Table 1 Baseline characteristics of participants in the phase Ib and the phase II trials
Characteristics | Phase Ib N (%) | Phase II N (%) | ||
|---|---|---|---|---|
(n=42) | Fruquintinib group (n=47) | Placebo group (n=24) | P value | |
Age (years) | ||||
Median, range | 55.5, 33.0–70.0 | 50.0, 25.0–69.0 | 54.0, 38.0–70.0 | 0.090 |
Gender | ||||
Male | 25 (59.5) | 35 (74.5) | 17 (70.8) | 0.743 |
Female | 17 (40.5) | 12 (25.5) | 7 (29.2) | |
Baseline ECOG PS score | ||||
0 | 8 (19.0) | 6 (12.8) | 5 (20.8) | 0.374 |
1 | 34 (81.0) | 41 (87.2) | 19 (79.2) | |
Duration from first metastasis Diagnosis to randomization | ||||
≤18 months | NA | 20 (42.6) | 14 (58.3) | 0.208 |
>18 months | NA | 27 (57.4) | 10 (41.7) | |
Prior treatment line on or above metastatic disease | ||||
2–3 | 18 (42.9) | 30 (63.8) | 17 (70.8) | 0.555 |
>3 | 24 (57.1) | 17 (36.2) | 7 (29.2) | |
Previous chemotherapy lines | ||||
2 | 5 (11.9) | 12 (25.5) | 7 (29.2) | 0.743 |
≥3 | 37 (88.1) | 35 (74.5) | 17 (70.8) | |
Prior VEGF inhibitor treatment | ||||
Yes | 10 (23.8) | 15 (31.9) | 7 (29.2) | 0.412 |
No | 32 (76.2) | 29 (61.7) | 17 (70.8) | |
Unknown | 0 | 3 (6.4) | 0 | |
Primary site | ||||
Colon | 21 (50.0) | 24 (51.1) | 13 (54.2) | 0.804 |
Rectal | 20 (47.6) | 23 (48.9) | 11 (45.8) | |
Cecum | 1 (2.4) | 0 | 0 | |
Metastatic site | ||||
Single | 5 (11.9) | 2 (4.3) | 2 (8.3) | 0.481 |
Multiple | 37 (88.1) | 45 (95.7) | 22 (91.7) | |
Liver metastasis | ||||
Yes | 29 (69.0) | 29 (61.7) | 17 (70.8) | 0.446 |
No | 13 (31.0) | 18 (38.3) | 7 (29.2) | |