The multi-center study included 449 women who were randomized to either TaxotereÒ 100mg/m2 (1 hour infusion) or paclitaxel 175 mg/m2 (3 hour infusion) every three weeks. Treatment was continued until progression of disease, unmanageable toxicity or intercurrent illness occurred, or until the patient decided to terminate treatment for any other reason. Eligibility criteria included: bi-dimensionally measurable metastatic breast cancer, having failed either one prior anthracycline-based regimen as first-line therapy for metastatic breast cancer or disease progression during or within 12 months of completing anthracycline-based adjuvant or neoadjuvant chemotherapy.
"While Taxotere is already the most widely used chemotherapy agent in the treatment of women with metastatic breast cancer, this trial offers more hope to women with breast cancer and has significance in treatment decisions," said Peter Ravdin, M.D., Ph.D., an Associate Professor of Oncology at the University of Texas Health Science Center at San Antonio and Principal Investigator of the study. "Taxanes have been proven to be a leading class of agents across a wide range of cancers. This trial is an important comparison of the taxanes that may influence future research and treatment strategies."
The primary endpoint of this study was the rate of overall response (tumor shrinkage). The secondary endpoints included time to disease progression (time without the cancer growing) and overall survival. In the "intent to treat" population, results are as follows:
- Median survival was 15.4 months for TaxotereÒ and 12.7 months for paclitaxel (P-value = 0.03).
- Median time to disease progression for patients treated with TaxotereÒ was 5.7 months compared to 3.6 months for those treated with paclitaxel (P-value = <0.0001).
- Response rates were numerically higher for TaxotereÒ (32.0%) compared to paclitaxel (25.0%), with P-value=0.10. The overall response rate was statistically significant for TaxotereÒ (37.4%) compared to paclitaxel (26.4%) in the "eligible and evaluable" population (P-value=0.02).
Taxotere was associated with increased incidence of grade 3/4 toxicities, including neutropenia (decrease in white blood cells which help fight infection), fever, diarrhea and edema (fluid retention).
"The study builds upon our base of research and provides additional support that Taxotere is one of the most active chemotherapy agents in the treatment of metastatic breast cancer after the failure of prior chemotherapy," said Michael L. Meyers, Senior Director, Oncology, Medical Affairs, Aventis Pharmaceuticals.
About Taxotere
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. TaxotereÒ promotes their assembly and blocks their disassembly, thereby preventing cancer cells from dividing and resulting in cancer cell death.
Taxotere is currently approved in the United States to treat patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy, and patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in combination with cisplatin, who had not received prior chemotherapy. It also is approved for patients with locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy.
The most common severe side effects associated with Taxotere include low blood cell count, fatigue, fluid retention and mouth sores. The most common non-severe side effects included hair loss, neurosensory, cutaneous, nail changes, nausea and diarrhea. These side effects are generally reversible and manageable. A premedication regimen with corticosteroids is recommended in order to prevent or reduce hypersensitivity and fluid retention. Taxotere is not appropriate therapy for patients with significant liver impairment or a low white blood cell count.
Patients 65 years of age or older may experience some side effects more frequently. For more information about Taxotere, visit http://www.taxotere.com or see full prescribing information including boxed WARNINGS. For more information about ongoing clinical trials, please call 1-800-RxTrial or visit http://www.aventisoncology.com.
About Aventis
Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2002, Aventis generated sales of € 17.6 billion (US $16.6 billion), invested € 3.1 billion (US $3 billion) in research and development and employed approximately 71,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. The company's prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For more information about Aventis in the U.S., please visit: www.aventis-us.com.
Full prescribing information is available by visiting the Aventis Pharmaceuticals U.S. Web site at http://www.aventis-us.com. Also available at this U.S. Web site are copies of this release or any recent release.
Statements in this news release containing projections or estimates of revenues, income, earnings per share, capital expenditures, capital structure, or other financial items; plans and objectives relating to future operations, products, or services; future economic performance; or assumptions underlying or relating to any such statements, are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the timing and effects of regulatory actions, the results of clinical trials, the company's relative success developing and gaining market acceptance for new products, the outcome of significant litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission and in the current Annual Report -"Document de Référence"- on file with the "Commission des Opérations de Bourse" in France.