XM02 is superior to placebo and equivalent to Neupogen™ in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy

BMC Cancer

Volumn 8, Issue , 2008, Pages

  del Giglio, Auro ^a,b   Eniu, Alexandru ^c   Ganea Motan, Doina ^d   Topuzov, Eskender ^e   Lubenau, Heinz ^f  

^a FACULDADE DE MEDICINA DO ABC   (Brazil)

^b HOSPITAL ISRAELITA ALBERT EINSTEIN   (Brazil)

^c THE ONCOLOGY INSTITUTE PROF DR ION CHIRICUTA   (Romania)

^d Spitalul Judetean de Urgenta   (Romania)

^e NORTH WESTERN STATE MEDICAL UNIVERSITY NAMED AFTER I I MECHNIKOV   (Russian Federation)

^f BioGeneriX AG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

DOCETAXEL; DOXORUBICIN; PLACEBO; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; UNCLASSIFIED DRUG; XM 02; ANTINEOPLASTIC AGENT; TAXOID;

ADULT; AGED; ALOPECIA; ARTICLE; ASTHENIA; BOLUS INJECTION; BONE PAIN; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CARDIOPULMONARY INSUFFICIENCY; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE DURATION; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG FATALITY; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERGLYCEMIA; INCIDENCE; LUNG INFARCTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; RANDOMIZED CONTROLLED TRIAL; SEPSIS; SIDE EFFECT; SYNCOPE; THROMBOCYTOPENIA; ANALYSIS OF VARIANCE; BREAST TUMOR; CANCER STAGING; CHEMICALLY INDUCED DISORDER; DOUBLE BLIND PROCEDURE; DRUG EFFECT; MIDDLE AGED; NEUTROPHIL; PATHOLOGY; PHASE 3 CLINICAL TRIAL; TREATMENT OUTCOME;

ADULT; AGED; ANALYSIS OF VARIANCE; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; BREAST NEOPLASMS, MALE; DOUBLE-BLIND METHOD; DOXORUBICIN; FEMALE; FILGRASTIM; HUMANS; MALE; MIDDLE AGED; NEOPLASM STAGING; NEUTROPENIA; NEUTROPHILS; TAXOIDS; TREATMENT OUTCOME;

EID: 60549103774     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-8-332     Document Type: Article

References (11)

1. 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):727-31 10.1200/JCO.20.3.727 11821454
2. Smith TJ Khatcheressian J Lyman GH et al American Society of Clinical Oncology. 2006 update of recommendations for the use of white blood cell growth factors: An evidence-based, clinical practice guideline J Clin Oncol 2006, 24(19):3187-205 10.1200/JCO.2006.06.4451 16682719
3. Aapro MS Cameron DA Pettengell R et al 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(15):2433-53 10.1016/ j.ejca.2006.05.002 16750358
4. Dale DC Colony-stimulating factors for the management of neutropenia in cancer patients Drugs 2002, 62(Suppl 1):1-15 10.2165/ 00003495-200262001-00001 12479591
5. Martin-Christin F Granulocyte colony stimulating factors: How different are they? How to make a decision? Anti-cancer Drugs 2001, 12:185-91 10.1097/00001813-200103000-00002 11290864
6. Lubenau H Bias P Maly AK et al Pharmacokinetic and Pharmacodynamic Profile of New Biosimilar Filgrastim XM02 Equivalent to Marketed Filgrastim Neupogen®: Single-blind, Randomised, Cross-over Trial BioDrugs
7. Timmer-Bonte JN de Boo TM Smit HJ et al Prevention of chemotherapy-induced febrile neutropenia by prophylactic antibiotics plus or minus granulocyte colony-stimulating factor in small-cell lung cancer: A Dutch randomized Phase III study J Clin Oncol 2005, 23(3):7974-84 10.1200/JCO.2004.00.7955 16258098
8. Brain EGC Bachelot T Serin D et al Life-threatening sepsis associated with adjuvant doxorubicin plus docetaxel for intermediate-risk breast cancer JAMA 2005, 293:2367-71 10.1001/jama.293.19.2367 15900007
9. 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, 23:1178-84 10.1200/JCO.2005.09.102 15718314
10. 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):164-70 1711156
11. Lilienfeld-Toal M Hahn-Ast C Kirchner H et al A randomized comparison of immediate versus delayed application of G-CSF in induction therapy for patients with acute myeloid leukemia unfit for intensive chemotherapy Haematologica 2007 92 12 1719 1720 10.3324/haematol.11516 18056004