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Bekir Ozturk - One of the best experts on this subject based on the ideXlab platform.
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comparative efficacy of reduced or standard doses of Lenograstim for peripheral blood stem cell mobilization and transplantation a randomized study in patients undergoing autologous peripheral stem cell transplantation
Journal of Clinical Oncology, 2016Co-Authors: Mustafa öztürk, Fikret Arpaci, Selmin Ataergin, Turker Cetin, Ahmet Ozet, Seref Komurcu, Bekir Ozturk, Okan Kuzhan, Selim Kilic, T GulerAbstract: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 de...
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reduced dose of Lenograstim is as efficacious as standard dose of filgrastim for peripheral blood stem cell mobilization and transplantation a randomized study in patients undergoing autologous peripheral stem cell transplantation
American Journal of Hematology, 2008Co-Authors: Selmin Ataergin, Mustafa öztürk, Fikret Arpaci, Mustafa Turan, Luis A Solchaga, Turker Cetin, Ahmet Ozet, Seref Komurcu, Bekir OzturkAbstract:In vitro studies have demonstrated a 27% increased efficacy of Lenograstim over filgrastim. However, equal doses of 10 lg/kg/day of filgrastim and Lenograstim have been recommended for mobilization of CD341 cells without associated chemotherapy. In this study, we investigated whether a 25% reduced dose of Lenograstim at 7.5 lg/kg/day is equavalent to 10 lg/kg/day filgrastim for autologous peripheral blood stem cell (PBSC) mobilization and transplantation. A total of 40 consecutive patients were randomized to either filgrastim (n 5 20) or Lenograstim (n 5 20). The two cohorts were similar in regard to disease, sex, body weight, body surface area, conditioning regimens, previous chemotherapy cycles and radiotherapy. Each growth factor was administered for 4 consecutive days. The first PBSC apheresis was done on the 5th day. In the posttransplant period, the same G-CSF was given at 5 lg/kg/day until leukocyte engraftment. Successful mobilization was achieved in 95% of patients. Successful mobilization with the first apheresis, was achieved in 10/20 (50%) patients in the filgrastim group versus 9/20 (46%) patients in the Lenograstim group. No significant difference was seen in the median number of CD341cells mobilized, as well as the median number of apheresis, median volume of apheresis, percentage of CD341 cells, and CD341 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. Lenograstim 7.5 lg/kg/day is as efficious as filgrastim 10 lg/kg/day for autologous PBSC mobilization and transplantation. Am. J. Hematol. 83:644–648, 2008. V C 2008 Wiley-Liss, Inc.
R Lovell - One of the best experts on this subject based on the ideXlab platform.
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colony stimulating factors pegfilgrastim or Lenograstim use in patients with myeloma undergoing autologous peripheral blood stem cell transplantation apbsct is associated with early neutrophil engraftment and shorter inpatient stay with no impact on
Blood, 2015Co-Authors: Georgina Mayer, Bhuvan Kishore, Emmanuel Nikolousis, R Lovell, Shankaranarayana PaneeshaAbstract:Introduction High dose chemotherapy followed by autologous peripheral blood stem cell transplant (APBSCT) is the current standard of care for myeloma patients younger than 70 years of age with good performance status. Busy haematology centres have severe pressure on bed availability which can limit their ability to deliver multiple cycles of intensive chemotherapy on time. G-CSF use in APBSCT has been shown to hasten neutrophil engraftment and to shorten the number of days of febrile neutropenia. In our centre we have had experience of using pegfilgastrim (day +1 post high dose therapy), Lenograstim(day+7 post high dose therapy) or no G-CSF. We reviewed these cohorts and compared engraftment kinetics, inpatient stay, progression free survival(PFS) and overall survival(OS). Patients and methods This retrospective study included 142 (M: 94; F: 48) patients who had APBSCT for myeloma between January 2006 and March 2014. Patients had induction treatment followed by autologous peripheral blood stem cell (PBSC) mobilisation with G-CSF alone or by cyclophosphamide (3g/m2) + G-CSF schedule. One hundred thirteen patients received first APBSCT and twenty nine received second APBSCT with high dose melphalan (200 mg/ m2) conditioning and the day of stem cell re-infusion was termed day 0. Statistical analysis was carried out using SPSS 23 for Windows. Median age at APBSCT was 62 years (range: 38-74). Prior to transplant 8.5%, 67.4% & 24.1% were in complete, very good partial and partial remission respectively. Twenty two