Table 1.
Baseline characteristics of patients with metastatic colorectal cancer (mCRC) who were treated with famitinib or placebo in the full analysis set
| Characteristic | Whole cohort | Famitinib group | Placebo group | P value |
|---|---|---|---|---|
| Total (cases) | 154 | 99 | 55 | |
| Age (years) | 0.352 | |||
| Mean ± SD | 54.1 ± 9.5 | 54.7 ± 9.9 | 53.2 ± 8.8 | |
| Median (range) | 55 (24–71) | 55 (24–70) | 54 (32–71) | |
| Age group [cases (%)] | 0.437 | |||
| > 60 years | 106 (68.8) | 66 (66.7) | 40 (72.7) | |
| ≤ 60 years | 48 (31.2) | 33 (33.3) | 15 (27.3) | |
| Gender [cases (%)] | 0.679 | |||
| Male | 89 (57.8) | 56 (56.6) | 33 (60.0) | |
| Female | 65 (42.2) | 43 (43.4) | 22 (40.0) | |
| ECOG performance status [cases (%)] | 0.776 | |||
| 0 | 27 (17.5) | 18 (18.2) | 9 (16.4) | |
| 1 | 127 (82.5) | 81 (81.8) | 46 (83.6) | |
| LDH level [cases (%)] | 0.663 | |||
| ≤ 1.5 × ULN | 126 (81.8) | 80 (80.8) | 46 (83.6) | |
| > 1.5 × ULN | 28 (18.2) | 19 (19.2) | 9 (16.4) | |
| Number of metastatic organs [cases (%)] | 0.499 | |||
| ≤ 2 | 84 (54.5) | 56 (56.6) | 28 (50.9) | |
| > 2 | 70 (45.5) | 43 (43.4) | 27 (49.1) | |
| Primary site of disease [cases (%)] | 0.485 | |||
| Rectum | 73 (47.4) | 49 (49.5) | 24 (43.6) | |
| Colon | 81 (52.6) | 50 (50.5) | 31 (56.4) | |
| History of primary tumor resection [cases (%)] | 0.559 | |||
| No | 14 (9.1) | 10 (10.1) | 4 (7.3) | |
| Yes | 140 (90.9) | 89 (89.9) | 51 (92.7) | |
| History of anti-tumor monoclonal antibody therapy [cases (%)] | 0.579 | |||
| No | 83 (53.9) | 55 (55.6) | 28 (50.9) | |
| Yes | 71 (46.1) | 44 (44.4) | 27 (49.1) | |
| Famitinib treatment as [cases (%)] | 0.622 | |||
| Third-line therapy | 60 (39.0) | 40 (40.4) | 20 (36.4) | |
| > Third-line therapy | 94 (61.0) | 59 (59.6) | 35 (63.6) | |
| White blood cell count (109/L) | 0.646 | |||
| Mean ± SD | 6.6 ± 2.5 | 6.7 ± 2.4 | 6.5 ± 2.7 | |
| Median (range) | 6.1 (3.0–17.0) | 6.2 (3.0–15.0) | 5.8 (3.0–17.0) | |
| Alkaline phosphatase (U/L) | 0.887 | |||
| Mean ± SD | 127.3 ± 82.8 | 126.6 ± 82.6 | 128.6 ± 84.0 | |
| Median (range) | 104.0 (26.0–580.0) | 105.0 (26.0–580.0) | 103.0 (46.0–458.0) | |
SD standard deviation, ECOG Eastern Cooperative Oncology Group, LDH lactate dehydrogenase, ULN upper limit of normal