Table 1. Population baseline and treatment characteristics.
| Cohort 1: capecitabine | Cohort 2: 5-FU | |||||||
|---|---|---|---|---|---|---|---|---|
| Overall (251), N(%) | PPI (51), N(%) | Non-PPI (200), N(%) | p value | Overall (196), N(%) | PPI (52), N(%) | Non-PPI (144), N(%) | p value | |
| Age Median (range) ≥65 years Missing |
58 (21–90) 83 (33.1) 1 (0.4) |
64 (31–90) 25 (49.0) 0 |
57 (21–89) 58 (29.0) 1 (0.5) |
0.05 0.01 |
59 (22–92) 63 (32.1) 0 |
59 (29–84) 17 (32.7) 0 |
60 (22–92) 46 (31.9) 0 |
0.96 1.00 |
| Sex Female Male |
103 (41.0) 148 (59.0) |
30 (58.8) 21 (41.2) |
73 (36.5) 127 (63.5) |
0.006 |
80 (40.8) 116 (59.2) |
26 (50.0) 26 (50.0) |
54 (37.5) 90 (62.5) |
0.14 |
| ECOG 0 ≥ 1 Missing |
83 (33.1) 164 (65.3) 4 (1.6) |
11 (21.6) 39 (76.5) 1 (1.9) |
72 (36.0) 125 (62.5) 3 (1.5) |
0.65 |
131 (66.8) 64 (32.6) 1 (0.8) |
31 (59.6) 21 (40.4) 0 |
100 (69.4) 43 (29.9) 1 (0.7) |
0.23 |
| Comorbidities | 149 (59.4) | 31 (60.8) | 118 (59.0) | 0.87 | 143 (73.0) | 40 (76.9) | 103 (71.5) | 0.58 |
| clinical stage II III |
50 (19.9) 201 (80.1) |
12 (23.5) 39 (76.5) |
38 (19.0) 162 (81.0) |
0.56 |
44 (22.4) 152 (77.6) |
12 (23.1) 40 (76.9) |
32 (22.2) 112 (77.8) |
1.00 |
| Localisation Distal Middle Upper Missing |
134 (53.4) 99 (39.4) 15 (6.0) 3 (1.2) |
31 (60.8) 17 (33.3) 3 (5.9) 0 |
103 (51.5) 82 (41.0) 12 (6.0) 3 (1.5) |
0.54 |
113 (57.7) 74 (37.7) 9 (4.6) 0 |
29 (55.8) 20 (38.5) 3 (4.6) 0 |
84 (58.3) 54 (37.5) 6 (4.2) 0 |
0.87 |
| Differentiation Well/moderate Poor Missing |
206 (82.1) 35 (13.9) 10 (4.0) |
44 (86.3) 5 (9.8) 2 (3.9) |
162 (81.0) 30 (15.0) 8 (4.0) |
0.49 |
175 (89.3) 12 (6.1) 9 (4.6) |
42 (80.8) 6 (11.5) 4 (7.7) |
133 (92.3) 6 (4.2) 5 (3.5) |
0.08 |
| CAPOX TNT | 46 (18.3) | 2 (5.3) | 35 (17.5) | 0.54 | - | - | - | - |
| radiotherapy 2D 3D IMRT Short course Missing |
1 (0.3) 185 (73.7) 30 (12.0) 25 (10.0) 10 (4.0) |
0 34 (66.6) 6 (11.8) 9 (17.6) 2 (4.0) |
1 (0.5) 151 (75.5) 24 (12.0) 16 (8.0) 8 (4.0) |
0.21 |
5 (2.5) 176 (89.8) 15 (7.7) 0 0 |
1 (1.9) 50 (96.2) 1 (1.9) 0 0 |
4 (2.8) 126 (87.5) 14 (9.7) 0 0 |
0.18 |
| ΔT Neo-TME (median, weeks) Neo ending RT ending |
13 (11.4–14.6) 14 (12.4–15.6) |
13 (9.5–16.5) 16 (14.3–17.7) |
12 (10.9–13.1) 13 (11.6–14.4) |
0.35 0.85 |
- 10 (9.6–10.4) |
- 11 (9.7–12.3) |
- 10 (9.6–10.4) |
0.10 |
| Adjuvant therapy None Capecitabine CAPOX 5-FU FOLFOX Missing |
85 (33.9) 62 (24.7) 64 (25.5) 0 38 (15.1) 2 (0.8) |
18 (35.3) 14 (27.5) 15 (29.4) 0 4 (7.8) 0 |
67 (33.5) 48 (24.0) 49 (24.5) 0 34 (17.0) 2 (1.0) |
0.42 |
54 (27.6) 10 (5.1) 12 (6.1) 34 (17.3) 86 (43.9) 0 |
16 (30.8) 4 (7.7) 2 (3.8) 12 (23.1) 18 (34.6) 0 |
38 (26.4) 6 (4.2) 10 (6.9) 22 (15.3) 68 (47.2) 0 |
0.34 |
PPI: proton-pump inhibitors; y: years; CAPOX: capecitabine + oxaliplatin; TNT: total neoadjuvant therapy; IMRT: intensity modulated radiotherapy; ΔT: median time; Neo: neoadjuvant therapy ending; RT: radiotherapy: TME: total mesorectal excision; FOLFOX: 5-Fluorouracil + oxaliplatin
The bold values represent statistical significant differences in baseline characteristics between PPI and non-PPI groups