Lipegfilgrastim for the prophylaxis and treatment of chemotherapy-induced neutropenia

References

• Lyman GH, Kuderer NM. Epidemiology of febrile neutropenia. Support Cancer Ther Kuderer Crawford 2003;1(1):23-35
   PubMedGoogle Scholar
• Herbst C, Naumann F, Kruse EB, et al. Prophylactic antibiotics or G-CSF for the prevention of infections and improvement of survival in cancer patients undergoing chemotherapy. Cochrane Database Syst Rev 2009;CD007107
   Google Scholar
• Crawford J, Dale DC, Lyman GH. Chemotherapy-induced neutropenia: risks, consequences, and new directions for its management. Cancer 2004;100(2):228-37
   PubMed Web of Science ®Google Scholar
• Lyman GH, Michels SL, Reynolds MW, et al. Risk of mortality in patients with cancer who experience febrile neutropenia. Cancer 2010;116(23):5555-63
   PubMed Web of Science ®Google Scholar
• Naik JD, Sathiyaseelan SR, Vasudev NS. Febrile neutropenia. BMJ 2010;341:c6981
   PubMed Web of Science ®Google Scholar
• Kuderer NM, Dale DC, Crawford J, et al. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer 2006;106(10):2258-66
   PubMed Web of Science ®Google Scholar
• Fiegl M, Steger GG, Studnicka M, et al. Pegfilgrastim prophylaxis in patients at different levels of risk for chemotherapy-associated febrile neutropenia: an observational study. Curr Med Res Opin 2013;29(5):505-15
   PubMed Web of Science ®Google Scholar
• 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 2010;47(2011):8-32
   PubMedGoogle Scholar
• Pirker R, Pereira JR, Szczesna A, et al. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet 2009;373(9674):1525-31
   PubMed Web of Science ®Google Scholar
• Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006;355(24):2542-50
   PubMed Web of Science ®Google Scholar
• Reck M, von Pawel J, Zatloukal P, et al. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J Clin Oncol 2009;27(8):1227-34
   PubMed Web of Science ®Google Scholar
• von Minckwitz G, Raab G, Caputo A, et al. Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German Breast Group. J Clin Oncol 2005;23(12):2676-85
   PubMed Web of Science ®Google Scholar
• Morris PG, McArthur HL, Hudis C, Norton L. Dose-dense chemotherapy for breast cancer: what does the future hold? Future Oncol 2010;6(6):951-65
   PubMedGoogle Scholar
• Gregory SA, Trumper L. Chemotherapy dose intensity in non-Hodgkin’s lymphoma: is dose intensity an emerging paradigm for better outcomes? Ann Oncol 2005;16(9):1413-24
   PubMed Web of Science ®Google Scholar
• Tjan-Heijnen VC, Wagener DJ, Postmus PE. An analysis of chemotherapy dose and dose-intensity in small-cell lung cancer: lessons to be drawn. Ann Oncol 2005;13(10):1519-30
   Google Scholar
• Bosly A, Bron D, Van Hoof A, et al. Achievement of optimal average relative dose intensity and correlation with survival in diffuse large B-cell lymphoma patients treated with CHOP. Ann Hematol 2008;87(4):277-83
   PubMed Web of Science ®Google Scholar
• Chirivella I, Bermejo B, Insa A, et al. Optimal delivery of anthracycline-based chemotherapy in the adjuvant setting improves outcome of breast cancer patients. Breast Cancer Res Treat 2009;114(3):479-84
   PubMed Web of Science ®Google Scholar
• Jakobsen A, Berglund A, Glimelius B, et al. Dose-effect relationship of bolus 5-fluorouracil in the treatment of advanced colorectal cancer. Acta Oncol 2002;41(6):525-31
   PubMedGoogle Scholar
• Foote M. The importance of planned dose of chemotherapy on time: do we need to change our clinical practice? Oncologist 1998;3(5):365-8
   PubMedGoogle Scholar
• Renwick W, Pettengell R, Green M. Use of filgrastim and pegfilgrastim to support delivery of chemotherapy: twenty years of clinical experience. BioDrugs 2009;23(3):175-86
   PubMed Web of Science ®Google Scholar
• Gomez H, Hidalgo M, Casanova L, et al. Risk factors for treatment-related death in elderly patients with aggressive non-Hodgkin’s lymphoma: results of a multivariate analysis. J Clin Oncol 1998;16(6):2065-9
   PubMedGoogle Scholar
