Table 2.
Clinical response and outcomes
| A (Placebo; PLAC) | B (Bevacizumab; BEV) | Total | |
|---|---|---|---|
| n = 48 | n = 48 | n = 96 | |
| Best Overall Response | n (%) | n (%) | n (%) |
| CR | 4(8) | 6(13) | 10(10) |
| PR | 22(46) | 23(48) | 45(47) |
| Stable | 13(27) | 9(19) | 22(23) |
| PD | 6(13) | 5(10) | 8(8) |
| Not evaluable | 3(6) | 5(10) | 8(8) |
| Progression-Free Survival | |||
| # of events | 44 | 39 | 83 |
| Median in months(95% CI) | 11.1(8.7–12.4) | 13.8(10.6–22.5) | |
| HR* (95%CI), p value** | |||
| Univariate | 0.73(0.43–1.23),0.24 | ||
| Multivariable*** | 1.09(0.61–1.97),0.75 | ||
| Overall Survival | |||
| # of events | 32 | 27 | 59 |
| Median Follow-up (months) | 71.4 | 70.6 | 70.7 |
| Median in months(95% CI) | 49.1(37.2–67.4) | 62.9(34.4–72.8 +) | |
| HR* (95%CI), p value** | |||
| Univariate | 1.09(0.61–1.97),p = 0.75 | ||
| Multivariable*** | 1.12(0.62–2.04),p = 0.69 |
*Bevacizumab vs. placebo
**P-values are two-sided and are based on stratified test using stratification factors at randomization
***Adjusted for Age, ERPR, Primary surgery
+ last censored observation as upper limit not reached