中国医科大学刘云鹏主任：抗血管生成对于肿瘤治疗重要意义.ppt

AVF2107g是贝伐单抗第一个III期临床研究，基于该研究结果，FDA批准其用于转移性结直肠癌治疗，这是美国第一个获得批准上市的肿瘤血管生成抑制药。 该研究将未经治疗的转移性结直肠癌随机分组，其中402例患者接受IFL+贝伐单抗（5mg/mg 每2周1次）治疗，411例患者接受IFL＋安慰剂治疗。主要终点为总生存期（OS）。 * 贝伐珠单抗的抑制VEGF的作用机制决定了其联合化疗可以提高肿瘤治疗的疗效。多种肿瘤的多项随机对照临床研究表明，抗血管生成药物贝伐珠单抗（Avastin）联合抗细胞增殖药物的A+方案能够显著延缓疾病进展，延长患者生存：AVF2107g研究（IFL+贝伐珠单抗与IFL的OS比较）显示：贝伐珠单抗（Avastin）与伊立替康、氟尿嘧啶、亚叶酸钙联合使用（贝伐珠单抗+IFL组），一线治疗转移性结直肠癌患者，显著优于IFL组, 使总生存期延长近5个月； * 这是一项随机、对照、多中心的III期研究，共纳入878名初治、复发性或晚期非鳞型NSCLC患者，旨在明确贝伐珠单抗＋PC方案的疗效和安全性。 * 对于非小细胞肺癌患者，一线联合卡铂和紫杉醇，使晚期非鳞癌患者的总生存期首次突破1年, 而腺癌患者的总生存期更是达到了14.2个月。 * Last updated September 2, 2009 This slide shows the study design for the E2100 phase III trial of weekly paclitaxel with or without Avastin as first-line therapy for LR/mBC. This was a multicentre randomised trial carried out by the Eastern Cooperative Oncology Group (ECOG) in the USA.1 722 patients with chemotherapy-na?ve LR/mBC were randomised to receive paclitaxel (90 mg/m2/week for 3 weeks of a 4-week cycle) either alone (n=354) or combined with Avastin (10 mg/kg every 2 weeks; n=368). Randomisation was stratified by disease-free interval (24 vs ≥24 months), number of metastatic sites (3 vs ≥3), treatment with chemotherapy in the adjuvant setting (yes vs no) and oestrogen receptor status (positive vs negative vs unknown). Patients were treated until disease progression (as assessed by the investigator) or unacceptable toxicity. Patients in the paclitaxel-alone arm were not permitted to cross over to receive Avastin at disease progression. If patients in the Avastin plus paclitaxel arm discontinued either agent before disease progression, they were allowed to continue with single-agent therapy (Avastin or paclitaxel alone) until progression. The primary objective was to evaluate the efficacy of Avastin plus paclitaxel compared with paclitaxel alone as measured by PFS. This was defined as time from randomisation until disease progression (determined by ECOG review of investigator-reported data) or death from any cause. Secondary object