A new form of Filgrastim with sustained duration in vivo and enhanced ability to mobilize PBPC in both mice and humans

Molineux, Graham; Kinstler, Olaf; Briddell, Bob; Hartley, Cynthia; McElroy, Patricia; Kerzic, Patrick; Sutherland, Weston; Stoney, Greg; Kern, Brent; Fletcher, Frederick A.; Cohen, Asaf; Korach, E S; Ulich, Tom; McNiece, Ian; Lockbaum, Pamela; Miller‐Messana, Mary Ann; Gardner, Sheila; Hunt, Thomas R.; Schwab, G.

doi:10.1016/s0301-472x(99)00112-5

Cited by 221 publications

(192 citation statements)

References 12 publications

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“…The optimal dose of PEGFIL for mobilization is still unknown. A study in eight healthy volunteers demonstrated that the neutrophil and progenitor cell response to PEGFIL administration was dose-and time-dependent [9]. In another study, in the allogeneic setting, PEGFIL at a dose of 12 mg was successfully used to mobilize and collect blood stem cells from 25 healthy family and unrelated donors [16].…”

Section: Discussionmentioning

confidence: 99%

“…A single dose of PEGFIL has been shown to be as effective as multiple doses of daily FIL in the management of chemotherapy-induced neutropenia [6][7][8]. There are also some reports on the use of PEGFIL for the mobilization of stem cells into peripheral blood [9][10][11][12][13]. The aim of this study was to compare stem cell mobilization using a single dose of PEGFIL with that achieved using daily FIL, both as adjuncts to chemotherapy, in patients with lymphoproliferative malignancies.…”

Section: Introductionmentioning

confidence: 99%

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Single-dose pegfilgrastim is comparable to daily filgrastim in mobilizing peripheral blood stem cells: a case-matched study in patients with lymphoproliferative malignancies

Putkonen

Rauhala

Pelliniemi³

et al. 2009

Ann Hematol

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To cite this version:Mervi Putkonen, Auvo Rauhala, Tarja-Terttu Pelliniemi, Kari Remes. Single-dose pegfilgrastim is comparable to daily filgrastim in mobilizing peripheral blood stem cells: a case-matched study in patients with lymphoproliferative malignancies. Annals of Hematology, Springer Verlag, 2009, 88 Abstract Pegfilgrastim (PEGFIL) has been found to be comparable to daily filgrastim (FIL) in managing chemotherapy-induced neutropenia. In the present study, we evaluated the ability of PEGFIL to mobilize stem cells in 38 consecutive patients with lymphoproliferative diseases (multiple myeloma, n=18; lymphomas, n=15; chronic lymphocytic leukemia, n=5). Patients were mobilized using PEGFIL (6-18 mg as a single dose) during [2005][2006]; 32 then received high-dose chemotherapy followed by autologous stem cell transplantation. PEGFIL-mobilized patients were matched by age, disease, and treatment line at a ratio of 1:2 to historical FIL-mobilized controls. The primary study endpoint was the blood CD34 + concentration at onset of leukapheresis. Leukapheresis began a median of 10 days from the beginning of mobilization chemotherapy in both groups. At the onset of leukapheresis, median blood CD34 + cell counts did not differ significantly in the FIL group compared with the PEGFIL group (79×10 6 /L vs 64×10 6 /L, respectively; p=0.44). In the different disease categories, the respective CD34 + cell counts after FIL and PEGFIL mobilization were 72×10 6 /L vs 123×10 6 /L (p=0.08) in myeloma, 51×10 6 /L vs 62×10 6 /L (p=0.6) in lymphomas, and 27×10 6 /L vs 30×10 6 /L (p=0.62) in CLL, respectively.The target CD34 + cell yield was harvested with one leukapheresis in 53% of PEGFIL-mobilized patients. Engraftment after autografting did not differ significantly in the two groups. Stem cell mobilization with a single dose of PEGFIL was, therefore, comparable to that achieved using daily FIL in patients with lymphoproliferative diseases. PEGFIL is a more practical way to mobilize stem cells than daily FIL.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Single-dose pegfilgrastim is comparable to daily filgrastim in mobilizing peripheral blood stem cells: a case-matched study in patients with lymphoproliferative malignancies

Putkonen

Rauhala

Pelliniemi³

et al. 2009

Ann Hematol

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“…16 Single fixed 6 and 12 mg doses of pegfilgrastim have been reported to mobilize CD34 þ cells in patients with lymphoma or multiple myeloma. 17,18 A correlation has been noted between CD34 þ -cell mobilization and progenitor-cell mobilization in response to pegfilgrastim in healthy human volunteers 7 and non-small cell lung cancer patients, both pre and postchemotherapy. 19 There has been little systematic investigation of the ability of fixed doses of pegfilgrastim pre and postchemotherapy to mobilize CD34 þ cells and progenitor cells in cancer patients.…”

