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Comparison Between Filgrastim and Lenograstim Plus Chemotherapy For Bone Marrow Transplantation (2010) 45, 277–281 & 2010 Macmillan Publishers Limited All rights reserved 0268-3369/10 $32.00 www.nature.com/bmt ORIGINAL ARTICLE Comparison between filgrastim and lenograstim plus chemotherapy for mobilization of PBPCs R Ria, T Gasparre, G Mangialardi, A Bruno, G Iodice, A Vacca and F Dammacco Department of Biomedical Sciences and Human Oncology, Section of Internal Medicine and Clinical Oncology, University of Bari Medical School, Bari, Italy Recombinant human (rHu) G-CSF has been widely used during transplantation.4 However, the use of G-CSF after to treat neutropenia and mobilize PBPCs for their autologous PBPC transplantation has been queried, as its autologous and allogeneic transplantation. It shortens further reduction in time to a safe neutrophil count5,6 does neutropenia and thus reduces the frequency of neutropenic not always imply fewer significant clinical events, such as fever. We compared the efficiency of glycosylated rHu infections, length of hospitalization, extrahematological and non-glycosylated Hu G-CSF in mobilizing hemato- toxicities or mortality.7,8 Even so, the ASCO guidelines still poietic progenitor cells (HPCs). In total, 86 patients were recommend the use of growth factors after autologous consecutively enrolled for mobilization with CY plus either PBPC transplantation.9 glycosylated or non-glycosylated G-CSF, and under- G-CSF induces the proliferation and differentiation of went leukapheresis. The HPC content of each collection, myeloid precursor cells, and also provides a functional toxicity, days of leukapheresis needed to reach the activity that influences chemotaxis, respiratory burst and minimum HPC target and days to recover WBC (X500 Ag expression of neutrophils. Comparison of HPC- and 41000/mm3) and plts (450 000/mm3) were evalu- mobilizing regimens is greatly impeded by the considerable ated. Glycosylated G-CSF mobilized more CD34 þ cells variability of their responses. The two G-CSF recombinant than did the non-glycosylated form. The ability to reach a preparations (lenograstim and filgrastim) currently avail- collection target of 43 Â 106 CD34 þ /kg body weight in able for HPC mobilization are produced in different ways. two leukaphereses was higher for glycosylated G-CSF. No Lenograstim is obtained from Chinese hamster ovarian significant differences between the two regimens were cells, and consists of 174 amino acids with 4% glycosyla- observed with regard to toxicity and days to WBC and plt tion.10 Filgrastim is produced using Escherichia coli, has a recovery. High-dose CY plus glycosylated G-CSF methionine group at its N-terminal end and is not achieved adequate mobilization and the collection target glycosylated.11 more quickly and with fewer leukaphereses. In this study, we compared the HSC-mobilizing efficacy Bone Marrow Transplantation (2010) 45, 277–281; of glycosylated vs non-glycosylated G-CSF in terms of the doi:10.1038/bmt.2009.150; published online 6 July 2009 number of CD34 þ cells collected and the number of Keywords: G-CSF; mobilization; PBPCs; recombinant leukaphereses needed to reach their collection target. human glycosylated G-CSF; recombinant non-glycosylated Secondary end points were the following: days to recover G-CSF WBC and plts, and assessment of toxicity and percentage of patients who achieved the collection target in a single course of mobilization (high-dose CY plus G-CSF plus three leukaphereses). Introduction GG-CSF-mobilized PBPCs have become the most widely Patients and methods used source of hematopoietic progenitor cells (HPCs) for transplantation procedures, and their mobilization is Patients clinically safe. G-CSF is used to mobilize PBPCs in patients A total of 86 patients (48 men and 38 women, Table 1) who with malignancies, as well as in healthy donors for underwent auto-SCT for multiple myeloma (MM: 44 autologous and allogeneic PBPC transplantation.1–3 It patients), non-Hodgkin’s lymphoma (NHL: 31 patients) reduces the aplasia period and hence fever and infections or Hodgkin’s lymphoma (HL: 11 patients) between 2000 and 2008 were consecutively included in this controlled, non-randomized study. Correspondence: Dr R Ria, Department of Internal Medicine and Inclusion criteria were the same as those for auto-SCT: Clinical Oncology, University of Bari Medical School, Policlinico— age o70 years, serum creatinine o200 mmol/l, cardiac Piazza Giulio Cesare, 11, I-70124 Bari, Italy. E-mail: [email protected] ejection fraction 450%, DLCO (diffusing capacity of the Received 6 October 2008; revised 5 May 