Comparison of EP2006, a filgrastim biosimilar, to the reference: A phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy

Annals of Oncology

Volumn 26, Issue 9, 2015, Pages 1948-1953

  Blackwell, Kimberly ^a   Semiglazov, V ^b   Krasnozhon, D ^c   Davidenko, I ^d   Nelyubina, L ^e   Nakov, R ^f   Stiegler, G ^f   Singh, P ^f   Schwebig, A ^f   Kramer, S ^f   Harbeck, N ^g  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b Railway Clinical Hospital of OJSC RZhD Non State Healthcare Institution (NSHI)   (Russian Federation)

^c Surgery Department 2   (Russian Federation)

^d Clinical Oncological Dispensary No 1 Healthcare Department of Krasnodar Territory State Healthcare Institution (SHI)   (Russian Federation)

^e INSTITUTE OF BIOMEDICAL CHEMISTRY   (Russian Federation)

^f Sandoz Biopharmaceuticals   (Germany)

^g UNIVERSITY OF MUNICH   (Germany)

Author keywords

Biosimilars; Filgrastim; Granulocyte colony stimulating factor; Neutropenia

Indexed keywords

CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; FILGRASTIM; ANTINEOPLASTIC AGENT; BIOSIMILAR AGENT; GRANULOCYTE COLONY STIMULATING FACTOR;

ADULT; AGED; ANEMIA; ARTICLE; BREAST CANCER; CONTROLLED STUDY; DIARRHEA; DISEASE DURATION; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERTENSION; IMMUNOGENICITY; INCIDENCE; INJECTION SITE REACTION; LEUKOPENIA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPHIL COUNT; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; ANALOGS AND DERIVATIVES; BREAST NEOPLASMS; CLINICAL TRIAL; COMPARATIVE STUDY; MIDDLE AGED; MULTICENTER STUDY; NEOADJUVANT THERAPY; NEUTROPENIA; YOUNG ADULT;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BIOSIMILAR PHARMACEUTICALS; BREAST NEOPLASMS; DOUBLE-BLIND METHOD; FEMALE; FILGRASTIM; GRANULOCYTE COLONY-STIMULATING FACTOR; HUMANS; MIDDLE AGED; NEOADJUVANT THERAPY; NEUTROPENIA; YOUNG ADULT;

EID: 84941636342     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdv281     Document Type: Article

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