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 |
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dc.contributor.author | Park, K. H. | - |
dc.contributor.author | Sohn, J. H. | - |
dc.contributor.author | Lee, S. | - |
dc.contributor.author | Park, J. H. | - |
dc.contributor.author | Kang, S. Y. | - |
dc.contributor.author | Kim, H. Y. | - |
dc.contributor.author | Park, I. H. | - |
dc.contributor.author | Park, Y. H. | - |
dc.contributor.author | Im, Y. H. | - |
dc.contributor.author | Lee, H. J. | - |
dc.contributor.author | Hong, D. S. | - |
dc.contributor.author | Park, S. | - |
dc.contributor.author | Shin, S. H. | - |
dc.contributor.author | Kwon, H. C. | - |
dc.contributor.author | Seo, J. H. | - |
dc.date.accessioned | 2021-09-05T20:49:54Z | - |
dc.date.available | 2021-09-05T20:49:54Z | - |
dc.date.created | 2021-06-15 | - |
dc.date.issued | 2013-10 | - |
dc.identifier.issn | 0167-6997 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/102058 | - |
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 mu g/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.language | English | - |
dc.language.iso | en | - |
dc.publisher | SPRINGER | - |
dc.subject | ADJUVANT TREATMENT | - |
dc.subject | DOSE INTENSITY | - |
dc.subject | TRIAL | - |
dc.subject | PEGFILGRASTIM | - |
dc.subject | COMBINATION | - |
dc.subject | CONCOMITANT | - |
dc.subject | EPIRUBICIN | - |
dc.subject | DENSE | - |
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.affiliatedAuthor | Park, K. H. | - |
dc.contributor.affiliatedAuthor | Seo, J. H. | - |
dc.identifier.doi | 10.1007/s10637-013-9973-4 | - |
dc.identifier.scopusid | 2-s2.0-84884813602 | - |
dc.identifier.wosid | 000324272100024 | - |
dc.identifier.bibliographicCitation | INVESTIGATIONAL NEW DRUGS, v.31, no.5, pp.1300 - 1306 | - |
dc.relation.isPartOf | INVESTIGATIONAL NEW DRUGS | - |
dc.citation.title | INVESTIGATIONAL NEW DRUGS | - |
dc.citation.volume | 31 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 1300 | - |
dc.citation.endPage | 1306 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.subject.keywordPlus | ADJUVANT TREATMENT | - |
dc.subject.keywordPlus | DOSE INTENSITY | - |
dc.subject.keywordPlus | TRIAL | - |
dc.subject.keywordPlus | PEGFILGRASTIM | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | CONCOMITANT | - |
dc.subject.keywordPlus | EPIRUBICIN | - |
dc.subject.keywordPlus | DENSE | - |
dc.subject.keywordAuthor | Breast cancer | - |
dc.subject.keywordAuthor | Neutropenia | - |
dc.subject.keywordAuthor | Pegylated G-CSF | - |
dc.subject.keywordAuthor | TAC chemotherapy | - |
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