课件：肉瘤化疗SUCCEED ASCO 2011.ppt

The study met its primary endpoint of Progression Free Survival with a Hazard ratio of 0.72 based on central review, with a p value of 0.0001. The parameters of 3 and 6 months PFS rates are commonly used in sarcoma field, including by the EORTC sarcoma group. The 3 month PFS rate was 70% in the rida arm and 54% in the placebo arm, which represents a 30% improvement. The 6 month PFS rates was 34% in the rida arm and 23% in the placebo arm, which represents a 51% improvement. The median PFS duration was 17.7 weeks in the rida arm and 14.6 weeks in the placebo arm . This is the Kaplan Meier curve as per local investigator assessment. The shape and trend of the curve is similar to the curve based on central radiology review as shown on the previous slide. The Hazard Ratio reported in this assessment was 0.69 with a p value of 0.0001. This represented a 31% reduction in the risk of death or disease progression in the rida arm. The 3 and 6 month PFS rates shown here are similar to those of central review showing an improvement of 30% in PFS at 3 months and 60% in 6 months in the rida arm. The median PFS duration was 22.4 weeks in the rida arm and 14.7 in the placebo arm. This Forest plot shows multiple sub groups analyzed. Almost all the points lie on the left side of the neutral point . This illustrates that the benefit of rida persists throughout almost the all the subgroups analyzed. This graph shows Overall survival. The median duration of OS was 21.4 months for the rida arm and 19.2 months for the placebo arm, with a difference of 2.2 months. This is a positive trend for improving survival in the rida arm, but it is not statistically significant. To power the study to demonstrate an overall survival benefit would require over 2000 patients. As stated before, Clinical Benefit Response was defined by CR, PR, or stable disease lasting over 4 months. Clinical Benefit Response was 41% in the rida group and 29% for the placebo group with a