Pegfilgrastim after high-dose chemotherapy and autologous peripheral blood stem cell transplant: phase II study

被引:32
作者
Jagasia, MH
Greer, JP
Morgan, DS
Mineishi, S
Kassim, AA
Ruffner, KL
Chen, H
Schuening, FG
机构
[1] Vanderbilt Ingram Canc Ctr, Div Hematol Oncol, Nashville, TN USA
[2] Vanderbilt Ingram Canc Ctr, Dept Med, Dept Prevent Med, Nashville, TN USA
关键词
pegfilgrastim; autologous stem cell transplant; engraftment;
D O I
10.1038/sj.bmt.1704994
中图分类号
Q6 [生物物理学];
学科分类号
071011 ;
摘要
Pegfilgrastim is equivalent to daily filgrastim after standard dose chemotherapy in decreasing the duration of neutropenia. Daily filgrastim started within 1 - 4 days after autologous stem cell transplant ( ASCT) leads to significant decrease in time to neutrophil engraftment. We undertook a study of pegfilgrastim after high-dose chemotherapy (HDC) and ASCT. In all, 38 patients with multiple myeloma or lymphoma, eligible to undergo HDC and ASCT, were enrolled. Patients received a single dose of 6 mg pegfilgrastim subcutaneously 24 h after ASCT. There were no adverse events secondary to pegfilgrastim. All patients engrafted neutrophils and platelets with a median of 10 and 18 days, respectively. The incidence of febrile neutropenia was 49% (18/37). Neutrophil engraftment results were compared to a historical cohort of patients who received no growth factors or prophylactic filgrastim after ASCT. Time to neutrophil engraftment using pegfilgrastim was comparable to daily filgrastim and was shorter than in a historical group receiving no filgrastim ( 10 vs 13.7 days, P<0.001). Pegfilgrastim given as a single fixed dose of 6 mg appears to be safe after HDC and ASCT. It accelerates neutrophil engraftment comparable to daily filgrastim after ASCT. Pegfilgrastim may be convenient to use in outpatient transplant units.
引用
收藏
页码:1165 / 1169
页数:5
相关论文
共 11 条
[1]   REGIMEN-RELATED TOXICITY AND EARLY POSTTRANSPLANT SURVIVAL IN PATIENTS UNDERGOING MARROW TRANSPLANTATION FOR LYMPHOMA [J].
BEARMAN, SI ;
APPELBAUM, FR ;
BACK, A ;
PETERSEN, FB ;
BUCKNER, CD ;
SULLIVAN, KM ;
SCHOCH, HG ;
FISHER, LD ;
THOMAS, ED .
JOURNAL OF CLINICAL ONCOLOGY, 1989, 7 (09) :1288-1294
[2]   A randomized trial of granulocyte colony-stimulating factor (Neupogen) starting day 1 vs day 7 post-autologous stem cell transplantation [J].
Bence-Bruckler, I ;
Bredeson, C ;
Atkins, H ;
McDiarmid, S ;
Hamelin, L ;
Hopkins, H ;
Perry, G ;
Genest, P ;
Huebsch, L .
BONE MARROW TRANSPLANTATION, 1998, 22 (10) :965-969
[3]   FACTORS THAT INFLUENCE COLLECTION AND ENGRAFTMENT OF AUTOLOGOUS PERIPHERAL-BLOOD STEM-CELLS [J].
BENSINGER, W ;
APPELBAUM, F ;
ROWLEY, S ;
STORB, R ;
SANDERS, J ;
LILLEBY, K ;
GOOLEY, T ;
DEMIRER, T ;
SCHIFFMAN, K ;
WEAVER, C ;
CLIFT, R ;
CHAUNCEY, T ;
KLARNET, J ;
MONTGOMERY, P ;
PETERSDORF, S ;
WEIDEN, P ;
WITHERSPOON, R ;
BUCKNER, CD .
JOURNAL OF CLINICAL ONCOLOGY, 1995, 13 (10) :2547-2555
[4]   A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy [J].
Green, MD ;
Koelbl, H ;
Baselga, J ;
Galid, A ;
Guillem, V ;
Gascon, P ;
Siena, S ;
Lalisang, RI ;
Samonigg, H ;
Clemens, MR ;
Zani, V ;
Liang, BC ;
Renwick, J ;
Piccart, MJ .
ANNALS OF ONCOLOGY, 2003, 14 (01) :29-35
[5]   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 [J].
Holmes, FA ;
Jones, SE ;
O'Shaughnessy, J ;
Vukelja, S ;
George, T ;
Savin, M ;
Richards, D ;
Glaspy, J ;
Mesa, L ;
Cohen, G ;
Dhami, M ;
Budman, DR ;
Hackett, J ;
Brassard, M ;
Yang, BB ;
Liang, BC .
ANNALS OF ONCOLOGY, 2002, 13 (06) :903-909
[6]   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].
Holmes, FA ;
O'Shaughnessy, JA ;
Vukelja, S ;
Jones, SE ;
Shogan, J ;
Savin, M ;
Glaspy, J ;
Moore, M ;
Meza, L ;
Wiznitzer, I ;
Neumann, TA ;
Hill, LR ;
Liang, BC .
JOURNAL OF CLINICAL ONCOLOGY, 2002, 20 (03) :727-731
[7]   The design and development of pegfilgrastim (PEG-rmetHuG-CSF, neulasta®) [J].
Molineux, G .
CURRENT PHARMACEUTICAL DESIGN, 2004, 10 (11) :1235-1244
[8]   A new form of Filgrastim with sustained duration in vivo and enhanced ability to mobilize PBPC in both mice and humans [J].
Molineux, G ;
Kinstler, O ;
Briddell, B ;
Hartley, C ;
McElroy, P ;
Kerzic, P ;
Sutherland, W ;
Stoney, G ;
Kern, B ;
Fletcher, FA ;
Cohen, A ;
Korach, E ;
Ulich, T ;
McNiece, I ;
Lockbaum, P ;
Miller-Messana, MA ;
Gardner, S ;
Hunt, T ;
Schwab, G .
EXPERIMENTAL HEMATOLOGY, 1999, 27 (12) :1724-1734
[9]   Pegylation: Engineering improved biopharmaceuticals for oncology [J].
Molineux, G .
PHARMACOTHERAPY, 2003, 23 (08) :3S-8S
[10]  
SCHMITZ N, 1995, BONE MARROW TRANSPL, V15, P261