Abstract
Pegfilgrastim (Neulasta®), the sustained-duration form of filgrastim (recombinant human granulocyte colony-stimulating factor [G-CSF]), is created by the addition of a polyethylene glycol (PEG) moiety to filgrastim. Its approved indication in the US is to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy.
A single subcutaneous injection of pegfilgrastim once per chemotherapy cycle was more effective than placebo as an adjunct to moderately myelosuppressive chemotherapy for breast cancer, no less effective than daily injections of filgrastim as an adjunct to highly myelosuppressive chemotherapy for breast cancer, and as effective as daily filgrastim as an adjunct to chemotherapy for lymphoma (predominantly non-Hodgkin lymphoma [NHL]) and acute myeloid leukemia. Pegfilgrastim has also successfully supported delivery of dose-dense chemotherapy, stem cell mobilization, and stem cell transplantation after high-dose chemotherapy in patients with non-myeloid or myeloid malignancies. By offering a convenient alternative to daily filgrastim, once-per-cycle administration of pegfilgrastim has the potential to simplify the management of chemotherapy-induced neutropenia, further improve patient health-related quality of life, and reduce total treatment costs in breast cancer and NHL, and possibly other cancer settings. Pegfilgrastim should, likewise, permit simplification of G-CSF-based stem cell mobilization and transplantation procedures.
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References
Molineux G. The design and development of pegfilgrastim (PEG-rmetHuG-CSF, Neulasta®). Curr Pharm Des 2004; 10(11): 1235–44
Lord BI, Woolford LB, Molineux G. Kinetics of neutrophil production in normal and neutropenic animals during the response to filgrastim (r-metHu G-CSF) or filgrastim SD/01 (PEG-r-metHu G-CSF). Clin Cancer Res 2001 Jul; 7: 2085–90
Molineux G. Pegylation: engineering improved biopharmaceuticals for oncology. Pharmacotherapy 2003 Aug; 23(8 Pt 2): 3S–8S
Johnston E, Crawford J, Blackwell S, et al. Randomized, dose-escalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy. J Clin Oncol 2000 Jul; 18(13): 2522–8
Holmes FA, Jones SE, O’Shaughnessy J, et al. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol 2002 Jun; 13(6): 903–9
Green MD, Koelbl H, Baselga J, et al. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol 2003 Jan; 14(1): 29–35
Zamboni WC. Pharmacokinetics of pegfilgrastim. Pharmacotherapy 2003 Aug; 23(8 Pt 2): 9S–14S
Vogel CL, Wojtukiewicz MZ, Carroll RR, et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol 2005; 23(6): 1178–84
Holmes FA, O’Shaughnessy JA, Vukelja S, et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol 2002 Feb 1; 20(3): 727–31
Vose JM, Crump M, Lazarus H, et al. Randomized, multicenter, open-label study of pegfilgrastim compared with daily filgrastim after chemotherapy for lymphoma. J Clin Oncol 2003 Feb 1; 21(3): 514–9
Grigg A, Solal-Celigny P, Hoskin P, et al. Open-label, randomized study of pegfilgrastim vs. daily filgrastim as an adjunct to chemotherapy in elderly patients with non-Hodgkin’s lymphoma. Leuk Lymphoma 2003 Sep; 44(9): 1503–8
George S, Yunus F, Case D, et al. Fixed-dose pegfilgrastim is safe and allows neutrophil recovery in patients with non-Hodgkin’s lymphoma. Leuk Lymphoma 2003 Oct; 44(10): 1691–6
Bosi A, Szer J, Kassis J, et al. A multicentre, double-blind, randomised, phase 2 trial comparing pegfilgrastim with filgrastim as an adjunct to chemotherapy for acute myeloid leukaemia (AML) [abstract no. 866]. Blood 2004 Nov 16; 104(11 Pt 1): 247a. Plus poster presented at the 46th Annual Meeting of the American Society of Hematology; 2004 Dec 4–7; San Diego (CA)
Siena S, Piccart MJ, Holmes FA, et al. A combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily filgrastim in patients with stage II-IV breast cancer. Oncol Rep 2003 May; 10(3): 715–24
Burstein HJ, Parker LM, Doherty J, et al. Use of the long-acting hematopoietic growth factors pegfilgrastim and darbepoetin alfa in support of dose-dense adjuvant chemotherapy [abstract no. 1055 plus poster]. San Antonio Breast Cancer Society Annual Meeting; 2004 Dec 8–11; San Antonio (TX)
Schwartzberg LS, Tauer KT, Barry FV, et al. Dose dense chemotherapy (DDC) supported by pegfilgrastim (peg) and an erythropoietic agent (EA) in operable breast cancer [abstract no. 6035 plus poster]. San Antonio Breast Cancer Society Annual Meeting; 2004 Dec 8–11; San Antonio (TX)
Pirker R, Ulsperger E, Aigner K, et al. A phase II study of pegfilgrastim to support ACE 14 chemotherapy for the treatment of subjects with small cell lung cancer (SCLC; extensive disease) [abstract no. 7216]. Proc Am Soc Clin Oncol 2004 Jun; 23: 667. Plus poster presented at the 40th Annual Meeting of the American Society of Clinical Oncology; 2004 Jun 5–8; New Orleans (LA)
