Abstract
To evaluate the safety and efficacy of pegfilgrastim administered as haematological support after autologous peripheral blood stem cell transplantation, we compared 44 patients with solid tumours and lymphomas receiving a 6-mg single dose of pegfilgrastim on day +5 after transplantation to a historical control group of 25 patients receiving filgrastim 5 μg kg−1 day−1 starting on day +5. There were no significant differences in haematological recovery nor in the incidence and duration of neutropenic fever. Median duration of grade 4 neutropenia in the pegfilgrastim and filgrastim group was similar. The incidence of grade III–IV mucositis was lower in pegfilgrastim than in filgrastim group due to the significant difference observed among the patients with solid tumours (p = 0.00). The only adverse event considered to be cytokine related was mild to moderate bone pain occurring during haematological recovery. According to the present study design and taking into account the current prices in our institution, the cost of the two drugs was similar in both treatment groups. In conclusion, a single injection of pegfilgrastim administered at day +5 post-transplantation shows comparable safety and efficacy profiles to daily injections of filgrastim and may be cost effective.
Similar content being viewed by others
References
Child JA, Morgan GJ, Davies FE et al (2003) High-dose chemotherapy with haematopoietic stem-cell rescue for multiple myeloma. N Engl J Med 348:1875–1883
Villanueva ML, Vose JM (2006) The role of hematopoietic stem cell transplantation in non-Hodgkin lymphoma. Clin Adv Hematol Oncol 4:521–530
Hiddemann W, Buske C, Dreyling M et al (2005) Treatment strategies in follicular lymphomas: current status and future perspectives. J Clin Oncol 23:6394–6399
Connors JM (2005) State-of-the-art therapeutics: Hodgkin’s lymphoma. J Clin Oncol 23:6400–6408
Rodenhuis S, Bontenbal M, Beex LVAM et al (2003) High-dose chemotherapy with hematopoietic stem-cell rescue for high-risk breast cancer. N Engl J Med 349:7–16
Nitz UA, Mohrmann S, Fischer J et al (2005) Comparison of rapidly cycled tandem high-dose chemotherapy plus peripheral-blood stem-cell support versus dose-dense conventional chemotherapy for adjuvant treatment of high-risk breast cancer: results of a multicentre phase III trial (for the West German Study Group). Lancet 366:1935–1944
Farquhar C, Marjoribanks J, Basser R, Hetrick S, Lethaby A (2005) High dose chemotherapy and autologous bone marrow or stem cell transplantation versus conventional chemotherapy for women with metastatic breast cancer. Cochrane Database Syst Rev 3:CD003142
Kirk JL Jr, Greenfield RA, Slease RB, Epstein RB (1988) Analysis of early infectious complications after autologous bone marrow transplantation. Cancer 62:2445–2450
Toor AA, van Burik JA, Weisdorf DJ (2001) Infections during mobilizing chemotherapy and following autologous stem cell transplantation. Bone Marrow Transplant 28:1129–1134
Klumpp TR, Goldberg SL, Mangan KF (1995) Granulocyte colony-stimulating factor accelerates neutrophil engraftment following peripheral-blood stem-cell transplantation: a prospective, randomized trial. J Clin Oncol 13:1323–1327
Hornedo J, Sola C, Solano C et al (2002) The role of granulocyte colony stimulating factor (G-CSF) in the post-transplant period (SOLTI Group). Bone Marrow Transplant 29:737–743
Welte K, Gabrilove J, Bronchud MH, Platzer E, Morstyn G (1996) filgrastim (r-metHuG-CSF): the first 10 years. Blood 88:1907–1929
Lord BI, Woolford LB, Molineux G (2001) 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 7:2085–2090
Molineux G (2004) The design and development of pegfilgrastim (PEG-rmetHuG-CSF). Curr Pharm Des 10:1235–1244
Molineux G, Kinstler O, Briddell B et al (1999) A new form of filgrastim with sustained duration in vivo and enhanced ability to mobilize PBPC in both mice and humans. Exp Hematol 27:1724–1734
Holmes FA, Jones SE, O’Shaughnessy J et al (2002) Comparable efficacy and safety profile 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 13:903–909
Holmes FA, O’Shaughnessy JA, Vukelja S et al (2002) 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 20:727–731
Vose JM, Crump M, Lazarus H et al (2003) Randomized, multicenter, open-label study of filgrastim compared with daily filgrastim after chemotherapy for lymphoma. J Clin Oncol 21:514–519
Steidl U, Fenk R, Bruns I et al (2005) 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 35:33–36
George S, Yunus F, Case D et al (2003) Fixed dose pegfilgrastim is safe and allows neutrophil recovery in patients with non-Hodgkin’s lymphoma. Leuk Lymphoma 44:1691–1996
Younes A, Fayad L, Romaguera J, Pro B, Goy A, Wang M (2006) Safety and efficacy of once-per-cycle pegfilgrastim in support of ABVD chemotherapy in patients with Hodgkin lymphoma. Eur J Cancer 42:2976–2981
Jagasia MH, Greer JP, Morgan DS et al (2005) Pegfilgrastim after high-dose chemotherapy and autologous peripheral blood stem cell transplant: phase II study. Bone Marrow Tranplant 35:1165–1169
