抗肿瘤靶向药物赵军(北京大学)分析.ppt

易瑞沙抗肿瘤的近期疗效方面,我们可以看到客观缓解率一致地保持在15%-55%左右 Reference Park K, Goto K. A review of the benefit-risk profile of Gefitinib in Asian patients with advanced non-small-cell lung cancer. Current Medical Research and Opinions 2006; 22 (3): 561-573. 中国注册临床显示，易瑞沙的常见药物不良反应有皮疹,腹泻等 但大部分为CTC I-II级,不需处理;与研究药物相关或可能相关的CTC III-IV级不良事件共5例;未见发生明确的肺间质病变的病例 Reference 管忠震, 张力, 李龙芸等. 吉非替尼治疗局部晚期或转移性非小细胞肺癌在中国的临床研究. 癌症 2005; 24(8): 980-984. Advances in the treatment of non-squamous metastatic NSCLC have led to increasingly longer overall survival (OS). In the 1970s, OS with best supportive care was 2–5 months. OS improved in the 1980s and 1990s with the introduction, respectively, of single-agent platinum (6–8 months) and platinum-based doublet chemotherapy (8–10 months) (Schiller et al. 2002). Avastin in combination with platinum-based doublet chemotherapy has achieved the longest OS in patients with non-squamous metastatic NSCLC (12.3 months) (Sandler et al 2006). References Schiller JH, et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 2002;346:92–8. Sandler A, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006;355:2542–50. In the E4599 trial (Sandler et al. 2006), 878 patients with recurrent or advanced NSCLC (stage IIIB or IV) were randomised to 15mg/kg Avastin with carboplatin/paclitaxel (CP) (n=434) or CP alone (n=444) every 3 weeks for six cycles until disease progression or unacceptable toxicity. The 15mg/kg dose was chosen based on its activity in an earlier phase II trial (Johnson et al. 2004). The primary endpoint for E4599 was overall survival (OS). In the Avastin in Lung cancer (AVAiL [BO17704]) trial (Manegold et al. 2007), 1,043 patients with advanced or recurrent non-squamous NSCLC were randomised to cisplatin/gemcitabine (CG) for up to six cycles plus 7.5?mg/kg Avastin (n=345), 15?mg/kg Avastin (n=351) or placebo (n=347) every 3 weeks until disease progression or un