Table 1.
Patients characteristics at baseline. Abbreviations: T, trifluridine/tipiracil; R, regorafenib; pts, patients; MSI, microsatellite instability; ECOG PS, Eastern Cooperative Oncology Group Performance Status; CT, chemotherapy.
| Duration of First Drug Treatment | ||||||||
|---|---|---|---|---|---|---|---|---|
| Overall | <3 Months | 3 to <6 Months | ≥6 Months | |||||
| T/R | R/T | T/R | R/T | T/R | R/T | T/R | R/T | |
| N (%) | 146 (100) | 116 (100) | 27 (100) | 18 (100) | 86 (100) | 62 (100) | 33 (100) | 36 (100) |
| Median age, years (range) | 69 (30–84) | 66 (43–84) | 64 (48–80) | 67 (51–82) | 70 (30–83) | 68 (43–83) | 69 (49–84) | 68 (53–82) |
| pts ≥ 70 years | ||||||||
| yes | 67 (45.9) | 42 (36.3) | 9 (33.3) | 7 (38.8) | 44 (51.2) | 20 (32.3) | 14 (42.4) | 15 (41.7) |
| no | 79 (54.1) | 74 (63.7) | 18 (66.7) | 11 (61.2) | 42 (48.8) | 42 (67.7) | 19 (57.6) | 21 (58.3) |
| Gender | ||||||||
| Female | 51 (35.0) | 44 (38.0) | 10 (37.0) | 4 (22.3) | 29 (33.7) | 15 (24.2) | 12 (36.4) | 25 (69.4) |
| Male | 95 (65.0) | 72 (62.0) | 17 (63.0) | 14 (77.7) | 57 (66.3) | 47 (75.8) | 21 (63.6) | 11 (30.6) |
| RAS status | ||||||||
| Wild type | 49 (33.5) | 42 (36.2) | 6 (22.3) | 6 (33.4) | 31 (36.0) | 21 (33.9) | 13 (39.4) | 15 (41.7) |
| Mutant type | 90 (61.7) | 67 (57.7) | 21 (77.7) | 10 (55.5) | 49 (57.0) | 37 (59.6) | 20 (60.6) | 20 (55.6) |
| Unknown | 7 (4.8) | 7 (6.1) | 0 (0.0) | 2 (11.1) | 6 (7.0) | 4 (6.5) | 0 (0.0) | 1 (2.7) |
| Primary tumor location | ||||||||
| Right side | 52 (35.6) | 34 (29.3) | 8 (29.6) | 4 (22.3) | 37 (43.0) | 18 (29.0) | 7 (21.2) | 12 (33.3) |
| Left side | 94 (64.4) | 82 (70.7) | 19 (70.4) | 14 (77.7) | 49 (57.0) | 44 (71.0) | 26 (78.8) | 24 (66.7) |
| MSI | ||||||||
| Yes | 3 (2.0) | 4 (3.4) | 0 (0.0) | 2 (11.1) | 2 (2.3) | 1 (1.6) | 1 (3.0) | 1 (2.7) |
| No | 89 (61.0) | 64 (55.2) | 17 (63.0) | 10 (55.5) | 49 (57.0) | 36 (58.0) | 23 (69.7) | 18 (50.0) |
| Unknown | 54 (37.0) | 48 (41.4) | 10 (37.0) | 6 (33.4) | 35 (40.7) | 25 (40.4) | 9 (27.3) | 17 (47.3) |
| PS ECOG | ||||||||
| 0–1 | 128 (87.7) | 108 (93.2) | 24 (88.9) | 16 (88.9) | 75 (87.2) | 57 (92.0) | 29 (87.9) | 35 (97.3) |
| 2 | 18 (12.3) | 8 (6.8) | 3 (11.1) | 2 (11.1) | 11 (12.8) | 5 (8.0) | 4 (12.1) | 1 (2.7) |
| Prior adjuvant therapy | ||||||||
| yes | 46 (31.5) | 43 (37.1) | 7 (26.0) | 4 (22.3) | 22 (25.6) | 22 (35.5) | 17 (51.5) | 17 (47.3) |
| no | 100 (68.5) | 66 (56.9) | 20 (74.0) | 14 (77.7) | 64 (74.4) | 40 (64.5) | 16 (48.5) | 19 (52.7) |
| Metastatic disease sites | ||||||||
| Liver only | 23 (15.7) | 14 (12.0) | 4 (14.8) | 1 (5.6) | 16 (18.6) | 7 (11.3) | 3 (9.1) | 6 (16.7) |
| Liver + other | 80 (54.8) | 51 (44.0) | 17 (62.9) | 9 (50.0) | 46 (53.5) | 29 (46.8) | 17 (51.5) | 13 (36.1) |
| Others | 43 (29.5) | 51 (44.0) | 6 (22.3) | 8 (44.4) | 24 (27.9) | 26 (41.9) | 13 (39.4) | 17 (47.2) |
| CT 1°line regimen | ||||||||
| Doublet chemotherapy | 112 (76.8) | 94 (81.1) | 21 (77.7) | 15 (83.3) | 69 (80.2) | 48 (77.4) | 29 (87.8) | 31 (86.1) |
| Triplet chemotherapy | 16 (10.9) | 9 (7.7) | 6 (22.3) | 1 (5.6) | 9 (10.5) | 7 (11.3) | 2 (6.1) | 1 (2.7) |
| Fluoropyrimdine alone | 18 (12.3) | 13 (11.2) | 0 (0.0) | 2 (11.1) | 8 (9.3) | 7 (11.3) | 2 (6.1) | 4 (11.2) |
| CT 2°line regimen | ||||||||
| Doublet chemotherapy | 119 (81.6) | 94 (81.1) | 24 (88.9) | 15 (83.3) | 72 (83.7) | 50 (80.6) | 23 (69.7) | 29 (80.6) |
| Triplet chemotherapy | 2 (1.3) | 2 (1.7) | 1 (3.7) | 1 (5.6) | 1 (1.2) | 0 (0.0) | 0 (0.0) | 1 (2.7) |
| Monochemotherapy | 25 (17.1) | 20 (17.2) | 2 (7.4) | 2 (11.1) | 13 (15.1) | 12 (19.4) | 10 (30.3) | 6 (16.7) |
| Biological agents 1°line | ||||||||
| Anti-EGFR use | 43 (29.5) | 30 (25.8) | 4 (14.8) | 3 (16.7) | 29 (33.7) | 15 (24.2) | 10 (30.3) | 12 (33.3) |
| Anti-VEGF use | 72 (49.4) | 65 (56.1) | 18 (66.6) | 10 (55.5) | 38 (44.2) | 34 (54.8) | 17 (51.5) | 19 (52.7) |
| None | 31 (21.1) | 21 (18.1) | 5 (18.6) | 5 (27.8) | 19 (22.1) | 13 (21.0) | 6 (18.2) | 5 (14.0) |
| Biological agents 2°line | ||||||||
| Anti-EGFR use | 9 (6.1) | 7 (6.0) | 0 (0.0) | 1 (5.6) | 6 (7.0) | 2 (3.2) | 3 (9.1) | 4 (11.2) |
| Anti-VEGF use | 97 (66.5) | 81 (69.9) | 19 (70.4) | 14 (77.7) | 57 (66.3) | 45 (72.6) | 21 (63.6) | 23 (63.8) |
| None | 40 (27.3) | 28 (24.1) | 8 (29.6) | 3 (16.7) | 23 (26.7) | 15 (24.2) | 9 (27.3) | 9 (25.0) |