Staber PB, Holub R, Linkesch W, Schmidt H, Neumeister P (2005) Fixed dose single administration of pegfilgrastim vs daily filgrastim in patients with haematological malignancies undergoing autologous peripheral blood stem cell transplantation. Bone Marrow Transplant 35:889–893
Musto P, Scalzulli PR, Melillo L et al (2004) Peg-filgrastim after autologous peripheral blood stem cell transplantation in haematological malignancies. Blood 104:Abst 5200
Vanstraelen G, Frère P, Ngirabacu MC, Willems E, Fillet G, Beguin Y (2006) Pegfilgrastim compared with filgrastim after autologous haematopoietic peripheral blood stem cell transplantation. Exp Hematol 34:382–388
Martino M, Praticò G, Messina G et al (2006) Pegfilgrastim compared with filgrastim after high-dose melphalan and autologous hematopoietic peripheral blood stem cell transplantation in multiple myeloma patients. Eur J Haematol 77:410–415
Patrone F, Ballestrero A, Ferrando F et al (1995) Four step high-dose sequential chemotherapy with double hematopoietic progenitor-cell rescue for metastatic breast cancer. J Clin Oncol 13:840–846
Gianni A, Bonadonna G (2001) Five-year results of the randomized clinical trial comparing standard versus high-dose myeloablative chemotherapy in the adjuvant treatment of breast cancer with >3 positive nodes (LN+). In: Grunberg SM (ed) Proceedings of the 37th annual meeting of the American Society of Clinical Oncology. San Francisco, CA, USA, Abstr 80
Zander AR, Kröger N, Schmoor C et al (2004) High-dose chemotherapy with autologous hematopoietic stem-cell support compared with standard-dose chemotherapy in breast cancer patients with 10 or more positive lymph nodes: first results of a randomized trial. J Clin Oncol 22:2273–2283
Vaena DA, Abonour R, Einhorn L (2003) Long-term survival after high-dose salvage chemotherapy for germ cell malignancies with adverse prognostic variables. J Clin Oncol 21:4100–4104
Chopra R, McMillan AK, Linch DC et al (1993) The place of high-dose BEAM therapy and autologous bone marrow transplantation in poor risk Hodgkin’s disease. A single-center eight-year study of 155 patients. Blood 81:1137–1145
Stewart DA, Bahlis N, Valentine K et al (2006) Upfront double high dose chemotherapy with DICEP followed by BEAM and autologous stem cell transplantation for poor prognosis aggressive non-Hodgkin lymphoma. Blood 107:4623–4627
Wang EH, Chen YA, Corringham S et al (2004) High-dose CEB vs BEAM with autologous stem cell transplant in lymphoma. Bone Marrow Transplant 34:581–587
Yang BB, Lum PK, Hayashi MM, Roskos LK (2004) Polyethylene glycol modification of filgrastim results in decreased renal clearance of the protein in rats. J Pharm Sci 93:1367–1373
Layton JE, Hockman H, Sheridan WP, Morstyn G (1989) Evidence for a novel in vivo control mechanism of granulopoiesis: mature cell-related control of a regulatory growth factor. Blood 74:1303–1307
Kuwabara T, Kobayashi S, Sugiyama Y (1996) Pharmacokinetics and pharmacodynamics of a recombinant human granulocyte colony-stimulating factor. Drug Metab Rev 28:625–658
Delgado C, Francis G, Fisher D (1992) The uses and properties of PEG-linked proteins. Crit Rev Ther Drug Carrier Syst 9:249–304
Ng R, Green MD (2005) Pegfilgrastim: evidence in support of its use with cytotoxic chemotherapy. Expert Rev Anticancer Ther 5:585–590
Johnston E, Crawford J, Blackwell S et al (2000) Randomized, dose-escalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy. J Clin Oncol 18:2522–2528
Vogel CL, Wojtukiewicz MZ, Carroll RR et al (2005) 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 23:1178–1184
Livi L, Paiar F, Santini R et al (2006) Alternating intravenous and oral vinorelbine plus epirubicin with pegfilgrastim as neoadjuvant treatment of locally advanced breast cancer. Anti-Cancer Drugs 17:1081–1085
Isidori A, Tani M, Bonifazi F et al (2005) 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 90:225–231
Nosari A, Cairoli R, Ciapanna D et al (2006) Efficacy of single dose pegfilgrastim in enhancing the mobilization of CD34+ peripheral blood stem cells in aggressive lymphoma patients treated with cisplatin–aracytin-containing regimens. Bone Marrow Tranplant 38:413–416
Hosing C, Qazilbash MH, Kebriaei P et al (2006) Fixed-dose single agent pegfilgrastim for peripheral blood progenitor cell mobilisation in patients with multiple myeloma. Br J Haematol 133:533–537
Fenk R, Hieronimus N, Steidl U et al (2006) Sustained G-CSF plasma levels following administration of pegfilgrastim fasten neutrophil reconstitution after high-dose chemotherapy and autologous blood stem cell transplantation in patients with multiple myeloma. Exp Hematol 34:1296–1302
Author information
Authors and Affiliations
Corresponding author
Additional information
Alberto Ballestrero and Davide Boy contributed equally to this article.
Rights and permissions
About this article
Cite this article
Ballestrero, A., Boy, D., Gonella, R. et al. Pegfilgrastim compared with filgrastim after autologous peripheral blood stem cell transplantation in patients with solid tumours and lymphomas. Ann Hematol 87, 49–55 (2008). https://doi.org/10.1007/s00277-007-0366-7
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00277-007-0366-7