Table 2.
Efficacy according to RECIST 1.1.
| Efficacy parameters | FOLFOX/bevacizumab (N = 121) | FOLFOXIRI/bevacizumab (N = 121) | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| PFS rate at 9 months | 56.2% | 66.9% | – | 0.086§ | |
| PFS | 10.3 months | 12.0 months | 0.84 (0.64–1.09) | 0.19* | |
| OS | 24.0 months | 28.0 months | 0.85 (0.62–1.12) | 0.24* | |
| CR + PR | 69 (60.5%) | 79 (69.3%) | – | 0.21# | |
| CR | 6 (5.3%) | 6 (5.3%) | |||
| PR | 63 (55.3%) | 73 (64%) | |||
| Sec. R0/1 resection | 15% | 20% | – | 0.39# | |
| Group 1 (potentially resectable) | PFS | 11.4 months | 12.9 months | 0.83 | 0.46 |
| OS | 29.0 months | 29.9 months | 0.73 | 0.23 | |
| RR | 56.2% | 67.6% | – | 0.45 | |
| Sec. R0/1 resection | 37.1% | 51.4% | – | 0.33 | |
| GHS mean ± SD (n) at w24 | 62.9 ± 12.6 (11) | 53.6 ± 16.6 (7) | – | 0.156$ | |
| Group 2 (unresectable/risk of rapid progression) | PFS | 9.6 months | 11.5 months | 0.94 | 0.73 |
| OS | 20.3 months | 25.6 months | 0.95 | 0.78 | |
| RR | 62.5% | 67.7% | – | 0.58 | |
| Sec. R0/1 resection | 6.0% | 7.5% | – | 1.0 | |
| GHS mean ± SD (n) at w24 | 65.2 ± 15.8 (22) | 61.6 ± 19.8 (28) | – | 0.556$ | |
| Group 3 (asymptomatic, slow progress) | PFS | 11.1 months | 16.1 months | 0.6 | 0.14 |
| OS | 30.8 months | 29.4 months | 0.84 | 0.62 | |
| RR | 61.1% | 77.8% | – | 0.47 | |
| Sec. R0/1 resection | 6% | 7.5% | – | 1.0 | |
| GHS mean ± SD (n) at w24 | 50 ± 13.9 (6) | 64.2 ± 22.6 (10) | – | 0.185$ | |
n number, PFS progression-free survival, OS overall survival, ORR overall response rate, CR complete response, PR partial response, CI confidence interval, SD standard deviation.
Test methods (two-sided): §stratified logistic regression, *logrank-test, #Fisher’s exact test, $Mann–Whitney U Test).
Significant P values are highlighted.