transplantation
Contributions
Type: Publication Only
Background
The optimal intensity of myeloablation delivered as part of a reduced-intensity/toxicity conditioning (RIC/RTC) regimen to decrease the recurrence rate, without increasing non relapse mortality (NRM), remains to be established and the disease control remains a major challenge. The introduction of RTC regimens has allowed allogeneic hematopoietic cell transplantation to be performed in patients who were previously considered too old or otherwise unfit.
Aims
When busulfan Pharmacokinetic is not available the optimal dose is difficult to determine. In this perspective we made the hypothesis that decreasing the daily dose can be safer and efficient in high risk patients.
Methods
We studied the outcome of 27 patients (median age, 50 years; range, 21-65 years) with hematological malignancies were included.
The conditioning regimen based on busulfan at a dose of 100 mg/m2 /day intravenously for 4 days, fludarabine at a dose of 30 mg/m2 /day for 5 days, and antithymocyte globulins at a dose of 2.5 mg/kg/day for 2 days. Patient, disease and transplant characteristics are shown in Table 1.
Results
No patients experienced graft rejection. The median HCT comorbidity index score was 2 (range, 0 to 5). With a median follow-up of 13 months (range, 3-16months), the cumulative incidences of grade 2 to 4 acute graft-versus-host disease (GVHD) and chronic GVHD (all grades) were 43% (95% CI, 26%>60%) and 44% (95% CI, 20%>68%), respectively.
The Kaplan-Meier estimates of overall and disease-free survival at 1 year were 63% (95% confidence interval [95% CI], 42%>84%) and 49% (95% CI, 27%>71%), respectively. At 1 year, the cumulative incidence of recurrence/disease progression was 32% (95% CI, 12%>52%). Non relapse mortality (NRM) was 4% and 19% at day 100 and at 1 year respectively.
Patient age, diagnosis, donor type, sex, presence of comorbidities, and the Hematopoietic cell transplantation-specific comorbidities index did not appear to have any statistically significant impact on NRM, recurrence/disease progression, disease-free survival, or overall survival.
Summary
This well-tolerated conditioning platform can lead to long-term disease control The RTC regimen used in the current study appeared to be safe, with a low NRM rate at 1 year noted among high-risk patients, and efficient disease control, warranting prospective phase 3 trials.
Session topic: Publication Only
Type: Publication Only
Background
The optimal intensity of myeloablation delivered as part of a reduced-intensity/toxicity conditioning (RIC/RTC) regimen to decrease the recurrence rate, without increasing non relapse mortality (NRM), remains to be established and the disease control remains a major challenge. The introduction of RTC regimens has allowed allogeneic hematopoietic cell transplantation to be performed in patients who were previously considered too old or otherwise unfit.
Aims
When busulfan Pharmacokinetic is not available the optimal dose is difficult to determine. In this perspective we made the hypothesis that decreasing the daily dose can be safer and efficient in high risk patients.
Methods
We studied the outcome of 27 patients (median age, 50 years; range, 21-65 years) with hematological malignancies were included.
The conditioning regimen based on busulfan at a dose of 100 mg/m2 /day intravenously for 4 days, fludarabine at a dose of 30 mg/m2 /day for 5 days, and antithymocyte globulins at a dose of 2.5 mg/kg/day for 2 days. Patient, disease and transplant characteristics are shown in Table 1.
Results
No patients experienced graft rejection. The median HCT comorbidity index score was 2 (range, 0 to 5). With a median follow-up of 13 months (range, 3-16months), the cumulative incidences of grade 2 to 4 acute graft-versus-host disease (GVHD) and chronic GVHD (all grades) were 43% (95% CI, 26%>60%) and 44% (95% CI, 20%>68%), respectively.
The Kaplan-Meier estimates of overall and disease-free survival at 1 year were 63% (95% confidence interval [95% CI], 42%>84%) and 49% (95% CI, 27%>71%), respectively. At 1 year, the cumulative incidence of recurrence/disease progression was 32% (95% CI, 12%>52%). Non relapse mortality (NRM) was 4% and 19% at day 100 and at 1 year respectively.
Patient age, diagnosis, donor type, sex, presence of comorbidities, and the Hematopoietic cell transplantation-specific comorbidities index did not appear to have any statistically significant impact on NRM, recurrence/disease progression, disease-free survival, or overall survival.
Summary
This well-tolerated conditioning platform can lead to long-term disease control The RTC regimen used in the current study appeared to be safe, with a low NRM rate at 1 year noted among high-risk patients, and efficient disease control, warranting prospective phase 3 trials.
Session topic: Publication Only