Patients' characteristics
. | . | Randomization . | . | |
|---|---|---|---|---|
. | Induction . | No further treatment; arm A . | Prolonged treatment; arm B . | |
| Categoric variable (% of patients) | ||||
| ECOG performance status | ||||
| 0 | 147 (73) | 70 (90) | 60 (82) | |
| 1 | 43 (21) | 8 (10) | 11 (15) | |
| 2 | 12 (6) | 0 | 1 (1) | |
| Sex | ||||
| Male | 87 (43) | (37) | 33 (45) | |
| Female | 115 (57) | (63) | 40 (55) | |
| Stage | ||||
| I | 6 (3) | 3 (4) | 3 (4) | |
| II | 23 (11) | 7 (9) | 10 (14) | |
| III | 59 (29) | 27 (35) | 24 (33) | |
| IV | 114 (56) | 41 (53) | 36 (49) | |
| B symptoms | 57 (28) | 23 (30) | 18 (25) | |
| Bone marrow involvement | 105 (52) | 20 (26) | 8 (11) | |
| Bulky disease, 5 cm or more | 106 (53) | 17 (22) | 22 (30) | |
| Elevated LDH | 74 (37) | 14 (18) | 16 (22) | |
| Chemotherapy naive | 64 (32) | 26 (33) | 25 (34) | |
| Responders to previous chemotherapy | 130 (64) | 49 (63) | 46 (63) | |
| REAL histology grade | ||||
| I | 68 (34) | 24 (31) | 31 (43) | |
| II | 90 (45) | 40 (51) | 33 (45) | |
| III | 25 (12) | 12 (15) | 6 (8) | |
| Continuous variable, median (range) | ||||
| Age, y* | 57 (28-81) | 57 (28-81) | 56 (31-79) | |
| Disease duration, y* | 1.5 (0-21) | 1.5 (0-21) | 1.1 (0-17) | |
| No. of previous regimens, pretreated patients* | 2 (1-4) | 2 (1-4) | 2 (1-4) | |
| No. of cycles of chemotherapy, pretreated patients* | 12 (3-56) | 10 (4-33) | 10 (3-56) | |
| Interval since last treatment, pretreated patients, mo* | 7.5 (0.4-179) | 7.2 (0.9-67) | 8.5 (0.7-179) | |
| Neutrophil count, × 109/L | 3.6 (0.1-11.1) | 3.7 (0.4-7.4) | 3.2 (0.1-9.7) | |
| B-cell count, × 109/L | 81 (0-3629) | 18 (0-239) | 23 (0-225) | |
| NK-cell count, × 109/L | 132 (8-773) | 161 (16-828) | 175 (38-469) | |
| Bone marrow infiltration, involved only, % | 25 (1-90) | 30 (4-90) | 16 (5-90) | |
. | . | Randomization . | . | |
|---|---|---|---|---|
. | Induction . | No further treatment; arm A . | Prolonged treatment; arm B . | |
| Categoric variable (% of patients) | ||||
| ECOG performance status | ||||
| 0 | 147 (73) | 70 (90) | 60 (82) | |
| 1 | 43 (21) | 8 (10) | 11 (15) | |
| 2 | 12 (6) | 0 | 1 (1) | |
| Sex | ||||
| Male | 87 (43) | (37) | 33 (45) | |
| Female | 115 (57) | (63) | 40 (55) | |
| Stage | ||||
| I | 6 (3) | 3 (4) | 3 (4) | |
| II | 23 (11) | 7 (9) | 10 (14) | |
| III | 59 (29) | 27 (35) | 24 (33) | |
| IV | 114 (56) | 41 (53) | 36 (49) | |
| B symptoms | 57 (28) | 23 (30) | 18 (25) | |
| Bone marrow involvement | 105 (52) | 20 (26) | 8 (11) | |
| Bulky disease, 5 cm or more | 106 (53) | 17 (22) | 22 (30) | |
| Elevated LDH | 74 (37) | 14 (18) | 16 (22) | |
| Chemotherapy naive | 64 (32) | 26 (33) | 25 (34) | |
| Responders to previous chemotherapy | 130 (64) | 49 (63) | 46 (63) | |
| REAL histology grade | ||||
| I | 68 (34) | 24 (31) | 31 (43) | |
| II | 90 (45) | 40 (51) | 33 (45) | |
| III | 25 (12) | 12 (15) | 6 (8) | |
| Continuous variable, median (range) | ||||
| Age, y* | 57 (28-81) | 57 (28-81) | 56 (31-79) | |
| Disease duration, y* | 1.5 (0-21) | 1.5 (0-21) | 1.1 (0-17) | |
| No. of previous regimens, pretreated patients* | 2 (1-4) | 2 (1-4) | 2 (1-4) | |
| No. of cycles of chemotherapy, pretreated patients* | 12 (3-56) | 10 (4-33) | 10 (3-56) | |
| Interval since last treatment, pretreated patients, mo* | 7.5 (0.4-179) | 7.2 (0.9-67) | 8.5 (0.7-179) | |
| Neutrophil count, × 109/L | 3.6 (0.1-11.1) | 3.7 (0.4-7.4) | 3.2 (0.1-9.7) | |
| B-cell count, × 109/L | 81 (0-3629) | 18 (0-239) | 23 (0-225) | |
| NK-cell count, × 109/L | 132 (8-773) | 161 (16-828) | 175 (38-469) | |
| Bone marrow infiltration, involved only, % | 25 (1-90) | 30 (4-90) | 16 (5-90) | |
Patient populations are as follows: induction, n = 202; no further treatment, arm A, n = 78; and prolonged treatment, arm B, n = 73. ECOG indicates Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; and REAL, Revised European-American Classification of Lymphoid Neoplasms.
The results for randomized patients reflect characteristics at baseline, not at randomization.