常见的贝伐在卵巢癌研究.ppt

* * 2008 * * * * * 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 * * * * * * * * * * * * * * * * * 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. * * * * * * * * GOG-0218:不同治疗时期的不良事件 Selected adverse events, No. of patients Arm I CP + Pla ? Pla Arm II CP + Bev ? Pla Arm III CP + Bev ? Bev (n=601) (n=483) (n=607) (n=457) (n=608) (n=464) Cycles, n 2906 4059 2911 4204 2891 4677 Treatment phasea Cytotoxic (cycles 2–6) Continued (cycles 7–22) Cytotoxic (cycles 2–6) Continued (cycles 7–22) Cytotoxic (cycles 2–6) Continued (cycles 7–22) GI eventsb (grade ≥2) 6 1 16 1 15 1 Hypertension (grade ≥2) 21 22 64 36 60 79 Proteinuria (grade ≥3) 2 2 4 0 0 10 Pain (grade ≥2) 127 123 117 135 112 174 Neutropenia (grade ≥4) 345 2 382 2 385 0 Febrile neutropenia (all grades) 21 0 30 0 26 0 VTE (all grades) 26 9 27 5 27 14 ATE (all grades) 4 1 1 3 3 1 Wound-healing complications (all gr