Sanofi-aventis has announced, at the ASCO Prostate Cancer Symposium, long term survival results of the large TAX 327 phase III clinical trial.
The overall survival benefit for the patients with metastatic hormone refractory prostate cancer (mHRPC), receiving 3-weekly 75mg/m2 Taxotere (docetaxel)-prednisone regimen compared to mitoxantrone-prednisone gives a median survival 19.3 months vs. 16.3 months, resulting in a reduction of the risk of death by 21 per cent for patients receiving the 3-weekly 75mg/m2 Taxotere-prednisone regimen.
These results are consistent with the data from the original analysis. The survival benefit is observed regardless of age, presence or absence of pain and baseline PSA (Prostate Specific Antigen) level, performance status and quality of life measured with FACT-P at baseline level.
These results were highly significant in patients with high PSA at baseline level, absence of pain, with good performance status and patients with impaired quality of life. Statistical significance of median survival was not reach regarding age, PSA < 115ng/ml, presence of pain, performance status 80 per cent and quality of life with FACT-P = 109.
The results of the weekly Taxotere regimen remain comparable as when reported in 20041, with the same trend for survival. From the initial 2004 results, the most commonly observed adverse events in patients receiving Taxotere 3-weekly were anaemia, alopecia, fatigue and nausea and the incidence of grade 3 and 4 neutropenia was 32 per cent vs. 22 per cent and febrile neutropenia occurring in 3 per cent of the patients treated with the 3-weekly 75mg/m2 Taxotere-prednisone regimen, compared to 2 per cent with the mitoxantrone-prednisone regimen.
"This update of the TAX327 study has demonstrated statistically significant improved survival for all patients and for those without pain or with high PSA level and confirms that 3-weekly 75mg/m2 Taxotere plus prednisone is the first-line standard of care in patients with metastatic hormone refractory prostate cancer", said Dr Ian Tannock, MD, Department of Medical Oncology and Haematology, princess Margaret Hospital and University of Toronto and co-chair of the TAX 327 study.