Table 2.
FOLFIRINOX (n=6) | FOLFIRINOX plus PF-04136309 (n=39) | |||||||
---|---|---|---|---|---|---|---|---|
Grade 1 or 2 | Grade 3 | Grade 4 | Grade 5 | Grade 1 or 2 | Grade 3 | Grade 4 | Grade 5 | |
Hematologic | ||||||||
Neutropenia | 0 | 2 (33%) | 4 (67%) | 0 | 2 (5%) | 15 (38%) | 12 (31%) | 0 |
Febrile neutropenia | 0 | 0 | 1 (17%) | 0 | 0 | 5 (13%) | 2 (5%) | 0 |
Anemia | 4 (67%) | 2 (33%) | 0 | 0 | 34 (87%) | 3 (8%) | 0 | 0 |
Lymphopenia | 2 (33%) | 1 (17%) | 0 | 0 | 20 (51%) | 4 (10%) | 0 | 0 |
Thrombocytopenia | 4 (67%) | 0 | 0 | 0 | 19 (49%) | 1 (3%) | 1 (3%) | 0 |
Non-Hematologic | ||||||||
Nausea | 3 (50%) | 0 | 0 | 0 | 23 (59%) | 1 (3%) | 0 | 0 |
Vomiting | 2 (33%) | 0 | 0 | 0 | 13 (33%) | 1 (3%) | 0 | 0 |
Diarrhea | 4 (67%) | 2 (33%) | 0 | 0 | 19 (49%) | 6 (15%) | 0 | 0 |
Mucositis | 3 (50%) | 0 | 0 | 0 | 16 (41%) | 1 (3%) | 0 | 0 |
Alopecia | 4 (67%) | 0 | 0 | 0 | 28 (72%) | 0 | 0 | 0 |
Peripheral neuropathy | 1 (17%) | 0 | 0 | 0 | 25 (64%) | 0 | 0 | 0 |
Hypoalbuminemia | 4 (67%) | 1 (17%) | 0 | 0 | 25 (64%) | 2 (5%) | 0 | 0 |
Hypokalemia | 1 (17%) | 3 (50%) | 0 | 0 | 17 (44%) | 5 (13%) | 2 (5%) | 0 |
ELEVATED ASPARTATE Aminotransferase | 2 (33%) | 0 | 0 | 0 | 12 (31%) | 2 (5%) | 0 | 0 |