Combination Docetaxel and Trastuzumab Treatment for Patients with HER-2-Overexpressing Metastatic Breast Cancer: A Multicenter, Phase-II Study
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- Sato Nobuaki
- Department of Surgery, Niigata Cancer Center Hospital
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- Sano Muneaki
- Department of Surgery, Niigata Cancer Center Hospital
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- Tabei Toshio
- Department of Breast Oncology, Saitama Cancer Center
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- Asaga Taro
- Department of Breast and Thyroid Surgery, Kanagawa Cancer Center Hospital
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- Ando Jiro
- Department of Surgery, Tochigi Cancer Center
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- Fujii Hirofumii
- Department of Medical Oncology, Tochigi Cancer Center
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- Yamamoto Naohito
- Department of Surgery, Chiba Cancer Center
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- Kurosumi Masafumi
- Department of Pathology, Saitama Cancer Center
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- Inoue Kenichi
- Department of Breast Oncology, Saitama Cancer Center
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- Kimura Morihikoa
- Department of Breast Surgery, Gunma Cancer Center, Fuji Heavy Industries Ltd Health Insurance Society
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Background: Pre-clinical and clinical studies indicate that a combination of docetaxel and trastuzumab may effectively treat patients with human epidermal growth factor receptor-2 (HER-2) overexpressing metastatic breast cancer. We evaluated the efficacy and safety of this combination in a multicenter, open-label phaseII study in Japan.<BR>Methods: Women with metastatic breast cancer whose tumors overexpressed HER-2, as assessed by immunohistochemistry and by fluorescence in situ hybridisation, received 2 to 6 cycles of docetaxel (70 mg/m2, every 3 weeks) and trastuzumab (4 mg/kg loading dose, 2 mg/kg weekly thereafter). The primary endpoint was tumor response. Secondary endpoints were time to disease progression and adverse events.<BR>Results: Of the 40 women enrolled in the study, 27 (68%) completed 6 cycles of treatment. Three patients discontinued the study before the second cycle. Median follow-up was 20.8 months (range, 0.6 to 30.9 months). The overall response rate was 65% (26/40; 95% CI, 48% to 79%). The median time to progression was 6.8 months (range, 0.6 to 21.2 months). Of the 40 patients, 35 (88%) had grade 3 or 4 leukopenia, and 33 (83%) had grade 3 or 4 neutropenia. Most instances of leukopenia and neutropenia were manageable by reducing the dose of docetaxel or by treatment with granulocyte colony-stimulating factor. In 4 patients, left ventricular ejection fraction decreased by more than 10% from baseline.<BR>Conclusions: The combination of docetaxel and trastuzumab was as effective as reported in other similar studies and was well tolerated in these patients.
収録刊行物
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- Breast Cancer
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Breast Cancer 13 (2), 166-171, 2006
日本乳癌学会
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詳細情報 詳細情報について
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- CRID
- 1390001204481590784
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- NII論文ID
- 130004467430
- 10018167804
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- NII書誌ID
- AA1103354X
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- ISSN
- 18804233
- 13406868
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- 本文言語コード
- en
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- データソース種別
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- JaLC
- Crossref
- CiNii Articles
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- 使用不可