Lopez A, Fernandez de Sevilla A, Castaigne S, et al. Pegfilgrastim supports delivery of CHOP-R chemotherapy administered every 14 days: a randomised phase II study [abstract no. 3311]. Blood 2004 Nov 16; 104(11 Pt 1): 904a. Plus poster presented at the 46th Annual Meeting of the American Society of Hematology; 2004 Dec 4–7; San Diego (CA)
Moore TD, Patel T, Segal ML, et al. A single pegfilgrastim dose per cycle supports dose-dense (ql4d) CHOP-R in patients with non-Hodgkin’s lymphoma [abstract no. 2365]. Blood 2003 Nov 16; 102(11 Pt 1): 641a. Plus poster presented at the 45th Annual Meeting of the American Society of Hematology; 2003 Dec 6–9; San Diego (CA)
Engert A, Doehner H, Ho AD, et al. Pegfilgrastim supports delivery of BEACOPP chemotherapy administered every 14 days [abstract no. 1316]. Blood 2004 Nov 16; 104(11 Pt 1): 370–1a. Plus poster presented at the 46th Annual Meeting of the American Society of Hematology; 2004 Dec 4–7; San Diego (CA)
Younes A, Fayad L, Romaguera J, et al. Long-term safety and efficacy of single administration of a fixed dose pegfilgrastim (Neulasta) in inducing neutrophil count recovery after ABVD chemotherapy in patients with Hodgkin lymphoma [abstract no. 4646]. Blood 2004 Nov 16; 104(11 Pt 2): 245b
Isidori A, Tani M, Bonifazi F, et al. Phase II study of a single pegfilgrastim injection as an adjunct to chemotherapy to mobilize stem cells into the peripheral blood of a pretreated lymphoma patients. Haematologica 2005; 90: 225–31
Willis F, Pettengell R, Woll PJ, et al. Pegfilgrastim alone successfully mobilizes peripheral CD34+ cells in chemotherapy naive subjects with solid tumours: initial results of a phase 1–2 study [abstract no. 2687.5]. Blood 2004 Nov 16; 104(11 Pt 1): 734a. Plus poster presented at the 46th Annual Meeting of the American Society of Hematology; 2004 Dec 4–7; San Diego (CA)
Steidl U, Fenk R, Brans I, et al. Successful transplantation of peripheral blood stem cells mobilized by chemotherapy and a single dose of pegylated G-CSF in patients with multiple myeloma. Bone Marrow Transplant 2005; 35: 33–6
Jagasia M, Greer J, Kassim A, et al. Pegylated filgrastim after high dose chemotherapy and autologous stem cell transplant [abstract no. 6639]. Proc Am Soc Clin Oncol 2004 Jun; 23: 590. Plus poster presented at the 40th Annual Meeting of the American Society of Clinical Oncology; 2004 Jun 5–8; New Orleans (LA)
Amgen Inc. Neulasta® (pegfilgrastim) prescribing information. 2005 Jan
Kubista E, Glaspy J, Holmes FA, et al. Bone pain associated with once-per-cycle pegfilgrastim is similar to daily filgrastim in patients with breast cancer. Clin Breast Cancer 2003 Feb; 3(6): 391–8
Green MD, Lu ZJ. Once-per-cycle fixed-dose administration of pegfilgrastim reduced resource utilization and costs compared with daily filgrastim in the prevention of chemotherapy-induced neutropenia [abstract no. PCN4]. Value Health 2002 Nov; 5: 537–8
Heckinger E, Lee J, Calhoun E, et al. Cost minimization analysis of figrastim versus pegfilgrastim for stage II-IV breast cancer patients receiving chemotherapy: assessments based on third-party and societal perspectives [abstract no. 2116]. Proc Am Soc Clin Oncol 2003 May 31; 22: 526
Suzcs TD, Standaert B, Lu ZJ. Analysis on cost difference between daily filgrastim and once per cycle pegfilgrastim for prophylaxis against chemotherapy-induced neutropenia in France and Germany. Value Health 2003 Nov; 6(6): 732
Lyman GH, Kuderer NM, Crawford J, et al. Economic impact of pegfilgrastim use based on the risk of febrile neutropenia in NHL patients treated with CHOP [abstract no. 2384]. Proc Am Soc Clin Oncol 2003 May 31; 22: 593
Eldar-Lissai A, Cosier L, Lyman GH. Economic analysis of prophylactic pegfilgrastim in cancer patients [abstract no. 2212]. Blood 2004 Nov 16; 104(11 Pt 1): 608a. Plus poster presented at the 46th Annual Meeting of the American Society of Hematology; 2004 Dec 4–7; San Diego (CA)
Acknowledgments
The full text article in American Journal of Cancer 2005; 4 (4): 255–74 was reviewed by: R.A. Beveridge, Inova Fairfax Hospital, Fairfax, Virginia, USA; P.S. Carey, Sunderland Royal Infirmary, Sunderland, England; D.C. Dale, University of Washington, Department of Medicine, Seattle, Washington, USA; D.B. Daniel, Duke University Medical Center, Department of Medicine, Durham, North Carolina, USA; M.D. Green, Royal Melbourne Hospital, Melbourne, Victoria, Australia; E. Kubista, Medical University of Vienna, Vienna, Austria; and F. Willis, St. George’s Hospital, London, England.
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This spotlight is derived from abstract and summary text of an Adis Drug Evaluation originally published in full in American Journal of Cancer 2005; 4 (4): 255–74. Reviewers of the original full text article are listed in the Acknowledgments section
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Frampton, J.E., Keating, G.M. Spotlight on Pegfilgrastim in Chemotherapy-Induced Neutropenia. BioDrugs 19, 405–407 (2005). https://doi.org/10.2165/00063030-200519060-00008
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DOI: https://doi.org/10.2165/00063030-200519060-00008