A single dose of pegfilgrastim compared with daily filgrastim for supporting neutrophil recovery in patients treated for low-to-intermediate risk acute myeloid leukemia: Results from a randomized, double-blind, phase 2 trial

BMC Cancer

Volumn 8, Issue , 2008, Pages

  Sierra, Jorge ^a   Szer, Jeffrey ^b   Kassis, Jeannine ^c   Herrmann, Richard ^d   Lazzarino, Mario ^e   Thomas, Xavier ^f   Noga, Stephen J ^g   Baker, Nigel ^h   Dansey, Roger ⁱ   Bosi, Alberto ^j  

^a HOSPITAL DE LA SANTA CREU I SANT PAU   (Spain)

^b ROYAL MELBOURNE HOSPITAL   (Australia)

^c MAISONNEUVE ROSEMONT HOSPITAL   (Canada)

^d ROYAL PERTH HOSPITAL   (Australia)

^e UNIVERSITY OF PAVIA   (Italy)

^f EDOUARD HERRIOT HOSPITAL   (France)

^g Alvin and Lois Lapidus Cancer Institute   (United States)

^h AMGEN LTD   (United Kingdom)

ⁱ AMGEN INC   (United States)

^j UNIVERSITY OF FLORENCE   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CYTARABINE; IDARUBICIN; PLACEBO; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; ANTINEOPLASTIC AGENT;

ACUTE GRANULOCYTIC LEUKEMIA; ADULT; ARTICLE; BONE PAIN; CANCER CHEMOTHERAPY; CANCER RISK; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOGENETICS; DISEASE DURATION; DOSAGE SCHEDULE COMPARISON; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG MEGADOSE; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HUMAN; LEUKEMIA REMISSION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEUTROPENIA; NEUTROPHIL; PHASE 2 CLINICAL TRIAL; PURPURA; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RISK ASSESSMENT; SINGLE DRUG DOSE; AGED; BLOOD; CHEMICALLY INDUCED DISORDER; COMPARATIVE STUDY; CONVALESCENCE; DRUG EFFECT; IMMUNOLOGY; MIDDLE AGED; PATHOLOGY; PATHOPHYSIOLOGY; REMISSION;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYTARABINE; DOUBLE-BLIND METHOD; FEMALE; FILGRASTIM; HUMANS; IDARUBICIN; LEUKEMIA, MYELOID, ACUTE; MALE; MIDDLE AGED; NEUTROPENIA; NEUTROPHILS; RECOVERY OF FUNCTION; REMISSION INDUCTION;

EID: 48449100628     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-8-195     Document Type: Article

References (29)

