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Two Docetaxel Studies Featured in New England Journal of Medicine

BRIDGEWATER, N.J., Oct. 6 /PRNewswire-FirstCall/ -- Aventis, part of the sanofi-aventis Group (NYSE:SNY) , announced today that The New England Journal of Medicine has published the results of two landmark phase III studies, which demonstrate that Taxotere (docetaxel) Injection Concentrate-based regimens significantly reduce the risk of death by 24 percent and 20 percent, respectively, in men with androgen-independent (hormone-refractory) metastatic prostate cancer.

Investigators from around the world led by the Johns Hopkins Kimmel Cancer Center and the Southwest Oncology Group (SWOG) with the chair institution NewYork-Presbyterian Hospital/Columbia University Medical Center conducted the two large, multicenter trials, TAX 327 and SWOG 9916, which involved nearly 1,800 patients. The principal investigators presented the results of these data in June at the plenary session of the annual meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, LA.

"Taxotere is the new standard in the treatment of men with advanced prostate cancer because it can help some patients live longer," said Daniel Petrylak, MD, Associate Professor of Medicine at Columbia University College of Physicians & Surgeons and Director of the Genitourinary Oncology Program at NewYork-Presbyterian Hospital/Columbia. "Prior to Taxotere, no chemotherapy drug has ever shown a survival benefit for men with prostate cancer resistant to hormone therapy."

"The publication of these two trials in The New England Journal of Medicine affirms the importance of these data for prostate cancer patients," said Susan Arbuck, MD, Vice President and Global Head, Development Oncology Therapeutic Area at Aventis. "The study results mark a very important milestone in cancer care because they demonstrate that a Taxotere-based regimen is the first and only treatment to extend survival in androgen- independent (hormone-refractory) metastatic prostate cancer."

Prostate cancer ranks third worldwide in cancer incidence and sixth in cancer mortality among men. In the United States, more than 230,000 men will be diagnosed with prostate cancer this year, and more than 29,900 will die of the disease.

TAX 327/SWOG 9916 Study Protocol and Results
The TAX 327 study, led by Mario Eisenberger, MD, Dale Hughes Professor of Oncology and Urology at the Johns Hopkins Kimmel Cancer Center, enrolled patients at 105 sites in 24 countries. The investigators randomized 1,006 eligible patients to receive one of three treatment regimens. Taxotere 75 mg/m2 once every three weeks plus daily prednisone, Taxotere 30 mg/m2 every week for five out of six weeks plus daily prednisone, or mitoxantrone 12 mg/m2 every three weeks plus daily prednisone. The majority of the patients were older than 65.

The SWOG 9916 study led by Dr. Petrylak randomized 770 patients in the United States to two treatment arms: Taxotere 60 mg/m2 every three weeks plus estramustine 280 mg three times daily for 5 days or mitoxantrone 12 mg/m2 every three weeks and prednisone daily.

The SWOG trial investigators reported that Taxotere treatment yielded a significant, 27 percent, increase in disease-progression-free survival, a significant, 55 percent, increase in objective response rate.

Investigators reported that in both studies, Taxotere was well tolerated. The most commonly observed adverse events in TAX 327 were alopecia, fatigue and nausea. Grade 3-4 neutropenia was reported more frequently in the Taxotere group than the mitoxantrone group (32 percent vs 21.7 percent, p=0.004).

In the SWOG 9916 study, gastrointestinal and cardiovascular events occurred more frequently in men treated with Taxotere plus estramustine than those treated with mitoxantrone.

About Taxotere(R)
Taxotere(R), 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(R) promotes their assembly and blocks their disassembly, thereby preventing many cancer cells from dividing and resulting in cancer cell death.

Taxotere(R) 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 (FDA) granted approval of Taxotere(R) for use in combination with prednisone as a treatment for men with androgen-independent (hormone- refractory) metastatic prostate cancer. On August 18, 2004, the FDA approved Taxotere(R) for use in combination with doxorubicin and cyclophosphamide (TAC regimen) for the adjuvant (post surgery) treatment of patients with operable, node-positive breast cancer.

Source: Aventis

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