Navigation Links
Updated Study Results Reinforce Survival Benefit of Taxotere,(Docetaxel) for Men with Advanced, Hormone-Resistant Prostate,Cancer

ASCO Oral Presentation Reports Significantly More Patients Treated with Taxotere(R)-Based Chemotherapy Regimen Survived at Least Three Years

CHICAGO, June 04, 2007 /PRNewswire-FirstCall/ -- Taxotere(R) (docetaxel) Injection Concentrate-based chemotherapy (Taxotere plus prednisone) maintained long-term efficacy as a treatment for advanced (metastatic) hormone-resistant prostate cancer patients, according to the three-year updated results of the landmark TAX 327 study. Results of the international multi-center phase III trial were reported in an oral presentation at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO).

The TAX 327 data show that among patients with metastatic hormone- resistant prostate cancer, significantly more of those treated with Taxotere(R) 75mg/m2 combined with prednisone 5 mg once every three weeks survived at least three years, than those treated with anti-cancer antibiotic mitoxantrone combined with prednisone. Patients treated with the Taxotere(R) regimen lived a median of three months longer (19.3 months versus 16.3 months, p=0.006) and had a 21% lower risk of dying (HR=17.6-21.3). These results are consistent with results published in 2004 in the New England Journal of Medicine and document the maintenance of the survival benefit previously reported in patients treated with the Taxotere-based therapy.

"The results confirm docetaxel's survival benefit in patients with metastatic hormone resistant prostate cancer," said study author Dominik R. Berthold, Department of Medical Oncology, Princess Margaret Hospital, Toronto, Canada. "Prolonged survival is extremely important for these patients and docetaxel is the only chemotherapeutic agent to demonstrate a survival benefit in this setting."

Original TAX 327 Analysis Showed Improved Survival

The TAX 327 study was initiated in 2000 to evaluate long-term survival among men with metastatic h ormone refractory prostate cancer treated with regimens of Taxotere(R) plus prednisone (n=335) or mitoxantrone plus prednisone (n=337). The primary analysis published in the New England Journal of Medicine in 2004 demonstrated that Taxotere(R) given every three weeks with prednisone led to a superior survival advantage, versus mitoxantrone plus prednisone. The median survival was 18.9 months in the group given docetaxel every 3 weeks and 16.5 months in the mitoxantrone group (HR=0.76, 95% CI [0.62-0.94], p=0.0094).

The primary endpoint was overall survival. Secondary endpoints measured pain and prostate-specific antigen (PSA) levels. PSA is a substance made by the prostate that may be found in an increased amount in the blood of men who have prostate cancer or other conditions such as enlarged prostate.

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(R) group than the mitoxantrone group (32 percent vs. 21.7 percent, p=0.004).

The once every three weeks 75mg/m2 Taxotere(R) (docetaxel) plus 5 mg prednisone regimen has been approved for use as a treatment for androgen independent (hormone-refractory) metastatic prostate cancer in the U.S. since May 2004 and October 2004 in Europe. It is the only standard of care first line chemotherapy option for patients with metastatic hormone refractory prostate cancer.

About Prostate Cancer

Prostate cancer ranks third worldwide in cancer incidence and sixth in cancer mortality among men. In Europe in 2004, according to the International Agency for Research on Cancer, 238,000 men were diagnosed with prostate cancer and 85,000 died from prostate cancer in the same year. Approximately 219,000 men in the U.S. are expected to be diagnosed with the disease in 2007 and over 27,000 men are expected to die from the disease. Although men of any age can get prostate cancer, it is found most often in men over age 50; more than 7 of 10 men with prostate cancer are over the age of 65.

Advanced prostate cancer means the cancer has spread to tissues next to the prostate, such as the muscles that help control urination, the rectum or the wall of the pelvis. The cancer may have also spread to lymph nodes near the prostate or, if it has metastasized, to other more distant places in the body. With early detection, the five-year survival rate of prostate cancer is almost 100%. But if it has spread, that rate goes down dramatically to 33%.

For full prescribing information, including boxed WARNING, call 800-633- 1610 or visit

About sanofi-aventis

Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris and in New York .

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward- looking information and statements. These risks and uncertainties include those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

    Contact: Noelle Boyd,  (908) 981-6489

             Lisa Kennedy, (908) 981-6569


CONTACT: Noelle Boyd, +1-908-981-6489, or Lisa Kennedy, +1-908-981-6569,both of sanofi-aventis

Web site:

Company News On-Call:

Ticker Symbol: (NYSE:SNY)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


Related medicine technology :

1. Infinity and MedImmune Present Updated Phase I Results of IPI-504 in GIST at ASCO Annual Meeting
2. Introgen Reports Updated Phase 2 Advexin Data Correlating Improved Survival, Tumor Responses and Predictive p53 Biomarker
3. Updated Overall Survival Data From Pivotal Herceptin Adjuvant Studies in HER2-Positive Breast Cancer
4. Vion Pharmaceuticals Presents Updated Clinical Data from a Phase II trial of Cloretazine (VNP40101M) in Patients with Relapsed or Refractory Small Cell Lung Cancer
5. Infinity and MedImmune Announce Updated Data On Ipi-504 to be Presented At ASCO
6. Avanir Pharmaceuticals Presents IEED Prevalence and Updated Zenvia Long-Term Safety Data at AAN Annual Meeting
7. Media Advisory: ACC Updated Schedule
8. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
9. Clinical Study Shows Regenecare Relieves Pain and Itching of Skin Rashes Caused by Widely Used Cancer Drugs
10. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
11. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
Post Your Comments:
(Date:11/25/2015)... Calif. , Nov. 25, 2015  Amgen (NASDAQ: ... Biologics License Application (BLA) with the United ... for ABP 501, a biosimilar candidate to Humira ® ... adalimumab biosimilar application submitted to the FDA and represents ... Sean E. Harper , M.D., executive vice ...
(Date:11/25/2015)... , Nov. 25, 2015 AAIPharma ... planned investment of at least $15.8  Million to ... Wilmington, NC . The expansion will ... to meet the growing demands of the pharmaceutical ... site expansion will provide up to 40,000 ...
(Date:11/25/2015)... Nov. 25, 2015  Henry Schein, Inc., the world,s ... office-based dental, medical and animal health practitioners, will unveil ... Henry Schein ConnectDental® Pavilion , which brings together ... open solutions designed to help any practice or laboratory ... for a schedule of experts appearing at the ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... November 26, 2015 , ... Jobs in hospital medical ... professionals and offered by healthcare staffing agency Aureus Medical Group . ... of October 2015 among those searching for healthcare jobs through the company’s website, ...
(Date:11/26/2015)... ... November 26, 2015 , ... WorldCare International, Inc., the first ... annual Employee Benefits Conference. The Employee Benefits Conference was hosted by the International ... November 11th, 2015. The conference was held at the Hawaii Convention Center in ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... and wellness consultation, has collaborated with Women’s Web – an online resource ... on topics on mental and emotional well-being relationship, life balance, stress, professional ...
(Date:11/25/2015)... ... November 25, 2015 , ... Additional breast cancers found with ... according to a study published online in the journal Radiology. Researchers said that ... necessitate a change in treatment. , Breast MRI is the most sensitive technique ...
(Date:11/25/2015)... ... November 25, 2015 , ... The holiday ... dish and pleasing the palates of attendees is of the utmost importance. Whether ... a seasonal get-together, give these recipes a try this holiday season. , Turkey ...
Breaking Medicine News(10 mins):