Lenograstim: A review of its use in chemotherapy-induced neutropenia, for acceleration of neutrophil recovery following haematopoietic stem cell transplantation and in peripheral blood stem cell mobilization

Drugs

Volumn 71, Issue 6, 2011, Pages 679-707

  Keating, Gillian M ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

Adis Drug Evaluations; Lenograstim, general; Neutropenia; Stem cell transplant

Indexed keywords

CISPLATIN; CYCLOPHOSPHAMIDE; DACARBAZINE; DOCETAXEL; DOXORUBICIN; EPIRUBICIN; ETOPOSIDE; MYELOSTIM; PLACEBO; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; UNCLASSIFIED DRUG;

ACUTE GRANULOCYTIC LEUKEMIA; ACUTE LYMPHOBLASTIC LEUKEMIA; AREA UNDER THE CURVE; BONE PAIN; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CHEMOTHERAPY INDUCED NEUTROPENIA; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG EFFICACY; DRUG HALF LIFE; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; LUNG SMALL CELL CANCER; LYMPHOMA; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; NEUTROPENIA; NEUTROPHIL; NONHUMAN; PERIPHERAL BLOOD STEM CELL; PROPHYLAXIS; REVIEW; SOLID TUMOR; STEM CELL MOBILIZATION; TIME TO MAXIMUM PLASMA CONCENTRATION;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; GRANULOCYTE COLONY-STIMULATING FACTOR; HEMATOPOIETIC STEM CELL MOBILIZATION; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; LEUKOCYTE COUNT; NEOPLASMS; NEUTROPENIA; NEUTROPHILS; RECOMBINANT PROTEINS; TREATMENT OUTCOME;

EID: 79955011393     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.2165/11206870-000000000-00000     Document Type: Review

References (123)

1. Turzanski J, Crouch SPM, Fletcher J, et al. Ex vivo neu-trophil function in response to three different doses of glycosylated rHuG-CSF (lenograstim). Br J Haematol 1997 Jan; 96 (1): 46-54
2. Ribeiro D, Veldwijk MR, Benner A, et al. Differences in functional activity and antigen expression of granulocytes primed in vivo with filgrastim, lenograstim, or pegfil-grastim. Transfusion (Paris) 2007 Jun; 47 (6): 969-80 (Pubitemid 46802093)
3. Martin-Christin F. Granulocyte colony stimulating fac-tors: how different are they? How to make a decision? Anticancer Drugs 2001 Mar; 12 (3): 185-91 (Pubitemid 32269913)
4. Ono M. Physicochemical and biochemical characteristics of glycosylated recombinant human granulocyte colony stimulating factor (lenograstim). Eur J Cancer 1994; 30A Suppl. 3: S7-11
5. Nissen C. Glycosylation of recombinant human granulo-cyte colony stimulating factor: implications for stability and potency. Eur J Cancer 1994; 30A Suppl. 3: S12-4 (Pubitemid 24345435)
6. Hoglund M. Glycosylated and non-glycosylated re-combinant human granulocyte colony-stimulating factor (rhG-CSF): what is the difference? Med Oncol 1998 Dec; 15 (4): 229-33 (Pubitemid 29049186)
7. Anderlini P. Effects and safety of granulocyte colony-sti-mulating factor in healthy volunteers. Curr Opin Hematol 2009 Jan; 16 (1): 35-40
8. Hayashi N, Kinoshita H, Yukawa E, et al. Pharmaco-kinetic and pharmacodynamic analysis of subcutaneous recombinant human granulocyte colony stimulating factor (lenograstim) administration. J Clin Pharmacol 1999 Jun; 39 (6): 583-92 (Pubitemid 30629038)
9. Houston AC, Stevens LA, Cour V. Pharmacokinetics of glycosylated recombinant human granulocyte colony-stimulating factor (lenograstim) in healthy male volunteers. Br J Clin Pharmacol 1999 Mar; 47 (3): 279-84 (Pubitemid 29131342)
10. Watts MJ, Addison I, Ings SJ, et al. Optimal timing for collection of PBPC after glycosylated G-CSF administration. Bone Marrow Transplant 1998 Feb; 21 (4): 365-8 (Pubitemid 28080472)
11. Fossat C, Stoppa AM, Sainty D, et al. In vivo stimulation of neutrophil function by lenograstim (glycosylated rHuG-CSF) in oncohematologic patients: results of a phase I trial. Stem Cells 1994 May; 12 (3): 322-8 (Pubitemid 24156074)
12. European Medicines Agency. Granocyte (lenograstim): EU summary of product characteristics. Chugai Pharmaceutical Co., 2009
