Cited 23 times in
A randomized, multi-center, open-label, phase II study of once-per-cycle DA-3031, a biosimilar pegylated G-CSF, compared with daily filgrastim in patients receiving TAC chemotherapy for early-stage breast cancer
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 손주혁 | - |
dc.contributor.author | 이수현 | - |
dc.date.accessioned | 2014-12-18T10:02:58Z | - |
dc.date.available | 2014-12-18T10:02:58Z | - |
dc.date.issued | 2013 | - |
dc.identifier.issn | 0167-6997 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/89317 | - |
dc.description.abstract | BACKGROUNDS: A pegylated form of recombinant granulocyte-colony stimulating factor (G-CSF) was developed for prophylactic use in breast cancer. The aim of this study was to evaluate the efficacy and safety of once-per-cycle DA-3031 in patients receiving chemotherapy for breast cancer. METHODS: A total of 61 patients receiving docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy were randomized in cycle 1 to receive daily injections of filgrastim (100 μg/m(2)) or a single subcutaneous injection of pegylated filgrastim DA-3031 at a dose of either 3.6 mg or 6 mg. RESULTS: The mean duration of grade 4 neutropenia in cycle 1 was comparable among the treatment groups (2.48, 2.20, and 2.05 days for filgrastim, DA-3031 3.6 mg and 6 mg, respectively; P=0.275). No statistically significant differences were observed in the incidence of febrile neutropenia between the treatment groups (9.5 %, 15.0 %, and 5.0 % for filgrastim, DA-3031 3.6 mg and 6 mg, respectively; P=0.681) in cycle 1. The incidences of adverse events attributable to G-CSF were similar among the treatment groups. CONCLUSIONS: Fixed doses of 3.6 mg or 6 mg DA-3031 have an efficacy comparable to that of daily injections of filgrastim in ameliorating grade 4 neutropenia in patients receiving TAC chemotherapy. | - |
dc.description.statementOfResponsibility | open | - |
dc.relation.isPartOf | INVESTIGATIONAL NEW DRUGS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols/adverse effects | - |
dc.subject.MESH | Biosimilar Pharmaceuticals/administration & dosage* | - |
dc.subject.MESH | Biosimilar Pharmaceuticals/adverse effects | - |
dc.subject.MESH | Breast Neoplasms/blood | - |
dc.subject.MESH | Breast Neoplasms/drug therapy* | - |
dc.subject.MESH | Cyclophosphamide/administration & dosage | - |
dc.subject.MESH | Doxorubicin/administration & dosage | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Filgrastim | - |
dc.subject.MESH | Granulocyte Colony-Stimulating Factor/administration & dosage* | - |
dc.subject.MESH | Granulocyte Colony-Stimulating Factor/adverse effects | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Leukocyte Count | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Neutropenia/blood | - |
dc.subject.MESH | Neutropenia/chemically induced | - |
dc.subject.MESH | Neutropenia/drug therapy* | - |
dc.subject.MESH | Polyethylene Glycols/administration & dosage* | - |
dc.subject.MESH | Polyethylene Glycols/adverse effects | - |
dc.subject.MESH | Recombinant Proteins/administration & dosage | - |
dc.subject.MESH | Recombinant Proteins/adverse effects | - |
dc.subject.MESH | Taxoids/administration & dosage | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | A randomized, multi-center, open-label, phase II study of once-per-cycle DA-3031, a biosimilar pegylated G-CSF, compared with daily filgrastim in patients receiving TAC chemotherapy for early-stage breast cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학) | - |
dc.contributor.googleauthor | K. H. Park | - |
dc.contributor.googleauthor | J. H. Sohn | - |
dc.contributor.googleauthor | S. Lee | - |
dc.contributor.googleauthor | J. H. Park | - |
dc.contributor.googleauthor | S. Y. Kang | - |
dc.contributor.googleauthor | H. Y. Kim | - |
dc.contributor.googleauthor | I. H. Park | - |
dc.contributor.googleauthor | Y. H. Park | - |
dc.contributor.googleauthor | Y. H. Im | - |
dc.contributor.googleauthor | H. J. Lee | - |
dc.contributor.googleauthor | D. S. Hong | - |
dc.contributor.googleauthor | S. Park | - |
dc.contributor.googleauthor | S. H. Shin | - |
dc.contributor.googleauthor | H. C. Kwon | - |
dc.contributor.googleauthor | J. H. Seo | - |
dc.identifier.doi | 10.1007/s10637-013-9973-4 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A01995 | - |
dc.contributor.localId | A02898 | - |
dc.relation.journalcode | J01184 | - |
dc.identifier.eissn | 1573-0646 | - |
dc.identifier.pmid | 23677653 | - |
dc.identifier.url | http://link.springer.com/article/10.1007%2Fs10637-013-9973-4 | - |
dc.subject.keyword | Breast cancer | - |
dc.subject.keyword | Neutropenia | - |
dc.subject.keyword | Pegylated G-CSF | - |
dc.subject.keyword | TAC chemotherapy | - |
dc.contributor.alternativeName | Sohn, Joo Hyuk | - |
dc.contributor.alternativeName | Lee, Soo Hyeon | - |
dc.contributor.affiliatedAuthor | Sohn, Joo Hyuk | - |
dc.contributor.affiliatedAuthor | Lee, Soo Hyeon | - |
dc.rights.accessRights | not free | - |
dc.citation.volume | 31 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 1300 | - |
dc.citation.endPage | 1306 | - |
dc.identifier.bibliographicCitation | INVESTIGATIONAL NEW DRUGS, Vol.31(5) : 1300-1306, 2013 | - |
dc.identifier.rimsid | 34530 | - |
dc.type.rims | ART | - |
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