Klin Onkol 2001; 14(5): 163-169.
Summary:
Purpose:
The comparison of kinetics and safety of hematopoietic reconstitution and time to relaps/ progression (EFS) and overall survival (OS) of patients with non-Hodgkin_s lymphoma undergoing ASCT, transplanted with selected or non selected harvest.
Patients and methods:
On the whole 35 transplanted patients were evaluated, 12 with CD 34+ selected harvest and as a control, group of 23 patients with non selected harvest transplanted. The control group was selected in 1:2 proportion, according to the disease status at time of transplantation (equal for both groups). For statistical analysis of non-parametric values we used the software program EpiInfo6, survival times (EFS and OS) were calculated using the Kaplan-Meier method. Comparisons of these times to event distributions were made using the log-rank test.
Results:
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Median of trombocyte engraftment over 20x109/l was 11 days for non-selected patients, resp. 14,5 days for selected group (p<0,05), also the median of trombocyte engraftment over to 50x109/l was significantly lower for non-selected –15 vs 22 (p<0,05). As well the median of granulocyte engraftment over 0,5 x109/l was significantly lower in favor of the non-selected group (10 vs 11 days), equally for leucocyte engraftment up to 1,0x109/l (10 vs 11 days) (p<0,05). Absolute period of leucopenia, divided into 3 grade (number of days with leucocytes under 1,0, 0,5, and 0,2 x109/l) was for all 3 grades significantly longer in the selected group. Median of days of febrile neutropenia (2,5 days for the non-selected group) was not significantly different in comparison to the selected group (median 4,5 days).
- The overall survival probability (OS) at 3 years for all patients was 63,5% represented by 75% and 57,3% for selected and non-selected group respectively. Event free survival probability (EFS) at 3 years was 35,9% for all patients, resp. 33,3% for selected and 37,2% for non-selected patients. Median follow-up was 33,5 months (12-61) for group of patients with selected harvest transplanted and 32 month (7-73) for non-selected group. Median time to relaps or/ progression measured from transplantation date was 21 months (4-25 months) for selected and 8 months (0,8-37 months) for nonselected patients (NS differ).
Conclusions:
We have not found the significant difference in survival between both groups of patients measured by OS and EFS at 3 years. Also the median time to relaps was not different. The slower kinetics of hematopoietic reconstitution observed in group of selected patients was probably caused by lower CD 34+ progenitors number in selected harvests because of their lost during ex vivo manipulation. However, in consequence of their sufficient absolute numbers, the complications rate was similar in both groups.
