Patient characteristics at baseline
| Characteristics | Age < 70 y(n = 162) | Age ≥ 70 y(n = 48) |
|---|---|---|
| Gender, n (%) | ||
| Men | 96 (60) | 33 (70) |
| Women | 64 (40) | 14 (30) |
| Age | ||
| Median, years | 59 | 72 |
| Range, years | 24–69 | 70–81 |
| ECOG performance status, n (%) | ||
| 0 | 104 (64) | 18 (38) |
| 1 | 52 (32) | 27 (56) |
| 2 | 6 (4) | 3 (6) |
| 3 | 0 | 0 |
| Site of metastatic disease, n (%) | ||
| Liver | 112 (69) | 35 (73) |
| Lung | 39 (24) | 12 (25) |
| Lymph nodes | 42 (26) | 12 (25) |
| Bones | 6 (4) | 3 (6) |
| Other | 64 (40) | 13 (27) |
| Primary tumour location, n (%) | ||
| Colon only | 106 (65) | 31 (65) |
| Rectum only | 56 (35) | 16 (33) |
| Colon and rectum | 0 | 1 (2) |
| Adjuvant chemotherapy, n (%) | 50 (31) | 18 (38) |
| Previous radiotherapy, n (%) | 30 (19) | 9 (19) |
| Surgical resection, n (%) | 132 (82) | 42 (88) |
Efficacy outcomes
| Outcomes | Age < 70 y(n = 162) | Age ≥ 70 y(n = 48) |
|---|---|---|
| Best response, n (%) | ||
| Complete | 9 (6) | 4 (8) |
| Partial | 60 (37) | 13 (27) |
| Stable disease | 57 (35) | 14 (29) |
| Progressive disease | 21 (13) | 6 (13) |
| Not evaluable | 7 (4) | 6 (13) |
| Overall response rate, % (95% CI) | 69 (43) | 17 (35) |
| Disease-control rate, % (95% CI) | 126 (78) | 31 (65) |
| Progression free survival, months | ||
| Median (95% CI) | 11.3 (10.2–12.6) | 10.2 (6.7–16.2) |
| Overall survival, months | ||
| Median (95% CI) | 27.4 (22.7–31.9) | 18.5 (12.4–28.9) |
| Metastasectomy, n (%) | 32 (21.2) | 6 (15) |
Targeted adverse events
| Adverse event | No. of patients (%) | Total | |||
|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | ||
| < 70 years (n = 162) | |||||
| Hypertension | 11 (6.8) | 15 (9.3) | 5 (3.1) | 0 (0) | 30 (18.5) |
| Thromboembolism | 1 (0.6) | 4 (2.5) | 4 (2.5) | 0 (0) | 9 (5.6) |
| Proteinuria | 23 (14.2) | 11 (6.8) | 2 (1.2) | 0 (0) | 36 (22.2) |
| Hemorrhage | 4 (2.5) | 1 (0.6) | 0 (0) | 1 (0.6) | 6 (3.7) |
| Infection | 4 (2.5) | 1 (0.6) | 4 (2.5) | 0 (0) | 8 (4.9) |
| > 70 years (n = 48) | |||||
| Hypertension | 3 (6.2) | 6 (12.5) | 2 (4.2) | 0 (0) | 12 (25) |
| Thromboembolism | 0 (0) | 1 (2.1) | 2 (4.2) | 2 (4.2) | 5 (10.4) |
| Proteinuria | 7 (14.6) | 3 (6.2) | 0 (0) | 0 (0) | 10 (20.8) |
| Hemorrhage | 0 (0) | 0 (0) | 1 (2.1) | 0 (0) | 1 (2.1) |
| Infection | 0 (0) | 1 (2.1) | 0 (0) | 0 (0) | 1 (2.1) |