patients received pegfilgrastim, 84 received Lenograstim from day+7 whereas some of the remaining 34 patients received varying duration of conventional G-CSF if they had no neutrophil engraftment by day +12. Results: Median duration for neutrophil engraftment in the pegfilgrastim, Lenograstim and no G-CSF cohort was 12, 12.7 and 14 days respectively (Mann Whitney test; p value: 0.0005). Median duration for platelet engraftment in the pegfilgrastim and the no G-CSF cohort was 21.5 and 16.5 days respectively (Mann Whitney test; p value: 0.253). Median inpatient stay in the pegfilgrastim, Lenograstim and the no G-CST cohort was 16, 16.5 and 18 days respectively (Mann Whitney test; p value: 0.024). Our data suggests that the use of colony stimulating factors (pegfilgrastim & Lenograstim) is associated with shorter duration to neutrophil engraftment and reduced inpatient stay which unfortunately does not translate into PFS or OS advantage. This is very useful considering the severe pressure on the bed availability in the tertiary referral centres. We also need to study whether bio similar colony stimulating factors provide the similar benefit. ![Figure 1.][1] Figure 1. ![Figure 2.][1] Figure 2. ![Figure 3.][1] Figure 3. Disclosures Kishore: Jazz pharma: Honoraria; Celgene: Honoraria. Nikolousis: Alexion: Honoraria. Paneesha: Janssen: Consultancy. [1]: pending:yes
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is daily Lenograstim from day 7 of autologous peripheral blood stem cell transplantation apbsct is as effective as pegfilgrastim in patients with myeloma
Blood, 2013Co-Authors: Ben Bailiff, Neil Phillips, Vidhya Murthy, Lynn Bratby, Kathy Holder, Bhuvan Kishore, Emmanuel Nikolousis, R Lovell, Guy Pratt, Joanne EwingAbstract:High dose melphalan conditioned APBSCT after induction therapy is thestandard of carefor patients with myeloma with good performance status. Busy haematology units are in the lookout for safe and effective strategies to hasten neutrophil engraftment, decrease inpatient stay and ease financial burden. Growth factors have been helpful in this regard. We describe our experience with the use of different growth factors in patients with myeloma undergoing APBSCT. Aims of the study To identify whether once daily Lenograstimfrom day + 7 following APBSCT is as efficacious as one dose of pegfilgrastim on day +1with regards to neutrophil engraftment, inpatient stay, days of antibiotic use and outcomes as compared no G-CSF use. Materials and Methods Patients had induction treatment followed by autologous PBSC mobilisation with G-CSF alone or by cyclophosphamide (3g/m2) + G-CSF schedule. APBSCT with high dose melphalan (140 or 200 mg/ m2) conditioning was carried out as per standard indications and the day of stem cell re-infusion was termed day 0. Statistical analysis was carried out using GraphPad Prism 4 and IBM SPSS 19 for Windows. Our retrospective study included 112 patients (71male&41 female) with a median age at transplantation of 61 years (range 38-72) with myeloma betweenJanuary2006 and December 2012. 35%patients did not receive any G-CSF, 19% received pegfilgrastim and46% received Lenograstim.58 % patients had IgG, 21 % IgA, 17 % light chain and 4 % had non-secretory myeloma. At transplant 7% patients were in complete remission, 20% in partial remission and 73% in very good partial remission. Results Median time for neutrophil engraftment was 14, 12 and 13 days in the no G-CSF, peg-filgrastim and Lenograstim respectively. Median inpatient stay was 18, 16 and 16 days in the no G-CSF, peg-filgrastim and Lenograstim respectively. Median days of broad spectrum intravenous antibiotic use were 6, 5 and 5 days in the no G-CSF, peg-filgrastim and Lenograstim respectively. Median dose of stem cells infused was 3.1, 2.7 and 2.5 CD 34 + cells per kg body weight in the no G-CSF, peg-filgrastim and Lenograstim respectively.There was no difference in the overall survival (Log Rank test; p value: 0.844) or progression free survival (Log Rank test; p value: 0.155) between the three cohorts. Summary Results of retrospective analysis suggests that the use of daily Lenograstim from day +7 is an effective strategy as day + 1 peg-filgrastim in patients with myeloma undergoing APBSCTin reducing the time to neutrophil engraftment, duration of inpatient stay and antibiotic useand superior to no G-CSF use. Our data confirms daily Lenograstim from day +7 is a cost effective alternative strategy to pegfilgrastimmaking use of use of Lenograstim post autologous stem cell transplantation as a standard practice. ![Figure][1] ![Figure][1] Disclosures: No relevant conflicts of interest to declare. [1]: pending:yes
