Event | Standard Gemcitabine Protocol (n = 40) | Gemcitabine LD6H (n = 42) | P* Value for Grade ≥ 3 Toxicities | ||
All Grades No (%) | Grade ≥ 3 No (%) | All Grades No (%) | Grade ≥ 3 No (%) | ||
Non-Hematologic |
|
|
|
|
|
Anorexia | 12 (30) | 4 (10) | 6 (12.3) | 2 (4.8) | 0.427 |
Nausea | 9 (22.5) | 3 (7.5) | 3 (7.1) | 0 | 0.112 |
Vomiting | 8 (20) | 3 (7.5) | 6 (14.3) | 0 | 0.112 |
Diarrhea | 9 (22.5) | 5 (12.5) | 7 (16.7) | 1 (2.4) | 0.105 |
Hypotension | 11 (27.5) | 7 (17.5) | 9 (21.4) | 1 (2.4) | 0.027 |
ALT | 9 (22.5) | 5 (12.5) | 9 (21.4) | 2 (4.8) | 0.259 |
AST | 10 (25) | 5 (12.5) | 6 (14.3) | 2 (4.8) | 0.259 |
Creatinine | 5 (12.5) | 2 (5) | 3 (7.1) | 0 | 0.235 |
Fatigue | 15 (37.5) | 9 (22.5) | 13 (31) | 2 (4.8) | 0.024 |
Hematologic |
|
|
|
|
|
Anemia | 15 (37.5) | 8 (20) | 16 (38.1) | 1 (2.4) | 0.012 |
Neutropenia | 16 (40) | 9 (22.5) | 9 (21.4) | 1 (2.4) | 0.006 |
Thrombocytopenia | 18 (45) | 8 (20) | 16 (38.1) | 1 (2.4) | 0.012 |