2009; accepted 26 May 2009; lung for carbon monoxide) 450% and no active infection published online 6 July 2009 or other disease causing comorbidity.12 Lenograstim vs filgrastim in PBPCs mobilization R Ria et al 278 Table 1 Patient characteristics Characteristics Total number of patients Treated with lenograstim Treated with filgrastim Numbers 86 55 31 Sex, M/F 48/38 29/26 19/12 Age, median (range) years 53.7 (36–64) 52.2 (36–64) 49.5 (34–60) MM/NHL/HL 44/31/11 32/16/7 12/15/4 Status at mobilization: CR/PR/SD/PD 11/58/11/6 7/39/6/3 4/19/5/3 Patients receiving radiotherapy 8 6 2 Patients with BM involvement 11 7 4 Mobilizing chemotherapy (MM/NHL/HL) CTX 7 g/m2 0/31/11 0/16/7 0/15/4 CTX 4 g/m2 32/0/0 23/0/0 9/0/0 CTX 3 g/m2 12/0/0 9/0/0 3/0/0 Abbreviations: F ¼ female; HL ¼ Hodgkin’s lymphoma; M ¼ male; MM ¼ multiple myeloma; NML ¼ non-Hodgkin’s lymphoma. Overall 55 patients (29 men and 26 women; median age those from the day of high-dose CY administration (day 0) 53.7 years, range 36–64) were enrolled in Arm A and 31 to the day of counts recovery. patients (19 males and 12 females; median age 49.5 years, range 34–60) were enrolled in arm B. At mobilization, 11 Statistical analysis patients had achieved CR, 58 had achieved PR, 11 had Data were analyzed with the SPSS (Chicago, IL, USA) stable disease and 6 had disease progression. This was a software package. All results are presented as median±1 single-center prospective study in which patients were s.d. (range). The medians were compared with the Mann– assigned 1.5:1 to the two arms, paying attention to their Whitney U-test. P values o0.005 were considered sig- characteristics to equilibrate the arms. Also the patient nificant. One-way ANOVA analysis was used to compare groups were well equilibrated for factors that could affect all parameters between patients with MM, NLH and HL, mobilization, such as number of earlier chemotherapy, also with respect to CY doses, earlier therapy and BM radiation therapy and BM involvement. involvement. The study was approved by the Local Ethical Commit- tee, and all patients gave their informed consent according to the Declaration of Helsinki Principles. Results Treatment program Results of mobilization and leukapheresis All patients received only induction therapy with dexametha- A significantly higher CD34 þ collection was obtained sone, adriamycin, vincristin (DAV) Â 4 courses (MM from patients in Arm A (glycosylated Hu G-CSF) than patients), CHOP Â 6 courses (NHL patients) or ABVD Â 6 from patients in Arm B (non-glycosylated rHu G-CSF): courses (HL patients). The transplant indication in NHL and 15.34±3.1 Â 106 CD34 þ cells/kg b.w. vs 11.04±2.41 Â 106 HL patients was related to high-risk disease: International CD34 þ /kg b.w., respectively (Po0.01) (Figure 1a), and Prognostic Index (IPI) 2–4 or refractory disease in NHL, the percentage of patients who reached the minimum refractory disease in HL. The mobilization regimen was collection target after two leukaphereses was higher in administered after 45±5 days after the end of induction those treated with glycosylated G-CSF (75 vs 48%, 2 therapy. In MM patients, it consisted of CY 3 or 4 g/m at respectively, Po0.001). The apheresis’ mean volume after day 0, on the basis of disease status at mobilization and plasma detraction was 54±14 ml in Arm A and 57±16 ml performance status; in patients with lymphomas, it was 7 g/m2 in Arm B. These results show that glycosylated G-CSF at day 0. Thereafter, patients received 10 mg/kg/day s.c. of provided more adequate mobilization and accelerated the glycosylated Hu G-CSF (Arm A) or non-glycosylated rHu target collection time, indicating that it mobilizes BM G-CSF (Arm B) on days 1–12. From day 12, patients were HSCs more effectively and in greater numbers. apheresed for 2 days and the CD34 þ cell content was No differences were observed between the MM, NLH evaluated by FACS analysis. If the patient did not reach the or HL groups, nor with regard to the different CY doses minimum CD34 þ cells target, a third apheresis was (3, 4 or 7 g/m2). Arm A ¼ MM patients: 14.21±2.8 Â 106 performed. The apheresis mean volume after plasma CD34 þ /kg b.w.; LNH patients: 16.14±3.6 Â 106 CD34 þ / detraction was 84±14 ml in Arm A and 87±16 ml in Arm kg b.w.; LH patients: 15.81±3.8 Â 106 CD34 þ /kg b.w. 6 B. If the minimum HPC target (X3 Â 10 /CD34 þ cells/kg (P ¼ NS). Arm B ¼ MM patients: 10.82±2.33 Â 106 body weight (b.w.)) was not reached after three apheretic CD34 þ /kg b.w.; LNH patients: 12.23±1.9 Â 106 procedures, patients were re-mobilized after at least CD34 þ /kg b.w.; LH patients 12.84±2.84 Â 106 CD34 þ / 1 month.
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