Evaluating the Clinical Efficacy of Increased Granulocyte Colony-Stimulation Factor (GCSF) in Patients Who Fail a Standard Dose Regimen during Peripheral Blood Stem Cell Collection.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2926-2926
Author(s):  
Shirong Wang ◽  
Nademanee Auayporn ◽  
Park Hyun Soon ◽  
Joy Fridey ◽  
Jocelynne Palmer ◽  
...  

Abstract Granulocyte Colony-Stimulating Factor (GCSF) at 10 microg/kg (with or without chemotherapy) is the standard dose commonly administered to patients undergoing Peripheral Blood Stem Cell (PBSC) mobilization and collection. Due to various host and disease factors, 10–20% of our patients failed to mobilize sufficient PBSC at this standard dose. At our institution it is common practice to increase GCSF from 10 microg/kg to 16–20 microg/kg during the initial or second mobilization attempt if the patient is able to tolerate the increased dose. To assess the clinical efficacy of increased GCSF administration among patients who fail to mobilize at the standard dose, we performed a retrospective chart review of 112 patients who underwent stem cell mobilization and collection between 01/31/2000 and 11/6/2003. The median age at the start of collection was 51.2 (range: 1.3–72.2); the case-series was made up of 52 men and 60 women. The majority of the cases were Lymphoma patients (Non-Hodgkin’s Lymphoma=52; Hodgkins Disease=15) with the remaining patients classified as Acute Myeloid Leukemia (AML=12), Multiple Myeloma (MM=13), or ‘Other’ (N=20). Initially all 112 patients received 4–10 days of GCSF at 10 microg/kg per day before the first day of PBSC collection. Because these patients failed to collect sufficient daily CD34 cells, the GCSF dose was increased to 16–20 microg/kg. Before increasing the GCSF dose, the median CD34 daily yield was 0.19 (range: 0.03–0.90), and the median peripheral WBC was 27.6 (range: 1.3–61.8). The median number of collection at 10 microg/kg was 4 (range 2–15), and the median number of days from the end of collection at 10 microg/kg to the start of 16–20 microg/kg was 1 (range: 0–53). After increasing the GCSF dose the median peripheral WBC was 37.1 (range: 3.1–70.2), and the median CD34 daily yield was 0.28 (range: 0.03–3.43). The median CD34 total yield was 3.1 (range 0.6–12.3). Ultimately 90 patients (80%) reached a CD34 cell target of 2*10–6/kg (range: 2.0–12.3), and 22 patients (20%) did not reach this target. The overall difference in CD34 counts pre-post increased GCSF administration was statistically significant (Wilcoxon p<0.01). The difference in CD34 counts (pre-post increase GCSF dose) was explained by age only; the patient’s diagnosis and gender had no statistically significant explanatory value. Patients less than 40 years of age were more likely to have successful PBSC collection with an increase dose of GCSF (p=0.02). The mean difference in daily CD34 yield for patients <40 years was 0.38; for patients ≥40 years was 0.11. Based on this analysis we recommend to increase GCSF dose to 16microg to 20 microgram/kg among the younger (<40 years) patients who failed a standard dose regimen at 10microg/kg, while other re-mobilization regimens should be considered for older patients irrespective of their gender or underlying diagnosis.

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 7099-7099
Author(s):  
M. Ozturk ◽  
F. Arpaci ◽  
S. Ataergin ◽  
A. Ozet ◽  
T. Cetin ◽  
...  

