Abstract | PURPOSE: This phase II study evaluated weekly trastuzumab and paclitaxel therapy in women with HER2-normal and HER2-overexpressing metastatic breast cancer. Efficacy was correlated with immunohistochemical and fluorescent in situ hybridization (FISH) assay results. PATIENTS AND METHODS: RESULTS: Patients received a median of 25 weekly infusions (range, one to 85 infusions). Median delivered paclitaxel dose-intensity was 82 mg/m2/wk (range, 52 to 90 mg/m2/wk). The intent-to-treat response rate for all 95 patients enrolled was 56.8% (95% confidence interval, 47% to 67%). A response rate of 61.4% (4.5% complete response, 56.8% partial response) was observed in 88 fully assessable patients. In patients with HER2-overexpressing tumors, overall response rates ranged from 67% to 81% compared with 41% to 46% in patients with HER2-normal expression (ranges reflect the different assay methods used to assess HER2 status). Differences in response rates between patients with HER2-overexpressing tumors and those with normal HER2 expression were statistically significant for all assay methods, with CB11 and TAB250 antibodies and FISH having the strongest significance. Therapy was generally well tolerated, although three patients had serious cardiac complications. CONCLUSION:
|
Authors | A D Seidman, M N Fornier, F J Esteva, L Tan, S Kaptain, A Bach, K S Panageas, C Arroyo, V Valero, V Currie, T Gilewski, M Theodoulou, M E Moynahan, M Moasser, N Sklarin, M Dickler, G D'Andrea, M Cristofanilli, E Rivera, G N Hortobagyi, L Norton, C A Hudis |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 19
Issue 10
Pg. 2587-95
(May 15 2001)
ISSN: 0732-183X [Print] United States |
PMID | 11352950
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Trastuzumab
- Paclitaxel
|
Topics |
- Adult
- Aged
- Antibodies, Monoclonal
(administration & dosage)
- Antibodies, Monoclonal, Humanized
- Antineoplastic Combined Chemotherapy Protocols
(therapeutic use)
- Breast Neoplasms
(drug therapy, genetics, secondary)
- Drug Administration Schedule
- Female
- Gene Amplification
- Genes, erbB-2
(immunology)
- Humans
- Immunophenotyping
- In Situ Hybridization, Fluorescence
- Middle Aged
- Paclitaxel
(administration & dosage)
- Trastuzumab
- Treatment Outcome
|