| The efficacy and safety of gemcitabine plus paclitaxel combination first-line therapy for Japanese patients with metastatic breast cancer including triple-negative phenotype. | |
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MedLine Citation:
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PMID: 20628744 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: Gemcitabine (GEM)-paclitaxel combination therapy has been confirmed as a standard therapy for metastatic/recurrent breast cancer (MBC) in Western countries. This study was conducted to assess the efficacy and safety of GEM-paclitaxel combination therapy in Japanese MBC patients. METHODS: Patients were administered paclitaxel 175 mg/m(2) on day 1, and GEM 1,000 or 1,250 mg/m(2) on days 1 and 8 of 21-day cycle. The primary endpoint of this study was overall response rate; secondary endpoints were duration of response, time to progression, survival time and rate. RESULTS: Paclitaxel 175 mg/m(2) plus GEM 1,250 mg/m(2) was determined as the recommended dose. A total of 56 patients received 506 cycles of treatment (median: 7.5 cycles) with a relative dose intensity of 79.6% for GEM and 85.8% for paclitaxel. The response rate was 44.6% (25/56 patients), median time to progression 8.6 months and median survival time 27.1 months. In triple-negative patients, the response rate was 35.7% (5/14 patients), and the median time to progression was 6.0 months. The most frequent grade ≥ 3 toxicities were neutropenia (82.1%), leukopenia (62.5%) and ALT increase (14.3%). CONCLUSIONS: This study confirmed the efficacy and safety of GEM-paclitaxel combination therapy in Japanese MBC patients. |
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Authors:
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Kenjiro Aogi; Masayuki Yoshida; Yoshiaki Sagara; Shunji Kamigaki; Minoru Okazaki; Jumpei Funai; Toshio Fujimoto; Masakazu Toi; Toshiaki Saeki; Shigemitsu Takashima |
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Publication Detail:
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Type: Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't Date: 2010-07-14 |
Journal Detail:
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Title: Cancer chemotherapy and pharmacology Volume: 67 ISSN: 1432-0843 ISO Abbreviation: Cancer Chemother. Pharmacol. Publication Date: 2011 May |
Date Detail:
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Created Date: 2011-04-26 Completed Date: 2011-06-23 Revised Date: 2013-06-03 |
Medline Journal Info:
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Nlm Unique ID: 7806519 Medline TA: Cancer Chemother Pharmacol Country: Germany |
Other Details:
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Languages: eng Pagination: 1007-15 Citation Subset: IM |
Affiliation:
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Department of Breast Oncology, Shikoku Cancer Center, 160 Kou, Minami-umemotocho, Matsuyama 791-0280, Japan. kaogi@shikoku-cc.go.jp |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Antineoplastic Combined Chemotherapy Protocols
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adverse effects,
therapeutic use* Breast Neoplasms / drug therapy*, genetics, pathology Deoxycytidine / administration & dosage, analogs & derivatives Female Humans Kaplan-Meier Estimate Middle Aged Neoplasm Metastasis Neoplasms, Hormone-Dependent / drug therapy*, genetics, pathology Paclitaxel / administration & dosage Phenotype Receptor, erbB-2 / biosynthesis*, genetics |
| Chemical | |
Reg. No./Substance:
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33069-62-4/Paclitaxel; 951-77-9/Deoxycytidine; B76N6SBZ8R/gemcitabine; EC 2.7.10.1/ERBB2 protein, human; EC 2.7.10.1/Receptor, erbB-2 |
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