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

被引:436
作者
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
机构
[1] PA, Houston, TX 77024 USA
[2] Oncol Hematol Assoc, Pittsburgh, PA USA
[3] Univ Calif Los Angeles, Med Ctr, Los Angeles, CA 90024 USA
[4] Amgen Inc, Thousand Oaks, CA 91320 USA
[5] Georgia Canc Specialists, Decatur, GA USA
[6] SW Oncol Associates, Lafayette, LA USA
[7] Midwest Canc Res Grp, Northfield, IL USA
关键词
D O I
10.1200/JCO.20.3.727
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: This multicenter, randomized, double-blind, active-control study was designed to determine whether a single subcutaneous injection of pegfilgrastim (SD/01, sustained-duration filgrastim; 100 mug/kg) is as safe and effective as daily filgrastim (5 mug/kg/cl) for reducing neutropenia in patients who received four cycles of myelosuppressive chemotherapy. Patients and Methods: Sixty-two centers enrolled 310 patients who received chemotherapy with docetaxel 75 mg/m(2) and doxorubicin 60 mg/m(2) on day I of each cycle for a maximum of four cycles. Patients were randomized to receive on day 2 either a single subcutaneous injection of pegfilgrastim 100 ug/kg per chemotherapy cycle (154 patients) or daily subcutaneous injections of filgrastim 5 mug/kg/d (156 patients). Absolute neutrophil count (ANC), duration of grade 4 neutropenia, and safety parameters were monitored. Results: One dose of pegfilgrastim per chemotherapy cycle was comparable to daily subcutaneous injections of filgrastim with regard to all efficacy end points, including the duration of severe neutropenia and the depth of ANC nadir in all cycles. Febrile neutropenia across all cycles occurred less often in patients who received pegfilgrastim. The difference in the mean duration of severe neutropenia between the pegfilgrastim and filgrastim treatment groups was less than I day. Pegfilgrastim was safe and well tolerated, and it was similar to filgrastim. Adverse event profiles in the pegfilgrastim and filgrastim groups were similar. Conclusion: A single injection of pegfilgrastim 100 mug/kg per cycle was as safe and effective as daily injections of filgrastim 5 mug/kg/d in reducing neutropenia and its complications in patients who received four cycles of doxorubicin 60 mg/m(2) and docetaxel 75 mg/m(2). (C) 2002 by American Society of Clinical Oncology.
引用
收藏
页码:727 / 731
页数:5
相关论文
共 12 条
  • [1] QUANTITATIVE RELATIONSHIPS BETWEEN CIRCULATING LEUKOCYTES AND INFECTION IN PATIENTS WITH ACUTE LEUKEMIA
    BODEY, GP
    BUCKLEY, M
    SATHE, YS
    FREIREICH, EJ
    [J]. ANNALS OF INTERNAL MEDICINE, 1966, 64 (02) : 328 - +
  • [2] PHASE-I/II STUDY OF RECOMBINANT HUMAN GRANULOCYTE COLONY-STIMULATING FACTOR IN PATIENTS RECEIVING INTENSIVE CHEMOTHERAPY FOR SMALL CELL LUNG-CANCER
    BRONCHUD, MH
    SCARFFE, JH
    THATCHER, N
    CROWTHER, D
    SOUZA, LM
    ALTON, NK
    TESTA, NG
    DEXTER, TM
    [J]. BRITISH JOURNAL OF CANCER, 1987, 56 (06) : 809 - 813
  • [3] REDUCTION BY GRANULOCYTE COLONY-STIMULATING FACTOR OF FEVER AND NEUTROPENIA INDUCED BY CHEMOTHERAPY IN PATIENTS WITH SMALL-CELL LUNG-CANCER
    CRAWFORD, J
    OZER, H
    STOLLER, R
    JOHNSON, D
    LYMAN, G
    TABBARA, I
    KRIS, M
    GROUS, J
    PICOZZI, V
    RAUSCH, G
    SMITH, R
    GRADISHAR, W
    YAHANDA, A
    VINCENT, M
    STEWART, M
    GLASPY, J
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 1991, 325 (03) : 164 - 170
  • [4] EFFECT OF GRANULOCYTE COLONY-STIMULATING FACTOR ON NEUTROPENIA AND ASSOCIATED MORBIDITY DUE TO CHEMOTHERAPY FOR TRANSITIONAL-CELL CARCINOMA OF THE UROTHELIUM
    GABRILOVE, JL
    JAKUBOWSKI, A
    SCHER, H
    STERNBERG, C
    WONG, G
    GROUS, J
    YAGODA, A
    FAIN, K
    MOORE, MAS
    CLARKSON, B
    OETTGEN, HF
    ALTON, K
    WELTE, K
    SOUZA, L
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 1988, 318 (22) : 1414 - 1422
  • [5] Randomized, dose-escalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy
    Johnston, E
    Crawford, J
    Blackwell, S
    Bjurstrom, T
    Lockbaum, P
    Roskos, L
    Yang, BB
    Gardner, S
    Miller-Messana, MA
    Shoemaker, D
    Garst, J
    Schwab, G
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2000, 18 (13) : 2522 - 2528
  • [6] A new form of Filgrastim with sustained duration in vivo and enhanced ability to mobilize PBPC in both mice and humans
    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
    [J]. EXPERIMENTAL HEMATOLOGY, 1999, 27 (12) : 1724 - 1734
  • [7] EFFECT OF GRANULOCYTE COLONY STIMULATING FACTOR ON NEUTROPENIA INDUCED BY CYTO-TOXIC CHEMOTHERAPY
    MORSTYN, G
    SOUZA, LM
    KEECH, J
    SHERIDAN, W
    CAMPBELL, L
    ALTON, NK
    GREEN, M
    METCALF, D
    FOX, R
    [J]. LANCET, 1988, 1 (8587) : 667 - 672
  • [8] SHERIDAN WP, 1989, LANCET, V2, P891
  • [9] Modeling the cost-effectiveness of granulocyte colony-stimulating factor use in early-stage breast cancer
    Silber, JH
    Fridman, M
    Shpilsky, A
    Even-Shoshan, O
    Smink, DS
    Jayaraman, J
    Fox, KR
    Pauly, MV
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 1998, 16 (07) : 2435 - 2444
  • [10] Phase II trial of doxorubicin and paclitaxel plus granulocyte colony-stimulating factor in metastatic breast cancer: An eastern cooperative oncology group study
    Sparano, JA
    Hu, P
    Rao, RM
    Falkson, CI
    Wolff, AC
    Wood, WC
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 1999, 17 (12) : 3828 - 3834