Table 2.
Toxicities possibly, probably, or definitely related to study treatment occurring during any treatment course
| Nature | DSI schedule (number of patients/%)
|
WLMI schedule (number of patients/%)
|
||
|---|---|---|---|---|
| Grade 3 | Grade 4 | Grade 3 | Grade 4 | |
| Hematologic | ||||
| Hemoglobin | 8 (57%) | 3 (21%) | 3 (21%) | 1 (7%) |
| Leukopenia | 7 (50%) | 6 (43%) | 6 (43%) | 7 (50%) |
| Lymphopenia | 1 (7%) | 1 (7%) | 8 (57%) | 4 (29%) |
| Neutropenia | 2 (14%) | 4 (29%) | 3 (21%) | 5 (36%) |
| Thrombocytopenia | 8 (57%) | 8 (57%) | 7 (50%) | 7 (50%) |
| Non-Hematologic | ||||
|
| ||||
| Anorexia | 3 (21%) | 0 | 1 (7%) | 0 |
| Diarrhea | 1 (7%) | 0 | 3 (21%) | 0 |
| Dyspnea | 2 (14%) | 0 | 0 | 0 |
| Fatigue | 4 (29%) | 1 (7%) | 4 (29%) | 2 (14%) |
| Febrile neutropenia | 3 (21%) | 0 | 0 | 0 |
| Hyperbilirubinemia | 2 (14%) | 0 | 0 | 0 |
| Hyperglycemia | 3 (21%) | 1 (7%) | 2 (14%) | 0 |
| Hypokalemia | 2 (14%) | 1 (7%) | 4 (29%) | 1 (7%) |
| Hypophosphatemia | 4 (29%) | 0 | 2 (14%) | 1 (7%) |
| Prolonged QTc | NOT MONITORED* | NOT MONITORED* | 5 (36%)** | 0** |
*
QTc monitoring was not required by protocol, however, all patients underwent evaluation for risks of QTc prolongation in the context of certain CYP modulating agents in combination with vorinostat.
**
Revised protocol criteria for QTc eligibility and monitoring were initiated based on findings of QTc changes in one subject which, due to the known risks of QTc prolongation with CYP modulating agents in combination with vorinostat, underwent QTc monitoring at initiation of study treatment.