13. Oh-eda M, Hasegawa M, Hattori K, et al. O-linked sugar chain of human granulocyte colony-stimulating factor protects it against polymerization and denaturation allowing it to retain its biological activity. J Biol Chem 1990 Jul 15; 265 (20): 11432-5
14. Mire-Sluis AR, Abernethy HA, Dolman C, et al. The effects of environmental influences and post-translational modification on the biological activity of granulocyte colony-stimulating factor. Pharm Pharmacol Commun 1999; 5 (1): 45-9 (Pubitemid 29095181)
15. Nissen C, Carbonare VD, Moser Y. In vitro comparison of the biological potency of glycosylated versus non-glycosylated rG-CSF. Drug Invest 1994; 7 (6): 346-52 (Pubitemid 24179773)
16. Pedrazzoli P, Gibelli N, Pavesi L, et al. Effects of glycosylated and non-glycosylated G-CSFs, alone and in combination with other cytokines, on the growth of human progenitor cells. Anticancer Res 1996 Jul-Aug; 16 (4A): 1781-5 (Pubitemid 26270684)
17. Hoglund M, Smedmyr B, Bengtsson M, et al. Mobilization of CD34+ cells by glycosylated and nonglycosylated G-CSF in healthy volunteers: a comparative study. Eur J Haematol 1997 Sep; 59 (3): 177-83 (Pubitemid 27392094)
18. Mire-Sluis AR, Das RG, Thorpe R. The international standard for granulocyte colony stimulating factor (G-CSF): evaluation in an international collaborative study. J Immunol Methods 1995 Feb 13; 179 (1): 117-26
19. Watts MJ, Addison I, Long SG, et al. Crossover study of the haematological effects and pharmacokinetics of glycosylated and non-glycosylated G-CSF in healthy volunteers. Br J Haematol 1997 Aug; 98 (2): 474-9 (Pubitemid 27345130)
20. Carulli G, Mattii L, Azzara A, et al. Actin polymerization in neutrophils from donors of peripheral blood stem cells: divergent effects of glycosylated and nonglycosylated recombinant human granulocyte colony-stimulating factor. Am J Hematol 2006 May; 81 (5): 318-23
21. DeclevaE, Cramer R, Zabucchi G. Glycosylation improves the priming effect exerted by recombinant human granulocyte colony-stimulating factor (lenograstim) on human neutrophil superoxide production. Int J Tissue React 1995; 17 (5-6): 191-8 (Pubitemid 26260892)
22. Mattii L, Azzara A, Fazzi R, et al. Glycosylated or non-glycosylated G-CSF differently influence human granulocyte functions through RhoA. Leuk Res 2005 Nov; 29 (11): 1285-92 (Pubitemid 41297641)
23. Mattii L, Battolla B, Azzara A, et al. Glycosylation inter-ference on RhoA activation: focus on G-CSF. Leuk Res 2011 Feb; 35 (2): 265-7
24. Chugai Pharmaceutical Co., Ltd. Recombinant human granulocyte colony-stimulating factor preparation (Neutrogin® injection 50 (J.g, Neutrogin® injection 100 (J.g, Neutrogin® injection 250 (J.g): Japanese prescribing information [online]. Available from URL: http://www.e-search.ne.jp/ -jpr/PDF/CHUGAI11.PDF [Accessed 2010 Oct 13]
25. Akizuki S, Mizorogi F, Inoue T, et al. Pharmacokinetics and adverse events following 5-day repeated administration of lenograstim, a recombinant human granulocyte colony-stimulating factor, in healthy subjects. Bone Marrow Transplant 2000 Nov; 26 (9): 939-46
26. Takatani H, Soda H, Fukuda M, et al. Levels of recombinant human granulocyte colony-stimulating factor in serum are inversely correlated with circulating neutrophil counts. Anti-microb Agents Chemother 1996 Apr; 40 (4): 988-91 (Pubitemid 26115236)
27. Marty M. The optimal dose of glycosylated recombinant human granulocyte colony stimulating factor for use in clinical practice: a review. Eur J Cancer 1994; 30A Suppl. 3: S20-5 (Pubitemid 24345437)
28. Seymour A-M, de Campos E, Thatcher N, et al. A single-blind, randomised, vehicle-controlled dose-finding study of recombinant human granulocyte colony-stimulating factor (lenograstim) in patients undergoing chemotherapy for solid cancers and lymphoma. Eur J Cancer 1995 Dec; 31A (13-14): 2157-63 (Pubitemid 26050554)