7099 Background: 10 microg/kg/day of filgrastim and lenograstim have been recommended for mobilization of CD34+ cells without associated chemotherapy. However,in our previous randomized study we demonstrated that a 7.5 microg/kg/day dose of lenograstim has been as efficacious as 10 microg/kg/day of filgrastim. In this study, we investigated whether a reduced dose of lenograstim is equavalent to standard dose for autologous peripheral blood stem cell (PBSC) mobilization and transplantation. Methods: A total of 49 consecutive patients were randomized to either low dose (7.5 microg/kg/day, n = 24) or standard dose (10 microg/kg/day, n = 25) of lenograstim. These two groups were similar in regard to disease, sex, body weight, body surface area, conditioning regimens, previous chemotherapy cycles and radiotherapy. Each dose of lenograstim was administered for 4 consecutive days. The first PBSC apheresis was done on the 5th day. In the posttransplant period, lenograstim was given at 5 microg/kg/day until leukocyte engraftment. Results: Successful mobilization with the first apheresis, was achieved in 10/24 (42%) patients in low dose group versus 14/25 (56%) patients in standard dose group. No significant difference was seen in the median number of CD34+cells mobilized, as well as the median number of apheresis, median volume of apheresis, percentage of CD34+ cells, and CD34+ cell number. Leukocyte and platelet engraftments, the number of days requiring G-CSF and parenteral antibiotics, the number of transfusions were similar in both groups in the posttransplant period. Conclusions: Lenograstim 7.5 microg/kg/day is as efficious as Lenograstim 10 microg/kg/day for autologous PBSC mobilization and transplantation. No significant financial relationships to disclose.


Amyloid ◽  
2014 ◽  
Vol 21 (3) ◽  
pp. 149-153 ◽  
Author(s):  
Steve Y. Lee ◽  
Vaishali Sanchorawala ◽  
David C. Seldin ◽  
J. Mark Sloan ◽  
Nancy Andrea ◽  
...  

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2314-2314
Author(s):  
Francois Lefrere ◽  
Dominique bastit-Barrau ◽  
Suzanne Mathieu ◽  
Alain Bohbot ◽  
Philippe Bourrin ◽  
...  

Abstract &lt;&gt;The ACVBP regimen is commonly used in young poor-risk patients with DLBCL candidates to first line consolidative high-dose therapy followed by autologous stem cells transplantation in GELA trials. The combination with the monoclonal anti-CD20 antibody rituximab (R-ACVBP) is now routinely used, as induction treatment and to mobilize peripheral blood stem cell (PBSC). The aim of the present study was to assess the impact of rituximab on PBSC mobilization and collection in patients with newly diagnosed DLBCL receiving ACVBP chemotherapy. We reviewed the data from two prospective controlled trials. The first, conducted between 1999 and 2003, involved patients presenting with 2 or 3 adverse prognostic factors on the basis of the age-adjusted IPI (aa-IPI), treated by ACVBP (LNH 98B-3) (ASCO2007:8018). In the second trial (LNH 03-3B), conducted between 2004 and 2007, similar patients received the same initial inductive chemotherapy combined to rituximab (375mg/m2 at D1). 137 and 91 patients in the ACVBP and the R-ACVBP groups are here analyzed, respectively. Clinical and biological characteristics at diagnosis of the two groups of patients were similar (aa-IPI 2 and aa-IPI 3: 75% and 25%, respectively). The conditions for G-CSF administration and stem cell collections were identical. PBSC mobilizations were performed following the third or fourth cycle of (R)-ACVBP. The median delay between day 1 of chemotherapy and the first hemapheresis was identical for both groups. First hemapheresis was performed with a median peripheral white blood cell concentration of 16.2 x 109/l and 16.6 x 109/l for ACVBP and R-ACVBP groups, respectively. The median peak number of peripheral blood CD34+ cells observed the same day of first hemapheresis in ACVBP and R-ACVBP group was 69 x 106/l and 63 x 106/l, respectively (p = 0.5). The median number of CD34+ cells collected were 7.1 x 106 and 6.0 x 106 CD34 cells/kg for ACVBP and R-ACVBP groups (p = 0.12) while the median number of hemapheresis to target a minimal number of 3 x 106 CD34 cells/kg was identical, of one, in both groups. Failure of stem cell collection , defined as less than 3 x 106 CD34 cells/kg harvested, was observed in 8% and 4% of the patients who received ACVBP or R-ACVBP , respectively (p = 0.13). We conclude that rituximab combined to ACVBP regimen does not impair PBSC mobilization and collection.


Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 3211-3211 ◽  
Author(s):  
Ivana Micallef ◽  
Stephen M Ansell ◽  
Francis Buadi ◽  
David Dingli ◽  
Angela Dispenzieri ◽  
...  