Section: Introductionmentioning

confidence: 99%

“…1,4 Pegfilgrastim is a polyethylene glycol-filgrastim conjugate with neutrophil-mediated pharmacokinetics and a sustained duration of action, allowing several daily injections of filgrastim to be replaced by a single injection of pegfilgrastim. [5][6][7] The non-inferiority of single-dose pegfilgrastim (6 mg) to daily filgrastim (5 mg/kg) in the treatment of chemotherapy-induced neutropenia has been shown in two phase III clinical trials in patients with breast cancer, [8][9][10] a pegfilgrastim dose-finding study in women with breast cancer, 11 two open-label studies in patients with lymphoma, 12,13 children with Ewing's sarcoma 14 and in a retrospective analysis of patients with various haematological malignancies. 15 Following PBPC mobilization, the number of CD34 þ cells in the leukapheresis product is predictive of engraftment success and subsequent haematopoietic recovery.…”

Section: Introductionmentioning

confidence: 99%

“…15 Following PBPC mobilization, the number of CD34 þ cells in the leukapheresis product is predictive of engraftment success and subsequent haematopoietic recovery. 1,2 Successful mobilization of CD34 þ cells with single-dose pegfilgrastim (30-300 mg/kg) has been shown in healthy human volunteers 7 and non-small cell lung cancer patients. 16 Single fixed 6 and 12 mg doses of pegfilgrastim have been reported to mobilize CD34 þ cells in patients with lymphoma or multiple myeloma.…”

Section: Introductionmentioning

confidence: 99%

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Pegfilgrastim for peripheral CD34+ mobilization in patients with solid tumours

Willis

Woll

Theti

et al. 2009

Bone Marrow Transplant

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The efficacy of pegfilgrastim±chemotherapy for mobilizing stem cells in patients with solid tumours was assessed. In cycle 0, a 14-day prechemotherapy cycle, patients (N ¼ 61) were randomized open-label to single doses of pegfilgrastim (6, 12 or 18 mg) on day 1, or daily filgrastim (10 lg/kg) for p7 days. Mean peak peripheral CD34 þ cell counts increased with pegfilgrastim dose, but were significantly higher than filgrastim only at the 18 mg dose (10.17 vs 4.96 Â 10 4 /ml; P ¼ 0.014). In the clinically relevant period of days 3-7, both 12 and 18 mg pegfilgrastim doses produced significantly higher peak CD34 þ counts (8.18 and 9.96 vs 4.51 Â 10 4 /ml for filgrastim; P ¼ 0.034 and 0.006). In cycle 1, patients received carboplatin/paclitaxel on day 1, followed from day 2 by pegfilgrastim 6-18 mg or daily filgrastim (5 lg/ kg/day for p14 days) as per randomization in cycle 0. There were no significant differences in mean peak CD34 þ count between pegfilgrastim and filgrastim, but there was an advantage for pegfilgrastim 18 mg in the relevant period of days 7-12 (3.14 vs 1.19 Â 10 4 /ml; P ¼ 0.043). A single pegfilgrastim dose (X6 mg) could be substituted for daily filgrastim in cytokine-only peripheral CD34 þ cell mobilization.

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Hematopoietic Agents

Pelus

Hoggatt

Singh

et al. 2010

Burger's Medicinal Chemistry and Drug Discovery

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Adult hematopoietic stem cells self‐renew, proliferate, and differentiate forming and maintaining appropriate levels of all the cellular components of blood as well as responding to increased demand. This lifelong process termed hematopoiesis is regulated in part by hematopoietic growth factors, interleukins, and chemokines. In an incredibly short period of time, since the discovery of culture systems and animal models that detected the growth of blood progenitor cells and identified the existence of hematopoietic stem cells in the 1960s, cytokines controlling their function have been identified, cloned, and brought into clinical practice. These agents have had a major impact on patient outcomes and the ability to treat disease. Clinicians now have the tools to modulate erythrocyte, neutrophil, and platelet production enabling treatment of congenital and iatrogenic conditions and harvest of hematopoietic stem and progenitor cells for curative hematopoietic transplantation. In this chapter, hematopoietic cytokines, mimetics, and other agents approved for use in humans are described. The fields of experimental hematology and cytokine research continue to expand and new interleukins continue to be identified. As our knowledge of hematopoietic cell function increases, so will our understanding of the cellular and molecular biology of cytokine actions, and the clinical use of these agents will be refined. The potential application of several newly defined cytokines is discussed as well as the potential for the future development of cytokines that directly regulate hematopoietic stem cell function.

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A new form of Filgrastim with sustained duration in vivo and enhanced ability to mobilize PBPC in both mice and humans

Cited by 221 publications

References 12 publications

Single-dose pegfilgrastim is comparable to daily filgrastim in mobilizing peripheral blood stem cells: a case-matched study in patients with lymphoproliferative malignancies

Single-dose pegfilgrastim is comparable to daily filgrastim in mobilizing peripheral blood stem cells: a case-matched study in patients with lymphoproliferative malignancies

Pegfilgrastim for peripheral CD34+ mobilization in patients with solid tumours

Hematopoietic Agents

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