29. Tominaga T, Ohta K, Yamaguchi S. Clinical effect of recombinant human G-CSF on neutropenia induced by adriamycin-containing chemotherapy in patients with advanced and recurrent breast cancer [in Japanese]. Biotherapy 1993 Nov; 7 (12): 1709-16
30. Yamaguchi T, Kurita Y, Saito R, et al. Clinical effect of recombinant human G-CSF on neutropenia induced by chemotherapy in small-cell lung cancer patients [in Japanese]. Biotherapy 1994 Nov; 8 (11): 1423-9
31. Nakajima H, Ikeda Y, Hirashima K, et al. A randomized controlled study of rG.CSF in patients with neutropenia after induction therapy for acute myelogenous leukemia. (rG.CSF Clinical Study Group) [in Japanese]. Rinsho Ketsueki 1995 Jun; 36 (6): 597-605
32. Takeshita A, Ohno R, Hirashima K, et al. A randomized double-blind controlled study of recombinant human granulocyte colony-stimulating factor in patients with neutropenia induced by consolidation chemotherapy for acute myeloid leukemia. (rG.CSF clinical study group) [in Japanese]. Rinsho Ketsueki 1995 Jun; 36 (6): 606-14
33. Bui BN, Chevallier B, Chevreau C, et al. Efficacy of leno-grastim on hematologic tolerance to MAID chemotherapy in patients with advanced soft tissue sarcoma and consequences on treatment dose-intensity. J Clin Oncol 1995 Oct; 13 (10): 2629-36
34. Chevallier B, Chollet P, Merrouche Y, et al. Lenograstim prevents morbidity from intensive induction chemotherapy in the treatment of inflammatory breast cancer. J Clin Oncol 1995 Jul; 13 (7): 1564-71
35. Gatzemeier U, Kleisbauer JP, Drings P, et al. Lenograstim as support for ACE chemotherapy of small-cell lung cancer: a phase III, multicenter, randomized study. Am J Clin Oncol 2000 Aug; 23 (4): 393-400 (Pubitemid 32429154)
36. Gisselbrecht C, Haioun C, Lepage E, et al. Placebo-controlled phase III study of lenograstim (glycosylated recombinant human granulocyte colony-stimulating factor) in aggressive non-Hodgkin's lymphoma: factors influencing chemotherapy administration. Leuk Lym-phoma 1997 Apr; 25 (3-4): 289-300 (Pubitemid 27248180)
37. Takagi T, Sawamura M, Sezaki T, et al. Clinical benefits of lenograstim in patients with neutropenia due to chemotherapy for multiple myeloma (MM). Support Care Cancer 2001 Jul; 9 (5): 397-9 (Pubitemid 32666893)
38. Chevreau C, Bui BN, Chevallier B, et al. Phase I-II trial of intensification of the MAID regimen with support of lenograstim (rHuG-CSF) in patients with advanced soft-tissue sarcoma (STS). Am J Clin Oncol 1999 Jun; 22 (3): 267-72 (Pubitemid 30263320)
39. Culine S, Romieu G, Fabbro M, et al. Reducing the time interval between cycles using standard doses of docetaxel and lenogastrim support: a feasibility study. Cancer 2004 Jul 1; 101 (1): 178-82 (Pubitemid 38812438)
40. Heigener DF, Manegold C, Jager E, et al. Multicenter randomized open-label phase III study comparing efficacy, safety, and tolerability of conventional carboplatin plus etoposide versus dose-intensified carboplatin plus eto-poside plus lenograstim in small-cell lung cancer in 'extensive disease' stage. Am J Clin Oncol 2009 Feb; 32 (1): 61-4
41. Itoh K, Ohtsu T, Fukuda H, et al. Randomized phase II study of biweekly CHOP and dose-escalated CHOP with prophylactic use of lenograstim (glycosylated G-CSF) in aggressive non-Hodgkin's lymphoma: Japan Clinical Oncology Group Study 9505. Ann Oncol 2002 Sep; 13 (9): 1347-55
42. Thatcher N, Girling DJ, Hopwood P, et al. Improving survival without reducing quality of life in small-cell lung cancer patients by increasing the dose-intensity of chemotherapy with granulocyte colony-stimulating factor support: results of a British Medical Research Council multicenter randomized trial. J Clin Oncol 2000 Jan; 18 (2): 395-404 (Pubitemid 30056430)
43. Woll PJ, Hodgetts J, Lomax L, et al. Can cytotoxic dose-intensity be increased by using granulocyte colony-stimulating factor? A randomized controlled trial of lenograstim in small-cell lung cancer. J Clin Oncol 1995 Mar; 13 (3): 652-9
