Table 1.
Patient baseline characteristics and demographics
| Demographic variable | FTD/TPI |
BSC |
|---|---|---|
| N = 185 | N = 9 | |
| Age, years | ||
| Arithmetic mean | 66.2 | 71.4 |
| SD | 9.8 | 11.0 |
| Median | 67.0 | 78.0 |
| Range | 40.0-88.0 | 54.0-82.0 |
| Sex, n (%) | ||
| Men | 117 (63.2) | 5 (55.6) |
| Women | 68 (36.8) | 4 (44.4) |
| Ethnicity, n (%) | ||
| Caucasian | 184 (99.5) | 8 (88.9) |
| Hispanic | 1 (0.5) | 0 (0.0) |
| Other | 0 (0.0) | 1 (11.1) |
| ECOG performance status, n (%) | ||
| 0 | 73 (39.5) | 0 (0.0) |
| 1 | 92 (49.7) | 4 (44.4) |
| 2 | 16 (8.6) | 3 (33.3) |
| 3 | 0 (0.0) | 1 (11.1) |
| Unknown | 4 (2.2) | 1 (11.1) |
| Primary tumour site, n (%) | ||
| Colon | 100 (54.1) | 4 (44.4) |
| Rectum | 73 (39.5) | 3 (33.3) |
| Colon, rectum | 10 (5.4) | 2 (22.2) |
| Unknown | 2 (1.1) | 0 (0.0) |
| Sidedness of primary tumour, n (%) | ||
| Left side | 135 (73.0) | 6 (66.7) |
| Right side | 42 (22.7) | 2 (22.2) |
| Both sides | 6 (3.2) | 1 (11.1) |
| Unknown | 2 (1.1) | 0 (0.0) |
| Metastatic sites, n (%) | ||
| Liver | 148 (80.0) | 8 (88.9) |
| Lung | 132 (71.4) | 5 (55.6) |
| Lymph node | 91 (49.2) | 5 (55.6) |
| Peritoneum | 39 (21.1) | 2 (22.2) |
| Other | 48 (25.9) | 1 (11.1) |
| Number of metastatic sites, n (%) | ||
| 1 | 24 (13.0) | 1 (11.1) |
| 2 | 74 (40.0) | 3 (33.3) |
| 3 | 61 (33.0) | 4 (44.4) |
| 4 | 22 (11.9) | 0 (0.0) |
| 5 | 3 (1.6) | 0 (0.0) |
| Unknown | 1 (0.5) | 1 (11.1) |
| Metastatic manifestation, n (%) | ||
| Synchronous | 96 (51.9) | 3 (33.3) |
| Metachronous | 58 (31.4) | 3 (33.3) |
| Unknown | 31 (16.8) | 3 (33.3) |
| Grading (World Health Organization), n (%) | ||
| G1 | 4 (2.2) | 0 (0.0) |
| G2 | 127 (68.6) | 7 (77.8) |
| G2-3 | 3 (1.6) | 0 (0.0) |
| G3 | 27 (14.6) | 1 (11.1) |
| G3-4 | 2 (1.1) | 0 (0.0) |
| G4 | 3 (1.6) | 0 (0.0) |
| GX | 6 (3.2) | 0 (0.0) |
| Unknown | 13 (7.0) | 1 (11.1) |
| RAS status, n (%) | ||
| Wild-type | 72 (38.9) | 4 (44.4) |
| Mutant | 101 (54.6) | 3 (33.3) |
| Unknown | 12 (6.5) | 2 (22.2) |
| BRAF V600E status, n (%) | ||
| Wild-type | 65 (35.1) | 1 (11.1) |
| Mutant | 1 (0.5) | 0 (0.0) |
| Unknown | 119 (64.3) | 8 (88.9) |
| Surgery of primary tumour, n (%) | ||
| No | 29 (15.7) | 2 (22.2) |
| Yes | 156 (84.3) | 7 (77.8) |
| Surgery of metastases, n (%) | ||
| No | 102 (55.1) | 4 (44.4) |
| Yes | 83 (44.9) | 5 (55.6) |
| Radiation, n (%) | ||
| No | 135 (73.0) | 6 (66.7) |
| Yes | 50 (27.0) | 3 (33.3) |
| Number of previous therapy lines for the treatment of mCRC, n (%) | ||
| 0 | 4 (2.2) | 3 (33.3) |
| 1 | 25 (13.5) | 1 (11.1) |
| 2 | 71 (38.4) | 3 (33.3) |
| 3 | 53 (28.6) | 0 (0.0) |
| ≥4 | 32 (17.3) | 2 (22.2) |
| Substances of previous systemic anti-CRC therapies, n (%) | ||
| Fluoropyrimidine | 184 (99.5) | 8 (88.9) |
| Irinotecan | 169 (91.4) | 5 (55.6) |
| Oxaliplatin | 173 (93.5) | 6 (66.7) |
| Bevacizumab | 149 (80.5) | 3 (33.3) |
| Anti-EGFR antibodies | 71 (38.4) | 3 (33.3) |
| Regorafenib | 0 (0.0) | 0 (0.0) |
| Other than the above | 47 (25.4) | 0 (0.0) |
| No previous therapy documented | 1 (0.5) | 1 (11.1) |
BSC, best supportive care; CRC, colorectal cancer; ECOG, Eastern Cooperative Oncology Group; FTD/TPI, trifluridine/tipiracil; mCRC, metastatic CRC; SD, standard deviation.