Table 2. Treatment-related adverse effects.
Adverse effect | Bolus 5-FU/LV N=75 n (%) | Continuous 5-FU/LV N=73 n (%) | Odds ratio (95% CI) | No Lactobacillus N=51 n (%) | Lactobacillus given N=97 n (%) | Odds ratio (95% CI) |
---|---|---|---|---|---|---|
Any | ||||||
Grade 0–2 | 10 (13) | 40 (55) | 0.14 (0.06–0.31) | 16 (31) | 34 (35) | 0.77 (0.35–1.72) |
Grade 3–4 | 65 (87) | 33 (45) | P<0.0001 | 35 (69) | 63 (65) | P=0.53 |
Stomatitis | ||||||
Grade 0–2 | 32 (43) | 64 (88) | 0.09 (0.04–0.22) | 30 (59) | 66 (68) | 0.59 (0.26–1.35) |
Grade 3–4 | 43 (57) | 9 (12) | P<0.0001 | 21 (41) | 31 (32) | P=0.21 |
Diarrhoea | ||||||
Grade 0–2 | 42 (56) | 66 (90) | 0.11 (0.04–0.29) | 32 (63) | 76 (78) | 0.38 (0.16–0.89) |
Grade 3–4 | 33 (44) | 7 (10) | P<0.0001 | 19 (37) | 21 (22) | P=0.027 |
Neutropenia | ||||||
Grade 0–2 | 53 (71) | 63 (86) | 0.38 (0.16–0.90) | 43 (84) | 73 (75) | 2.00 (0.74–4.89) |
Grade 3–4 | 22 (29) | 10 (14) | P=0.029 | 8 (16) | 24 (25) | P=0.19 |
Neutropenic infection | ||||||
No | 67 (89) | 70 (96) | 0.34 (0.08–1.4) | 49 (96) | 88 (90) | 2.62 (0.53–13) |
Yes | 8 (11) | 3 (4) | P=0.13 | 2 (4) | 9 (10) | P=0.24 |
Hand–foot syndrome | ||||||
Grade 0–2 | 75 (100) | 70 (96) | −(0.0– | 50 (98) | 95 (98) | −(0.0– |
Grade 3 | 0 (0) | 3 (4) | P=0.98 | 1 (2) | 2 (2) | P=0.97 |
Abbreviations: CI=confidence interval; 5-FU=5-fluorouracil; LV=leucovorin.