Table 2.
Acute toxicity according to treatment groupsa)
| Toxicity | Cisplatin (n=126) | Gemcitabine (n=63) | p-valueb) | ||
|---|---|---|---|---|---|
|
|
|
||||
| G1–2 | G3–4 | G1–2 | G3–4 | ||
| Neutropenia | 57 (45.2) | 7 (5.5) | 24 (38.0) | 4 (6.3) | 0.646 |
|
| |||||
| Leukopenia | 98 (77.7) | 13 (10.3) | 29 (46.0) | 3 (4.8) | < 0.001 |
|
| |||||
| Lymphopenia | 70 (55.5) | 35 (27.8) | 9 (14.3) | 1 (1.6) | < 0.001 |
|
| |||||
| Anemia | 22 (17.4) | - | 11 (17.4) | 2 (3.2) | 0.132 |
|
| |||||
| Thrombocytopenia | 7 (5.5) | - | 4 (6.3) | - | 0.530 |
|
| |||||
| Nausea | 110 (87.3) | 7 (5.6) | 59 (93.6) | - | 0.155 |
|
| |||||
| Vomit | 69 (54.7) | 4 (3.2) | 49 (77.7) | - | 0.003 |
|
| |||||
| Constipation | 14 (11.1) | - | 18 (28.5) | - | 0.003 |
|
| |||||
| Diarrhea | 63 (50.0) | 5 (4.0) | 44 (69.8) | 8 (12.7) | < 0.001 |
|
| |||||
| Pruritus | 3 (2.4) | - | 3 (4.7) | - | 0.318 |
|
| |||||
| Fever | 3 (2.4) | - | 11 (17.5) | - | < 0.001 |
|
| |||||
| Neuropathy | 8 (6.3) | - | 1 (1.6) | - | 0.047 |
|
| |||||
| Cephalea | 9 (7.1) | - | 5 (7.9) | - | 0.522 |
|
| |||||
| Anorexia | 3 (2.4) | - | 3 (4.7) | 1 (1.6) | 0.244 |
|
| |||||
| Fatigue | 71 (56.3) | - | 55 (87.3) | 1 (1.6) | < 0.001 |
|
| |||||
| Edema | 2 (1.6) | - | 5 (7.9) | - | 0.042 |
|
| |||||
| Abdominal pain | 37 (29.3) | - | 27 (42.8) | - | 0.065 |
|
| |||||
| Non-infectious cystitis | 23 (18.2) | 1 (0.8) | 27 (42.8) | - | 0.001 |
|
| |||||
| Proctitis | 14 (11.1) | 10 (7.9) | 4 (6.3) | 3 (4.8) | 0.381 |
|
| |||||
| Dermal toxicity | 14 (11.1) | 1 (0.8) | 3 (4.7) | 1 (1.6) | 0.516 |
Values are presented as number (%).
a)
Assessed by Common Terminology Criteria for Adverse Events (v.4.03),
b)
Chi-square test.