转移性乳腺癌的化疗进展—培训课件.pptVIP

* 目前另一个评估泰素…治疗MBC的随机III期临床试验ACCOG BR研究正在进行中，这个研究比较了… 毫无疑问，ACCOG BR研究将进一步确立泰素每周方案在MBC治疗中的地位 * * * This slide lecture program provides an overview of results from a multicenter, randomized phase III trial conducted by the TAX 311 Clinical Trialists to compare single-agent docetaxel with single-agent paclitaxel in patients with metastatic breast cancer that had progressed after treatment with an anthracycline-containing chemotherapy regimen. This multicenter study was conducted at 56 institutions in the U.S. and Canada. Results were presented by Dr. Peter Ravdin at the 12th European Cancer Conference held in Copenhagen, Denmark, September 21-25, 2003. This is the first randomized phase III trial to directly compare the taxanes, docetaxel and paclitaxel, in patients with advanced breast cancer. U.S. Food and Drug Administration (FDA)-approved doses and schedules were used. Due to molecular, pharmacokinetic, and pharmacodynamic differences observed between docetaxel and paclitaxel, as well as distinct preclinical activity, with only indirect clinical comparisons, the rationale for the TAX 311 study to compare their safety and efficacy in metastatic breast cancer patients is strong. Results of phase II and phase III trials have demonstrated high activity for both docetaxel and paclitaxel in patients with advanced breast cancer. Response rates with single-agent docetaxel in phase III trials have ranged from 30% to 48%, with time to tumor progression ranging from 4.0 to 6.5 months and overall survival ranging from 10.4 to 18.3 months. Response rates with single-agent paclitaxel in phase III trials have ranged from 16% to 34%, with time to tumor progression ranging from 3.0 to 4.2 months and overall survival ranging from 9.8 to 22.2 months. Thus, a randomized comparison of taxane monotherapy in the treatment of advanced breast cancer represents a key study to accurately compare the clinical efficacy and safety of docetaxel and paclitaxel. References Bonneterre et a