44. Milla-Santos A, Milla L, Rallo L, et al. High-dose epir-ubicin plus docetaxel at standard dose with lenograstim support as first-line therapy in advanced breast cancer. Am J Clin Oncol 2001; 24 (2): 138-42 (Pubitemid 32323350)
45. Mori K, Saitoh Y, Tominaga K. Recombinant human granulocyte colony-stimulating factor in patients receiving intensive chemotherapy for non-small cell lung cancer. Eur J Cancer 1993; 29A (5): 677-80 (Pubitemid 23077044)
46. Thatcher N, Anderson H, Bleehen NM, et al. The feasi-bility of using glycosylated recombinant human granulo-cyte colony-stimulating factor (G-CSF) to increase the planned dose intensity of doxorubicin, cyclophosphamide and etoposide (ACE) in the treatment of small cell lung cancer. Eur J Cancer 1995; 31A (2): 152-6
47. Ardizzoni A, Favaretto A, Boni L, et al. Platinum-etopo-side chemotherapy in elderly patients with small-cell lung cancer: results of a randomized multicenter phase II study assessing attenuated-dose or full-dose with lenograstim prophylaxis - a Forza Operativa Nazionale Italiana Carcinoma Polmonare and Gruppo Studio Tumori Polmonari Veneto (FONICAP-GSTPV) study. J Clin Oncol 2005 Jan 20; 23 (3): 569-75 (Pubitemid 46224234)
48. Toner GC, Shapiro JD, Laidlaw CR, et al. Low-dose ver-sus standard-dose lenograstim prophylaxis after chemotherapy: a randomized, crossover comparison. J Clin Oncol 1998 Dec; 16 (12): 3874-9 (Pubitemid 29001541)
49. Juan O, Campos JM, Caranana V, et al. A randomized, crossover comparison of standard-dose versus low-dose lenograstim in the prophylaxis of post-chemotherapy neutropenia. Support Care Cancer 2001 Jun; 9 (4): 241-6 (Pubitemid 32537282)
50. Hashino S, Morioka M, Irie T, et al. Cost benefit and clinical efficacy of low-dose granulocyte colony-stimulating factor after standard chemotherapy in patients with non-Hodgkin's lymphoma. Int J Lab Hematol 2008 Aug; 30 (4): 292-9
51. Amadori S, Suciu S, Jehn U, et al. Use of glycosylated re-combinant human G-CSF (lenograstim) during and/or after induction chemotherapy in patients 61 years of age and older with acute myeloid leukemia: final results of AML-13, a randomized phase-3 study. Blood 2005 Jul 1; 106 (1): 27-34 (Pubitemid 40967170)
52. Bradstock K, Matthews J, Young G, et al. Effects of glycosylated recombinant human granulocyte colony-stimulating factor after high-dose cytarabine-based induction chemotherapy for adult acute myeloid leukaemia. Leukemia 2001 Sep; 15 (9): 1331-8 (Pubitemid 32785302)
53. Dombret H, Chastang C, Fenaux P, et al. A controlled study of recombinant human granulocyte colony-stimulating factor in elderly patients after treatment for acute myelogenous leukemia. N Engl J Med 1995 Jun 22; 332 (25): 1678-83
54. Wheatley K, Goldstone AH, Littlewood T, et al. Ran-domized placebo-controlled trial of granulocyte colony stimulating factor (G-CSF) as supportive care after induction chemotherapy in adult patients with acute myeloid leukaemia: a study of the United Kingdom Medical Research Council Adult Leukaemia Working Party. Br J Haematol 2009 Jun; 146 (1): 54-63
55. Hofmann WK, Seipelt G, Langenhan S, et al. Prospective randomized trial to evaluate two delayed granulocyte colony stimulating factor administration schedules after high-dose cytarabine therapy in adult patients with acute lymphoblastic leukemia. Ann Hematol 2002 Oct; 81 (10): 570-4 (Pubitemid 36097042)
56. Holowiecki J, Giebel S, Krzemien S, et al. G-CSF adminis-tered in time-sequenced setting during remission induction and consolidation therapy of adult acute lymphoblastic leukemia has beneficial influence on early recovery and possibly improves long-term outcome: a randomized multicenter study. Leuk Lymphoma 2002 Feb; 43 (2): 315-25 (Pubitemid 34202110)
