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

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.