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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 | Lee, Keun Seok | - |
dc.contributor.author | Chung, Hyun Cheol | - |
dc.contributor.author | Im, Seock Ah | - |
dc.contributor.author | Park, Yeon Hee | - |
dc.contributor.author | Kim, Chul Soo | - |
dc.contributor.author | Kim, Sung-Bae | - |
dc.contributor.author | Rha, Sun Young | - |
dc.contributor.author | Lee, Min Young | - |
dc.contributor.author | Ro, Jungsil | - |
dc.date.accessioned | 2009-12-31 | - |
dc.date.available | 2009-12-31 | - |
dc.date.created | 2021-11-23 | - |
dc.date.created | 2021-11-23 | - |
dc.date.issued | 2008-03 | - |
dc.identifier.citation | Breast Cancer Research and Treatment, Vol.108 No.2, pp.241-250 | - |
dc.identifier.issn | 0167-6806 | - |
dc.identifier.other | 148331 | - |
dc.identifier.uri | https://hdl.handle.net/10371/23795 | - |
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/m(2) 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.language | 영어 | - |
dc.language.iso | en | en |
dc.publisher | Kluwer Academic Publishers | - |
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.AlternativeAuthor | 임석아 | - |
dc.identifier.doi | 10.1007/s10549-007-9591-y | - |
dc.citation.journaltitle | Breast Cancer Research and Treatment | - |
dc.identifier.wosid | 000253524500009 | - |
dc.identifier.scopusid | 2-s2.0-39749178252 | - |
dc.citation.endpage | 250 | - |
dc.citation.number | 2 | - |
dc.citation.startpage | 241 | - |
dc.citation.volume | 108 | - |
dc.identifier.sci | 000253524500009 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Im, Seock Ah | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | ALBUMIN-BOUND PACLITAXEL | - |
dc.subject.keywordPlus | PERIPHERAL NEUROPATHY | - |
dc.subject.keywordPlus | RANDOMIZED-TRIAL | - |
dc.subject.keywordPlus | DOSE PACLITAXEL | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | INFUSION | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | ANTHRACYCLINES | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | DOXORUBICIN | - |
dc.subject.keywordAuthor | breast cancer | - |
dc.subject.keywordAuthor | clinical trial | - |
dc.subject.keywordAuthor | genexol-PM | - |
dc.subject.keywordAuthor | phase II | - |
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