• Morrison VA, Picozzi V, Scott S, et al. The impact of age on delivered dose intensity and hospitalizations for febrile neutropenia in patients with intermediate-grade non-Hodgkin’s lymphoma receiving initial CHOP chemotherapy: a risk factor analysis. Clin Lymphoma 2001;2(1):47-56
   PubMedGoogle Scholar
• 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;13(6):903-9
   PubMed Web of Science ®Google Scholar
• Aarts MJ, Peters FP, Mandigers CM, et al. Primary granulocyte colony-stimulating factor prophylaxis during the first two cycles only or throughout all chemotherapy cycles in patients with breast cancer at risk for febrile neutropenia. J Clin Oncol 2013;31(34):4290-6
   PubMed Web of Science ®Google Scholar
• Chrischilles E, Delgado DJ, Stolshek BS, et al. Impact of age and colony-stimulating factor use on hospital length of stay for febrile neutropenia in CHOP-treated non-Hodgkin’s lymphoma. Cancer Contr 2002;9(3):203-11
   PubMedGoogle Scholar
• Balducci L, Lyman GH. Patients aged > or = 70 are at high risk for neutropenic infection and should receive hemopoietic growth factors when treated with moderately toxic chemotherapy. J Clin Oncol 2001;19(5):1583-5
   PubMedGoogle Scholar
• Ozer H, Armitage JO, Bennett CL, et al. 2000 update of recommendations for the use of hematopoietic colony-stimulating factors: evidence-based, clinical practice guidelines. American Society of Clinical Oncology Growth Factors Expert Panel. J Clin Oncol 2000;18(20):3558-85
   PubMed Web of Science ®Google Scholar
• Lyman GH, Lyman CH, Agboola O. Risk models for predicting chemotherapy-induced neutropenia. Oncologist 2005;10(6):427-37
   PubMed Web of Science ®Google Scholar
• Lyman GH. Guidelines of the National Comprehensive Cancer Network on the use of myeloid growth factors with cancer chemotherapy: a review of the evidence. J Natl Compr Canc Netw 2005;3(4):557-71
   PubMedGoogle Scholar
• Aapro M, Crawford J, Kamioner D. Prophylaxis of chemotherapy-induced febrile neutropenia with granulocyte colony-stimulating factors: where are we now? Support Care Cancer 2010;18(5):529-41
   PubMedGoogle Scholar
• Welte K, Gabrilove J, Bronchud MH, et al. Filgrastim (r-metHuG-CSF): the first 10 years. Blood 1996;88(6):1907-29
   PubMed Web of Science ®Google Scholar
• Cooper KL, Madan J, Whyte S, et al. Granulocyte colony-stimulating factors for febrile neutropenia prophylaxis following chemotherapy: systematic review and meta-analysis. BMC Cancer 2011;11:404
   PubMed Web of Science ®Google Scholar
• Rossi L, Tomao F, Lo Russo G, et al. Efficacy and safety analysis of once per cycle pegfilgrastim and daily lenograstim in patients with breast cancer receiving adjuvant myelosuppressive chemotherapy FEC 100: a pilot study. Ther Clin Risk Manage 2013;2013(9):457-62
   Google Scholar
• Amadori S, Suciu S, Jehn U, et al. Use of glycosylated recombinant 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;106(1):27-34
   PubMed Web of Science ®Google Scholar
• 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 etoposide plus lenograstim in small-cell lung cancer in "extensive disease" stage. Am J Clin Oncol 2009;32(1):61-4
   PubMedGoogle Scholar
• Muhonen T, Jantunen I, Pertovaara H, et al. Prophylactic filgrastim (G-CSF) during mitomycin-C, mitoxantrone, and methotrexate (MMM) treatment for metastatic breast cancer. A randomized study. Am J Clin Oncol 1996;19(3):232-4
   PubMed Web of Science ®Google Scholar
• Sung L, Nathan PC, Alibhai SM, et al. Meta-analysis: effect of prophylactic hematopoietic colony-stimulating factors on mortality and outcomes of infection. Ann Intern Med 2007;147(6):400-11
   PubMed Web of Science ®Google Scholar
• Dubois RW, Pinto LA, Bernal M, Badamgarav E. Lyman GH benefits of GM-CSF versus placebo or G-CSF in reducing chemotherapy-induced complications: a systematic review of the literature. Support Cancer Ther 2004;2(1):34-41
   PubMedGoogle Scholar
• Banerjee SS, Aher N, Patil R, Khandare J. Poly(ethylene glycol)-Prodrug Conjugates: Concept, Design, and Applications. J Drug Deliv 2012;103973
