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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

From the Vanderbilt Clinic, Vanderbilt University Medical Center, Nashville, TN; Department of Oncology, Oklahoma University Health Science Center, Oklahoma City, OK; Department of Oncology, Fox Chase Cancer Center, Philadelphia, PA; Department of Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago; Evanston Hospital, Evanston, IL; Department of Oncology, Indiana University Medical Center, Indianapolis, IN.

Address reprint requests to David H. Johnson, MD, Division of Hematology and Oncology, 777 Preston Research Bldg, 2220 Pierce Ave, Nashville, TN 37232-6307; e-mail: david.johnson{at}vanderbilt.edu

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.

Supported in part by National Cancer Institute grant Nos. CA-21115 and CA-68485. Funding was provided by Aven-tis, Bridgewater, NJ, and trastuzumab was provided by Genentech Inc, South San Francisco, CA.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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