Aventis, part of the sanofi-aventis Group announced that the European Commission has approved Taxotere (docetaxel) Injection Concentrate for use in combination with prednisone as a treatment for men with androgen-independent (hormone-refractory) metastatic prostate cancer.
The Commission approval is based on the results of a large landmark phase III clinical trial, TAX 327, which demonstrated that a Taxotere-based regimen significantly reduced the risk of death by 24 per cent in men with androgen-independent (hormone-refractory) metastatic prostate cancer. Investigators in the TAX 327 trial also reported that Taxotere significantly improved patients' Prostate Specific Antigen (PSA) response by 43 per cent and improved pain response by 59 per cent, relative to mitoxantrone, the company release says.
In the TAX 327 trial, investigators reported that 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% Vs 21.7%, p=0.004).
"Finally, we can offer our patients an effective chemotherapy for prostate cancer. The pivotal results of the TAX 327 study not only demonstrated a significant survival improvement, but also a significant improvement in the quality of life and improved pain response of patients, even during their chemotherapy." said Ronald de Wit, lead European Investigator for TAX 327, Associate Professor, Senior Staff Medical Oncologist, Erasmus University Medical Centre, Rotterdam, the Netherlands, and service chief of medical oncology, Rotterdam Cancer Institute.
The results of this pivotal study were presented in June 2004 at the American Society of Clinical Oncology meeting (ASCO). On May 19, 2004, the US FDA granted Taxotere approval for use in combination with prednisone as a treatment for men with hormone-refractory metastatic prostate cancer.
Prostate cancer ranks third worldwide in cancer incidence and sixth in cancer mortality among men. In the European Union, 138,000 new cases will be diagnosed, and 45,000 patients will die of the disease.
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.