在胃癌及卵巢癌中的应用课件.ppt

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 * 2007 09 27 - 02:06:42 PM 52 43 ESA 1255 2007 05 14 - 04:33:17 PM 51 39 ESA 1217Study #: ABI-036 Reviewed and Approved by External Scientific Affairs: Slide Deck ID - ESA 1255 - September 2007 * 2007 09 27 - 02:06:42 PM 52 44 ESA 1255 2007 05 14 - 04:33:17 PM 51 40 ESA 1217Non-randomized trial Patient characteristics Median age (range) 67 years (32-83 years) Male 22 (44%) Female 28 (56%) ECOG PS 0 26 (52%) 1 24 (48%) Site of metastatic disease (patients may have had more than 1 site) Adrenals 6 (12%) Bone 14 (28%) Liver 14 (28%