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a randomised study comparing peripheral blood progenitor mobilisation using intermediate dose cyclophosphamide plus Lenograstim with Lenograstim alone
Bone Marrow Transplantation, 2004Co-Authors: M Karanth, R Lovell, Suparno Chakrabarti, C Harvey, Kathleen Holder, Christopher C. Mcconkey, Dorothy Mcdonald, Christopher Fegan, Donald MilliganAbstract:We conducted a prospective randomised study to compare the efficiency of out-patient progenitor cell mobilisation using either intermediate-dose cyclophosphamide (2 g/m2) and Lenograstim at 5 μg/kg (Cyclo-G-CSF group, n=39) or Lenograstim alone at 10 μg/kg (G-CSF group, n=40). The end points were to compare the impact of the two regimens on mobilisation efficiency, morbidity, time spent in hospital, the number of apheresis procedures required and engraftment kinetics. Successful mobilisation was achieved in 28/40 (70%) in the G-CSF group vs 22/39 (56.4%) for Cyclo-G-CSF (P=0.21). The median number of CD34+ cells mobilised was 2.3 × 106/kg and 2.2 × 106/kg for G-CSF and cyclo-G-CSF arms following a median of two apheresis procedures. Nausea and vomiting and total time spent in the hospital during mobilisation were significantly greater after Cyclo-G-CSF (P<0.05). Rapid neutrophil and platelet engraftment was achieved in all transplanted patients in both groups. In conclusion, G-CSF at 10 μg/kg was as efficient at mobilising progenitor cells as a combination of cyclophosphamide and G-CSF with reduced hospitalisation and side effects and prompt engraftment. When aggressive in-patient cytoreductive regimens are not required to both control disease and generate progenitor cells, the use of G-CSF alone appears preferable to combination with intermediate-dose cyclophosphamide.
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A randomised study comparing peripheral blood progenitor mobilisation using intermediate-dose cyclophosphamide plus Lenograstim with Lenograstim alone.
Bone Marrow Transplantation, 2004Co-Authors: M Karanth, R Lovell, Suparno Chakrabarti, C Harvey, Kathleen Holder, Christopher C. Mcconkey, Dorothy Mcdonald, Christopher Fegan, Donald MilliganAbstract:We conducted a prospective randomised study to compare the efficiency of out-patient progenitor cell mobilisation using either intermediate-dose cyclophosphamide (2 g/m2) and Lenograstim at 5 μg/kg (Cyclo-G-CSF group, n=39) or Lenograstim alone at 10 μg/kg (G-CSF group, n=40). The end points were to compare the impact of the two regimens on mobilisation efficiency, morbidity, time spent in hospital, the number of apheresis procedures required and engraftment kinetics. Successful mobilisation was achieved in 28/40 (70%) in the G-CSF group vs 22/39 (56.4%) for Cyclo-G-CSF (P=0.21). The median number of CD34+ cells mobilised was 2.3 × 106/kg and 2.2 × 106/kg for G-CSF and cyclo-G-CSF arms following a median of two apheresis procedures. Nausea and vomiting and total time spent in the hospital during mobilisation were significantly greater after Cyclo-G-CSF (P
C Gisselbrecht - One of the best experts on this subject based on the ideXlab platform.
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cost effectiveness of day 5 g csf Lenograstim administration after pbsc transplantation results of a sfgm tc randomised trial
Bone Marrow Transplantation, 2005Co-Authors: Dominique Valteaucouanet, C Gisselbrecht, Catherine Faucher, Anne Auperin, Jean Michon, N Milpied, J.-m. Boiron, J. H. Bourhis, J. P. Vernant, A. PinnaAbstract:This randomised trial was designed to compare two groups treated with different G-CSF administration schedules with a third group receiving no G-CSF, after autologous peripheral blood stem cell transplantation (APBSCT). Children and adults with haematological malignancies or solid tumours were randomly assigned to receive either 150 μg/m2/day of Lenograstim starting on day 1 (G1) or on day 5 (G5) post APBSCT, or no Lenograstim (G0). Randomisation was stratified according to the conditioning regimen (Busulfan vs TBI vs no Busulfan and no TBI) and the graft CD 34+ cell count. A total of 240 patients were randomised; 239 were evaluable. All three patient groups were comparable. Median duration of neutropenia was 9 days (4–40), and 10 days (5–15) in the G1 and G5 groups, respectively, significantly shorter than in the G0 group, 13 days (7–36) (P<0.0001). No difference was observed in the duration of thrombocytopenia, transfusion support and extra-haematological complications. The duration of post transplant hospitalisation was significantly shorter in adults who received G-CSF. Clinical and cost arguments favour the initiation of G-CSF on day 5 in adults. The same policy could be applied in children given that clinical management is easier and costs are similar.
