The trial, conducted by the European Organization for Research and Treatment of Cancer (EORTC) Head and Neck Cooperative Group, involved 358 patients and demonstrated that patients receiving Taxotere® plus cisplatin and 5-fluorouracil (5-FU) had significant prolongation of progression-free survival, the trial's primary endpoint, (12.7 months vs. 8.4 months, p=0.006) compared to those who received the standard treatment of cisplatin and 5-fluorouracil (5-FU). The Taxotere® combination also resulted in significantly improved overall survival (18.6 months vs. 14.5 months, p=0.016) and significantly increased overall response rates (67.8 percent vs. 53.6 percent, p=0.007), the trial's secondary endpoints.
"Head and neck cancer patients have very limited treatment options. The addition of Taxotere® to this standard treatment regimen is very encouraging and may change the paradigm by which we treat this disease," said Jan B. Vermorken, MD, PhD, EORTC Principal Investigator, Professor of Oncology and Head of the Department of Medical Oncology at the University Hospital of the University of Antwerp in Belgium. "The trial findings provide new important information for oral surgeons, medical oncologists and radiation oncologists."
Head and neck cancer is the seventh most frequently occurring cancer worldwide with an incidence rate of 390,000 cases annually. In the United States, it is estimated that more than 38,000 cases will occur in 2004.
"We are encouraged by today's results that suggest a benefit with Taxotere® for patients with advanced head and neck cancer, a difficult to treat disease," said Frank Douglas, MD, PhD, Executive Vice President of Drug Innovation and Approval and a Member of the Board of Management at Aventis.
Study Results and Protocol
Patients in the multicenter trial were randomly assigned to receive one of two treatments. Of the 358 participants, 177 received an infusion of Taxotere® plus cisplatin on day one and a five-day continuous infusion of 5-fluorouracil (5-FU) and 181 patients received an infusion of a standard treatment consisting of cisplatin on day one followed by a five-day continuous infusion of 5-fluorouracil (5-FU). Treatment cycles were to be repeated every three weeks for a total of four cycles. All patients received radiation therapy following chemotherapy within four to seven weeks after completing the last cycle of chemotherapy. Radiation therapy was administered five days a week for up to seven weeks.
In this trial, investigators reported that Taxotere® regimen was well tolerated and had a generally predictable and manageable safety profile. Patients receiving the cisplatin and 5-fluorouracil (5-FU) regimen showed greater grade 3-4 nausea (7.3 percent vs. 0.6 percent), vomiting (5.0 percent vs. 0.6 percent) stomatitis (11.2 percent vs. 4.6 percent) and more toxic deaths (5.5 percent vs. 2.3 percent) when compared to the Taxotere® regimen.
These results are one of three large randomized phase III Taxotere® studies highlighted at this premier oncology meeting from which investigators reported survival advantages for cancer patients. Also two landmark phase III trials, TAX 327 (abstract 4) and SWOG 9916 (abstract 3), demonstrated a Taxotere®-based regimen yielded a statistically significant survival benefit for men with androgen-independent (hormone-refractory) metastatic prostate cancer.
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. Taxotere® promotes their assembly and blocks their disassembly, thereby preventing many 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 unresectable locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy. On May 19, 2004, the U.S. Food and Drug Administration granted approval of Taxotere® for use in combination with prednisone as a treatment for men with androgen-independent (hormone-refractory) metastatic prostate cancer.
Among patients receiving Taxotere® the most common severe adverse events were low blood cell count, fatigue, diarrhea, and mouth and throat irritation.
The most common non-severe side effects include hair loss, numbness, a tingling and/or burning sensation, rash, nail changes, nausea, vomiting, and muscle pain.
Less common severe or potentially life threatening side effects include fluid retention, infections, and allergic reactions.
Patients 65 years of age or older may experience some side effects more frequently. For more information about Taxotere®, visit www.taxotere.com or see full prescribing information including boxed WARNING.
For more information about ongoing clinical trials, please call 1-800-RxTrial or visit www.aventisoncology.com.
About Aventis
Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2003, Aventis generated sales of € 16.79 billion (US $18.99), invested € 2.86 billion (US $3.24) in research and development and employed approximately 69,000 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, please visit: www.aventis-us.com.
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, recently renamed "Autorité des marchés financiers".
Additional Contact:
Marisol Peron, U.S. Product Communications, 908-243-7592, marisol.peron@aventis.com
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