>>Another asked specifically about the taxotere study which had 2.5 month median survival advantage..the CEO went back to his response that "these survival #'s are better than any published P3 prostate late stage prostate cancer.">>
The study he was referring to was most probably TAX 327.
Aventis Receives FDA Approval for Taxotere®
24 May 2004
London, UK, May 24, 2004 – Aventis announced that the U.S. Food and Drug Administration (FDA) has approved, in record time, Taxotere® (docetaxel) Injection Concentrate for use in combination with prednisone as a treatment for men with androgen-independent (hormone-refractory) metastatic prostate cancer.
The fast-tracked FDA approval - taking a total of 113 days - supports the strength of the phase III clinical data and the survival benefit it will bring to prostate cancer patients.
The FDA approval is based on the final results of a landmark phase III clinical trial that met its primary endpoint of increasing survival in this patient population. The pivotal study, TAX 327 - which involved six centres across the UK - along with an additional study of Taxotere in this patient population, have been selected for presentation at the Plenary Session at the American Society of Clinical Oncology (ASCO) annual meeting on Monday, 7th June, New Orleans, LA.
And this is the abstract as published in NEJM for this study.
Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer
Ian F. Tannock, M.D., Ph.D., Ronald de Wit, M.D., William R. Berry, M.D., Jozsef Horti, M.D., Anna Pluzanska, M.D., Kim N. Chi, M.D., Stephane Oudard, M.D., Christine Théodore, M.D., Nicholas D. James, M.D., Ph.D., Ingela Turesson, M.D., Ph.D., Mark A. Rosenthal, M.D., Ph.D., Mario A. Eisenberger, M.D., for the TAX 327 Investigators
N Engl J Med. 2004 Oct 7; 351(15): 1502-12
ABSTRACT
Background
Mitoxantrone plus prednisone reduces pain and improves the quality of life in men with advanced, hormone-refractory prostate cancer, but it does not improve survival. We compared such treatment with docetaxel plus prednisone in men with this disease.
Methods
From March 2000 through June 2002, 1006 men with metastatic hormone-refractory prostate cancer received 5 mg of prednisone twice daily and were randomly assigned to receive 12 mg of mitoxantrone per square meter of body-surface area every three weeks, 75 mg of docetaxel per square meter every three weeks, or 30 mg of docetaxel per square meter weekly for five of every six weeks. The primary end point was overall survival. Secondary end points were pain, prostate-specific antigen (PSA) levels, and the quality of life. All statistical comparisons were against mitoxantrone.
Results
As compared with the men in the mitoxantrone group, men in the group given docetaxel every three weeks had a hazard ratio for death of 0.76 (95 percent confidence interval, 0.62 to 0.94; P=0.009 by the stratified log-rank test) and those given weekly docetaxel had a hazard ratio for death of 0.91 (95 percent confidence interval, 0.75 to 1.11; P=0.36). The median survival was 16.5 months in the mitoxantrone group, 18.9 months in the group given docetaxel every 3 weeks, and 17.4 months in the group given weekly docetaxel. Among these three groups, 32 percent, 45 percent, and 48 percent of men, respectively, had at least a 50 percent decrease in the serum PSA level (P<0.001 for both comparisons with mitoxantrone); 22 percent, 35 percent (P=0.01), and 31 percent (P=0.08) had predefined reductions in pain; and 13 percent, 22 percent (P=0.009), and 23 percent (P=0.005) had improvements in the quality of life. Adverse events were also more common in the groups that received docetaxel.
Conclusions
When given with prednisone, treatment with docetaxel every three weeks led to superior survival and improved rates of response in terms of pain, serum PSA level, and quality of life, as compared with mitoxantrone plus prednisone. |
