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TEPADINA 15 mg powder for concentrate for solution for infusion(十)
2018-01-24 02:34:52 来源: 作者: 【 】 浏览:7951次 评论:0
ing the efficacy of thiotepa are summarised:
Autologous HPCT
Haematological diseases
Engraftment: Conditioning treatments including thiotepa have proved to be myeloablative.
Disease Free Survival (DFS): An estimated 43% at five years has been reported, confirming that conditioning treatments containing thiotepa following autologous HPCT are effective therapeutic strategies for treating patients with haematological diseases.
Relapse: In all conditioning treatments containing thiotepa, relapse rates at more than 1 year have been reported as being 60% or lower, which was considered by the physicians as the threshold to prove efficacy. In some of the conditioning treatments eva luated, relapse rates lower than 60% have also been reported at 5 years.
Overall Survival (OS): OS ranged from 29% to 87% with a follow-up ranging from 22 up to 63 months.
Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 2.5% to 29% have been reported. TRM values ranged from 0% to 21% at 1 year, confirming the safety of the conditioning treatment including thiotepa for autologous HPCT in adult patients with haematological diseases.
Solid tumours
Engraftment: Conditioning treatments including thiotepa have proved to be myeloablative.
Disease Free Survival (DFS): Percentages reported with follow-up periods of more than 1 year confirm that conditioning treatments containing thiotepa following autologous HPCT are effective choices for treating patients with solid tumours.
Relapse: In all conditioning treatments containing thiotepa, relapse rates at more than 1 year have been reported as being lower than 60%, which was considered by the physicians as the threshold to prove efficacy. In some cases, relapse rates of 35% and of 45% have been reported at 5 years and 6 years respectively.
Overall Survival: OS ranged from 30% to 87% with a follow-up ranging from 11.7 up to 87 months.
Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): RRM values ranging from 0% to 2% have been reported. TRM values ranged from 0% to 7.4% confirming the safety of the conditioning treatment including thiotepa for autologous HPCT in adult patients with solid tumours.
Allogeneic HPCT
Haematological diseases
Engraftment: Engraftment has been achieved (92%-100%) in all reported conditioning treatments and it was considered to occur at the expected time. Therefore it can be concluded that conditioning treatments including thiotepa are myeloablative.
GvHD (graft versus host disease): all conditioning treatments eva luated assured a low incidence of acute GvHD grade III-IV (from 4% to 24%).
Disease Free Survival (DFS): Percentages reported with follow-up periods of more than 1 year and up to 5 years confirm that conditioning treatments containing thiotepa following allogeneic HPCT are effective choices for treating patients with haematological diseases.
Relapse: In all conditioning treatments containing thiotepa, relapse rates at more than 1 year have been reported as being lower than 40% (which was considered by the physicians as the threshold to prove efficacy). In some cases, relapse rates lower than 40% have also been reported at 5 years and 10 years.
Overall Survival: OS ranged from 31% to 81% with a follow-up ranging from 7.3 up to 120 months.
Regimen Related Mortality (RRM) and Transplant Related Mortality (TRM): low values have been reported, confirming the safety of the conditioning treatments including thiote
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