Table 3.
Adverse events
| Adverse event | D (n=23) |
DC (n=24) |
Total (D vs. DC) |
DS (n=23) |
Total (D vs. DS) |
|||
|---|---|---|---|---|---|---|---|---|
| Grade ≥ 3 | Total | Grade ≥ 3 | Total | p-value | Grade ≥ 3 | Total | p-value | |
| Hematological | ||||||||
| Leukopenia | 3 (13) | 6 (26) | 1 (4) | 8 (33) | 0.752 | 0 | 11 (48) | 0.221 |
| Neutropenia | 5 (22) | 8 (35) | 6 (25) | 12 (50) | 0.380 | 2 (9) | 8 (35) | > 0.990 |
| Anemia | 0 | 20 (87) | 3 (13) | 24 (100) | 0.109 | 1 (4) | 23 (100) | 0.233 |
| Thrombocytopenia | 0 | 3 (13) | 0 | 3 (13) | > 0.990 | 1 (4) | 5 (22) | 0.699 |
| Non-hematological | ||||||||
| Febrile neutropenia | 2 (9) | 2 (9) | 2 (9) | 2 (8) | > 0.990 | 1 (4) | 1 (4) | 0.665 |
| Infection with neutropenia | 2 (9) | 4 (17) | 0 | 0 | 0.050 | 1 (4)a) | 1 (4) | 0.346 |
| Infection without neutropenia | 3 (13) | 6 (26) | 1 (4)a) | 1 (4) | 0.048a) | 1 (4) | 3 (13) | 0.459 |
| Stomatitis | 1 (4) | 8 (35) | 1 (4) | 8 (33) | > 0.990 | 3 (13) | 13 (57) | 0.236 |
| Anorexia | 3 (13) | 17 (74) | 5 (21) | 18 (75) | > 0.990 | 1 (4) | 21 (91) | 0.243 |
| Nausea | 0 | 3 (13) | 1 (4) | 9 (38) | 0.093 | 0 | 10 (44) | 0.047b) |
| Diarrhea | 1 (4) | 11 (48) | 0 | 6 (25) | 0.135 | 2 (9) | 11 (48) | > 0.990 |
| Fatigue | 2 (9) | 17 (74) | 5 (21) | 19 (79) | 0.740 | 2 (9) | 20 (87) | 0.459 |
| Peripheral neuropathy | 0 | 10 (44) | 1 (4) | 10 (42) | > 0.990 | 0 | 12 (52) | 0.768 |
| AST/ALT elevation | 0 | 3 (13) | 0 | 10 (42) | 0.049b) | 1 (4) | 6 (26) | 0.459 |
| Hyperbilirubinemia | 0 | 2 (9) | 0 | 3 (13) | > 0.990 | 2 (9) | 5 (22) | 0.414 |
| Creatinine elevation | 0 | 2 (9) | 0 | 3 (13) | > 0.990 | 0 | 1 (4) | > 0.990 |
Values are presented as number (%). D, docetaxel; DC, docetaxel plus cisplatin; DS, docetaxel plus S-1; AST, aspartate aminotransferase; ALT, alanine aminotransferase.
a)
G5 adverse event,
b)
p < 0.05 when compared with docetaxel; DS vs. D for all grades nausea (p=0.047), DC vs. D for all grades infection without neutropenia (p=0.048) and all grades AST/ALT elevation (p=0.049).