束永前幻灯.pptVIP

Abraxane?在胃癌及卵巢癌中的应用 江苏省人民医院 束永前 试验设计 晚期/复发胃或胃食管结合部腺癌 未接受过化疗，或经新辅助、辅助化疗结束超过6个月出现进展 有可测量病灶 KPS70 重要脏器功能符合要求 研究初步结果 181例，现可评价126例(其余正在随访中) CR 3例，PR 54例 (RR45.3%) SD 43例（36.8%） PD 25例（21.4％） 不良反应（3/4度，5%） 白细胞减少、中性粒细胞减少、脱发 → III 期临床试验 Abraxane?治疗晚期胃癌应用经验（日本） Phase II Study of ABI-007 for Gastric Cancer Purpose The purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for recurrence or unresectable gastric cancer patients who have received one prior regimen containing fluoropyrimidine and developed disease progression or recurrence. Endpoints Primary endpoint: Overall response rate Secondary endpoints: Safety Progression-free survival Overall survival Disease control rate Sample size: 53 expected response rate 25% threshold 10% Eligibility Inclusion Criteria: Histologically or cytologically confirmed gastric adenocarcinoma Received one prior regimen containing fluoropyrimidine analogs and developed disease progression or recurrence Age: 20 - 74 At least one measurable lesion by RECIST criteria Eligibility Exclusion Criteria: History of Taxane use Patients with another active malignancy Pre-existing peripheral neuropathy of Grade 2 (CTCAE) Chronic treatment with steroids Patient Characteristics Treatment course Response rate Adverse　Events 2nd line chemotherapy trials Abraxane?治疗卵巢癌 紫杉类药物胃癌治疗评价 目前常用化疗方案 ( 转移性/局部晚期胃癌 ) 一线 5-FU/CAPE+DDP/EPI/OXA/DOC 二线 DOC/PAC IRI 国内胃癌化疗方案现状 晚期胃癌一线治疗III期临床研究 Study Regimen N RR (%) p-value MST p-value V325 2006 DCF CF 221 224 37 25 .012 9.2m 8.6m 0.02 Kang Y 2006 XP FP 160 156 41 29 0.03 10.5m 9.3 m 0.27 S. Al-Batran 2006 FLO FP 98 102 34 27 0.012 5.7(TTP) 3.8 0.081 Wasaburo 2008 S-1+PDD S-1 145 150 54 31 .002 13.0m 11.0 m 0.04 Cunningham 2008 ECF ECX EOF EOX 249 241 235 239 40.7 46.4 42.4 47.9 NS 9.9 m 9.9 m 9.3m 11.2 m NS 紫杉醇联合卡培他滨序贯卡培他滨 维持方案一线治疗晚期胃癌的 开放、非对照