Document Detail

An open-label multicenter safety, tolerability, and efficacy study of recombinant granulocyte colony-stimulating factor in the prevention of neutropenic complications in breast cancer patients.
MedLine Citation:
PMID:  22123557     Owner:  NLM     Status:  MEDLINE    
MATERIAL AND METHODS: A total of 50 patients who were treated with a maximum of 6 cycles of either docetaxel-doxorubicin (36 patients) or docetaxel alone (14 patients) every 21 days were recruited from 3 centers in Lithuania. All the patients received study medication rG-CSF at a dosage of 5 μg/kg per day (Sicor Biotech UAB, Teva Group) from day 2 of each cycle and continued for minimum 5 days or until absolute neutrophil count reached ≥1.5×10(9)/L.
RESULTS: A total of 611 adverse events were reported. Most of them were related to myelotoxic chemotherapy. Two patients withdrew due to adverse events (neuropathy and bone pain). One patient died possibly because of pulmonary thromboembolism. The most frequently reported adverse events related to study drug in the docetaxel-doxorubicin and docetaxel groups were leukocytosis (22% and 21%, respectively), bone pain (19% and 21%, respectively), and headache (8% and 14%, respectively). The incidence of grade 4 neutropenia in both the groups was 47% and 29%, respectively, in all cycles and 42% and 21%, respectively, in cycle 1. The incidence of febrile neutropenia was 8% in cycle 1 and 14% across all cycles. The mean duration of febrile neutropenia was 2.1 days (SD, 1.9) in cycle 1 and 2.14 days (SD 2.0) across all cycles in both the treatment groups.
CONCLUSION: This study provide data that the study drug rG-CSF has the expected safety and could be an efficacious medication to decrease the risk of febrile neutropenia and related complications of myelosuppressive chemotherapy in patients with metastatic breast cancer.
Audrius Sveikata; Sigita Liutkauskienė; Elona Juozaitytė; Dainius Characiejus; Laimutė Tamošaitytė; Kastytis Šeštakauskas
Related Documents :
17671537 - Glutathione s-transferase gstm1 and gstt1 polymorphisms in adult acute myeloid leukemia...
18696067 - A limited number of 5-azacitidine cycles can be effective treatment in mds.
8202047 - Therapy-related acute myeloid leukemia following treatment with epipodophyllotoxins: es...
20087177 - Induction therapy in acute myeloid leukemia: intensifying and targeting the approach.
12057157 - Malignant pleural mesothelioma.
17205387 - Successful neoadjuvant synchronous chemo- and radiotherapy for disseminated primary int...
Publication Detail:
Type:  Clinical Trial, Phase IV; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't     Date:  2011-11-18
Journal Detail:
Title:  Medicina (Kaunas, Lithuania)     Volume:  47     ISSN:  1648-9144     ISO Abbreviation:  Medicina (Kaunas)     Publication Date:  2011  
Date Detail:
Created Date:  2011-12-20     Completed Date:  2012-02-24     Revised Date:  2013-05-28    
Medline Journal Info:
Nlm Unique ID:  9425208     Medline TA:  Medicina (Kaunas)     Country:  Lithuania    
Other Details:
Languages:  eng     Pagination:  428-33     Citation Subset:  IM    
Institute of Physiology and Pharmacology, Medical Academy, Lithuanian University of Health Science, A. Mickevičiaus 9, 44307 Kaunas, Lithuania.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Antineoplastic Combined Chemotherapy Protocols
Breast Neoplasms / drug therapy*
Doxorubicin / therapeutic use
Fever / prevention & control
Granulocyte Colony-Stimulating Factor / adverse effects,  therapeutic use*
Middle Aged
Neutropenia / prevention & control*
Recombinant Proteins / adverse effects,  therapeutic use*
Taxoids / therapeutic use
Treatment Outcome
Reg. No./Substance:
0/Recombinant Proteins; 0/Taxoids; 143011-72-7/Granulocyte Colony-Stimulating Factor; 15H5577CQD/docetaxel; 23214-92-8/Doxorubicin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document:  Assessment of Reliability in Isokinetic Testing Among Adolescent Basketball Players.
Next Document:  Risk Factors for Erosive Esophagitis and Barrett's Esophagus in a high Helicobacter Pylori Prevalenc...