Table 1.
Baseline characteristics: geographical subgroups in RECOURSE.
| USA |
EU |
Japan |
||||
|---|---|---|---|---|---|---|
| FTD/TPI (n = 64) | Placebo (n = 35) | FTD/TPI (n = 271) | Placebo (n = 132) | FTD/TPI (n = 178) | Placebo (n = 88) | |
| Male, n (%) | 31 (48.4) | 18 (51.4) | 167 (61.6) | 82 (62.1) | 113 (63.5) | 58 (65.9) |
| Age, years, mean (SD) | 60.2 (11.86) | 58.5 (11.02) | 61.8 (9.98) | 62.1 (10.42) | 61.9 (10.09) | 62.1 (10.40) |
| Race, n (%) | ||||||
| Caucasian | 56 (87.5) | 27 (77.1) | 229 (84.5) | 119 (90.2) | 0 | 0 |
| Black/African-American | 3 (4.7) | 5 (14.3) | 1 (0.4) | 0 | 0 | 0 |
| Asian | 5 (7.8) | 3 (8.6) | 1 (0.4) | 1 (0.8) | 178 (100) | 88 (100) |
| Primary tumour site, n (%) | ||||||
| Colon | 47 (73.4) | 27 (77.1) | 176 (64.9) | 81 (61.4) | 100 (56.2) | 45 (51.1) |
| Rectum | 17 (26.6) | 8 (22.9) | 95 (35.1) | 51 (38.6) | 78 (43.8) | 43 (48.9) |
| ECOG PS, n (%) | ||||||
| 0 | 28 (43.8) | 13 (37.1) | 138 (50.9) | 68 (51.5) | 128 (71.9) | 60 (68.2) |
| 1 | 36 (56.3) | 22 (62.9) | 133 (49.1) | 64 (48.5) | 50 (28.1) | 28 (31.8) |
| KRAS statusa, n (%) | ||||||
| Wild type | 35 (54.7) | 17 (48.6) | 123 (45.4) | 68 (51.5) | 94 (52.8) | 40 (45.5) |
| Mutant | 29 (45.3) | 18 (51.4) | 148 (54.6) | 64 (48.5) | 84 (47.2) | 48 (54.5) |
| Time since diagnosis of first metastasisa, n (%) | ||||||
| <18 months | 14 (21.9) | 11 (31.4) | 61 (22.5) | 24 (18.2) | 33 (18.5) | 17 (19.3) |
| ≥18 months | 50 (78.1) | 24 (68.6) | 210 (77.5) | 108 (81.8) | 145 (81.5) | 71 (80.7) |
| Baseline renal functionb, n (%) | ||||||
| Normal (CrCL ≥90 ml/min/1.73 m2) | 43 (67.2) | 16 (45.7) | 164 (60.5) | 72 (54.5) | 86 (48.3) | 46 (52.3) |
| Mild impairment (CrCL 60–89 ml/min/1.73 m2) | 16 (25.0) | 17 (48.6) | 86 (31.7) | 41 (31.1) | 70 (39.3) | 33 (37.5) |
| Moderate impairment (CrCL 30–59 ml/min/1.73 m2) | 5 (7.8) | 2 (5.7) | 21 (7.7) | 16 (12.1) | 20 (11.2) | 9 (10.2) |
| Missing | 0 | 0 | 0 | 3 (2.3) | 2(1.1) | 0 |
| Baseline eGFRc, n (%) | ||||||
| Normal (CrCL ≥90 ml/min/1.73 m2) | 34 (53.1) | 14 (40.0) | 153 (56.5) | 72 (54.5) | 135 (75.8) | 65 (73.9) |
| Mild impairment (CrCL 60–89 ml/min/1.73 m2) | 24 (37.5) | 17 (48.6) | 92 (33.9) | 42 (31.8) | 30 (16.9) | 21 (23.9) |
| Moderate impairment (CrCL 30–59 ml/min/1.73 m2) | 5 (7.8) | 3 (8.6) | 18 (6.6) | 12 (9.1) | 9(5.1) | 1 (1.1) |
| Missing | 1 (1.6) | 1 (2.9) | 8 (3.0) | 6 (4.5) | 4 (2.2) | 1(1.1) |
Abbreviations: CrCL, creatinine clearance; ECOG PS, Eastern Cooperative Oncology Group performance status; eGFR, estimated glomerular filtration rate; FTD/TPI, trifluridine/tipiracil; SD, standard deviation.
a
As randomised.
b
CrCL based on Cockcroft-Gault using baseline creatinine.
c
eGFR (ml/min/1.73 m2) = 175 × (baseline creatinine)−1.154 × (age)−0.203 × (0.742 if female) × (1.212 if African-American).