New data presented at the European Haematology Association (EHA) 2011 Annual Meeting in London show better control of nausea and vomiting with the combination palonosetron plus aprepitant when compared to granisetron in patients receiving multiday highly emetogenic conditioning chemotherapy regimens.
The combination of palonosetron (0.25mg IV every 48 hours) and aprepitant (125mg on day one, followed by 80mg each of the remaining days) improves control of CINV (chemotherapy induced nausea and vomiting) compared with daily granisetron (3mg IV) during the conditioning period (five to six days) of
patients prior to stem cell transplantation (HSCT).
The results come from a prospective, multi-centre, randomised, stratified by conditioning regimen, double-blind study (AMENO Study) presented at the EHA 2011 Annual Meeting in London by the Spanish groups GETH (Grupo Espanol de Trasplante Hematopoyetico y Terapia Celular) and PETHEMA (Programa de Estudio y Tratamiento de las Hemopatias Malignas).
“Nausea and vomiting in patients receiving high-dose, multi-day conditioning regimens prior to stem cell transplantation is particularly common and affects between 55–100% of the patients,” Javier Lopez-Jimenez, Hospital Ramon y Cajal, Hematology Department and the lead investigator, said. “CINV is particularly troublesome, especially in the delayed phase beginning 24 hours after the start of conditioning. Though newer anti-emetics as palonosetron and aprepitant appear to significantly reduce acute and delayed CINV, in comparison to the older 5-HT3 receptor antagonists, few studies had prospectively evaluated the efficacy of these drugs in this very challenging setting,” he explained.
Sixty consenting patients were included in the study, received a conditioning regimen prior to HSCT, and an anti-emetic prophylaxis (31, palonosetron + aprepitant; 29, granisetron). Significantly more patients in the group treated with the combination of palonosetron and aprepitant had a complete response – defined as no emesis and no use of rescue medication – during the acute (zero to 24 hours; 92.3% versus 67.9% in the granisetron group), delayed (24 to 120 hours; 61.5% versus 28.6%, respectively) and overall (zero to 120 hours; 61.5% versus 28.6%, respectively) periods.
In addition, palonosetron plus aprepitant significantly reduced the proportion of patients with emesis during the acute, delayed and overall periods and showed a trend toward a reduction in percentage of patients with significant nausea during the delayed period.
There were no significant differences between the groups in adverse events or in the times of engraftment or severe infections.