   PubMedGoogle Scholar
• Yang BB, Kido A. Pharmacokinetics and pharmacodynamics of pegfilgrastim. Clin Pharmacokinet 2011;50(5):295-306
   PubMed Web of Science ®Google Scholar
• Agency. EM. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000825/WC500047793.pdf
   Google Scholar
• Grabowski H, Guha R, Salgado M. Biosimilar competition: lessons from Europe. Nat Rev Drug Discov 2014;13(2):99-100
   PubMed Web of Science ®Google Scholar
• Agency EM. Available from: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002556/WC500148382.pdf 2013
   Google Scholar
• Bondarenko I, Gladkov OA, Elaesser R, Buchner A. Bias PEfficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy. BMC Cancer 2013;13:386
   PubMed Web of Science ®Google Scholar
• Gascon P. Presently available biosimilars in hematology-oncology: G-CSF. Target Oncol 2012;7(Suppl 1):S29-34
   PubMedGoogle Scholar
• Khatcheressian JL, Wolff AC, Smith TJ, et al. American Society of Clinical Oncology 2006 update of the breast cancer follow-up and management guidelines in the adjuvant setting. J Clin Oncol 2006;24(31):5091-7
   PubMedGoogle Scholar
• 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;24(19):3187-205
   PubMed Web of Science ®Google Scholar
• NCCN. Clinical practice guidelines in oncology (NCCN Guidelines). Breast Cancer Version 1.2014. Available from: www.nccn.org [Last accessed on 22 April 2014]
   Google Scholar
• Aapro MS, Cameron DA, Pettengell R, et al. EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours. Eur J Cancer 2006;42(15):2433-53
   PubMed Web of Science ®Google Scholar
• Haim N, Shulman K, Goldberg H, Tsalic M. The safety of full-dose chemotherapy with secondary prophylactic granulocyte colony stimulating factor (G-CSF) following a prior cycle with febrile neutropenia. Med Oncol 2005;22(3):229-32
   PubMedGoogle Scholar
• Crawford J, Ozer H, Stoller R, et al. Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med 1991;325(3):164-70
   PubMed Web of Science ®Google Scholar
• Nicola NA, Begley CG, Metcalf D. Identification of the human analogue of a regulator that induces differentiation in murine leukaemic cells. Nature 1985;314(6012):625-8
   PubMedGoogle Scholar
• Nomura H, Imazeki I, Oheda M, et al. Purification and characterization of human granulocyte colony-stimulating factor (G-CSF). Embo J 1986;5(5):871-6
   PubMedGoogle Scholar
• Demetri GD, Griffin JD. Granulocyte colony-stimulating factor and its receptor. Blood 1991;78(11):2791-808
   PubMed Web of Science ®Google Scholar
• Bronchud MH, Scarffe JH, Thatcher N, et al. Phase I/II study of recombinant human granulocyte colony-stimulating factor in patients receiving intensive chemotherapy for small cell lung cancer. Br J Cancer 1987;56(6):809-13
   PubMedGoogle Scholar
• Rader M. Granulocyte colony-stimulating factor use in patients with chemotherapy-induced neutropenia: clinical and economic benefits. Oncology (Williston Park) 2006;20(Suppl 4):16-21
   PubMedGoogle Scholar
• Papaldo P, Lopez M, Marolla P, et al. Impact of five prophylactic filgrastim schedules on hematologic toxicity in early breast cancer patients treated with epirubicin and cyclophosphamide. J Clin Oncol 2005;23(28):6908-18
   PubMedGoogle Scholar
• Sourgens H, Lefrere F. A systematic review of available clinical evidence - filgrastim compared with lenograstim. Int J Clin Pharmacol Ther 2011;49(8):510-18
   PubMedGoogle Scholar
• 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;18(13):2522-8
   PubMed Web of Science ®Google Scholar
• 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;20(3):727-31
   PubMed Web of Science ®Google Scholar
• 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;14(1):29-35
   PubMed Web of Science ®Google Scholar
• 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;44(10):1691-6
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• 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;10(3):715-24
   PubMed Web of Science ®Google Scholar