1. Grimwade D Walker H Harrison G Oliver F Chatters S Harrison CJ Wheatley K Burnett AK Goldstone AH Medical Research Council Adult Leukaemia Working Party The predictive value of hierarchical cytogenetic classification in older adults with acute myeloid leukemia (AML): analysis of 1065 patients entered into the United Kingdom Medical Research Council AML11 trial Blood 2001, 98:1312-1320 10.1182/ blood.V98.5.1312 11520776
2. Jabbour EJ Estey E Kantarjian HM Adult acute myeloid leukemia Mayo Clin Proc 2006, 81:247-260 16471082
3. Lowenberg B Downing JR Burnett A Acute myeloid leukemia N Engl J Med 1999, 341:1051-1062 10.1056/NEJM199909303411407 10502596
4. Heil G Hoelzer D Sanz MA Lechner K Liu Yin JA Papa G Noens L Szer J Ganser A O'Brien C Matcham J Barge A A randomized, double-blind, placebo-controlled, phase III study of filgrastim in remission induction and consolidation therapy for adults with de novo acute myeloid leukemia. The International Acute Myeloid Leukemia Study Group Blood 1997, 90:4710-4718 9389686
5. Godwin JE Kopecky KJ Head DR Willman CL Leith CP Hynes HE Balcerzak SP Appelbaum FR A double-blind placebo-controlled trial of granulocyte colony-stimulating factor in elderly patients with previously untreated acute myeloid leukemia: A Southwest Oncology Group study (9031) Blood 1998, 91:3607-3615 9572995
6. Bodey GP Buckley M Sathe YS Freireich EJ Quantitative relationships between circulating leukocytes and infection in patients with acute leukemia Ann Intern Med 1966, 64:328-340 5216294
7. 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, 112:406-411 10.1016/ S0002-9343(02)01036-7 11904116
8. Smith TJ Khatcheressian J Lyman GH Ozer H Armitage JO Balducci L Bennett CL Cantor SB Crawford J Cross SJ Demetri G Desch CE Pizzo PA Schiffer CA Schwartzberg L Somerfeld MR Somlo G Wade JC Wade JL Winn RJ Wozniak AJ Wolff AC 2006 Update of recommendations for the use of white blood cell growth factors: An evidence-based clinical practice guideline J Clin Oncol 2006, 24:3187-3205 10.1200/JCO.2006.06.4451 16682719
9. Aapro MS Cameron DA Pettengell R Bohlius J Crawford J Ellis M Kearney N Lyman G Tjan-Heijnan VC Walewski J Weber DC Zielinski C 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, 42:2433-2453 10.1016/ j.ejca.2006.05.002 16750358
10. Harousseau JL Witz B Lioure B Hunault-Berger M Desablens B Delain M Guilhot F Le Prise PY Abgrall JF Deconinck E Guyotat D Vilque JP Casassus P Tournilhac O Audhuy B Solary E Granulocyte colony-stimulating factor after intensive consolidation chemotherapy in acute myeloid leukemia: Results of a randomized trial of the Groupe Ouest-Est Leucemies Aigues Myeloblastiques J Clin Oncol 2000, 18:780-787 10673519
11. Molineux G The design and development of pegfilgrastim (PEG-rmetHuG-CSF, Neulasta) Curr Pharm Des 2004, 10:1235-1244 10.2174/1381612043452613 15078138
12. Vogel CL Wojtukiewicz MZ Carroll RR Tjulandin SA Barajas-Figueroa LJ Wiens BL Neumann TA Schwartzberg LS 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, 23:1178-1184 10.1200/JCO.2005.09.102 15718314
13. 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 International Pegfilgrastim 749 Study Group 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, 14:29-35 10.1093/annonc/ mdg019 12488289
14. 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 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, 20:727-731 10.1200/JCO.20.3.727 11821454
15. Younes A Fayad L Romaguera J Pro B Goy A Wang M Safety and efficacy of once-per-cycle pegfilgrastim in support of ABVD chemotherapy in patients with Hodgkin lymphoma Eur J Cancer 2006, 42:2976-2981 10.1016/ j.ejca.2006.07.012 17008093
16. Wolf M Bentley M Marlton P Horvath N Lewis ID Spencer A Herrmann R Arthur C Durrant S van Kerkhoven M MacMillan J Mrongovius R Pegfilgrastim to support CHOP-14 in elderly patients with non-Hodgkin's lymphoma Leuk Lymphoma 2006, 47:2344-2350 10.1080/10428190600881017 17107908
17. Lopez A Fernandez de Sevilla A Castaigne S Greil R Sierra J Sanchez J Easton V Bacon P Pegfilgrastim Supports Delivery of CHOP-R Chemotherapy Administered Every 14 Days: A Randomised Phase II Study Blood 2004, 104:3311
18. Byrd JC Mrozek K Dodge RK Carroll AJ Edwards CG Arthur DC Pettenati MJ Patil SR Rao KW Watson MS Koduru PR Moore JO Stone RM Mayer RJ Feldman EJ Davey FR Schiffer CA Larson RA Bloomfield CD Pretreatment cytogenetic abnormalities are predictive of induction success, cumulative incidence of relapse, and overall survival in adult patients with de novo acute myeloid leukemia: Results from Cancer and Leukemia Group B (CALGB 8461) Blood 2002, 100:4325-4336 10.1182/blood-2002-03-0772 12393746
19. Grimwade D Walker H Oliver F Wheatley K Harrison C Harrison G Rees J Hann I Stevens R Burnett A Goldstone A The importance of diagnostic cytogenetics on outcome in AML: Analysis of 1,612 patients entered into the MRC AML 10 trial Blood 1998, 92:2322-2333 9746770
20. Cheson BD Cassileth PA Head DR Schiffer CA Bennett JM Bloomfield CD Brunning R Gale RP Grever MR Keating MJ Report of the National Cancer Institute-sponsored workshop on definitions of diagnosis and response in acute myeloid leukemia J Clin Oncol 1990, 8:813-819 2185339
21. Yang BB Kido A Shibata A Serum pegfilgrastim concentrations during recovery of absolute neutrophil counts in patients with cancer receiving pegfilgrastim after chemotherapy Pharmacotherapy 2007, 27:1387-1393 10.1592/phco.27.10.1387 17896894
22. Hansen OP Pedersen-Bjergaard J Ellegaard J Brincker H Boesen AM Christensen BE Drivsholm A Hippe E Jans H Jensen KB Aclarubicin plus cytosine arabinoside versus daunorubicin plus cytosine arabinoside in previously untreated patients with acute myeloid leukemia: A Danish national phase III trial. The Danish Society of Hematology Study Group on AML Leukemia 1991, 5:510-516 2056774
23. Wiernik PH Banks PL Case DC Jr Arlin ZA Periman PO Todd MB Ritch PS Enck RE Weitberg AB Cytarabine plus idarubicin or daunorubicin as induction and consolidation therapy for previously untreated adult patients with acute myeloid leukemia Blood 1992, 79:313-319 1730080
24. Arlin Z Case DC Jr Moore J Wiernik P Feldman E Saletan S Desai P Sia L Cartwright K Randomized multicenter trial of cytosine arabinoside with mitoxantrone or daunorubicin in previously untreated adult patients with acute nonlymphocytic leukemia (ANLL). Lederle Cooperative Group Leukemia 1990, 4:177-183 2179638
25. Berman E Arlin ZA Gaynor J Miller W Gee T Kempin SJ Mertelsmann R Andreeff M Reich L Nahmias N Comparative trial of cytarabine and thioguanine in combination with amsacrine or daunorubicin in patients with untreated acute nonlymphocytic leukemia: Results of the L-16M protocol Leukemia 1989, 3:115-121 2911205
26. Terpstra W Lowenberg B Application of myeloid growth factors in the treatment of acute myeloid leukemia Leukemia 1997, 11:315-327 10.1038/ sj.leu.2400561 9067569
27. Buchner T Hiddemann W Wormann B Zuhlsdorf M Rottmann R Innig G Maschmeier G Ludwig WD Sauerland MC Heinecke A Hematopoietic growth factors in acute myeloid leukemia: Supportive and priming effects Semin Oncol 1997, 24:124-131 9045298
28. Rowe JM Liesveld JL Hematopoietic growth factors in acute leukemia Leukemia 1997, 11:328-341 10.1038/sj.leu.2400592 9067570
29. Heil G Hoelzer D Sanz MA Lechner K Noens L Szer J Ganser A Matcham J Renwick J International Acute Myeloid Leukemia Study Group Long-term survival data from a phase 3 study of filgrastim as an adjunct to chemotherapy in adults with de novo acute myeloid leukemia Leukemia 2006, 20:404-409 10.1038/sj.leu.2404090 16424872