 98% of patients achieved a complete response. Only 17 patients (28%) experienced moderate nausea.
Double-dose palonosetron displayed a trend for a better control of delayed nausea, which occurred in 77% of patients versus 53% of those treated with a single dose (p=0.0581). In addition, double palonosetron dosing had a highly significant impact on nausea-related modifications of daily activities
as self-assessed by patients at 120 hours from starting of HDT.
Dr Antonio Pinto, said: “We have previously shown that a single dose of palonosetron effectively prevented CINV, with prevention rates higher than those obtained with the historical 5-HT3 receptor antagonists. The objective of this study was to evaluate whether a subsequent dose of palonosetron may result more effective than a single dose administration in controlling CINV after multiday chemotherapy regimens.”
“And it did, impressively. Despite the emesis control achieved with a single dose, nausea was still experienced by about half of the patients. The administration of the second dose minimised the
negative effects of nausea in the delayed phase thus leading to a significant amelioration of patient’s quality of life in the overall period.”
Palonosetron is developed by Helsinn of Switzerland and is marketed as Aloxi, Onicit, and Paloxi in more than 40 countries world-wide.