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Taxotere Significantly Improves Survival Compared with Paclitaxel in Women With Advanced Breast Cancer

Results of a Head-to-Head Study Compare Two of the Most Widely Used Chemotherapy Agents in Breast Cancer

NEW YORK, N.Y. -- August 19, 2005 -- A study published in the Journal of Clinical Oncology reports that treatment with Taxotere(R) offers a significant improvement over paclitaxel in overall survival for women with advanced breast cancer, whose cancer had progressed after previous treatment with an anthracycline-based therapy.

Breast cancer is the second most common cancer worldwide, with more than one million new cases reported worldwide annually and more than 400,000 women a year dying of the disease. Approximately one out of seven women will develop breast cancer in her lifetime.

While the number of diagnoses is growing, so are the advances in treatment. This head-to-head study of two of the most widely used chemotherapy agents in breast cancer shows a significantly increased overall survival of 15.4 months for those patients who received Taxotere versus 12.7 months for those who took paclitaxel.

This is the first trial to directly compare these treatments. Preclinical evidence suggested that Taxotere and paclitaxel are different, and the results from these findings provide oncologists with the clinical evidence of these differences.

Among patients evaluable for response (tumor shrinkage), those who received Taxotere had significantly higher response rates (37% vs. 26%; P =.02) and significantly longer median duration of response (7.5 months vs. 4.6 months; P =.01), than those who received paclitaxel.

Adverse events reported in the study were consistent with those previously observed in Taxotere(R) studies and are not different from those observed in routine clinical practice. The incidence of treatment-related hematologic and nonhematologic adverse events was greater for Taxotere than for paclitaxel; however, quality of life scores were not statistically different between treatment groups over time.

This study was supported by Aventis Pharmaceuticals, Bridgewater, New Jersey, and presented in 2003 at the European Cancer Conference (ECCO12), Copenhagen, Denmark, and the 26th Annual San Antonio Breast Cancer Symposium, San Antonio, Texas.

Indications and Usage

Breast Cancer

- Taxotere is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy.

Taxotere in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer.

Important safety information

WARNING: Taxotere treatment can cause serious, physically limiting, and potentially life-threatening side effects, such as infection, low blood-cell counts, allergic reaction, and retention of excess fluid (edema).

Taxotere should not be given to patients with low white-blood-cell counts, abnormal liver function, or a history of allergic reactions to Taxotere(R) or any of the ingredients in Taxotere.

Before each Taxotere treatment, all patients treated with Taxotere must receive another medicine called dexamethasone. This drug can help reduce the risk of fluid retention (edema) and allergic reactions.

Taxotere should be administered only under the supervision of a qualified physician experienced in the use of anticancer treatments. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

Treatment-related acute myeloid leukemia (AML) has occurred in patients given anthracyclines and/or cyclophosphamide, including use with Taxotere in adjuvant therapy for breast cancer.

The most common severe side effects are low white-blood-cell count, anemia, fatigue, diarrhea, and mouth and throat irritation. Low white-blood- cell count can lead to life-threatening infections. The earliest sign of infection may be fever, so tell your doctor right away if you have a fever.

Other common side effects from Taxotere include nausea, vomiting, hair loss, rash, infusion-site reactions, odd sensations (such as numbness, tingling, or burning) or weakness in the hands and feet, nail changes, muscle and/or bone pain, or excessive tearing.

Patients 65 years of age or older may experience some side effects more frequently than younger patients.

Because of the potential risk of fetal harm, pregnant women should not receive Taxotere. Women of childbearing potential should avoid becoming pregnant during treatment with Taxotere.

Before receiving Taxotere, tell your doctor if

* You have any allergies

* You are taking any other medicines -- including nonprescription (over-the-counter) drugs, vitamins, and dietary or herbal supplements

When taking Taxotere, contact your doctor if

* You have symptoms of an allergic reaction (warm sensation, tightness in your chest, itching/hives, or shortness of breath)

* You experience any other side effects


REFERENCE:
Jones SE, et al. Randomized Phase III Study of Docetaxel Compared With Paclitaxel in Metastatic Breast Cancer. J Clin Oncol August 20, 2005. 23(24):5542-5551.


SOURCE: sanofi-aventis

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