57. Ohno R, Tomonaga M, Ohshima T, et al. A randomized controlled study of granulocyte colony stimulating factor after intensive induction and consolidation therapy in patients with acute lymphoblastic leukemia. Int J Hematol 1993 Aug; 58 (1-2): 73-81 (Pubitemid 23291839)
58. Linch DC, Scarffe H, Proctor S, et al. Randomised vehicle-controlled dose-finding study of glycosylated recombinant human granulocyte colony-stimulating factor after bone marrow transplantation. Bone Marrow Transplant 1993 Apr; 11 (4): 307-11 (Pubitemid 23108439)
59. Gisselbrecht C, Prentice HG, Bacigalupo A, et al. Placebo-controlled phase III trial of lenograstim in bone-marrow transplantation. Lancet 1994 Mar 19; 343 (8899): 696-700 (Pubitemid 24087848)
60. Linch DC, Milligan DW, Winfield DA, et al. G-CSF after peripheral blood stem cell transplantation in lymphoma patients significantly accelerated neutrophil recovery and shortened time in hospital: results of a randomized BNLI trial. Br J Haematol 1997 Dec; 99 (4): 933-8 (Pubitemid 28047163)
61. Schmitz N, Ljungman P, Cordonnier C, et al. Lenograstim after autologous peripheral blood progenitor cell transplantation: results of a double-blind, randomized trial. Bone Marrow Transplant 2004 Dec; 34 (11): 955-62 (Pubitemid 39600112)
62. Himmelmann B, Himmelmann A, Furrer K, et al. Late G-CSF after allogeneic bone marrow or peripheral blood stem cell transplantation: a prospective controlled trial. Bone Marrow Transplant 2002 Oct; 30 (8): 491-6 (Pubitemid 35331714)
63. Jang G, Ko OB, Kim S, et al. Prospective randomized comparative observation of single- versus split-dose lenograstim to enhance engraftment after autologous stem cell transplantation in patients with multiple myeloma or non-Hodgkin's lymphoma. Transfusion (Paris) 2008 Apr; 48 (4): 640-6 (Pubitemid 351430337)
64. Valteau-Couanet D, Faucher C, Auperin A, et al. Cost ef-fectiveness of day 5 G-CSF (lenograstim®) administration after PBSC transplantation: results of a SFGM-TC randomised trial. Bone Marrow Transplant 2005 Sep; 36 (6): 547-52 (Pubitemid 43118150)
65. Narabayashi M, Takeyama K, Fukutomi T, et al. A dose-finding study of lenograstim (glycosylated rHuG-CSF) for peripheral blood stem cell mobilization during postoperative adjuvant chemotherapy in patients with breast cancer. Jpn J Clin Oncol 1999 Jun; 29 (6): 285-90
66. Karanth M, Chakrabarti S, Lovell RA, et al. A randomised study comparing peripheral blood progenitor mobilisation using intermediate-dose cyclophosphamide plus lenograstim with lenograstim alone. Bone Marrow Transplant 2004 Sep; 34 (5): 399-403 (Pubitemid 39232368)
67. Kim S, Kim H-J, Park JS, et al. Prospective randomized comparative observation of single- vs split-dose leno-grastim to mobilize peripheral blood progenitor cells following chemotherapy in patients with multiple myeloma or non-Hodgkin's lymphoma. Ann Hematol 2005 Oct; 84 (11): 742-7 (Pubitemid 41447809)
68. Kim JE, Yoo C, Kim S, et al. Optimal timing of G-CSF administration for effective autologous stem cell collection. Bone Marrow Transplant. Epub 2010 Aug 9
69. Takeyama K, Ogura M, Morishima Y, et al. A dose-find-ing study of glycosylated G-CSF (lenograstim) combined with CHOP therapy for stem cell mobilization in patients with non-Hodgkin's lymphoma. Jpn J Clin Oncol 2003 Feb; 33 (2): 78-85 (Pubitemid 43115272)
70. Ataergin S, Arpaci F, Turan M, et al. 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. Am J Hematol 2008 Aug; 83 (8): 644-8
71. de Arriba F, Lozano ML, Ortuno F, et al. Prospective randomized study comparing the efficacy of bioequivalent doses of glycosylated and nonglycosylated rG-CSF for mobilizing peripheral blood progenitor cells. Br J Hae-matol 1997 Feb; 96 (2): 418-20 (Pubitemid 27077383)
72. Hovenga S, de Wolf JT, Guikema JE, et al. Autologous stem cell transplantation in multiple myeloma after VAD and EDAP courses: a high incidence of oligoclonal serum Igs post transplantation. Bone Marrow Transplant 2000 Apr; 25 (7): 723-8 (Pubitemid 30189512)
