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Bristol-Myers Squibb SA

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.
References:
[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.

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