Cited 480 times in
Multicenter phase II trial of Genexol-PM, a Cremophor-free, polymeric micelle formulation of paclitaxel, in patients with metastatic breast cancer
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 라선영 | - |
dc.contributor.author | 정현철 | - |
dc.date.accessioned | 2015-05-19T16:24:39Z | - |
dc.date.available | 2015-05-19T16:24:39Z | - |
dc.date.issued | 2008 | - |
dc.identifier.issn | 0167-6806 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/106255 | - |
dc.description.abstract | Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase II study was designed to evaluate the efficacy and safety of Genexol-PM in patients with histologically confirmed metastatic breast cancer (MBC). Forty-one women received Genexol-PM by intravenous infusion at 300 mg/m2 over 3 h every 3 weeks without premedication until disease progression or intolerability. A total of 331 chemotherapy cycles were administered, with a median of 8 cycles per patient (range, 1-16). Overall response rate was 58.5% (95% CI: 43.5-72.3) with 5 complete responses and 19 partial responses. Thirty-seven patients who received Genexol-PM as a first-line therapy for their metastatic disease showed a response rate of 59.5% (95% CI: 43.5-73.7), and two responses were reported in four patients treated in the second-line setting for their metastatic disease. The median time to progression (TTP) for all patients was 9.0 months (range, 1.0-17.0+ months). Grade 3 non-hematologic toxicities included sensory peripheral neuropathy (51.2%), and myalgia (2.4%). Eight patients (19.5%) experienced hypersensitivity reactions, with grade 3 in two patients. Hematologic toxicities were grade 3 and 4 neutropenia (51.2 and 17.1%, respectively), and grade 1 and 2 thrombocytopenia (22.0%). Notably, no febrile neutropenia was observed. Genexol-PM appears a promising new paclitaxel in view of significant efficacies. Further trials with different dosing schedules, durations of delivery, or in combination with other drugs are warranted. | - |
dc.description.statementOfResponsibility | open | - |
dc.format.extent | 241~250 | - |
dc.relation.isPartOf | BREAST CANCER RESEARCH AND TREATMENT | - |
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 Agents, Phytogenic/administration & dosage | - |
dc.subject.MESH | Antineoplastic Agents, Phytogenic/adverse effects | - |
dc.subject.MESH | Antineoplastic Agents, Phytogenic/chemistry | - |
dc.subject.MESH | Antineoplastic Agents, Phytogenic/therapeutic use* | - |
dc.subject.MESH | Breast Neoplasms/drug therapy* | - |
dc.subject.MESH | Breast Neoplasms/mortality | - |
dc.subject.MESH | Breast Neoplasms/pathology | - |
dc.subject.MESH | Chemistry, Pharmaceutical | - |
dc.subject.MESH | Drug Administration Schedule | - |
dc.subject.MESH | Drug Carriers* | - |
dc.subject.MESH | Drug Compounding | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Infusions, Intravenous | - |
dc.subject.MESH | Kaplan-Meier Estimate | - |
dc.subject.MESH | Korea | - |
dc.subject.MESH | Micelles* | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Neoplasm Metastasis | - |
dc.subject.MESH | Paclitaxel/administration & dosage | - |
dc.subject.MESH | Paclitaxel/adverse effects | - |
dc.subject.MESH | Paclitaxel/chemistry | - |
dc.subject.MESH | Paclitaxel/therapeutic use* | - |
dc.subject.MESH | Polyethylene Glycols/chemistry | - |
dc.subject.MESH | Polymers/chemistry* | - |
dc.subject.MESH | Time Factors | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Multicenter phase II trial of Genexol-PM, a Cremophor-free, polymeric micelle formulation of paclitaxel, in patients with metastatic breast cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학) | - |
dc.contributor.googleauthor | Keun Seok Lee | - |
dc.contributor.googleauthor | Hyun Cheol Chung | - |
dc.contributor.googleauthor | Seock Ah Im | - |
dc.contributor.googleauthor | Yeon Hee Park | - |
dc.contributor.googleauthor | Chul Soo Kim | - |
dc.contributor.googleauthor | Sung-Bae Kim | - |
dc.contributor.googleauthor | Sun Young Rha | - |
dc.contributor.googleauthor | Min Young Lee | - |
dc.contributor.googleauthor | Jungsil Ro | - |
dc.identifier.doi | 10.1007/s10549-007-9591-y | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A03773 | - |
dc.contributor.localId | A01316 | - |
dc.relation.journalcode | J00403 | - |
dc.identifier.eissn | 1573-7217 | - |
dc.identifier.pmid | 17476588 | - |
dc.identifier.url | http://link.springer.com/article/10.1007/s10549-007-9591-y | - |
dc.subject.keyword | Breast cancer | - |
dc.subject.keyword | Clinical trial | - |
dc.subject.keyword | Genexol-PM | - |
dc.subject.keyword | Phase II | - |
dc.contributor.alternativeName | Rha, Sun Young | - |
dc.contributor.alternativeName | Chung, Hyun Cheol | - |
dc.contributor.affiliatedAuthor | Chung, Hyun Cheol | - |
dc.contributor.affiliatedAuthor | Rha, Sun Young | - |
dc.rights.accessRights | not free | - |
dc.citation.volume | 108 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 241 | - |
dc.citation.endPage | 250 | - |
dc.identifier.bibliographicCitation | BREAST CANCER RESEARCH AND TREATMENT, Vol.108(2) : 241-250, 2008 | - |
dc.identifier.rimsid | 56313 | - |
dc.type.rims | ART | - |
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