73. Kopf B, De Giorgi U, Vertogen B, et al. A randomized study comparing filgrastim versus lenograstim versus molgramostim plus chemotherapy for peripheral blood progenitor cell mobilization. Bone Marrow Transplant 2006 Sep; 38 (6): 407-12 (Pubitemid 44340369)
74. Orciuolo E, Buda G, Marturano E, et al. Lenograstim re-duces the incidence of febrile episodes, when compared with filgrastim, in multiple myeloma patients undergoing stem cell mobilization. Leuk Res. Epub 2010 Dec 4
75. Ria R, Gasparre T, Mangialardi G, et al. Comparison be-tween filgrastim and lenograstim plus chemotherapy for mobilization of PBPCs. Bone Marrow Transplant 2010 Feb; 45 (2): 277-81
76. Watts MJ, Sullivan AM, Jamieson E, et al. Progenitor-cell mobilization after low-dose cyclophosphamide and granulocyte colony-stimulating factor: an analysis of progenitor-cell quantity and quality and factors predicting for these parameters in 101 pretreated patients with malignant lymphoma. J Clin Oncol 1997 Feb; 15 (2): 535-46 (Pubitemid 27074220)
77. Basara N, Schmetzer B, Blau IW, et al. Lenograstim-mobilized peripheral blood progenitor cells in volunteer donors: an open label randomized split dose escalating study. Bone Marrow Transplant 2000 Feb; 25 (4): 371-6 (Pubitemid 30114030)
78. Hoglund M, Smedmyr B, Simonsson B, et al. Dose-dependent mobilisation of haematopoietic progenitor cells in healthy volunteers receiving glycosylated rHuG-CSF. Bone Marrow Transplant 1996 Jul; 18 (1): 19-27 (Pubitemid 26289630)
79. Fischer JC, Frick M, Wassmuth R, et al. Superior mobili-sation of haematopoietic progenitor cells with glycosy-lated G-CSF in male but not female unrelated stem cell donors. Br J Haematol 2005 Sep; 130 (5): 740-6 (Pubitemid 43906646)
80. Ings SJ, Balsa C, Leverett D, et al. Peripheral blood stem cell yield in 400 normal donors mobilised with granulo-cyte colony-stimulating factor (G-CSF): impact of age, sex, donor weight and type of G-CSF used. Br J Haematol 2006 Sep; 134 (5): 517-25 (Pubitemid 44141718)
81. Martino M, Console G, Irrera G, et al. Harvesting peri-pheral blood progenitor cells from healthy donors: retrospective comparison of filgrastim and lenograstim. J Clin Apheresis 2005 Oct; 20 (3): 129-36 (Pubitemid 43081860)
82. Holig K, Kramer M, Kroschinsky F, et al. Safety and efficacy of hematopoietic stem cell collection from mobilized peripheral blood in unrelated volunteers: 12 years of single-center experience in 3928 donors. Blood 2009 Oct 29; 114 (18): 3757-63
83. Martino M, Console G, Dattola A, et al. Short and long-term safety of lenograstim administration in healthy peripheral haematopoietic progenitor cell donors: a single centre experience. Bone Marrow Transplant 2009 Aug; 44(3): 163-8
84. Platzbecker U, Bornhauser M, Zimmer K, et al. Second donation of granulocyte-colony-stimulating factor-mobilized peripheral blood progenitor cells: risk factors associated with a low yield of CD34+ cells. Transfusion (Paris) 2005 Jan; 45(1): 11-5
85. Kuderer NM, Dale DC, Crawford J, et al. Impact of pri-mary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review. J Clin Oncol 2007 Jul 20; 25 (21): 3158-67 (Pubitemid 47218066)
86. Zielinski CC, Awada A, Cameron DA, et al. The impact of new European Organisation for Research and Treatment of Cancer guidelines on the use of granulocyte colony-stimulating factor on the management of breast cancer patients. Eur J Cancer 2008 Feb; 44 (3): 353-65
87. Pettengell R, Aapro M, Brusamolino E, et al. Implications of the European Organisation for Research And Treatment Of Cancer (EORTC) guidelines on the use of gran-ulocyte colony-stimulating factor (G-CSF) for lymphoma care. Clin Drug Investig 2009; 29 (8): 491-513
88. Aapro MS, Bohlius J, Cameron DA, et al. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer 2011 Jan; 47 (1): 8-32
