Table 1. Baseline Patient Characteristics.
| Treatment allocation | No. (%) | ||||
|---|---|---|---|---|---|
| CHEMO-INTENSITYa pathway | CHEMO-BSCa pathway | ||||
| Level A (n = 170) | Level B (n = 171) | Level C (n = 173) | Level C (n = 23) | BSC (n = 22) | |
| Age, median (range), y | 76 (57-96) | 76 (51-91) | 77 (56-88) | 79 (66-89) | 78.5 (58-88) |
| Male gender | 131 (77) | 129 (75) | 125 (72) | 14 (61) | 13 (59) |
| WHO performance status | |||||
| 0 | 27 (16) | 23 (13) | 22 (13) | 0 | 0 |
| 1 | 90 (53) | 94 (55) | 95 (55) | 9 (39) | 6 (27) |
| 2 | 49 (29) | 47 (27) | 52 (30) | 11 (48) | 14 (64) |
| >2 | 3 (1.8) | 7 (4.1) | 3 (1.7) | 3 (13) | 2 (9.1) |
| Frailty | |||||
| Not frail (0-1 domains) | 23 (14) | 30 (18) | 41 (24) | 2 (8.7) | 1 (4.5) |
| Slightly frail (2 domains) | 44 (26) | 45 (26) | 32 (18) | 5 (22) | 6 (27) |
| Severely frail (≥3 domains) | 103 (61) | 96 (56) | 100 (58) | 16 (70) | 15 (69) |
| Frailty/age | |||||
| Age ≥75 y and frail | 74 (44) | 81 (47) | 71 (41) | 15 (65) | 16 (73) |
| Age ≥75 y and nonfrail | 16 (9) | 15 (9) | 20 (12) | 1 (4) | 1 (4) |
| Age <75 y and frail | 73 (43) | 60 (35) | 61 (35) | 6 (26) | 5 (23) |
| Age <75 y and nonfrail | 7 (4) | 15 (9) | 21 (12) | 1 (4) | 0 |
| Squamous histology | 20 (12) | 18 (11) | 20 (12) | 4 (17) | 5 (23) |
| Site of primary tumor | |||||
| Esophagus | 55 (32) | 73 (43) | 69 (40) | 13 (57) | 9 (49) |
| GO junction | 50 (29) | 34 (20) | 39 (23) | 4 (17) | 4 (18) |
| Gastric | 64 (38) | 64 (37) | 64 (37) | 6 (26) | 9 (41) |
| Distant metastases | 115 (68) | 118 (69) | 121 (70) | 11 (48) | 10 (46) |
| Trastuzumab use | 7 (4.1) | 10 (5.8) | 10 (5.8) | 0 | 0 |
| Individual domains contributing to the Frailty Scoreb | |||||
| BMI<18.5 | 7 (4.1) | 13 (7.6) | 11 (6.4) | 2 (8.7) | 6 (27) |
| Weight loss | 92 (54) | 94 (55) | 85 (49) | 11 (48) | 10 (45) |
| Mobility (TUGT) | 103 (61) | 91 (53) | 95 (55) | 19 (83) | 14 (64) |
| Falls | 8 (4.7) | 9 (5.3) | 7 (4.0) | 2 (8.7) | 0 |
| Cognition | 22 (13) | 25 (15) | 26 (15) | 4 (17) | 3 (14) |
| Function (ADL) | 97 (57) | 97 (57) | 100 (58) | 16 (70) | 19 (86) |
| Social care | 0 | 2 (1.2) | 1 (0.6) | 23 (100) | 21 (95) |
| Mood | 2 (1.2) | 4 (2.3) | 3 (1.7) | 21 (91) | 22 (100) |
| Fatigue | 42 (25) | 42 (25) | 42 (24) | 5 (22) | 7 (32) |
| Polypharmacy | 127 (75) | 129 (75) | 116 (67) | 19 (83) | 14 (64) |
Abbreviations: ADL, activities of daily living; BMI, body mass index; WHO, World Health Organization; TUGT, Timed Up and Go Test. BMI is calculated as weight in kilograms divided by height in meters squared.
a
Treatment pathways are detailed in the Randomization section of Methods.
b
For frailty definitions, see the trial protocol (Supplement 2).