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Drug Evaluation

Pegfilgrastim: a granulocyte colony-stimulating factor with sustained duration of action

Pages 1635-1646 | Published online: 30 Nov 2005

Bibliography

  • BODEY GP, BUCKLEY M, SATHE YS, FREIREICH EJ: Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia. Ann. Intern. Med. (1966) 64(2):328–340.
  • MEZA L, BASELGA J, HOLMES FA, LIANG B, BREDDY J: Incidence of febrile neutropenia (FN) is directly related to duration of severe neutropenia (DSN) after myelosuppressive chemotherapy. Proc. Am. Soc. Clin. Oncol. (2002) 21:255b. Abstract 2840.
  • LYMAN GH, KUDERER NM: Epidemiology of febrile neutropenia. Supp. Cancer Ther. (2003) 1:23–35.
  • LYMAN GH, KUDERER NM: The economics of the colony-stimulating factors for the prevention and treatment of febrile neutropenia. Crit. Rev. Oncol. Hematol. (2004) 50:129–146.
  • LYMAN GH, MORRISON VA, DALE DC, CRAWFORD J, DELGADO DJ, FRIDMAN M: Risk of febrile neutropenia among patients with intermediate-grade non-Hodgkin's lymphoma receiving CHOP chemotherapy. OPPS Working Group; ANC Study Group. Leuk. Lymphoma (2003) 44:2069–2076.
  • LYMAN GH, DELGADO D: Risk and timing of hospitalization for febrile neutropenia in patients receiving CHOP, CHOP-R, or CNOP chemotherapy for intermediate-grade non-Hodgkin's lymphoma. Cancer (2003) 98:2402–2409.
  • LINK BK, BUDD GT, SCOTT S et al.: Delivering adjuvant chemotherapy to women with early-stage breast carcinoma: current patterns of care. Cancer (2001) 92(6):1354–1367.
  • CRAWFORD J, DALE D, LYMAN GH: Chemotherapy-induced neutropenia: risks, consequences, and new directions for its management. Cancer (2004) 100:228–237.
  • BUDMAN DR, BERRY DA, CIRRINCIONE CT et al.: Dose and dose intensity as determinants of outcome in the adjuvant treatment of breast cancer. The Cancer and Leukemia Group B. J. Nail. Cancer Inst. (1998) 90(161:1205–1211.
  • BONNETERRE J, ROCHE H, KERBRAT P et al.: Epirubicin increases long-term survival in adjuvant chemotherapy of patients with poor-prognosis, node-positive, early breast cancer: 10-year follow-up results of the French Adjuvant Study Group 05 randomized trial. J. Clin. Oncol. (2005) 23(12):2686–2693.
  • BONADONNA G, VALAGUSSA P, MOLITERNI A. ZAMBETTI M, BRAMBILLA C: Adjuvant cyclophosphamide, methotrexate, and fluorouracil in nodepositive breast cancer: the results of 20 years of follow-up. N Engl. J. Med. (1995) 332:901–906.
  • KWAK LW, HALPERN J, OLSHEN RA, HORNING SJ: Prognostic significance of actual dose intensity in diffuse large-cell lymphoma: results of a tree-structured survival analysis. J. Clin. Oncol (1990) 8(6):963–977.
  • EPELBAUM R, FARAGGI D, BEN ARIE Yet al.: Survival of diffuse large cell lymphoma. A multivariate analysis including dose intensity variables. Cancer (1990) 66(6):1124–1129.
  • LEPAGE E, GISSELBRECHT C, HAIOUN C et al.: Prognostic significance of received relative dose intensity in nonHHodgkin's lymphoma patients: application to LNH-87 protocol. The GELA. (Groupe d'Etude des Lymphomes de l'Adulte). Ann. Oncol (1993) 4(8):651–656.
  • LYMAN GH, DALE DC, CRAWFORD J: Incidence and predictors of low dose-intensity in adjuvant breast cancer chemotherapy: a nationwide study of community practices. J. Clin. Oncol (2003) 21(24):4524–4531.
  • LYMAN GH, DALE DC, FRIEDBERG J, CRAWFORD J, FISHER RI: Incidence and predictors of low chemotherapy dose-intensity in aggressive non-Hodgkin's lymphoma: a nationwide study./ Clin. Oncol (2004) 22(21):4302–4311.
  • GRIGGS JJ, SORBERO ME, LYMAN GH: Systematic undertreatment of overweight and obese women receiving chemotherapy for breast cancer. Arch. Int. Med. (2005) 165(11):1267–1273.
