Cited 72 times in
An Open-Label, Randomized, Parallel, Phase III Trial Evaluating the Efficacy and Safety of Polymeric Micelle-Formulated Paclitaxel Compared to Conventional Cremophor EL-Based Paclitaxel for Recurrent or Metastatic HER2-Negative Breast Cancer
DC Field | Value | Language |
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dc.contributor.author | 손주혁 | - |
dc.contributor.author | 이수현 | - |
dc.date.accessioned | 2018-07-20T08:09:18Z | - |
dc.date.available | 2018-07-20T08:09:18Z | - |
dc.date.issued | 2017 | - |
dc.identifier.issn | 1598-2998 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/160898 | - |
dc.description.abstract | PURPOSE: Genexol-PM is a Cremophor EL-free formulation of low-molecular-weight, non-toxic, and biodegradable polymeric micelle-bound paclitaxel. We conducted a phase III study comparing the clinical efficacy and toxicity of Genexol-PM with conventional paclitaxel (Genexol). MATERIALS AND METHODS: Patients were randomly assigned (1:1) to receive Genexol-PM 260 mg/m2 or Genexol 175 mg/m2 intravenously every 3 weeks. The primary outcome was the objective response rate (ORR). RESULTS: The study enrolled 212 patients, of whom 105 were allocated to receive Genexol-PM. The mean received dose intensity of Genexol-PM was 246.8±21.3 mg/m2 (95.0%), and that of Genexol was 168.3±10.6 mg/m2 (96.2%). After a median follow-up of 24.5 months (range, 0.0 to 48.7 months), the ORR of Genexol-PM was 39.1% (95% confidence interval [CI], 31.2 to 46.9) and the ORR of Genexol was 24.3% (95% CI, 17.5 to 31.1) (pnon-inferiority=0.021, psuperiority=0.016). The two groups did not differ significantly in overall survival (28.8 months for Genexol-PM vs. 23.8 months for Genexol; p=0.52) or progression-free survival (8.0 months for Genexol-PM vs. 6.7 months for Genexol; p=0.26). In both groups, the most common toxicities were neutropenia, with 68.6% occurrence in the Genexol-PM group versus 40.2% in the Genexol group (p < 0.01). The incidences of peripheral neuropathy of greater than grade 2 did not differ significantly between study treatments. CONCLUSION: Compared with standard paclitaxel, Genexol-PM demonstrated non-inferior and even superior clinical efficacy with a manageable safety profile in patients with metastatic breast cancer. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English, Korean | - |
dc.publisher | Official journal of Korean Cancer Association | - |
dc.relation.isPartOf | CANCER RESEARCH AND TREATMENT | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | 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 | Antineoplastic Combined Chemotherapy Protocols/therapeutic use* | - |
dc.subject.MESH | Biomarkers, Tumor | - |
dc.subject.MESH | Breast Neoplasms/drug therapy* | - |
dc.subject.MESH | Breast Neoplasms/metabolism | - |
dc.subject.MESH | Breast Neoplasms/mortality | - |
dc.subject.MESH | Breast Neoplasms/pathology | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Glycerol/administration & dosage | - |
dc.subject.MESH | Glycerol/adverse effects | - |
dc.subject.MESH | Glycerol/analogs & derivatives* | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Micelles* | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Neoplasm Metastasis | - |
dc.subject.MESH | Neoplasm Staging | - |
dc.subject.MESH | Paclitaxel/administration & dosage* | - |
dc.subject.MESH | Paclitaxel/adverse effects | - |
dc.subject.MESH | Polymers* | - |
dc.subject.MESH | Proportional Hazards Models | - |
dc.subject.MESH | Receptor, ErbB-2 | - |
dc.subject.MESH | Recurrence | - |
dc.subject.MESH | Retreatment | - |
dc.subject.MESH | Risk Factors | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | An Open-Label, Randomized, Parallel, Phase III Trial Evaluating the Efficacy and Safety of Polymeric Micelle-Formulated Paclitaxel Compared to Conventional Cremophor EL-Based Paclitaxel for Recurrent or Metastatic HER2-Negative Breast Cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | In Hae Park | - |
dc.contributor.googleauthor | Joo Hyuk Sohn | - |
dc.contributor.googleauthor | Sung Bae Kim | - |
dc.contributor.googleauthor | Keun Seok Lee | - |
dc.contributor.googleauthor | Joo Seop Chung | - |
dc.contributor.googleauthor | Soo Hyeon Lee | - |
dc.contributor.googleauthor | Tae You Kim | - |
dc.contributor.googleauthor | Kyung Hae Jung | - |
dc.contributor.googleauthor | Eun Kyung Cho | - |
dc.contributor.googleauthor | Yang Soo Kim | - |
dc.contributor.googleauthor | Hong Suk Song | - |
dc.contributor.googleauthor | Jae Hong Seo | - |
dc.contributor.googleauthor | Hun Mo Ryoo | - |
dc.contributor.googleauthor | Sun Ah Lee | - |
dc.contributor.googleauthor | So Young Yoon | - |
dc.contributor.googleauthor | Chul Soo Kim | - |
dc.contributor.googleauthor | Yong Tai Kim | - |
dc.contributor.googleauthor | Si Young Kim | - |
dc.contributor.googleauthor | Mi Ryung Jin | - |
dc.contributor.googleauthor | Jungsil Ro | - |
dc.identifier.doi | 10.4143/crt.2016.289 | - |
dc.contributor.localId | A01995 | - |
dc.contributor.localId | A02898 | - |
dc.relation.journalcode | J00453 | - |
dc.identifier.eissn | 2005-9256 | - |
dc.identifier.pmid | 27618821 | - |
dc.subject.keyword | Cremophor EL-free | - |
dc.subject.keyword | Genexol-PM | - |
dc.subject.keyword | Metastatic breast cancer | - |
dc.subject.keyword | Polymeric micelle paclitaxel | - |
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.citation.volume | 49 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 569 | - |
dc.citation.endPage | 577 | - |
dc.identifier.bibliographicCitation | CANCER RESEARCH AND TREATMENT, Vol.49(3) : 569-577, 2017 | - |
dc.identifier.rimsid | 60777 | - |
dc.type.rims | ART | - |
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