Table III.
Safety according to grade 3/4 toxicitya.
| Toxicity | All patients (n=100) | ECOG PS 0–1 (n=80) | ECOG PS 2 (n=20) | P-value |
|---|---|---|---|---|
| Hematological | ||||
| Anemia | 33 (33) | 23 (29) | 10 (50) | 0.071 |
| Neutropenia | 23 (23) | 19 (24) | 4 (20) | 0.722 |
| Febrile neutropenia | 13 (13) | 10 (13) | 3 (15) | 0.766 |
| Thrombocytopenia | 3 (3) | 3 (4) | 0 (0) | 0.379 |
| Non-hematological | ||||
| Fatigue | 36 (36) | 24 (30) | 12 (60) | 0.012 |
| Constipation | 22 (22) | 20 (25) | 2 (10) | 0.148 |
| Abdominal pain | 12 (12) | 8 (10) | 4 (20) | 0.218 |
| Infusion site reaction | 5 (5) | 4 (5) | 1 (5) | 1.000 |
| Stomatitis | 4 (4) | 4 (5) | 0 (0) | 0.518 |
| Nausea | 2 (2) | 2 (3) | 0 (0) | 0.475 |
| Vomiting | 2 (2) | 2 (3) | 0 (0) | 0.475 |
| Myalgia | 2 (2) | 2 (3) | 0 (0) | 0.475 |
| ≥1 Toxicity | 76 (76) | 57 (71) | 19 (95) | 0.026 |
All data are presented as n (%).
a
Graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 4.0). P-value showing the difference between ECOG PS 0–1 and 2 was assessed by the Pearson's χ2 test. ECOG PS, Eastern Cooperative Oncology Group performance status.