NCI criteria defined response rates according to treatment arms in all randomized patients (intent-to-treat population)
| . | No. of patients . | P . | |
|---|---|---|---|
| Chlorambucil (n = 100) . | Fludarabine (n = 93) . | ||
| All patients | |||
| CR | 0 (0) | 6 (7) | .011 |
| Overall response | 51 (51) | 67 (72) | .003 |
| Binet stage A | n = 16 | n = 12 | |
| CR | 0 (0) | 1 (8) | .4 |
| Overall response | 7 (44) | 10 (83) | .04 |
| Binet stage B | n = 43 | n = 46 | |
| CR | 0 (0) | 3 (7) | .2 |
| Overall response | 23 (54) | 36 (78) | .01 |
| Binet stage C | n = 40 | n = 32 | |
| CR | 0 (0) | 2 (6) | .2 |
| Overall response | 21 (53) | 21 (66) | .3 |
| TK > 10 U/L | n = 55 | n = 51 | |
| CR | 0 (0) | 3 (6) | .1 |
| Overall response | 27 (49) | 38 (75) | .007 |
| β2 M > 3.5 mg/L | n = 47 | n = 44 | |
| CR | 0 (0) | 2 (5) | .2 |
| Overall response | 20 (43) | 31 (71) | .007 |
| del(11q) | n = 8 | n = 14 | |
| CR | 0 (0) | 1 (7) | 1.0 |
| Overall response | 3 (38) | 11 (79) | .08 |
| del(17p)− | n = 5 | n = 5 | |
| CR | 0 (0) | 0 (0) | — |
| Overall response | 0 (0) | 1 (20) | 1.0 |
| . | No. of patients . | P . | |
|---|---|---|---|
| Chlorambucil (n = 100) . | Fludarabine (n = 93) . | ||
| All patients | |||
| CR | 0 (0) | 6 (7) | .011 |
| Overall response | 51 (51) | 67 (72) | .003 |
| Binet stage A | n = 16 | n = 12 | |
| CR | 0 (0) | 1 (8) | .4 |
| Overall response | 7 (44) | 10 (83) | .04 |
| Binet stage B | n = 43 | n = 46 | |
| CR | 0 (0) | 3 (7) | .2 |
| Overall response | 23 (54) | 36 (78) | .01 |
| Binet stage C | n = 40 | n = 32 | |
| CR | 0 (0) | 2 (6) | .2 |
| Overall response | 21 (53) | 21 (66) | .3 |
| TK > 10 U/L | n = 55 | n = 51 | |
| CR | 0 (0) | 3 (6) | .1 |
| Overall response | 27 (49) | 38 (75) | .007 |
| β2 M > 3.5 mg/L | n = 47 | n = 44 | |
| CR | 0 (0) | 2 (5) | .2 |
| Overall response | 20 (43) | 31 (71) | .007 |
| del(11q) | n = 8 | n = 14 | |
| CR | 0 (0) | 1 (7) | 1.0 |
| Overall response | 3 (38) | 11 (79) | .08 |
| del(17p)− | n = 5 | n = 5 | |
| CR | 0 (0) | 0 (0) | — |
| Overall response | 0 (0) | 1 (20) | 1.0 |
Complete response (CR) was defined according to the NCI criteria10 as normal physical examination, normal blood count, and less than 30% lymphocytes in a sample obtained by bone marrow biopsy. Nonresponse was defined as stable disease or progression.
TK indicates thymidine kinase; and β2 M, β2 microglobulin.