Efficacy and safety of neoadjuvant trastuzumab combined with paclitaxel and epirubicin

A retrospective review of the M. D. Anderson experience

Authors

  • Shaheenah Dawood MBBCh, MRCP,

    1. Department of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
    2. Department of Medical Oncology, Department of Health and Medical Services, Dubai Hospital, Dubai, United Arab Emirates
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  • Ana M. Gonzalez-Angulo MD,

    1. Department of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • Florentia Peintinger MD,

    1. Department of Pathology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • Kristine Broglio MS,

    1. Department of Quantitative Sciences, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • William F. Symmans MD,

    1. Department of Pathology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • Shu-Wan Kau MD,

    1. Department of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • Rabiul Islam MD,

    1. Department of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • Gabriel N. Hortobagyi MD,

    1. Department of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • Aman U. Buzdar MD

    Corresponding author
    1. Department of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
    • Department of Breast Medical Oncology, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030
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    • Fax: (713) 383-0234


Abstract

BACKGROUND.

A previously published prospective randomized phase 3 trial showed that administration of 24 weeks of primary systemic chemotherapy (PST) with paclitaxel and FEC75 (fluorouracil, epirubicin, cyclophosphamide) concurrently with trastuzumab in patients with HER2-positive primary breast cancer resulted in a 60% pathologic complete response rate (PCR) with no associated severe cardiac toxicity. The purpose of this study was to review the efficacy and safety of a similar regimen outside the setting of a clinical trial.

METHODS.

Patients with HER2-positive breast cancer (defined as either immunohistochemical 3+ or fluorescence in situ hybridization-positive) that had received 24 weeks of neoadjuvant trastuzumab concurrently with taxane and anthracycline-based chemotherapy between 2004 and 2006 were included in the analysis. PST chemotherapy consisted of paclitaxel (80 mg/m2) weekly for 12 weeks followed by 4 cycles of FEC75 (500 mg/m2, 75 mg/m2, and 500 mg/m2, respectively).

RESULTS.

Forty patients were identified. The median age was 48 years (range, 29–81). In all, 60% of patients had stage III disease and 4 had inflammatory breast cancer. The PCR rate was 55% (95% confidence interval [CI], 38.5%–70.7%). At a median follow-up of 19 months. 5 patients had a recurrence, of which 4 did not achieve a PCR. No severe cardiac events were observed.

CONCLUSIONS.

Stage II and III HER2-positive breast cancer patients achieved a high rate of PCR with trastuzumab given concurrently with paclitaxel and FEC75 chemotherapy. No severe cardiac events were observed with the regimen. The data concur with the results of a previously published trial. Cancer 2007. © 2007 American Cancer Society.

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