An Open-Label, Randomized, Parallel, Phase Ill 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 | Park, In Hae | - |
dc.contributor.author | Sohn, Joo Hyuk | - |
dc.contributor.author | Kim, Sung Bae | - |
dc.contributor.author | Lee, Keun Seok | - |
dc.contributor.author | Chung, Joo Seop | - |
dc.contributor.author | Lee, Soo Hyeon | - |
dc.contributor.author | Kim, Tae You | - |
dc.contributor.author | Jung, Kyung Hae | - |
dc.contributor.author | Cho, Eun Kyung | - |
dc.contributor.author | Kim, Yang Soo | - |
dc.contributor.author | Song, Hong Suk | - |
dc.contributor.author | Seo, Jae Hong | - |
dc.contributor.author | Ryoo, Hun Mo | - |
dc.contributor.author | Lee, Sun Ah | - |
dc.contributor.author | Yoon, So Young | - |
dc.contributor.author | Kim, Chul Soo | - |
dc.contributor.author | Kim, Yong Tai | - |
dc.contributor.author | Kim, Si Young | - |
dc.contributor.author | Jin, Mi Ryung | - |
dc.contributor.author | Ro, Jungsil | - |
dc.date.available | 2020-02-27T18:41:18Z | - |
dc.date.created | 2020-02-06 | - |
dc.date.issued | 2017-07 | - |
dc.identifier.issn | 1598-2998 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/5962 | - |
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/m(2) or Genexol 175 mg/m(2) 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/m(2) (95.0%), and that of Genexol was 168.3 +/- 10.6 mg/m(2) (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) (p(non-infertorny)=0.021, p(superioray)=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.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | KOREAN CANCER ASSOCIATION | - |
dc.relation.isPartOf | CANCER RESEARCH AND TREATMENT | - |
dc.subject | NAB-PACLITAXEL | - |
dc.subject | III TRIAL | - |
dc.subject | CARCINOMA CELLS | - |
dc.subject | GENEXOL-PM | - |
dc.subject | CHEMOTHERAPY | - |
dc.subject | THERAPY | - |
dc.subject | TAXANES | - |
dc.subject | TAXOL | - |
dc.title | An Open-Label, Randomized, Parallel, Phase Ill 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.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000405537800002 | - |
dc.identifier.doi | 10.4143/crt.2016.289 | - |
dc.identifier.bibliographicCitation | CANCER RESEARCH AND TREATMENT, v.49, no.3, pp.569 - 577 | - |
dc.identifier.kciid | ART002243108 | - |
dc.identifier.scopusid | 2-s2.0-85022057541 | - |
dc.citation.endPage | 577 | - |
dc.citation.startPage | 569 | - |
dc.citation.title | CANCER RESEARCH AND TREATMENT | - |
dc.citation.volume | 49 | - |
dc.citation.number | 3 | - |
dc.contributor.affiliatedAuthor | Cho, Eun Kyung | - |
dc.type.docType | Article | - |
dc.subject.keywordAuthor | Polymeric micelle paclitaxel | - |
dc.subject.keywordAuthor | Cremophor EL-free | - |
dc.subject.keywordAuthor | Genexol-PM | - |
dc.subject.keywordAuthor | Metastatic breast cancer | - |
dc.subject.keywordPlus | NAB-PACLITAXEL | - |
dc.subject.keywordPlus | III TRIAL | - |
dc.subject.keywordPlus | CARCINOMA CELLS | - |
dc.subject.keywordPlus | GENEXOL-PM | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | TAXANES | - |
dc.subject.keywordPlus | TAXOL | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.description.journalRegisteredClass | kci | - |
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