  • KOMROKJI RS, LYMAN GH: The colony-stimulating factors: use to prevent and treat neutropenia and its complications. Expert Opin. Biol. Ther. (2004) 4(12):1897–1910.
  • 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):406–411.
  • 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):164–170.
  • TRILLET-LENOIR V GREEN J, MANEGOLD C et al.: Recombinant granulocyte colony stimulating factor reduces the infectious complications of cytotoxic chemotherapy. Eur. J. Cancer (1993) 29A(3):319–324.
  • AMGEN, INC.: Neupogen (Filgrastim) prescribing information. Amgen, Thousand Oaks, CA, USA (2002).
  • MOLINEUX G: The design and development of pegfilgrastim (PEG-rmetHuG-CSF, Neulasta). Curr. Pharm. Des. (2004) 10(11):1235–1244.
  • HAITHCOX S, RAMNES R, LEE H et al.: The impact of frequent injections for hematopoietic growth factor support on patients receiving chemotherapy: an observational study. BMC Nurs. (2003) 2:2.
  • LYMAN GH, KUDERER NM: Filgrastim in patients with neutropenia: potential effects on quality of life. Drugs (2002) 62\(Suppl. 1):65–78.
  • FORTNER By, OKON TA, ZHU L et al.: Costs of human resources in delivering cancer chemotherapy and managing chemotherapy-induced neutropenia in community practice. Commun. Oncol (2004) 1:23–28.
  • AMGEN, INC.: Neulasta (pegfilgrastim) prescribing information. Amgen, Thousand Oaks, CA, USA (2005).
  • JOHNSTON E, CRAWFORD J, BLACKWELL S et al.: Randomized, dose-escalation study of SD/ 01 compared with daily filgrastim in patients receiving chemotherapy./ Clin. Oncol (2000) 18(13):2522–2528.
  • MOLINEUX G, KINSTLER O, BRIDDELL B et al.: A new form of filgrastim with sustained duration in vivo and enhanced ability to mobilize PBPC in both mice and humans. Exp. Hematol (1999) 27(12):1724–1734.
  • 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):727–731.
  • KOTTO-KOME AC, FOX SE, LU W, YANG BB, CHRISTENSEND RD, CALHOUN DA: Evidence that the granulocyte colony-stimulating factor (G-CSF) receptor plays a role in the pharmacokinetics of G-CSF and PegG-CSF using a G-CSF-R KO model. PharmacoL Res. (2004) 50(1):55–58.
  • YANG BB, LUM PK, HAYASHI MM, ROSKOS LK: Polyethylene glycol modification of filgrastim results in decreased renal clearance of the protein in rats. J. Pharm. Sci. (2004) 93(5):1367–1373.
  • GRIGG A, SOLAL-CELIGNY P, HOSKIN P et al.: Open-label, randomized study of pegfilgrastim versus daily filgrastim as an adjunct to chemotherapy in elderly patients with non-Hodgkin's lymphoma. Leuk. Lymphoma (2003) 44(9):1503–1508.
  • 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):514–519.
  • GEORGE S, YUNUS F, CASED et al.: Fixed-dose pegfilgrastim is safe and allows neutrophil recovery in patients with non-Hodgkin's lymphoma. Leuk. Lymphoma (2003) 44(10):1691–1696.
  • 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):903–909.
  • 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.
  • YANG B-B, LUMP, RENWICK J et aL: Pharmacokinetic rationale for a fixed-dose regimen of a sustained-duration form of filgrastim in cancer patients. Blood (2000) 96(11):157b. Abstract 4384.
  • MISSET JL, DIERAS V, GRUIA G et al.: Dose-finding study of docetaxel and doxorubicin in first-line treatment of patients with metastatic breast cancer. Ann. OncoL (1999) 10(5):553–560.
  • SIENA S, PICCART MJ, HOLMES FA, GLASPY J, HACKETT J, RENWICK JJ: 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):715–724.
  • 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) 3(6):391–398.
  • 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(0:1178–1184.
  • CHAN S, FRIEDRICHS K, NOEL D et aL: Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J. Clin. OncoL (1999) 17(8):2341–2354.
  • BEAR HD, ANDERSON S, BROWN A et aL: The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J. Clin. OncoL (2003) 21(22):4165–4174.
  • KUNDERER NM, CRAWFORD J, DALE DC, LYMAN GH: Meta-analysis of prophylactic granulocyte colony-stimulating factor (G-CSF) in cancer patients receiving chemotherapy. J. Clin. OncoL (2005) 23:758s.
