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17.03.2005 – 12:07

Bristol-Myers Squibb GmbH & Co. KGaA

Taxol(r) (paclitaxel) Approved in Europe for the Adjuvant Treatment of Node-Positive Breast Cancer

    Paris (ots/PRNewswire)

    - New Indication Means More Patients Could Benefit From Earlier Treatment

    Bristol-Myers Squibb announces the approval of Taxol(r) (paclitaxel) for the treatment of early stage node-positive breast cancer following standard anthracycline and cyclophosphamide (AC) therapy. According to the approval, adjuvant treatment with Taxol should be regarded as an alternative to extended AC therapy.

    Through the mutual recognition procedure initiated via the Medicines Evaluation Board in the Netherlands, this new indication applies to 15 European Union member states[1]. Taxol is already approved in the adjuvant setting in the USA and Switzerland. The recommended dose of Taxol for node-positive breast cancer is the already approved single agent dose of 175mg/m2 administered over 3 hours, every 3 weeks for four cycles.

    "Bristol-Myers Squibb clearly intends to continue to have a major influence in the field of oncology. The granting of this new indication for Taxol illustrates the importance that the Company places on research into expanding the use of existing treatments such as Taxol, and into the development of new treatments with the aim of enhancing and extending the lives of people with cancer," said Annalisa Jenkins, European Vice President and Chief Medical Officer, Europe, Middle East and Africa, of Bristol-Myers Squibb.

    "While we already know that Taxol is effective for advanced disease, this significant development means that even more women could benefit through the earlier treatment of their breast cancer with Taxol."

    Over 300,000 patients are diagnosed with node-positive early breast cancer in Europe each year. Early stage disease means that the patient's cancer is contained (or localized) within the breast, with or without lymph node involvement. Following surgery to remove the bulk of the tumour, there is often a greater chance that the cancer will not recur if any residual tumour cells are eradicated via additional treatments such as adjuvant chemotherapy.

    The decision to grant this approval was based on evidence from the Cancer and Leukemia Group B 9344 study (CALGB 9344),[2] which demonstrated that patients with node-positive breast cancer derived a statistically significant benefit from the addition of Taxol following standard AC chemotherapy.

    The aim of the CALGB 9344 study was to determine if an increase in dose of doxorubicin, (an anthracycline frequently used to treat patients with early breast cancer) and the addition of Taxol following standard AC chemotherapy would prolong survival and disease-free survival. In this large randomised phase III study, 3,121 women received one of three doses of doxorubicin plus cyclophosphamide (standard therapy), followed by no further treatment or Taxol.

    According to the study, at a median follow-up of 69 months, an increase in the doxorubicin dose conferred no additional benefit to the patient, while with the addition of Taxol, patients had a significant reduction of 18% in the risk of disease recurrence relative to patients receiving AC alone (p = 0.0014), and a significant reduction of 19% in the risk of death (p = 0.0044) relative to patients receiving AC alone. There was no interaction between doxorubicin dose and the addition of Taxol, as in each of the study arms (across all doses of doxorubicin) the patients who had Taxol performed better than those who did not receive Taxol. The safety profile was consistent with the known safety profile of single agent Taxol.

    The principal Investigator of the CALGB 9344 study, Dr I Craig Henderson, University of California, San Francisco, USA, said, "This study clearly demonstrates the significant impact that Taxol has on survival in women with early stage, node-positive breast cancer. Adjuvant combination chemotherapy reduces the risk of cancer recurrence and death. In our study, we decided to add Taxol to older forms of chemotherapy because it has a different effect on the tumour cells and has relatively few overlapping toxicities with the other drugs we commonly use to treat breast cancer."

    With Taxol, Bristol-Myers Squibb has a 12-year history of an advanced cancer therapy, and continues to work in Europe in partnership with the oncology community in order to provide the best service to healthcare professionals and to patients, and to invest in clinical development.

    Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

    Editor's notes

    - Paclitaxel (TAXOL(R)) in Europe is indicated in metastatic breast cancer as a single agent for the treatment of patients who have failed, or are not candidates for standard, anthracycline containing therapy, and for the initial treatment of advanced or metastatic breast cancer in combination with an anthracycline in patients for whom anthracycline therapy is suitable, or in combination with Herceptin (trastuzumab), in patients who over-express HER-2 at a 3+ level and for whom an anthracycline is not suitable. For first-line chemotherapy in patients with advanced cancer of the ovary or with residual disease (> 1 cm) after initial laparotomy, in combination with cisplatin and for the treatment of metastatic cancer of the ovary after failure of standard, platinum containing therapy. It is indicated in combination with cisplatin for the treatment of non-small cell lung cancer (NSCLC) in patients who are not candidates for potentially curative surgery and/or radiation therapy. Taxol is indicated for the treatment of patients with advanced AIDS-related Kaposi's sarcoma (KS) who have failed prior liposomal anthracycline therapy. In the adjuvant setting, Taxol is indicated for the treatment of patients with node-positive breast carcinoma following anthracycline and cyclophosphamide (AC) therapy. Adjuvant treatment with Taxol should be regarded as an alternative to extended AC therapy.


    [1] Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden, United Kingdom.

    [2] Henderson IC et al. Improved disease-free (DFS) and overall survival (OS) from the addition of sequential paclitaxel (T) but not from the escalation of doxorubicin (A) dose level in the adjuvant chemotherapy of patients with node-positive primary breast cancer. J. Clin. Oncol. 2003: p. JCO.02.063.

ots Originaltext: Bristol-Myers Squibb
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Original content of: Bristol-Myers Squibb GmbH & Co. KGaA, transmitted by news aktuell

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