89. Smith TJ, Khatcheressian J, Lyman GH, et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol 2006 Jul 1; 24 (19): 3187-205 (Pubitemid 46638957)
90. Lowenberg B, van Putten W, Theobald M, et al. Effect of priming with granulocyte colony-stimulating factor on the outcome of chemotherapy for acute myeloid leukemia. N Engl J Med 2003 Aug 21; 349 (8): 743-52 (Pubitemid 37010778)
91. Soda H, Oka M, Fukuda M, et al. Optimal schedule for administering granulocyte colony-stimulating factor in chemotherapy-induced neutropenia in non-small-cell lung cancer. Cancer Chemother Pharmacol 1996; 38 (1): 9-12 (Pubitemid 26096570)
92. Clark OA, Lyman GH, Castro AA, et al. Colony-stimu-lating factors for chemotherapy-induced febrile neutro-penia: a meta-analysis of randomized controlled trials. J Clin Oncol 2005 Jun 20; 23 (18): 4198-214 (Pubitemid 46211326)
93. Trivedi M, Martinez S, Corringham S, et al. Optimal use of G-CSF administration after hematopoietic SCT. Bone Marrow Transplant 2009 Jun; 43 (12): 895-908
94. Huttmann A, Schirsafi K, Seeber S, et al. Comparison of lenograstim and filgrastim: effects on blood cell recovery after high-dose chemotherapy and autologous peripheral blood stem cell transplantation. J Cancer Res Clin Oncol 2005 Mar; 131 (3): 152-6 (Pubitemid 40175008)
95. Kim IH, Park SK, Suh OK, et al. Comparison of leno-grastim and filgrastim on haematological effects after autologous peripheral blood stem cell transplantation with high-dose chemotherapy. Curr Med Res Opin 2003; 19 (8): 753-9 (Pubitemid 37466146)
96. Ocheni S, Zabelina T, Bacher U, et al. Pegfilgrastim com-pared to lenograstim after allogeneic peripheral blood stem-cell transplantation from unrelated donors. Leuk Lymphoma 2009 Apr; 50 (4): 612-8
97. Rosenbeck LL, Srivastava S, Kiel PJ. Peripheral blood stem cell mobilization tactics. Ann Pharmacother 2010 Jan; 44 (1): 107-16
98. Vose JM, Ho AD, Coiffier B, et al. Advances in mobiliza-tion for the optimization of autologous stem cell transplantation. Leuk Lymphoma 2009 Sep; 50 (9): 1412-21
99. Cashen AF, Lazarus HM, Devine SM. Mobilizing stem cells from normal donors: is it possible to improve upon G-CSF? Bone Marrow Transplant 2007 May; 39 (10): 577-88 (Pubitemid 46729051)
100. European Medicines Agency. Mozobil (plerixafor) 20mg/mL solution for injection: EU summary of product characteristics [online]. Available from URL: http://www.ema.europa [Accessed 2010 Oct 26]
101. DiPersio JF, Micallef IN, Stiff PJ, et al. Phase III pro-spective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin's lymphoma. J Clin Oncol 2009 Oct 1; 27 (28): 4767-73
102. DiPersio JF, Stadtmauer EA, Nademanee A, et al. Plerix-afor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. Blood 2009 Jun 4; 113 (23): 5720-6
103. Wells JC, Shaw BE, Smith MA. The effect of mobilisation using plerixafor in combination with G-CSF on the efficiency of haematopoietic progenitor cell harvesting [abstract no. PO26]. Tranfusion Medicine 2009 Oct; 19 Suppl. 1: 32
104. Sato Y, Kobayashi A, Yamamoto K. Stability of a new formulation of lenograstim at room temperature for 2 years. J Drug Assess 2003; 6: 49-58
105. Electronic Medicines Compendium. Neupogen (filgrastim) 30 MU (0.3 mg/mL) and 48 MU (0.3 mg/mL) solution for injection: UK summary of product characteristics [online]. Available from URL: http://www.medicines.org.uk/ EMC/medicine/23294/SPC/Neupogen+30+MU+(0.3+mg+ ml)+and+48+MU+(0.3+mg+ml). +Solution+for+injection/ [Accessed 2011 Jan 10]
106. Electronic Medicines Compendium. Neulasta (pegfilgrastim) 6 mg solution for injection: UK summary of product characteristics [online]. Available from URL: http://www.medi cines.org.uk/EMC/medicine/11783/SPC/NEULASTA/ [Accessed 2011 Jan 10]
107. Heuser M, Ganser A, Bokemeyer C. Use of colony-stimu-lating factors for chemotherapy-associated neutropenia: review of current guidelines. Semin Hematol 2007 Jul; 44 (3): 148-56 (Pubitemid 47031224)
