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Refractory prostate cancer drug cabazitaxel increases survival rates in patients: Sanofi-Aventis

Thursday, March 4, 2010, 13:30 This news item was posted in Clinical Trials category and has 0 Comments so far.

Cabazitaxel, an investigational compound from Sanofi-Aventis, has been found to improve survival rates in prostate cancer patients.

Data from a phase 3 trial using cabazitaxel along with prednisone/prednisolone significantly improved overall survival and progression-free survival in patients with metastatic (advanced) hormone-refractory prostate cancer whose disease progressed following treatment with docetaxel-based chemotherapy.

Cabazitaxel is a taxane compound that may be active in cell lines refractory to taxanes. Cabazitaxel has been shown to inhibit cell division and tumor cell proliferation by binding to and stabilizing tubulin, a protein in the microtubules of cells which provides a skeleton for maintaining cell shape.

Cabazitaxel recently received fast track designation from the U.S. Food and Drug Administration.

The TROPIC trial compared the combination of cabazitaxel plus prednisone/prednisolone to the active agent mitoxantrone plus prednisone/prednisolone.

For many patients with metastatic hormone-refractory prostate cancer, their disease continues to progress despite prior chemotherapy.

Currently, there are no approved therapies to treat these patients.

“Improved overall survival was demonstrated in this trial – and these are the first data to show a statistical improvement in overall survival in patients with this difficult-to-treat and aggressive form of prostate cancer,” stated  Dr. Oliver Sartor, North American principal investigator, Piltz Professor for Cancer Research at Tulane Medical School, New Orleans.

TROPIC was designed to assess patients with metastatic hormone-refractory prostate cancer whose disease had progressed following treatment with docetaxel-based chemotherapy.

TROPIC was conducted in 146 trial sites in 26 countries throughout the world, including the U.S.

The multi-center Phase 3 randomized registrational trial assessed 755 metastatic hormone-refractory prostate cancer patients whose disease had progressed despite previous docetaxel-based chemotherapy.

The primary endpoint was overall survival. Secondary endpoints included progression-free survival, tumor response rate, tumor progression, prostate-specific antigen (PSA) response, (PSA) progression, pain response, pain progression.

Results showed that the combination of cabazitaxel and prednisone/prednisolone significantly reduced the risk of death by 30% with a clinically meaningful improvement in the median overall survival of 15.1 months in the cabazitaxel combination arm vs. 12.7 months in the mitoxantrone combination arm.

Patients who received the combination treatment with cabazitaxel also experienced a significant increase in median progression-free survival of 2.8 months against 1.4 months.

Sanofi will present cabazitaxel results in San Francisco, CA on March 5 at the 2010 Genitourinary Cancers Symposium sponsored by the American Society for Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO).

What is castration resistant prostate cancer?

Metastatic prostate cancer indicates that the cancer has spread, or metastasized, to the lymph nodes or other parts of the body, mostly to the bones. Castration resistant/hormone-refractory prostate cancer means that the cancer has continued to grow despite the suppression of male hormones that fuel the growth of prostate cancer cells.

More than 80% of all prostate cancer cases are discovered when the disease is limited to the prostate and surrounding organs, while 10-20% of patients are diagnosed when the cancer has already metastasized.

Prostate cancer ranks third in cancer incidence and sixth in cancer mortality in men, worldwide.

In the U.S., prostate cancer remains the second most common cause of cancer death among men after lung cancer. In 2009, an estimated 192,000 new cases were anticipated in the U.S., while 27,000 were expected to have died from the disease.

Sanofi-aventis, a leading global pharmaceutical company.

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