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Randomized Controlled Trial
. 2005 Sep;20(3):224-31.
doi: 10.3904/kjim.2005.20.3.224.

High-dose versus low-dose cyclophosphamide in combination with G-CSF for peripheral blood progenitor cell mobilization

Jin Seok Ahn  1 , Seonyang Park, Seock-Ah Im, Sung-Soo Yoon, Jong-Seok Lee, Byoung Kook Kim, Soo-Mee Bang, Eun Kyung Cho, Jae Hoon Lee, Chul Won Jung, Hugh Chul Kim, Chu Myung Seong, Moon Hee Lee, Chul Soo Kim, Keun Seok Lee, Jung Ae Lee, Myung-Ju Ahn
Affiliations
Randomized Controlled Trial

High-dose versus low-dose cyclophosphamide in combination with G-CSF for peripheral blood progenitor cell mobilization

Jin Seok Ahn et al. Korean J Intern Med. 2005 Sep.

Abstract

Background: To compare the mobilizing effects and toxicities of two different doses of cyclophosphamide (CY) plus lenograstim (glycosylated G-CSF), we performed a prospective randomized study by enrolling patients suffering with either high-risk Non-Hodgkin's lymphoma (NHL) or breast cancer undergoing ablative chemotherapy.

Methods: The NHL patients received 4 cycles of CHOP and the breast cancer patients received 2-3 cycles of FAC (FEC) adjuvant chemotherapy. Then, the patients were randomly allocated to receive CY 4 g/m2 (arm A) or 1.5 g/m2 (arm B) in combination with lenograstim. Large volume leukapheresis was carried out and it was continued daily until the target cell dose of 2 x 10(6) CD34+ cell/kg was reached.

Results: Twenty-seven patients were enrolled in the study. The median number of leukaphereis sessions actually performed was 2.5 sessions in arm A and 3 sessions in arm B. The target cell dose was obtained with the median number of one leukapheresis session in both arms of the study (p=0.09). The collected number of CD34+ cells in the leukapheresis products was higher in arm A than arm B (22.4 vs. 9.9 x 10(6)/kg, respectively, p=0.05). Grade III or IV leukopenia was present in 14/15 patients (94%) in arm A and in 1/12 patients (8%) in arm B (p<0.0001). Grade Ill or IV thrombocytopenia was present in 8/15 patients (54%) in arm A, but this was not present in any patients of arm B (p=0.0004). Neutropenic fever occurred in 6/15 patients (40%) in arm A, and in 1/12 patients (8%) in arm B (p=0.09). The hematological recovery of the leukocytes and platelets after transplantation was not statistically different between the two doses.

Conclusion: Low-dose CY plus lenograstim is a safe and effective mobilizing regimen.

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Figures

Figure 1
Figure 1
Schematic representation of the treatment protocol. Patients with high-risk non-Hodgkin's lymphoma or breast cancer who were eligible for autologous transplantation were randomized to receive high-dose (4 g/m2) or low-dose (1.5 g/m2) cyclophosphamide in combination with lenograstim after induction chemotherapy with CHOP for the NHL patients or adjuvant chemotherapy with FAC for the breast cancer patients.
Figure 2
Figure 2
The peripheral blood kinetics of mobilization. The serial peripheral blood WBC count (A), the CD34+ cell count (B), and the CFU-GM count (C) in the patients undergoing PBPC mobilization following cyclophosphamide 4 g/m2 (Arm A, solid line) or 1.5 g/m2 (Arm B, dotted line) in combination with lenograstim (250 mg/d) starting on day 3. The leukapheresis sessions were begun at a median day of 11 in arm A and at a median day of 10 in arm B, respectively. The data are plotted as the mean and the standard error of the mean.
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