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The purpose of this study is to determine the presence of disseminated tumor cells in bone marrow or apheresis product, and also to evaluate the clinical significance of contaminated products and the efficacy of CD34+ selection and high-dose chemotherapy in patients with Stage III breast cancer. Fifty-five patients were enrolled in this prospective cohort study. Whereas CD34+ positive selection was not carried out in the first group (unselected group, n:31), CD34+ positive selection was performed in the second group (CD34 selected group, n:24). Tumor cells were detected with anticytokeratin monoclonal antibody in the bone marrow, apheresis product and positive fraction. Tumor cells were found in six (19.3%) patients in unselected group and four patients (16.6%) in CD34 selected group ( P = 0.76). The percentages of distant metastases were found higher in unselected group (51.6% vs. 25%, P < 0.01). Although there were no differences between the two groups for disease free survival (DFS; 44% vs. 74%, P = 0.24) or overall survival (54% vs. 68%, P = 0.84), DFS was significantly lower in patients with tumor cells than in patients without tumor cells (21% vs. 62%, P = 0.02). In conclusion, the presence of tumor cells in bone marrow or apheresis product decreases DFS in patients with Stage III breast cancer who underwent high-dose chemotherapy. CD34+ selection does not change survivals, but it may decrease the distant metastases. J. Clin. Apheresis 2009. © 2009 Wiley-Liss, Inc. [ABSTRACT FROM AUTHOR]

This prospective study was carried out in healthy donors and patients. The performance of the CliniMACS was evaluated with the comparison of the numbers of total nucleated cell (TNC) within and over the capacity of the normal scale column. In addition, large vs. normal scale column and manual vs. automated washing systems were also compared. A total of 44 selections were done. Eighteen normal scale selections were done with initial TNC numbers over 6 x 10(10) and 14 selections were performed below this number. None of the cases had CD34+ cell numbers over the capacity. Flow cytometry was used to check each separation performance for purity and recovery of CD34+ cells along with T- and B-cell depletion level parameters. All healthy donors had significantly better mean purity and recovery of CD34+ cells, and T- and B-cell depletion status than that of patients with values 95 vs. 85%, P: 0.006; 77 vs. 58%, P: 0.004; 4.55 log vs. 4.06 log, P: 0.004; 3.19 log vs. 2.63 log, P: 0.01, respectively. However, the performance of the system was not dependent on using the normal or large-scale column; automated or manual washing systems; and initial TNC numbers above (>6 x 10(10), range: 7.05-21.84 x 10(10), mean: 12.32 x 10(10)) or within (<6 x 10(10), range: 0.86-5.89 x 10(10), mean: 4.15 x 10(10)) the column capacity. In conclusion, the performance of the CliniMACS is more efficient in healthy donors than in patients. However, the performance of the system did not change as long as the numbers of CD34+ cells (range: 0.34-5.87 x 10(8)) were not exceeding the column capacity despite that more than 6 x 10(10) TNCs were used.

In the past, variable results were reported for single daily and two divided daily doses of granulocyte colony-stimulating factor (G-CSF) in stem cell collection where no study exists investigating the effect of body mass index (BMI) on mobilization. The numbers of CD34(+) cells collected were compared in 86 patients with solid or hematological malignancies receiving either single daily (14 mug/kg/day) G-CSF (filgrastim) as group I (n=36) or two divided doses of G-CSF daily (2 x 7 mug/kg/day) as group II (n = 50). Both groups were divided into subgroups according to their BMI as group a (BMI 25 kg/m(2)). Two groups were similar in terms of BMI, gender, and disease characteristics. All patients have received G-CSF as a single or two divided doses subcutaneously and aphereses have been done on the 5th day. No significant difference in numbers of CD34(+) cells between groups Ia and Ib, groups IIa and IIb, and groups Ia and IIa was found. On the other hand, the mean ratio and the number of CD34(+) cells in group Ib were significantly higher than those of group IIb (0.58 +/- 0.06% vs. 0.37 +/- 0.26%, P = 0.01 and 3.67 +/- 0.65 x 10(4)/kg/ml vs. 1.92 +/- 0.37 x 10(4)/kg/ml, P= 0.02). In conclusion, in patients with BMI >25 kg/m(2), once daily G-CSF compared to split dose administration induces a greater number of CD34(+) stem cell mobilization, which suggests the presence of a different pharmacokinetics in obese patients., (Copyright 2003 Wiley-Liss, Inc.)