NCI criteria–defined response rates according to treatment arm
. | Fludarabine . | FC . | P . |
|---|---|---|---|
| All patients, no. (%) | 164 (100.0) | 164 (100.0) | |
| CR | 11 (6.7) | 39 (23.8) | < .001 |
| CR with imaging | 8 (4.9) | 27 (16.5) | .001 |
| CR + uCR | 30 (18.3) | 58 (35.4) | < .001 |
| Partial response | 128 (78.0) | 128 (78.0) | >.999 |
| Overall response | 136 (82.9) | 155 (94.5) | .001 |
| Nonresponse | 28 (17.1) | 9 (5.5) | .001 |
| Binet stage, no. (%) | |||
| A | |||
| CR | 4 (21.1) | 6 (46.2) | .24 |
| Overall response | 17 (89.5) | 12 (92.3) | .79 |
| B | |||
| CR | 7 (7.9) | 25 (25.5) | .001 |
| Overall response | 76 (85.4) | 92 (93.9) | .05 |
| C | |||
| CR | 0 (0) | 8 (15.1) | .002 |
| Overall response | 43 (76.8) | 51 (96.2) | .003 |
. | Fludarabine . | FC . | P . |
|---|---|---|---|
| All patients, no. (%) | 164 (100.0) | 164 (100.0) | |
| CR | 11 (6.7) | 39 (23.8) | < .001 |
| CR with imaging | 8 (4.9) | 27 (16.5) | .001 |
| CR + uCR | 30 (18.3) | 58 (35.4) | < .001 |
| Partial response | 128 (78.0) | 128 (78.0) | >.999 |
| Overall response | 136 (82.9) | 155 (94.5) | .001 |
| Nonresponse | 28 (17.1) | 9 (5.5) | .001 |
| Binet stage, no. (%) | |||
| A | |||
| CR | 4 (21.1) | 6 (46.2) | .24 |
| Overall response | 17 (89.5) | 12 (92.3) | .79 |
| B | |||
| CR | 7 (7.9) | 25 (25.5) | .001 |
| Overall response | 76 (85.4) | 92 (93.9) | .05 |
| C | |||
| CR | 0 (0) | 8 (15.1) | .002 |
| Overall response | 43 (76.8) | 51 (96.2) | .003 |
CR was defined according to the NCI criteria as normal findings on physical examination, normal blood count, and less than 30% lymphocytes in bone marrow biopsy. CR with imaging was defined as CR and aspiration plus normal findings on CT or ultrasound examination. Finally, uCR was defined as CR, irrespective of the bone marrow biopsy result. Nonresponse was defined as stable disease or disease progression.