108. Halter J, Kodera Y, Ispizua AU, et al. Severe events in donors after allogeneic hematopoietic stem cell donation. Haematologica 2009 Jan; 94 (1): 94-101
109. de la Rubia J, de Arriba F, Arbona C, et al. Follow-up of healthy donors receiving granulocyte colony-stimulating factor for peripheral blood progenitor cell mobilization and collection. Results of the Spanish Donor Registry. Haematologica 2008 May; 93 (5): 735-40 (Pubitemid 351669314)
110. Bessho M, Hotta T, Ohyashiki K, et al. Multicenter pro-spective study of clonal complications in adult aplastic anemia patients following recombinant human granulo-cyte colony-stimulating factor (lenograstim) administration. Int J Hematol 2003 Feb; 77 (2): 152-8 (Pubitemid 37127567)
111. Beekman R, Touw IP. G-CSF and its receptor in myeloid malignancy. Blood 2010 Jun 24; 115 (25): 5131-6
112. Lyman GH, Dale DC, Wolff DA, et al. Acute myeloid leukemia or myelodysplastic syndrome in randomized controlled clinical trials of cancer chemotherapy with granulocyte colony-stimulating factor: a systematic review. J Clin Oncol 2010 Jun 10; 28 (17): 2914-24
113. Bacigalupo A, Broccia G, Corda G, et al. Antilymphocyte globulin, cyclosporin, and granulocyte colony-stimulating factor in patients with acquired severe aplastic anemia (SAA): a pilot study of the EBMT SAA Working Party. Blood 1995 Mar 1; 85 (5): 1348-53
114. Teramura M, Kimura A, Iwase S, et al. Treatment of severe aplastic anemia with antithymocyte globulin and cyclosporin A with or without G-CSF in adults: a multicenter randomized study in Japan. Blood 2007 Sep 15; 110 (6): 1756-61 (Pubitemid 47443885)
115. Kojima S, Matsuyama T, Kato S, et al. Outcome of 154 patients with severe aplastic anemia who received transplants from unrelated donors: the Japan Marrow Donor Program. Blood 2002 Aug 1; 100 (3): 799-803 (Pubitemid 34832604)
116. Gluckman E, Rokicka-Milewska R, Hann I, et al. Results and follow-up of a phase III randomized study of recombinant human-granulocyte stimulating factor as support for im-munosuppressive therapy in patients with severe aplastic anaemia. Br J Haematol 2002 Dec; 119 (4): 1075-82 (Pubitemid 35463836)
117. Dubreuil-Lemaire M-L, Gori A, Vittecoq D, et al. Leno-grastim for the treatment of neutropenia in patients receiving ganciclovir for cytomegalovirus infection: a randomised, placebo-controlled trial in AIDS patients. Eur J Haematol 2000 Nov; 65 (5): 337-43
118. Carlsson G, Ahlin A, Dahllof G, et al. Efficacy and safety of two different rG-CSF preparations in the treatment of patients with severe congenital neutropenia. Br J Hae-matol 2004 Jul; 126 (1): 127-32 (Pubitemid 38859493)
119. Tsukimoto I, Hanawa Y, Takaku F, et al. Clinical evalua-tion of recombinant human G-CSF in children with cancer [in Japanese]. Rinsho Ketsueki 1990 Oct; 31 (10): 1647-55
120. Michel G, Landman-Parker J, Auclerc MF, et al. Use of recombinant human granulocyte colony-stimulating factor to increase chemotherapy dose-intensity: a randomized trial in very high-risk childhood acute lymphoblastic leukemia. J Clin Oncol 2000 Apr; 18 (7): 1517-24 (Pubitemid 30205398)
121. Rutkowski J, Derylo L, Fedyna M, et al. Cost-effectiveness of lenograstim neutropenia duration in adults receiving chemotherapy for leukemia [abstract no. PCN88]. 15th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research; 2010 May 15-19; Atlanta (GA)
122. Rutkowski J, Derylo L, Fedyna M, et al. Cost-effectiveness of lenograstym on neutropenia duration in adults receiving chemotherapy for solid tumors or lymphomas [abstract no. PCN83]. 15th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research; 2010 May 15-19; Atlanta (GA)
123. Rutkowski J, Derylo L, Fedyna M, et al. Cost-effectiveness of lenograstym on neutropenia duration in children receiving chemotherapy for leukemia [abstract no. PCN69]. 15th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research; 2010 May 15-19; Atlanta (GA)