西妥昔单抗CRC关键临床研究及策略解读.pptVIP

Take home message 一、核心策略以及信息：总体策略，pap，内外科 二、如何应对 * * * * - Baseline treatment characteristics, in terms of the type and number of prior lines of therapy, were well balanced between the two treatment arms. - Nearly 80% of the patients who underwent randomization had received two or more lines of prior treatment for cancer. - All the patients had received prior irinotecan therapy. - In addition, 206 (62.6%) patients had received prior oxaliplatin therapy. 1. Cunningham D, Humblet Y, Siena S, et al. N Engl J Med 2004;351:337-345 * - The ITT analysis showed a statistically significantly longer median time to progression (4.1 versus 1.5 months, p0.001) for the ERBITUX plus irinotecan combination compared with ERBITUX monotherapy. - The hazard ratio for disease progression in the combination therapy group as compared with the monotherapy group was 0.54, indicating a 46% reduction in the risk of progression with combination therapy compared with monotherapy. 1. Cunningham D, Humblet Y, Siena S, et al. N Engl J Med 2004;351:337-345 * * * * * * * * 在2008年公布了CRYSTAL的部分患者的KRAS结果分析后，研究者又依据原留存的标本检测了更多患者的KRAS表达状态，取得了将近90%的患者的KRAS表达结果，同时在随访时间延长了近1.5年后，增加了161例死亡事件，而KRAS野生型患者中的事件发生率也从62.9%上升到79.6%，使得该研究的数据及后续分析更加全面。 * * * * * * * * * * * Many possible differences, in the end only small numbers and thus not convincing * * * * * * * * * * * The reviewers did not have all information on patients (additional MRI scans may have existed that were not considered) Central, standardized review did not play a part in clinical decision-making * * * * * * * * * * Page * 研究示意图 选择1： FOLFORI + 爱必妥?, q2w KRAS 评估 选择2： FOLFOX + 爱必妥?, q2w 预筛选 筛选/基线 治疗及 每八周一次评价直到PD 无治疗 每三月一次随访 入组 除非已计划进行 二线治疗抗癌治 疗，治疗结束后 至少6周 生存 状态 Page * TAILOR研究：增加样本量，年底完成入组 一项比较西妥昔单抗联合FOLFOX4 方案和单用FOLFOX4 方案一线治疗中国KRAS 野生型转移性结直肠癌患者的开放性、随机的、对照的、多中心Ⅲ期临床研究 （TAILOR研究） 样本量：350－430 西妥昔单抗联合mFOLFOX-6一线治疗KRAS野生型不可切除的结直肠癌肝转移的开放性、非随机、多中心II期临床试验 CLIME研究：入组结束，CSCO期间中期分析 开放、单臂、非随机、多中心的前瞻性研究 研究性质：IST（复旦肿蔡三军教授） 研究人群：90例KRA