• Brusamolino E, Rusconi C, Montalbetti L, et al. Dose-dense R-CHOP-14 supported by pegfilgrastim in patients with diffuse large B-cell lymphoma: a phase II study of feasibility and toxicity. Haematologica 2006;91(4):496-502
   PubMedGoogle Scholar
• Balducci L, Al-Halawani H, Charu V, et al. Elderly cancer patients receiving chemotherapy benefit from first-cycle pegfilgrastim. Oncologist 2007;12(12):1416-24
   PubMed Web of Science ®Google Scholar
• 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;21(3):514-19
   PubMed Web of Science ®Google Scholar
• 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;44(9):1503-8
   PubMed Web of Science ®Google Scholar
• Pinto L, Liu Z, Doan Q, et al. Comparison of pegfilgrastim with filgrastim on febrile neutropenia, grade IV neutropenia and bone pain: a meta-analysis of randomized controlled trials. Curr Med Res Opin 2007;23(9):2283-95
   PubMed Web of Science ®Google Scholar
• Lyman GH, Kuderer NM, Djulbegovic B. Prophylactic granulocyte colony-stimulating factor in patients receiving dose-intensive cancer chemotherapy: a meta-analysis. Am J Med 2002;112(5):406-11
   PubMed Web of Science ®Google Scholar
• Engert A, del Giglio A, Bias P, et al. Incidence of febrile neutropenia and myelotoxicity of chemotherapy: a meta-analysis of biosimilar G-CSF studies in breast cancer, lung cancer, and non-Hodgkin’s lymphoma. Onkologie 2009;32(10):599-604
   PubMedGoogle Scholar
• Gascon P, Fuhr U, Sorgel F, et al. Development of a new G-CSF product based on biosimilarity assessment. Ann Oncol 2010;21(7):1419-29
   PubMed Web of Science ®Google Scholar
• Skrlin A, Radic I, Vuletic M, et al. Comparison of the physicochemical properties of a biosimilar filgrastim with those of reference filgrastim. Biologicals 2010;38(5):557-66
   PubMed Web of Science ®Google Scholar
• Mahlert F SK, Allgaier H, Liu P, et al. Rational development of lipegfilgrastim, a novel long-acting granulocyte colony-stimulating factor, using glycopegylation technology. Blood 2013;122(21):abstract 4853
   Google Scholar
• Scheckermann C SK, Abdolzade-Bavil A, et al. Lipegfilgrastim: a long-acting, once-per-cycle, glycopegylated recombinant human filgrastim. J Clin Oncol 2013(Suppl 31):abstract e13548
   Google Scholar
• Gladkov OA BI, Elsaesser R, Buchner A, Bias P. Absolute neutrophil counts in a study of lipegfilgrastim compared with pegfilgrastim in patients with breast cancer who are receiving chemotherapy. Ann Oncol 2012;23:500
   Google Scholar
• Volovat C, Bondarenko IM, Gladkov OA, et al. Efficacy and safety of lipegfilgrastim in elderly patients with non-small-cell lung cancer receiving cisplatin/etoposide chemotherapy. Presented at 12th Meeting of the International Society of Geriatric Oncology. Manchester, United Kingdom, 25-27 October 2012
   Google Scholar
• Martin M, Segui MA, Anton A, et al. Adjuvant docetaxel for high-risk, node-negative breast cancer. N Engl J Med 2010;363(23):2200-10
   PubMed Web of Science ®Google Scholar
• Lal A, Bhurgri Y, Rizvi N, et al. Factors influencing in-hospital length of stay and mortality in cancer patients suffering from febrile neutropenia. Asian Pac J Cancer Prev 2008;9(2):303-8
   PubMedGoogle Scholar
• Cullen M, Baijal S. Prevention of febrile neutropenia: use of prophylactic antibiotics. Br J Cancer 2009;101(S1):11-14
   Google Scholar
• Coiffier B, Lepage E, Briere J, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med 2002;346(4):235-42
   PubMed Web of Science ®Google Scholar
• von der Maase H, Hansen SW, Roberts JT, et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 2000;18(17):3068-77
   PubMed Web of Science ®Google Scholar
• Patel SR, Vadhan-Raj S, Burgess MA, et al. Results of two consecutive trials of dose-intensive chemotherapy with doxorubicin and ifosfamide in patients with sarcomas. Am J Clin Oncol 1998;21(3):317-21
   PubMed Web of Science ®Google Scholar
• Van Cutsem E, Moiseyenko VM, Tjulandin S. Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: a report of the V325 Study Group. J Clin Oncol 2006;24(31):4991-7
   PubMed Web of Science ®Google Scholar