Docetaxel combined with trastuzumab is an active regimen in HER-2 3+ overexpressing and fluorescent in situ hybridization-positive metastatic breast cancer: A multi-institutional phase II trial

K. L. Tedesco, A. D. Thor, David H. Johnson, Y. Shyr, K. A. Blum, L. J. Goldstein, W. J. Gradishar, B. P. Nicholson, D. E. Merkel, D. Murrey, S. Edgerton, G. W. Sledge

研究成果: Article

95 引文 斯高帕斯(Scopus)

摘要

Purpose: To determine the efficacy and safety of weekly docetaxel and trastuzumab as first- or second-line therapy in women with HER-2-overexpressing metastatic breast cancer and to correlate the efficacy of trastuzumab with HER-2 status as determined by immunohistochemistry assay and fluorescent in situ hybridization (FISH). Patients and Methods: Twenty-six women with HER-2-positive (HercepTest [Dako Corp, Carpenteria, CA]2 to 3+) metastatic breast cancer were enrolled onto this study of trastuzumab (4 mg/kg load; 2 mg/kg/wk administered intravenously) and docetaxel (35 mg/m2/wk for 6 weeks). Results: Using an intent-to-treat analysis, the overall response rate was 50% (13 of 26 patients). Eight patients (31%) had a period of stable disease posttherapy. Among HER-2 3+ patients, the overall response rate was 63% (12 of 19 patients) compared with a 14% response rate (one of seven patients) for HER-2 2+ patients (P = .07). Patients with FISH-positive tumors experienced an overall response rate of 64%. Median time to progression was 12.4 months for the entire cohort (HER-2 3+ tumors, 12.3 months; HER-2 2+ lesions, 9.5 months) and median survival was 22.1 months. All HER-2 3+ patients were FISH-positive; the only HER-2 2+ patient responding to treatment was also FISH-positive. Grade 4 toxicities occurred in four patients; most toxicities were mild. Conclusion: Trastuzumab plus docetaxel is an active and well-tolerated regimen in women with HER-2 3+ overexpressing or FISH-positive metastatic breast cancer.

原文English
頁(從 - 到)1071-1077
頁數7
期刊Journal of Clinical Oncology
22
發行號6
DOIs
出版狀態Published - 2004 十二月 1

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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    Tedesco, K. L., Thor, A. D., Johnson, D. H., Shyr, Y., Blum, K. A., Goldstein, L. J., Gradishar, W. J., Nicholson, B. P., Merkel, D. E., Murrey, D., Edgerton, S., & Sledge, G. W. (2004). Docetaxel combined with trastuzumab is an active regimen in HER-2 3+ overexpressing and fluorescent in situ hybridization-positive metastatic breast cancer: A multi-institutional phase II trial. Journal of Clinical Oncology, 22(6), 1071-1077. https://doi.org/10.1200/JCO.2004.10.046