성인 동종 조혈모세포이식 환자에서 Busulfan 투여 횟수에 따른 효과 및 안전성 비교
Comparison of Therapeutic Effects and Safety of Once-daily versus Four-times-daily Intravenous Busulfan in Allogenic Transplantation
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Background : The conventional four-times-daily intravenous conditioning regimen of busulfan for hematopoietic stem cell transplantation (HSCT) has shown limitations, such as low patient compliance, inconvenient preparation and administration, and stability. In this study, we compared the efficacy and safety between four-times-daily regimen of busulfan and once-a-day regimen of busulfan in adult patients undergoing allogeneic HSCT. Methods : We retrospectively analyzed the electronic medical records until September 2019 of patients who were administered busulfan once a day (ivBU1 group) and four times daily (ivBU4 group) between January 2016 to December 2016. Primary outcomes were 1-year survival, disease-free survival, relapse rate, non-relapse mortality, the incidence of graft-versus-host disease (GVHD), and neutrophil and platelet recovery time. The secondary outcomes were cytomegalovirus (CMV) infection and veno-occlusive disease (VOD) incidence. Results : Comparison of the ivBU1 group (n=75) and the ivBU4 group (n=59) showed that the 1-year survival rate was 75.1% vs 62.6% (p=0.127) and the 1-year disease free survival rate was 62.4% vs 56.2% (p=0.736), respectively. There was no significant difference in multivariate analysis of the relapse rate adjusted by HLA (human leukocyte antigen) match and the type of transplantation (p=0.129). In terms of the non-relapse mortality rate, the ivBU1 group showed a significantly lower rate in the multivariate analysis than the ivBU4 group (13.5% vs 29.8%, p=0.025). The incidence of GVHD was also lower in the ivBU1 group regardless of the patient characteristics (Odds Ratio= 0.333, 95%CI 0.130-0.851, p=0.022). There were no significant differences in neutrophil and platelet recovery, CMV infection, and VOD incidence. Conclusion : There were no significant differences in survival, disease-free survival, and relapse rate according to the number of busulfan administrations, and non-relapse mortality and GVHD incidence were lower in the ivBU1 group. Based on the results of this study, it is expected that the once-daily method can replace the four-times-daily method.
Abstract
Background : The conventional four-times-daily intravenous conditioning regimen of busulfan for hematopoietic stem cell transplantation (HSCT) has shown limitations, such as low patient compliance, inconvenient preparation and administration, and stability. In this study, we compared the efficacy and safety between four-times-daily regimen of busulfan and once-a-day regimen of busulfan in adult patients undergoing allogeneic HSCT. Methods : We retrospectively analyzed the electronic medical records until September 2019 of patients who were administered busulfan once a day (ivBU1 group) and four times daily (ivBU4 group) between January 2016 to December 2016. Primary outcomes were 1-year survival, disease-free survival, relapse rate, non-relapse mortality, the incidence of graft-versus-host disease (GVHD), and neutrophil and platelet recovery time. The secondary outcomes were cytomegalovirus (CMV) infection and veno-occlusive disease (VOD) incidence. Results : Comparison of the ivBU1 group (n=75) and the ivBU4 group (n=59) showed that the 1-year survival rate was 75.1% vs 62.6% (p=0.127) and the 1-year disease free survival rate was 62.4% vs 56.2% (p=0.736), respectively. There was no significant difference in multivariate analysis of the relapse rate adjusted by HLA (human leukocyte antigen) match and the type of transplantation (p=0.129). In terms of the non-relapse mortality rate, the ivBU1 group showed a significantly lower rate in the multivariate analysis than the ivBU4 group (13.5% vs 29.8%, p=0.025). The incidence of GVHD was also lower in the ivBU1 group regardless of the patient characteristics (Odds Ratio= 0.333, 95%CI 0.130-0.851, p=0.022). There were no significant differences in neutrophil and platelet recovery, CMV infection, and VOD incidence. Conclusion : There were no significant differences in survival, disease-free survival, and relapse rate according to the number of busulfan administrations, and non-relapse mortality and GVHD incidence were lower in the ivBU1 group. Based on the results of this study, it is expected that the once-daily method can replace the four-times-daily method.
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