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Cost effectiveness of day 5 G-CSF (Lenograstim) administration after PBSC transplantation: results of a SFGM-TC randomised trial.
Bone Marrow Transplantation, 2005Co-Authors: Dominique Valteau-couanet, C Gisselbrecht, Catherine Faucher, Anne Auperin, Jean Michon, N Milpied, J.-m. Boiron, J. H. Bourhis, J. P. Vernant, A. PinnaAbstract:This randomised trial was designed to compare two groups treated with different G-CSF administration schedules with a third group receiving no G-CSF, after autologous peripheral blood stem cell transplantation (APBSCT). Children and adults with haematological malignancies or solid tumours were randomly assigned to receive either 150 μg/m2/day of Lenograstim starting on day 1 (G1) or on day 5 (G5) post APBSCT, or no Lenograstim (G0). Randomisation was stratified according to the conditioning regimen (Busulfan vs TBI vs no Busulfan and no TBI) and the graft CD 34+ cell count. A total of 240 patients were randomised; 239 were evaluable. All three patient groups were comparable. Median duration of neutropenia was 9 days (4–40), and 10 days (5–15) in the G1 and G5 groups, respectively, significantly shorter than in the G0 group, 13 days (7–36) (P
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chemotherapy dose intensity facilitated by use of Lenograstim implications for quality of life and survival
European Journal of Cancer, 1994Co-Authors: C GisselbrechtAbstract:: Increasingly more aggressive chemotherapeutic regimens are being used in pursuit of better tumour response and patient survival. Studies in advanced breast cancer, small cell lung cancer (SCLC), urothelial cancer and sarcoma indicate that recombinant human granulocyte colony stimulating factor (rHuG-CSF) (Lenograstim) facilitates modest dose intensification (20-30%), but at high intensity doses, chemotherapy-related toxicity remains a problem. Survival outcome in SCLC patients is still uncertain although in one randomised trial Lenograstim facilitated a 20% increase in chemotherapy dosage which resulted in a 25% increase in complete remissions. In studies of breast cancer, an initially improved response rate was not maintained. However, increased dose intensity of chemotherapeutic agents in aggressive lymphoma was possible using Lenograstim. Studies to date with haematopoietic growth factors have not been designed to specifically address the issue of survival and/or quality of life, although they have inferred that this is possible through dose intensification. The use of haematopoietic growth factors will allow the design of such studies, but a modest chemotherapy dose increase may be insufficient to improve survival. The future for dose intensification in cancer therapy may lie in the use of Lenograstim-primed peripheral blood progenitor cells (PBPC) transplants to enhance haematopoietic recovery after high-dose sequential or myeloablative chemotherapy.
A Cariello - One of the best experts on this subject based on the ideXlab platform.
