Objective: A clinical study of palonosetron was performed to evaluate its efficacy in preventing both acute and delayed emesis after high-dose chemotherapy (HDC) before hematopoietic stem cell transplantation (HSCT) using a historical control group of patients treated with ondansetron as the comparative drug.
Methods: Among the 46 evaluated patients 20 with lymphoma received BEAM as the conditioning regimen; 16 has relapsed germ cell tumors treated with CARBOPEC; and 10 with acute myeloid leukemia received BuCY. Increasing severity of nausea was evaluated according to the following 4-grade scale: none (no nausea); mild (slight nausea but no disruption to daily activities); moderate (nausea and some disruption to daily activities); and severe (extreme nausea and severe disruption to daily activities). The emetic response rate was evaluated using the criteria: complete (no emetic episode); major (1-2 episodes); minor (3-5 episodes); and failure (>5 episodes). The response rate of the study drugs was evaluated by the following 4-grade scale based on the condition of nausea and vomiting: highly effective, moderately effective, slightly effective, and not effective.
Results: Patients treated with palonosetron showed significantly greater response rates than those receiving ondansetron during the both the acute and the delayed phases: highly and moderately effective: acute phase 15% versus 5% CARBOPEC; 70% versus 35% BEAM and 32% versus 20% BuCY; delayed phase: 60% versus 30% BuCY; 100% versus 50% BEAM and 25% versus 10% CARBOPEC.
Conclusions: Single-dose palonosetron was more effective than ondansetron treatment to prevent acute and delayed nausea and vomiting following HDC before HSCT.