Aventis, part of the sanofi-aventis Group announced the results of a large phase III study demonstrated that Taxotere (docetaxel) Injection Concentrate-based regimen significantly improved overall survival of women with operable, node-positive early stage breast cancer compared to a standard regimen of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC-100). These data were disclosed during an oral presentation at the 27th Charles A. Coltman, Jr. San Antonio Breast Cancer Symposium (SABCS).

The trial, PACS 01, conducted by investigators from the Federation National des Centres de Lutte contre le Cancer (FNCLCC) in France, showed that women with operable, node-positive, early stage breast cancer who received 3 cycles of Taxotere after 3 cycles of FEC-100 experienced a significant 17 per cent reduction in the risk of relapse as compared to women treated with 6 cycles of FEC-100. Investigators also reported women receiving Taxotere following the FEC regimen experienced a 23 per cent reduction in the risk of death at five-years of follow-up. These results were observed regardless of a woman's hormone receptor status.

PACS 01 is the first to show the survival benefit with Taxotere in a sequential regimen containing epirubicin. However, this is the second phase III study to demonstrate a long-term survival advantage for a Taxotere containing regimen in the adjuvant treatment of operable, node-positive breast cancer, the company release said.

"These results may provide additional hope for women with node-positive, early stage breast cancer; women aged 50 years or older may particularly benefit from this regimen," said Henri Roche, MD, Institut Claudius Regaud- Toulouse, France, member of French Federation of Cancer Centers (FNCLCC), and principal investigator of the trial. "This study represents the first long-term outcomes of the sequential use of TAXOTERE(R) with epirubicin, in early stage breast cancer."

It is estimated that worldwide more than 300,000 women per year will be diagnosed with node-positive, early stage breast cancer. Most patients with early stage breast cancer (cancer localized to the breast with or without invasion of the lymph nodes under the arm) undergo surgery to remove the tumour. After surgery, most patients receive additional treatments, which may include chemotherapy to reduce the probability of tumour recurrence. Earlier diagnosis of breast cancer results in earlier treatment and may offer a better chance for cure.

Docetaxel (Taxotere), a drug in the taxoid class of chemotherapeutic agents, inhibits cancer cell division by essentially "freezing" the cell's internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. Docetaxel promotes their assembly and blocks their disassembly, thereby preventing many cancer cells from dividing and resulting in death in some cancer cells.

On August 18, 2004, the FDA approved Taxotere for use in combination with doxorubicin and cyclophosphamide (TAC regimen) for the adjuvant (post surgery) treatment of patients with operable, node-positive breast cancer.

In 2003, Taxotere generated worldwide sales of over euro 1.3 billion. Important safety information, the release added.