  • LYMAN GH, KUDERER NM: Economicsof hematopoietic growth factors in hematopoietic growth factors in oncology: In: Basic Science and Clinical Therapeutics. Morstyn G, M Foote M, Lieschke GJ (Eds), Humana Press Inc, Totowa, New Jersey, USA (2004):409–443.
  • COSLER LE, SIVASUBRAMANIAIVI V, AGBOOLA O, CRAWFORD J, DALE D, LYMAN GH: Effect of outpatient treatment of febrile neutropenia on the risk threshold for the use of CSF in patients with cancer treated with chemotherapy. Value Health (2005) 8:47–52.
  • NATIONAL COMPREHENSIVE CANCER NETWORK: NCCN Clinical Practice Guidelines in Oncology: Myeloid Growth Factors in Cancer Treatment. Version 1.2005. 17 February (2005).
  • LYMAN GH: Guidelines of the NationalComprehensive Cancer Network on the use of myeloid growth factors with cancer chemotherapy: a review of the evidence. J. NatL Comp. Cancer Network (2005) 3:557–571.
  • US FOOD AND DRUG ADMINISTRATION (FDA): Pegfilgrastim approval letter. January 31(2002).
  • CITRON ML, BERRY DA, CIRRINCIONE C et al.: Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup trial C9741/Cancer and Leukemia Group B trial 9741 [erratum in J. Clin. OncoL (2003) 21(10:2226]. J. Clin. OncoL (2003) 21(8):1431–1439.
  • PFREUNDSCHUH M, TRUMPER L, KLOESS M et al.: Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of elderly patients with aggressive lymphomas: results of the NHL-B2 trial of the DSHNHL. Blood (2004) 104(3):634–641.
  • YANG B-B, HILL RL, HOLLIFELD AM et al.: Pegfilgrastim serum concentrations on the twelfth day after dosing are unlikely to stimulate granulopoiesis: a retrospective analysis of 6 clinical trials in a variety of cancer populations. Blood (2003) 102(11):524a. Abstract 1918.
  • BENTLEY M, MARLTON P, HOVARTH N et al.: Single dose per cycle pegfilgrastim successfully supports full dose intensity CHOP-14 in patients over 60 years with non-Hodgkin's lymphoma (NHL) and successfully mobilises peripheral blood progenitor cells (PBPC). Blood (2003) 102(11):636a. Abstract 2348.
  • MOORE TD, PATEL T, SEGAL ML et aL:A single pegfilgrastim dose per cycle supports dose-dense (q14d) CHOP-R in patients with non-Hodgkin's lymphoma. Blood (2003) 102(11):641a. Abstract 2365.
  • YOUNES A, FAYAD L, ROMAGUERA J, PRO B, DANG N, WANG M: A single administration of a fixed dose pegfilgrastim (Neulasta) in inducing neutrophil count recovery after 170 consecutive doses of ABVD chemotherapy in patients with Hodgkin lymphoma: safety of pegfilgrastim with q14-day chemotherapy regimens. Blood (2003) 102(10:637a. Abstract 2352.
  • ENGERT A, DOEHNER H, HO AD et al.: Pegfilgrastim supports delivery of BEACOPP chemotherapy administered every 14 days. Blood (2004) 104(10:370a-371a. Abstract 1316.
  • BURSTEIN HJ, PARKER LM, KESHAVIAH A et al.: Efficacy of pegfilgrastim and darbepoetin alfa as hematopoietic support for dose-dense every-2-week adjuvant breast cancer chemotherapy. J. Clin. OncoL (2005). 23(33):8340–8347.
  • SCHNEEWEISS A. RUDLOWSKI C, SINN H-P, BELDERMANN F, VON FOURNIER D, BASTERT G: Dose dense gemcitabine/epirubicin (GE) followed sequentially by dose dense docetaxel (Doc) as primary systemic therapy (PST) of patients (pts) with early breast cancer (BC): first results of a Phase I/II trial. Proc. Am. Soc. Clin. Oncol. (2004) 23:60. Abstract 734.
  • PIRKER R, ULSPERGER E, AIGNER K, MESSNER J: A Phase II study of pegfilgrastim to support ACE 14 chemotherapy for the treatment of subjects with small cell lung cancer (SCLC; extensive disease). Proc. Am. Soc. Clin. OncoL (2004) 23:667. Abstract 7216.
  • LOPEZ k FERNANDEZ DE SEVILLA A,CASTAIGNE S: Pegfilgrastim supports delivery of CHOP-R chemotherapy administered every 14 days: a randomised Phase II study. Blood (2004) 104:904a-905a. Abstract 3311.
