Comparison of Nordic studies of rituximab and rituximab combination therapies for CAD
| . | BR (n = 45)45 . | Fludarabine-rituximab (n = 29)46 . | Rituximab (n = 27)40 . |
|---|---|---|---|
| Regimen | Rituximab: 375 mg/m2 day 1 Bendamustine: 90 mg/m2 days 1 and 2, 4 cycles at a 28-d interval | Rituximab: 375 mg/m2 day 1 Fludarabine (oral): 40 mg/m2 days 1 to 5, 4 cycles at a 28-d interval | Rituximab: 375 mg/m2 day 1 (weekly for 4 wk) |
| Response rate, % | |||
| Overall response | 71 | 76 | 52 |
| Complete response | 40 | 21 | 4 |
| Median time to response (range), mo | 1.9 (0.25-12) | 4.0 (0.3-6.0) | 1.5 (0.5-4.0)* |
| Sustained response | |||
| % | 91% at median FU 36 mo | 77% at median FU 33 mo | Not reported |
| Median response duration | Observed = 32 mo | Estimated > 66 mo | Observed = 11 mo (range 2-42)* |
| Tolerance | 33% G3 or G4 neutropenia | 41% G3 or G4 hematologic toxicity | 3% G4 hematologic toxicity |
| 11% infections | 59% G1 to G3 infections | 3% G1 infection* | |
| 1 fatal pneumonia at 5 mo | 1 fatal pneumonia at 9 mo | ||
| 1 fatal episode of hypothermia during rituximab |
| . | BR (n = 45)45 . | Fludarabine-rituximab (n = 29)46 . | Rituximab (n = 27)40 . |
|---|---|---|---|
| Regimen | Rituximab: 375 mg/m2 day 1 Bendamustine: 90 mg/m2 days 1 and 2, 4 cycles at a 28-d interval | Rituximab: 375 mg/m2 day 1 Fludarabine (oral): 40 mg/m2 days 1 to 5, 4 cycles at a 28-d interval | Rituximab: 375 mg/m2 day 1 (weekly for 4 wk) |
| Response rate, % | |||
| Overall response | 71 | 76 | 52 |
| Complete response | 40 | 21 | 4 |
| Median time to response (range), mo | 1.9 (0.25-12) | 4.0 (0.3-6.0) | 1.5 (0.5-4.0)* |
| Sustained response | |||
| % | 91% at median FU 36 mo | 77% at median FU 33 mo | Not reported |
| Median response duration | Observed = 32 mo | Estimated > 66 mo | Observed = 11 mo (range 2-42)* |
| Tolerance | 33% G3 or G4 neutropenia | 41% G3 or G4 hematologic toxicity | 3% G4 hematologic toxicity |
| 11% infections | 59% G1 to G3 infections | 3% G1 infection* | |
| 1 fatal pneumonia at 5 mo | 1 fatal pneumonia at 9 mo | ||
| 1 fatal episode of hypothermia during rituximab |
Response criteria for all 3 studies were the same.
FU, follow-up; G, grade.
Values are calculated from 37 treatment episodes in 27 patients.