Journal of Clinical Oncology, Vol 20, Issue 7
(April), 2002: 1800-1808
© 2002 American Society for Clinical Oncology
Phase II Study of Weekly Docetaxel and Trastuzumab for Patients With HER-2–Overexpressing Metastatic Breast Cancer
By Francisco J. Esteva,
Vicente Valero,
Daniel Booser,
Laura T. Guerra,
James L. Murray,
Lajos Pusztai,
Massimo Cristofanilli,
Banu Arun,
Bita Esmaeli,
Herbert A. Fritsche,
Nour Sneige,
Terry L. Smith,
Gabriel N. Hortobagyi
From the Departments of Breast Medical Oncology, Ophthalmology, Laboratory Medicine, Pathology, and Biostatistics, The University of Texas M.D. Anderson Cancer Center, Houston, TX.
Address reprint requests to Francisco J. Esteva, MD, PhD, Department of Breast Medical Oncology, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 424, Houston, TX 77030; email: festeva{at}mdanderson.org
PURPOSE: To evaluate the safety and efficacy of weekly docetaxel plus trastuzumab in women with HER-2–overexpressing metastatic breast cancer. Efficacy was correlated with serum HER-2 extracellular domain (ECD) levels.
PATIENTS AND METHODS: Thirty women with metastatic breast cancer were treated with weekly docetaxel and trastuzumab as first- or second-line therapy. Both docetaxel 35 mg/m2/wk and trastuzumab 2 mg/kg/wk were delivered in 4-week cycles consisting of three weekly treatments followed by 1 week of rest. A loading dose of trastuzumab 4 mg/kg was administered 1 day before the start of the first cycle.
RESULTS: The median delivered dose-intensity of docetaxel was 24 mg/m2/wk (range, 18 to 27 mg/m2/wk). The intent-to-treat overall response rate (ORR) was 63% (95% confidence interval [CI], 44% to 80%). The ORR in patients whose tumors were HER-2–positive by fluorescence in situ hybridization was 67% (16 of 24 patients; 95% CI, 45% to 84%). In patients with elevated serum HER-2 ECD at baseline, the ORR was 76% (95% CI, 53% to 92%), compared with 33% (95% CI, 7% to 70%) in patients with low HER-2 ECD levels (P = .04). Variations in HER-2 ECD concentrations during treatment correlated with response to treatment. Median time to progression was 9 months. Acute toxicity, including myelosuppression, was mild. Fatigue, fluid retention, and excessive tearing became more common with repetitive dosing.
CONCLUSION: Weekly docetaxel and trastuzumab is an active combination for treating patients with HER-2–overexpressing metastatic breast cancer. Serum HER-2 ECD testing may be a promising method for monitoring patients on trastuzumab-based therapy.
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J. S. Ross, J. A. Fletcher, G. P. Linette, J. Stec, E. Clark, M. Ayers, W. F. Symmans, L. Pusztai, and K. J. Bloom
The HER-2/neu Gene and Protein in Breast Cancer 2003: Biomarker and Target of Therapy
Oncologist,
August 1, 2003;
8(4):
307 - 325.
[Abstract]
[Full Text]
[PDF]
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R. Nahta, S. Trent, C. Yang, and E. V. Schmidt
Epidermal Growth Factor Receptor Expression Is a Candidate Target of the Synergistic Combination of Trastuzumab and Flavopiridol in Breast Cancer
Cancer Res.,
July 1, 2003;
63(13):
3626 - 3631.
[Abstract]
[Full Text]
[PDF]
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R. Nahta, G. N. Hortobagyi, and F. J. Esteva
Growth Factor Receptors in Breast Cancer: Potential for Therapeutic Intervention
Oncologist,
February 1, 2003;
8(1):
5 - 17.
[Abstract]
[Full Text]
[PDF]
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H. J. Burstein, L. N. Harris, R. Gelman, S. C. Lester, R. A. Nunes, C. M. Kaelin, L. M. Parker, L. W. Ellisen, I. Kuter, M. A. Gadd, et al.
Preoperative Therapy With Trastuzumab and Paclitaxel Followed by Sequential Adjuvant Doxorubicin/Cyclophosphamide for HER2 Overexpressing Stage II or III Breast Cancer: A Pilot Study
J. Clin. Oncol.,
January 1, 2003;
21(1):
46 - 53.
[Abstract]
[Full Text]
[PDF]
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M. Jahanzeb, J. E. Mortimer, F. Yunus, D. H. Irwin, J. Speyer, A. J. Koletsky, P. Klein, T. Sabir, and L. Kronish
Phase II Trial of Weekly Vinorelbine and Trastuzumab as First-Line Therapy in Patients with HER2+ Metastatic Breast Cancer
Oncologist,
October 1, 2002;
7(5):
410 - 417.
[Abstract]
[Full Text]
[PDF]
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