晚期乳腺癌化疗.ppt

晚期乳腺癌化疗 北京大学临床肿瘤学院 任 军 2007--04--24 转移性乳腺癌的主要治疗手段 1．传统化疗 2．密集化疗 3．内分泌治疗 4．分子靶向治疗　 5．干细胞支持下大剂量化疗和造血干细胞　移植 6．新药: 　Epothilone(BMS-247550) Satraplatin (三代铂类） 单药治疗晚期乳腺癌——紫杉醇或多西紫杉醇 TAX 311 -- Study design TAX 311 -- Objective Response  TAX 311 -- Hematologic Toxicity TAX 311 --Non-Hematologic Toxicity Randomized Phase 2 Trial of Weekly or Every-3-Week Docetaxel in Metastatic Breast Cancer (MBC) Climent MA et al. Proc Am Soc Clin Oncol. 2002;21:52a. (abstr 205) Docetaxel weekly vs q 3wk: Schema Docetaxel weekly vs q 3wk: : Results Docetaxel weekly vs q 3wk: : Toxicity Docetaxel weekly vs q 3wk: : Toxicity 联合化疗治疗转移性乳腺癌 目前仅有两个大规模随机、III期临床试验评估了联合化疗方案治疗蒽环类复治转移性乳腺癌的疗效 So 14999研究－泰索帝联合希罗达治疗蒽环类化疗失败MBC的疗效明显优于治疗标准的泰索帝单药 ? JHOG 研究－ 健择联合紫杉醇治疗蒽环类化疗失败MBC的疗效明显优于紫杉醇单药? 分子靶向治疗 Inhibitors of HER pathway Herceptin, Laptinib Antiagiogeneis agents Avastin mTOR inhibitors Sirolimus(西罗莫司）,CCI-779,RAD-001 FTIS Herceptin单药一线治疗MBC(H0650) 病例数114例 (Her2 2+/3+) OR 26% （IHC 3+ 35%） TTP 3.5月 MS 24.4月 赫赛汀单药治疗HER2阳性转移性乳腺癌Ⅲ期临床 研究设计：开放、单组、多中心临床研究 赫赛汀单药二/三线治疗MBC疗效总结 CALGB 9840 Phase III study of weekly paclitaxel via 1-hr infusion vs. standard 3-hr infusion every third week in the treatment of metastatic breast cancer, with trastuzumab for HER2 + MBC and randomized for trastuzumab for HER2 normal MBC CALGB 9840: Rationale Apparent Efficacy and Decreased Toxicity of Weekly Paclitaxel in MBC Survival Benefit for Paclitaxel + Trastuzumab in HER2 (+) MBC Unexplored Potential Efficacy for Trastuzumab in HER2 (-) MBC CALGB 9840Primary Objectives Weekly (W) paclitaxel (P) improves response in MBC Adding trastuzumab (T) to W or S P improves response for HER2 normal MBC CALGB 9840Secondary Objectives Weekly paclitaxel improves TTP or OS Adding trastuzumab (T) to W or S P improves TTP or OS for HER2 normal MBC CALGB 9840: Design (2) Line of Therapy (1st/2nd) HER2 status CALGB 9840Major Eligibility Criteria (I) Measurable