Two landmark studies show Taxotere (R) significantly improves survival in men with prostate cancer

06/04/04

Taxotere-based regimen is first and only treatment with proven significant survival benefit for men with androgen-independent (hormone-refractory) metastatic prostate cancer

BRIDGEWATER, NJ - June 7, 2004 - Aventis (NYSE: AVE) announced today that the results of two landmark phase III trials using Taxotere® (docetaxel) Injection Concentrate based regimens in the treatment of androgen-independent (hormone-refractory) metastatic prostate cancer have been presented at the plenary session of the annual meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, LA.

The clinical trials TAX 327 and SWOG 9916, were led by investigators from the Johns Hopkins Kimmel Cancer Center and NewYork-Presbyterian Hospital/Columbia University Medical Center and the Southwest Oncology Group (SWOG). The trials involved nearly 1,800 patients and demonstrated that Taxotere®-based regimens significantly reduced the risk of death by 24 percent and 20 percent, respectively. Investigators in the TAX 327 trial also reported that Taxotere® significantly improved patients' PSA responses by 43 percent (p=0.0005) and improved pain responses by 59 percent (p=0.0107), relative to mitoxantrone response rates.

The SWOG trial investigators reported a 27 percent increase in disease-progression-free survival and a 55 percent increase in objective response rate in the Taxotere®-containing arm. In addition, the majority of patients had a PSA decline of more than 50 percent.

"These studies are the first to show that a chemotherapy agent, Taxotere®, can deliver a significant survival benefit in androgen-independent (hormone-refractory) metastatic prostate cancer patients, giving hope to thousands of men worldwide," said Daniel Petrylak, MD, Associate Professor of Medicine at Columbia University College of Physicians & Surgeons, Director of the Genitourinary Oncology Program at NewYork-Presbyterian Hospital. "These data represent an important new treatment option for men with prostate cancer because it can help some patients live longer."

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.

"The results of these studies mark a significant milestone in cancer care. Taxotere® is the only drug approved for patients with breast, lung and prostate cancer, three of the most prevalent cancers in the world today," said Frank Douglas, MD, PhD, Executive Vice President of Drug Innovation and Approval and a Member of the Board of Management at Aventis.

TAX 327/SWOG 9916 Study Protocol

The TAX 327 study reported by Mario Eisenberger, MD, Dale Hughes Professor of Oncology and Urology at the Johns Hopkins Kimmel Cancer Center, enrolled patients at 240 sites in 24 countries. One thousand six (1,006) eligible patients were randomized to receive one of three treatment regimens. Taxotere® 75mg/m2 once every three weeks plus daily prednisone, or Taxotere® 30 mg/m² every week for five out of six weeks plus daily prednisone, or mitoxantrone 12mg/m2 every three weeks plus daily prednisone, the established standard of care. The majority of the patients were over the age of 65.

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

Taxotere® was well tolerated and had a generally predictable and manageable safety profile in both studies. The most commonly observed adverse events in TAX 327 were alopecia, fatigue, and nausea, but the rates were comparable to mitoxantrone. Hematological events seen in the trial were consistent with the expected safety profile for both treatments, with grade 3-4 neutropenia reported more frequently in the Taxotere® group than the mitoxantrone group (32 percent vs 21.7 percent, p=0.004). However, complications of neutropenia appeared comparable in both groups.

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®

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 WARNINGS. For more information about ongoing clinical trials, please call 1-800-RxTrial or visit www.aventisoncology.com.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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