  • ANDERLINI P, CHAMPLIN R: Use of filgrastim for stem cell mobilisation and transplantation in high-dose cancer 1645 chemotherapy. Drugs (2002) 62\(Supp1.1):79–88.
  • TAKEYAMA K, OHTO H: PBSC mobilization. Transfus. Apheresis Sci. (2004) 31(3):233–243.
  • ISIDORINS 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 pretreated lymphoma patients. Haematologica (2005) 90(2):225–231.
  • STEIDL U, FENK R, BRUNS 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(1):33–36.
  • KROSCHINSKY F, HOLIG K, PLATZBECKER U et al.: Pegfilgrastim is able to mobilize autologous CD34+ peripheral blood progenitor cells in patients with lymphoid malignancies and solid tumors. Bone Marrow Transplant. (2004) 33:S79-S79. Abstract P408.
  • MANDANAS RA, UNDERWOOD BJ, GEISTER BV SMITH JW: Pegfilgrastim (Neulasta) following chemotherapy leads to successful mobilization of hematopoietic progenitor cells among transplant patients with various diagnoses. Biol. Blood Marrow Transplant. (2004) 10(2):14. Abstract 21.
  • NOGA SJ, OROSZLAN M, ZHANG YL et al.: Single dose pegfilgrastim successfully mobilizes optimal numbers of autologous CD34* cells for peripheral blood stem cell collection. Blood (2002) 100(11):826a. Abstract 3262.
  • NOGA S, OROSZLAN M, HETHERINGTON J et al.: Use of pegfilgrastim for autologous peripheral blood stem cell mobilization: comparison to a daily filgrastim regimen. Bone Marrow Transplant. (2003) 31:S18–S18.
  • STABER PB, HOLUB R, LINKESCH W, SCHMIDT H, NEUMEISTER P: Fixed-dose single administration of pegfilgrastim versus daily filgrastim in patients with haematological malignancies undergoing autologous peripheral blood stem cell transplantation. Bone Marrow Transplant. (2005) 35(9):889–893.
  • SUNG L, NATHAN PC, LANGE B, BEYENE J, BUCHANAN GR: Prophylactic granulocyte colony-stimulating factor and granulocyte-macrophage colony-stimulating factor decrease febrile neutropenia after chemotherapy in children with cancer: a meta-analysis of randomized controlled trials. J. Clin. Oncol. (2004) 22(10:3350–3356.
  • SPUNT SL, SENDER L, SANTANA VM: Pegfilgrastim in pediatric patients with sarcoma receiving intensive chemotherapy. Pediatr. Res. (2003) 53(4):Abstract 1656.
  • KOONTZ SE, MOHASSEL LR, JAFFE N et al.: Safety and efficacy of pegfilgrastim in pediatric oncology patients: the M.D. Anderson Cancer Center experience. Proc. Am. Soc. Clin. Oncol. (2004) 23:792. Abstract 8272.
  • BOSI A, SZER J, KASSIS J, SIERRA J, DESBOROUGH C, BUCHANAN K: A multicentre, double-blind, randomized, Phase II trial comparing pegfilgrastim with filgrastim as an adjunct to chemotherapy for acute myeloid leukaemia (AML). Blood (2004) 104(11):247a. Abstract 866.
  • RANZE OP, ARLAND M, HOEFFKES H-G: Comparison of pegfilgrastim versus lenograstim in the treatment of chemotherapy-induced neutropenia in adult patients with acute myelogenous leukemia. Proc. Am. Soc. Clin. Oncol. (2004) 23:597. Abstract 6669.
  • KUDERER NM, CRAWFORD J, DALE DC, LYMAN GH: Meta-analysis of prophylactic granulocyte colony-stimulating factor (G-CSF) in cancer patients receiving chemotherapy. Proc. Am. Soc. Clin. Oncol. (2005) 23(165):758s. Abstract 8117.
  • COSLER LE, ELDAR-LISSAI A, DALE DC, CRAWFORD J, LYMAN GH: Economic analysis of pegfilgrastim in patients receiving cancer chemotherapy. Proc. Am. Soc. Clin. Oncol. (2005) 23(165):538s. Abstract 6041.
  • LYMAN GH, CRAWFORD J, WOLFF DA, CULAKOVA E, PONIEWIERSKI MS, DALE DC: A risk model for first cycle febrile neutropenia in cancer patients receiving systemic chemotherapy. ANC Study Group. Proc. Am. Soc. Clin. Oncol. (2005) 23(165):759s. Abstract 8122.

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