Table 2:
UGT1A1 genotype group | Overall (n=49) | |||
---|---|---|---|---|
*1/*1 (n=23) | *1/*28 (n=19) | *28/*28 (n=7) | ||
# with DLTs (%) | 5 (22%) | 1 (5%) | 0 | 6 (12%) |
DLT Description | Gr 3 diarrhea (3 pts) Gr 3 nausea (1 pt) Grade 3 FN (1 pt) |
Grade 3 nausea (1 pt) | Gr 3 diarrhea (3 pts) Gr 3 nausea (2 pts) Grade 3 FN (1 pt) |
|
Complete Response | 1 (4%) | 0 | 0 | 1 (2%) |
Partial Response | 6 (26%) | 6 (32%) | 2 (29%) | 14 (29%) |
Stable Disease | 11 (48%) | 9 (47%) | 4 (57%) | 24 (49%) |
Disease Control | 18 (78%) | 15 (79%) | 6 (86%) | 39 (80%) |
Progressive Disease | 4 (17%) | 2 (11%) | 1 (14%) | 7 (14%) |
Not Evaluable | 1 (4%) | 2 (11%) | 0 | 3 (6%) |
Abbreviations: DLT: Dose limiting toxicity; FN: Febrile neutropenia; Gr: Grade; pt: patient