Table 4.
Adverse events in intervention and control patients, depending on chemotherapy regimen.
| Chemotherapy regimen | 1 | 2 | 3 | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Toxicity | Intervention, N = 21 | Control, N = 26 | P | Intervention, N = 35 | Control, N = 23 | P | Intervention, N = 15 | Control, N = 22 | P |
| All grades | |||||||||
| Neuropathy | 2 (10) | 4 (15) | 0.439 | 25 (71) | 18 (78) | 0.260 | 1 (7) | 1 (45) | 0.341 |
| PPE | 11 (52) | 15 (58) | 0.174 | 8 (23) | 7 (30) | 0.708 | 0 | 6 (27) | 0.030 |
| Infection | 2 (10) | 3 (12) | 0.824 | 6 (17) | 4 (17) | 0.413 | 1 (7) | 4 (18) | 0.297 |
| Fatigue | 16 (76) | 23 (88) | 0.427 | 34 (97) | 21 (91) | 0.512 | 13 (87) | 22 (100) | 0.207 |
| Diarrhoea | 8 (38) | 13 (50) | 0.704 | 16 (46) | 14 (61) | 0.055 | 8 (53) | 10 (45) | 0.427 |
| Nausea | 7 (33) | 10 (38) | 0.930 | 21 (60) | 12 (52) | 0.912 | 10 (67) | 16 (73) | 0.187 |
| Mucostomatitis | 4 (19) | 12 (46) | 0.107 | 9 (26) | 9 (39) | 0.349 | 6 (40) | 6 (27) | 0.417 |
| Neutropenia | 0 | 0 | NA | 4 (11) | 4 (17) | 0.475 | 4 (27) | 2 (9) | 0.217 |
| Thromboembolism | 0 | 0 | NA | 2 (5.7) | 0 | 0.506 | 0 | 0 | NA |
| Grades 1–2 | |||||||||
| Neuropathy | 2 (9.5) | 2 (7.7) | 0.827 | 28 (80) | 14 (61) | 0.116 | 1 (6.7) | 1 (4.5) | 0.774 |
| PPE | 9 (43) | 12 (57) | 0.345 | 7 (20) | 7 (30) | 0.367 | 0 | 6 (27) | 0.030 |
| Infection | 2 (9.5) | 3 (12) | 0.787 | 2 (5.7) | 4 (17) | 0.165 | 6 (40) | 4 (18) | 0.147 |
| Fatigue | 16 (76) | 21 (81) | 0.711 | 31 (89) | 20 (87) | 0.829 | 13 (87) | 20 (91) | 0.675 |
| Diarrhoea | 7 (33) | 12 (46) | 0.375 | 13 (37) | 12 (52) | 0.263 | 8 (53) | 9 (41) | 0.458 |
| Nausea | 7 (33) | 10 (39) | 0.674 | 19 (54) | 11 (48) | 0.658 | 10 (67) | 12 (55) | 0.478 |
| Mucostomatitis | 4 (19) | 12 (46) | 0.055 | 9 (26) | 9 (39) | 0.284 | 6 (40) | 6 (27) | 0.417 |
| Neutropenia | 0 | 0 | NA | 3 (8.6) | 3 (13) | 0.593 | 3 (20) | 2 (9.1) | 0.347 |
| Thromboembolism | 0 | 0 | NA | 1 (2.9) | 0 | 0.414 | 0 | 0 | NA |
| Gade 3+ | |||||||||
| Neuropathy | 0 | 2 (7.7) | 0.199 | 1 (2.9) | 4 (17) | 0.062 | 0 | 0 | NA |
| PPE | 2 (9.5) | 3 (12) | 0.787 | 1 (2.9) | 0 | 0.414 | 0 | 0 | NA |
| Infection | 0 | 0 | NA | 6 (17) | 2 (8.7) | 0.373 | 2 (20) | 2 (9.1) | 0.347 |
| Fatigue | 0 | 2 (7.7) | 0.199 | 3 (8.6) | 1 (4.3) | 0.531 | 0 | 2 (9.1) | 0.236 |
| Diarrhoea | 1 (4.8) | 1 (3.8) | 0.876 | 3 (8.6) | 2 (8.7) | 0.989 | 0 | 1 (4.5) | 0.414 |
| Nausea | 0 | 0 | NA | 2 (5.7) | 1 (4.3) | 0.815 | 0 | 4 (18) | 0.080 |
| Mucostomatitis | 0 | 0 | NA | 0 | 0 | NA | 0 | 0 | NA |
| Neutropenia | 0 | 0 | NA | 1 (2.9) | 1 (4.3) | 0.777 | 1 (6.7) | 0 | 0.225 |
| Thromboembolism | 0 | 0 | NA | 1 (2.9) | 0 | 0.414 | 0 | 0 | NA |
NA not applicable, PPE palmar-plantar erythrodysesthesia.
Note: Data presented as no. (%). Chemotherapy regimen; (1) capecitabine or 5-fluorouracil (+/÷ bevacizumab); (2) capecitabine or 5-fluorouracil + oxaliplatin; (3) capecitabine or 5-fluorouracil + irinotecan.