课件：贝伐在卵巢癌研究.ppt

* * In this slide, we see the academic (MRC) analysis of PFS. This is very similar to the regulatory analysis. The striking point is the crossing of the curves at around 23 months (11 months after the last dose of bevacizumab). As Dr Tim Perren explained at ESMO, this presents a challenge when interpreting the statistics. The crossing implies that the hazards are not proportional. As the assumption that hazards are proportional is not true, the hazard ratio and the median may not be the most appropriate way of describing the differences between the two treatment regimens. * * * * * * * * * * 2008 * * * * GOG-0218 (Arm I vs III) ICON7 Results of primary analysis n PFS (HR) Median PFS, months PFS ? , months p value 1,248 0.70 10.6 vs 14.7 4.1 0.0001 1,528 0.87 17.4 vs 19.8 2.4 0.039 CA125 and NPT censored RECIST n PFS (HR) Median PFS, months PFS ? , months p value 1,248 0.62 12.0 vs 18.2 6.2 0.0001 1,528 0.87 17.4 vs 19.8 2.4 0.039 1. Burger, et al. Gynecologic Oncology Group.N Engl J Med. 2011 Dec 29;365(26):2473-83 2. Perren, et al. N Engl J Med. 2011 Dec 29;365(26):2484-96 在卵巢癌的两个III期临床研究中一线接受 bevacizumab 联合标准化疗后续 bevacizumab 单药治疗明显提高患者 PFS GOG-0218以及ICON7高风险亚组分析结果支持bevacizumab运用于晚期具有肿瘤残余的卵巢癌患者 Bevacizumab 无论联合化疗或单用时均显示出可控制的毒性反应且并无新的安全隐患出现 Avastin Summary of Product Characteristics * Avastin represents a major and much needed breakthrough and clinical advance for women with OC, as well as a very important growth opportunity and focus for the franchise and the company Our two positive phase II trials have demonstrated that advanced patients with residual disease benefit the greatest from Avastin. Both GOG 218 and ICON 7 show the clinical benefit of Avastin in this front line population And now we have OCEANS, and you will soon see the results of this trial, showing clinical benefit in the recurrent platinum sensitive setting. * * 2008 * * * * * * * * * * * * * * * Number at risk Early 265 247 211 165 131 94 72 39 27 22 15 Delayed 264 236 203 167 129 103