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

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)1071-1077
Number of pages7
JournalJournal of Clinical Oncology
Volume22
Issue number6
DOIs
StatePublished - 2004

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docetaxel
Fluorescence In Situ Hybridization
Breast Neoplasms
Trastuzumab

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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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. / Tedesco, K. L.; Thor, A. D.; Johnson, David 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.

In: Journal of Clinical Oncology, Vol. 22, No. 6, 2004, p. 1071-1077.

Research output: Contribution to journalArticle

Tedesco, K. L. ; Thor, A. D. ; Johnson, David 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. / 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. In: Journal of Clinical Oncology. 2004 ; Vol. 22, No. 6. pp. 1071-1077.
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title = "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",
abstract = "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.",
author = "Tedesco, {K. L.} and Thor, {A. D.} and Johnson, {David H.} and Y. Shyr and Blum, {K. A.} and Goldstein, {L. J.} and Gradishar, {W. J.} and Nicholson, {B. P.} and Merkel, {D. E.} and D. Murrey and S. Edgerton and Sledge, {G. W.}",
year = "2004",
doi = "10.1200/JCO.2004.10.046",
language = "English (US)",
volume = "22",
pages = "1071--1077",
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TY - JOUR

T1 - Docetaxel combined with trastuzumab is an active regimen in HER-2 3+ overexpressing and fluorescent in situ hybridization-positive metastatic breast cancer

T2 - A multi-institutional phase II trial

AU - Tedesco, K. L.

AU - Thor, A. D.

AU - Johnson, David H.

AU - Shyr, Y.

AU - Blum, K. A.

AU - Goldstein, L. J.

AU - Gradishar, W. J.

AU - Nicholson, B. P.

AU - Merkel, D. E.

AU - Murrey, D.

AU - Edgerton, S.

AU - Sledge, G. W.

PY - 2004

Y1 - 2004

N2 - 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.

AB - 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.

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DO - 10.1200/JCO.2004.10.046

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