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A randomized study comparing filgrastim versus Lenograstim versus molgramostim plus chemotherapy for peripheral blood progenitor cell mobilization
Bone Marrow Transplantation, 2006Co-Authors: Boris Köpf, U De Giorgi, B Vertogen, D Turci, C Dazzi, Matteo Leoni, A Tienghi, G Monti, A Molinari, A CarielloAbstract:We conducted a prospective randomized clinical trial to assess the mobilizing efficacy of filgrastim, Lenograstim and molgramostim following a disease-specific chemotherapy regimen. Mobilization consisted of high-dose cyclophosphamide in 45 cases (44%), and cisplatin/ifosfamide/etoposide or vinblastine in 22 (21%), followed by randomization to either filgrastim or Lenograstim or molgramostim at 5 μ g/kg/day. One hundred and three patients were randomized, and 82 (79%) performed apheresis. Forty-four (43%) patients were chemonaive, whereas 59 (57%) were pretreated. A median number of one apheresis per patient (range, 1–3) was performed. The median number of CD34+ cells obtained after mobilization was 8.4 × 10^6/kg in the filgrastim arm versus 5.8 × 10^6/kg in the Lenograstim arm versus 4.0 × 10^6/kg in the molgramostim arm ( P =0.1). A statistically significant difference was observed for the median number of days of growth factor administration in favor of Lenograstim (12 days) versus filgrastim (13 days) and molgramostim (14 days) ( P
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a randomized study comparing filgrastim versus Lenograstim versus molgramostim plus chemotherapy for peripheral blood progenitor cell mobilization
Bone Marrow Transplantation, 2006Co-Authors: Boris Köpf, U De Giorgi, B Vertogen, D Turci, C Dazzi, Matteo Leoni, A Tienghi, G Monti, A Molinari, A CarielloAbstract:We conducted a prospective randomized clinical trial to assess the mobilizing efficacy of filgrastim, Lenograstim and molgramostim following a disease-specific chemotherapy regimen. Mobilization consisted of high-dose cyclophosphamide in 45 cases (44%), and cisplatin/ifosfamide/etoposide or vinblastine in 22 (21%), followed by randomization to either filgrastim or Lenograstim or molgramostim at 5 μg/kg/day. One hundred and three patients were randomized, and 82 (79%) performed apheresis. Forty-four (43%) patients were chemonaive, whereas 59 (57%) were pretreated. A median number of one apheresis per patient (range, 1–3) was performed. The median number of CD34+ cells obtained after mobilization was 8.4 × 106/kg in the filgrastim arm versus 5.8 × 106/kg in the Lenograstim arm versus 4.0 × 106/kg in the molgramostim arm (P=0.1). A statistically significant difference was observed for the median number of days of growth factor administration in favor of Lenograstim (12 days) versus filgrastim (13 days) and molgramostim (14 days) (P<0.0001) and for the subgroup of chemonaive patients (12 days) versus pretreated patients (14 days) (P<0.001). In conclusion, all three growth factors were efficacious in mobilizing peripheral blood progenitor cells with no statistically significant difference between CD34+ cell yield and the different regimens, and the time to apheresis is likely confounded by the different mobilization regimens.
P. Bojko - One of the best experts on this subject based on the ideXlab platform.
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Comparison of Lenograstim and filgrastim: effects on blood cell recovery after high-dose chemotherapy and autologous peripheral blood stem cell transplantation
Journal of Cancer Research and Clinical Oncology, 2005Co-Authors: A. Hüttmann, K. Schirsafi, S. Seeber, P. BojkoAbstract:Purpose The aim of the study was to evaluate whether glycosylated granulocyte colony-stimulating factor (G-CSF) (Lenograstim) offers a benefit over non-glycosylated G-CSF (filgrastim) in clinically relevant end points after high-dose chemotherapy (HDC) and autologous peripheral blood stem cell transplantation (PBSCT). Methods We retrospectively analyzed the outcome of 261 patients treated with either Lenograstim ( n =68) or filgrastim ( n =193). Time to blood cell recovery, toxicities, and infectious complications were analyzed in a total of 469 G-CSF treatment cycles. Results Mean time to leukocyte recovery was 10.7 days (SD±0.9) (Lenograstim) and 10.8 days (SD±0.6) (filgrastim), respectively. Likewise, time to thrombocyte engraftment, febrile days, duration of therapeutic antibiotic treatment, severity of non-hematological toxicities, duration of in-hospital stay, and duration of G-CSF treatment were similar in both groups. Owing to the physicochemical and pharmacokinetic properties of Lenograstim, the required dose until leukocyte recovery was significantly smaller as compared to filgrastim (38.5 vs 54.0 µg/kg of body weight). Conclusions Collectively, our data indicate that both G-CSF preparations are equally effective in hastening leukocyte recovery in the setting of high-dose chemotherapy followed by autologous PBSCT.
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comparison of Lenograstim and filgrastim effects on blood cell recovery after high dose chemotherapy and autologous peripheral blood stem cell transplantation
Journal of Cancer Research and Clinical Oncology, 2005Co-Authors: A. Hüttmann, K. Schirsafi, S. Seeber, P. BojkoAbstract:Purpose The aim of the study was to evaluate whether glycosylated granulocyte colony-stimulating factor (G-CSF) (Lenograstim) offers a benefit over non-glycosylated G-CSF (filgrastim) in clinically relevant end points after high-dose chemotherapy (HDC) and autologous peripheral blood stem cell transplantation (PBSCT).