Efficacy, complication rates and cost-effectiveness of chemotherapy + G-CSF and single agent C-CSF as mobilizing regimens for autologous PBSC: analysis of 125 patients with hematological malignancies
Journal
Bone Marrow Transplantation Journal
Date Issued
2010
Author(s)
DOI
10.1038/bmt.2010.41
Abstract
Mobilized PBSC have largely replaced conventional,
unprimed BM as source during the autologous transplant
setting, because of a faster hematopoietic reconstitution,
less transfusion requirements, less infective complications
and earlier hospital discharge. Choosing the optimal mobilizing
regimen is the goal for achieving the suffi cient amount
of PBSC for autologous transplant. G-CSF is the standard
agent commonly administered undergoing PBPC mobilization
and collection in a dose of 10 micro/gr in a 4 days
regimen. The additional chemotherapy to G-SCF is still associated
with higher rate of hemorrhagic cystitis, prolonged
neutropenia, infective complications, secondary malignancies
and other toxicities. Therefore in this study we evaluated
the effi cacy, complication rates and cost-effectiveness
of chemotherapy + G-CSF versus single agent C-CSF as
mobilizing regimens. We analyzed 125 patients with haematological
malignancies (49 AML in fi rst remission, 26 HD, 30
MM, 16 NHL, 4ALL) who underwent mobilization of PBSC in
our centre and the attempt to reach 2 × 10(6)/kgCD34 cells.
In 6% of patients adequate cell dose was not reachable and
overall failure rate of mobilization of 17,5%. Furthermore
15.6% failed to harvest the optimal 4 × 10(6)/kgCD34 + cells
with > 1 aphaeresis attempt. The analysis of factors contributing
in this effect in the univariante analysis were: > 2 lines
of previous chemotherapy and neutropenic events (P = 0,002
and P = 0,005), those also remained signifi cant in the multivariate
analysis (RR:4,4 and 6,2). No differences have been
noticed between the diagnostic groups of patients. The mortality
rate was 2% (intracranial bleeding and sepsis). The
statistical analysis preformed for analyzed patients transplanted
with single G-CSF as mobilizing regimen, compared
with the chemotherapy + G-CSF group showed P < 0,0001 for febrile days, microbiological positive isolates, days of hospital
stay, transfusion requirements. The median cost of PBSC
collection in the Chemotherapy + G-CSF group was E 8550
(E220-10110) compared with the G-CSF group alone E3110
(E2200-4120) that showed P < 0,0001. Taking these results
in consideration for the potential candidates for ASCT, transplant
centers should consider the use of less myelosupressive
agents or dose reduction strategies for the mobilization
and autologous stem cell procurement.
unprimed BM as source during the autologous transplant
setting, because of a faster hematopoietic reconstitution,
less transfusion requirements, less infective complications
and earlier hospital discharge. Choosing the optimal mobilizing
regimen is the goal for achieving the suffi cient amount
of PBSC for autologous transplant. G-CSF is the standard
agent commonly administered undergoing PBPC mobilization
and collection in a dose of 10 micro/gr in a 4 days
regimen. The additional chemotherapy to G-SCF is still associated
with higher rate of hemorrhagic cystitis, prolonged
neutropenia, infective complications, secondary malignancies
and other toxicities. Therefore in this study we evaluated
the effi cacy, complication rates and cost-effectiveness
of chemotherapy + G-CSF versus single agent C-CSF as
mobilizing regimens. We analyzed 125 patients with haematological
malignancies (49 AML in fi rst remission, 26 HD, 30
MM, 16 NHL, 4ALL) who underwent mobilization of PBSC in
our centre and the attempt to reach 2 × 10(6)/kgCD34 cells.
In 6% of patients adequate cell dose was not reachable and
overall failure rate of mobilization of 17,5%. Furthermore
15.6% failed to harvest the optimal 4 × 10(6)/kgCD34 + cells
with > 1 aphaeresis attempt. The analysis of factors contributing
in this effect in the univariante analysis were: > 2 lines
of previous chemotherapy and neutropenic events (P = 0,002
and P = 0,005), those also remained signifi cant in the multivariate
analysis (RR:4,4 and 6,2). No differences have been
noticed between the diagnostic groups of patients. The mortality
rate was 2% (intracranial bleeding and sepsis). The
statistical analysis preformed for analyzed patients transplanted
with single G-CSF as mobilizing regimen, compared
with the chemotherapy + G-CSF group showed P < 0,0001 for febrile days, microbiological positive isolates, days of hospital
stay, transfusion requirements. The median cost of PBSC
collection in the Chemotherapy + G-CSF group was E 8550
(E220-10110) compared with the G-CSF group alone E3110
(E2200-4120) that showed P < 0,0001. Taking these results
in consideration for the potential candidates for ASCT, transplant
centers should consider the use of less myelosupressive
agents or dose reduction strategies for the mobilization
and autologous stem cell procurement.
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