Abstract Abstract 3211 Poster Board III-148 Although autologous stem cell transplantation (ASCT) has become standard of care for many patients with hematologic malignancies, many patients fail to collect a minimum number of CD34 + stem cells to support high dose chemotherapy and ASCT. Recently, plerixafor, a CXCR4 antagonist, was FDA approved for use in combination with G-CSF for autologous peripheral blood stem cell mobilization in patients with NHL or Multiple Myeloma. In February 2009, we commenced a risk adapted approach to the utilization of plerixafor. The study was restricted to patients mobilized with GCSF alone and patients undergoing chemotherapy primed PBSC mobilization were excluded. Peripheral blood stem cell mobilization was commenced with G-CSF at 10 mcg/kg/day. On day 4, a peripheral blood (PB) CD34 count was measured. For patients whose PB CD34 was ≥10/μL, apheresis was commenced the following morning. For patients whose PB CD34 was <10/μL, it was measured again on day 5; if ≥10/μL then apheresis was commenced the following morning. If PB CD34 was <10/μL on day 5, plerixafor (0.24 mg/kg sc) was administered on the evening of day 5 and apheresis was commenced the following day (Group A). In addition, during apheresis, for patients whose collection yield was < 0.5 × 106 CD34/kg, in the absence of instrument failure or problems with the collection procedure, plerixafor was added (Group B). Morning administration of G-CSF and evening dosing of plerixafor continued daily until apheresis was complete. From February to July 2009, 174 mobilization attempts occurred; 27 with chemotherapy and 147 with cytokines alone. The 147 pts who underwent mobilization with cytokines alone are presented here. The underlying diagnosis was as follows: Myeloma 61 pts, NHL 54 pts, Amyloid 17 pts, Hodgkin 10 pts, POEMS 4 pts and 1 pt with a solid tumor. For the entire group the median number of CD34 cells collected was 5.5 × 106 CD34/kg (range 0.1-17). The median number of apheresis was 3 (range 1-12). 67 patients (46%) received plerixafor; 37 patients started plerixafor during mobilization (Group A) and 30 patients during collections due to a poor yield (Group B). 12 pts of the 37 received plerixafor on day 4 because of prior mobilization failure or high risk of mobilization failure and are included in Group A. Table 1 outlines the details of mobilization and collection by groups. By disease category, of the 61 patients with MM, 28 (46%) received plerixafor (8 Group A and 20 Group B). Median apheresis in all the MM pts was 2 (range 1-12) with a total of 6.8 × 106 CD34/kg (2.2-16.7). In the 54 NHL pts, 32 (59%) received plerixafor (24 Group A and 8 Group B). Median apheresis for all pts with NHL was 3 (range 1-7) with a total of 4.6 × 106 CD34/kg (range 0-11.4). Overall, only 7 of 147 (5%) mobilization attempts failed to achieve a minimum of 2 × 106 CD34/kg. This compares to a 22% failure rate prior to institution of this risk adapted approach. In conclusion, implementing this risk adapted approach allows poor mobilizers to be identified promptly and for plerixafor to be initiated during mobilization and collection, thereby reducing the number of mobilization failures. In patients who predictably would not have successful collection based on a PB CD34 <10/μL, addition of plerixafor results in a majority of patients achieving an adequate collection. This risk adapted approach may be more cost effective than reattempting mobilization after a prior failure or utilizing combination G-CSF and plerixafor for upfront mobilization. Table 1. Mobilization and Collection data. All patients N=147 Group A1 N=37 Group B2 N=30 No Plerixafor N=80 PB CD34 day 4     Median 11 0 7 19     Range 0-331 0-7 0-32 0-331 PB CD34 day 5     Median 10 4.5 12 15     Range 0-51 2-9 11-23 9-51 Apheresis Yield     Median 5.5 4.4 6.0 6.2     Range 0.1-17 3.1-12.7 3.0-12.2 2-17 Number of Apheresis     Median 3 3 5 2     Range 1-12 1-7 4-12 1-8 Days of Plerixafor     Median n/a 3 2 n/a     Rang 1-7 1-8 1 Group A – Plerixafor initiated prior to apheresis 2 Group B – Plerixafor initiated during apheresis Disclosures No relevant conflicts of interest to declare.


Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3727-3727
Author(s):  
Ying Pang ◽  
Ying Feng ◽  
Ruizhen Chen ◽  
Xu Ye

Abstract Objective: To observe the safety and effect of allogeneic peripheral blood stem cell transplantation (allo-PBSCT) on hematopoietic reconstitution of refractory paroxysmal nocturnal hemoglobinuria(PNH)and reversion of hemolysis. Methods: A 20 years old female patient diagnosed with PNH complicated with cerebral infarction underwent allo-PBSCT. The donor was the patient’s 18 years old biological brother. Six loci on HLA-A, B, and DRB1 were completely matched with those of the recipient. Four days after the administration of G-CSF (250 μg/day) to the recipient, peripheral blood stem cells (PBSCs) were collected from the donor for 2 consecutive days. A total volume of 112 ml was harvested. A median nucleated cell (MNC) count of 6.2×108/kg with 2.4×106 /kg of CD34+ cells were actually administered to the recipient. The standard conditioning regimen was busulfan/cyclophosphamide (BU/CY). The recipient was started on intravenous infusion (IV) of cyclosporine A (CSA) on Day -1 and a plasma concentration of 150–250 ng/L was maintained. IV methotrexate (MTX) 10mg/m2 was given on Days +1, +3, +6, and +11. Oral mycophenolate mofetil(MMF)was administrated from Days +1 to +28 for prophylaxis of acute graft-versus-host disease (GVHD). If the concentration of hemoglobin (Hb) decreased below 70 g/L and/or platelet count (BPC) below 15×109 /L, the recipient was transfused with 60Co 25cGy irradiated and leuko-depleted red blood cells (RBCs) and/or single-donor platelets. Starting from Day +3, G-CSF was given to the recipient until white blood cells (WBC) increased to above 3.0× 109 /L. EPO and Interleukin-11 were also administrated to stimulate the proliferation of the progenitors of erythrocytes and megakaryocytes. Results: DNA-STR on Day +33 indicated a complete chimerism in the recipient. Chromatin bodies were observed as 46XY on Day +45. CD55/CD59 expression on the membranes of leucocytes and erythrocytes, hemolysis index, and coagulation parameters returned to normal. The patient has been relapse-free for one year since the time of discharge. Conclusion: 1. When conventional therapy with hormone and immunosuppressant becomes unsuccessful to control PNH, allo-PBSCT may be an alternative measure with promising effect. 2. In comparison to the reduced dose regimen, the standard dose regimen of BU/CY shown lower rate of relapse. 3. To decrease the mortality rate related to transplantation, allo-PBSCT needs to be considered as early as possible for refractory paroxysmal nocturnal hemoglobinuria.


2001 ◽  
Vol 40 (06) ◽  
pp. 215-220 ◽  
Author(s):  
S. Bielack ◽  
S. Flege ◽  
J. Eckardt ◽  
J. Sciuk ◽  
H. Jürgens ◽  
...  

Summary Purpose: Despite highly efficacious chemotherapy, patients with osteosarcomas still have a poor prognosis if adequate surgical control cannot be obtained. These patients may benefit from therapy with radiolabeled phosphonates. Patients and Methods: Six patients (three male, three female; seven to 41 years) with unresectable primary osteosarcoma (n = 3) or unresectable recurrent sites of osteosarcomas (n = 3) were treated with high-activity of Sm-153-EDTMP (150 MBq/kg BW). In all patients autologous peripheral blood stem cells had been collected before Sm-153-EDTMP therapy. Results: No immediate adverse reactions were observed in the patients. In one patient bone pain increased during the first 48 hrs after therapy. Three patients received pain relief. Autologous peripheral blood stem cell reinfusion was performed on day +12 to +27 in all patients to overcome potentially irreversible damage to the hematopoietic stem cells. In three patient external radiotherapy of the primary tumor site was performed after Sm-153-EDTMP therapy and in two of them polychemotherapy was continued. Thirty-six months later one of these patients is still free of progression. Two further patients are still alive. However, they have developed new metastases. The three patients who had no accompanying external radiotherapy, all died of disease progression five to 20 months after therapy. Conclusion: These preliminary results show that high-dose Sm-153-EDTMP therapy is feasible and warrants further evaluation of efficacy. The combination with external radiation and polychemotherapy seems to be most promising. Although osteosarcoma is believed to be relatively radioresistant, the total focal dose achieved may delay local progression or even achieve permanent local tumor control in patients with surgically inaccessible primary or relapsing tumors.


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