Quality assessment of autologous hematopoietic blood progenitor and stem cell grafting

In this study, we report clinical and laboratory data collected from 432 consecutive patients (397 adults, 35-pediatric; mean age of 50 years +/-12 SD for adults and 7+/-5 for pediatric patients; 200 non Hodgkin lymphoma-NHL; 32 Hodgkin lymphoma-HL; 165 multiple myeloma- MM; 10 autoimmune diseases AD; 22 acute myeloid leukaemia-AML; 3 acute lymphoblastic leukaemia-ALL) who underwent an autologous stem cell transplantion (auto-SCT). We considered primary end-points evaluating efficacy, ie health economic issues, including antibiotic administration, transfusion of blood components and time in hospital, scondary end points evaluating toxiciity, in accordance with Common Toxicity Criteria (CTC),and tertiary end points evaluating safety, i.e. the risk of regimen related death or disease progression within the first 3 months following graft reinfusion. A time-dependent grading of efficacy is proposed with day 21 for MM and day 25 for the other diseases categories, as the acceptable maximum time in hospital, which together with antibiotics, antifungal or transfusion therapy delineates three groups: an acceptable outcome for patients discharged before day 22 with no therapy; an unacceptable outcome for patients who stay in hospital more than 21 days on continuous therapy. The multivariate analysis showed evidence that : a) pediatric patients resulted to have less toxicity (p=0,0001); b) one or 2 apheresis (p=0,001) predicted good outcome; c) toxicity increased with higher graft volume reinfused (>500ml) (p=0,002); d) PBSC collection having CD34+ cells > 4 x 10°6/kg in one apheresis was associated with a better outcome in all patients categories except AML and ALL; e) > 5 x 10°6/kg CD34+ cells infused predicted better transplant outcome in all patients categories except AML and ALL. Our data support the notion that the number of transplanted CD34+ cells is associated with a better outcome in autografts; however, further variables play a role in determining the occurrence of toxicity in the early phases post-SCT.