Prospective randomized comparative observation of single- vs split-dose lenograstim to mobilize peripheral blood progenitor cells following chemotherapy in patients with multiple myeloma or non-Hodgkin's lymphoma.

In patients with hematologic malignancies, granulocyte colony-stimulating factor (G-CSF) following chemotherapy is widely used to mobilize peripheral blood progenitor cells (PBPCs), but there have been no trials comparing schedules of G-CSF following chemotherapy. We conducted a prospective randomized comparative observation of the mobilization with a single dose (10 microg kg once a day) or split dose (5 microg kg twice a day) of lenograstim following chemotherapy in 25 multiple myeloma (MM) and 15 non-Hodgkin's lymphoma (NHL) patients. Chemotherapy was cyclophosphamide 4 g/m2 for MM and ESHAP with or without Rituximab for NHL. The median number of harvested CD34+ cells was 19.4 x 10(6)/kg and 15.8 x 10(6)/kg in the single- and split-dose groups, respectively (p=0.47). Targeted collection of 5 x 10(6) CD34+ cells/kg was achieved in 18/20 patients in the single-dose group and in all 20 patients of the split-dose group (p=0.24), with the median number of sessions 1 and 2 in the single- and split-dose groups, respectively (p=0.13). We could not observe statistically significant differences between a single-dose and split-dose lenograstim following chemotherapy in enhancing the mobilization of PBPCs in MM or NHL patients.

Initiation of peripheral blood progenitor cell harvest based on peripheral blood hematopoietic progenitor cell counts enumerated by the Sysmex SE9000.

BACKGROUND: The most reliable index for timing peripheral blood progenitor cell (PBPC) collection following mobilization is still to be determined. The techniques to enumerate peripheral blood (PB) CD34+ cells are expensive and time-consuming. The SE9000 (Sysmex) provides an estimate of immature cells, called hematopoietic progenitor cells (HPCs). The aim of this study was to prospectively evaluate the efficacy of PB HPC levels for timing PBPC harvest. STUDY DESIGN AND METHODS: Thirty-five patients (15 non-Hodgkin's lymphoma and 20 multiple myeloma) were enrolled. PB HPCs and harvested CD34+ cells were counted with the SE9000 and flow cytometry, respectively. Circulating HPCs were monitored daily. PBPC harvest was initiated when HPC levels reached at least 5 per mm(3). RESULTS: HPC levels reached 5 per mm(3) or more on Median Day 12 (range, days 9 to 16) of mobilizing chemotherapy. The median number of CD34+ cells collected per patient was 19.40 x 10(6) per kg (range, 1.94 x 10(6)-52.55 x 10(6) per kg). Both successful and optimal harvest was achieved in 97 percent of patients. PBPCs were successfully harvested in 25 patients (71%) in one session. An optimal harvest in a single session was attained in 16 patients (46%). CONCLUSION: This might be the first prospective study showing the PB HPC level for timing PBPC harvest.

Low-dose lenograstim to enhance engraftment after autologous stem cell transplantation: a prospective randomized evaluation of two different fixed doses.

BACKGROUND: G-CSF is used to enhance hematopoietic recovery after autologous stem cell transplantation (ASCT), but the optimal dose of G-CSF during engraftment has not been established. The medical cost of ASCT is a serious financial burden in developing countries, and G-CSF is the most costly drug used in this procedure. We evaluated whether a lower, vial-size fitted dose of lenograstim is clinically equivalent to a higher fixed dose. STUDY DESIGN AND METHODS: A prospective randomized study was performed on 33 patients (11 non-Hodgkin's lymphoma, 8 multiple myeloma, 14 breast cancer) undergoing ASCT. Patients were randomly administered 100 micro g or 250 micro g lenograstim daily starting on the next day of ASCT, with a minimum infusion of 3 x 10(6) CD34+ cells per kg. RESULTS: For both lenograstim doses, median time to neutrophil engraftment was 9 days and median time to PLT engraftment was 11 days. Episodes of clinically documented infections were 10 per 379 patient-days in the 100 microg per day group and 10 per 320 patient-days in the 250 microg per day group. There were no between-group differences in requirements for transfusion of RBCs or PLTs. Duration of hospitalization was 16 days for the 100 microg per day group and 17 days for the 250 microg per day group. Daily lenograstim dose per patient's body weight and total amount of lenograstim used during ASCT were both significantly lower in the 100 microg per day group. CONCLUSION: Administration of 100 microg per day of lenograstim showed comparable clinical efficacy to 250 microg per day lenograstim for immediate hematopoietic recovery after ASCT. Use of the lower dose was associated with lower overall lenograstim usage and lower cost.