Patient characteristics at baseline
| . | TN ≥65 years (n = 31) . | R/R (n = 101) . | All patients (N = 132) . |
|---|---|---|---|
| Median age, years (range) | 71 (65-84) | 64 (37-82) | 68 (37-84) |
| ≥70 y, n (%) | 23 (74) | 34 (34) | 57 (43) |
| Sex, n (%) | |||
| Male | 19 (61) | 79 (78) | 98 (74) |
| Female | 12 (39) | 22 (22) | 34 (26) |
| ECOG PS, n (%) | |||
| 0 | 23 (74) | 43 (43) | 66 (50) |
| 1 | 8 (26) | 54 (53) | 62 (47) |
| 2 | 0 (0) | 4 (4) | 4 (3) |
| Bulky disease, n (%) | |||
| ≥5 cm | 6 (19) | 55 (54) | 61 (46) |
| ≥10 cm | 0 | 15 (15) | 15 (11) |
| Baseline Rai stage, n (%) | |||
| 0-II | 13 (42) | 38 (38) | 51 (39) |
| III-IV | 17 (55) | 58 (57) | 75 (57) |
| Unknown | 1 (3) | 5 (5) | 6 (5) |
| Cytogenetics/FISH, n (%) | |||
| Del(17p) | 2 (6) | 34 (34) | 36 (27) |
| Del(11q) | 1 (3) | 35 (35) | 36 (27) |
| Trisomy 12 | 8 (26) | 12 (12) | 20 (15) |
| Del(13q) | 17 (55) | 47 (47) | 64 (49) |
| β2-microglobulin level >3 mg/L, n (%) | 8 (26) | 49 (49) | 57 (43) |
| Unmutated IGHV, n (%) | 15 (48) | 79 (78) | 94 (71) |
| Median ANC, × 109/L (range) | 3.9 (0-19.4) | 2.5 (0-19) | 2.6 (0-19.4) |
| ANC ≤1.5 × 109/L | 1 (3) | 34 (34) | 35 (27) |
| Median hemoglobin, g/L (range) | 122 (77-157) | 115 (62-176) | 117 (62-176) |
| ≤11 g/dL, n (%) | 11 (35) | 42 (42) | 53 (40) |
| Median platelets, × 109/L (range) | 113 (32-217) | 105 (2-310) | 105 (2-310) |
| ≤100 × 109/L, n (%) | 12 (39) | 49 (49) | 61 (46) |
| Hemoglobin ≤11 g/dL or platelets ≤100 × 109/L, n (%) | 20 (65) | 61 (60) | 81 (61) |
| Median ALC, × 109/L (range) | 41.1 (0.3-240.2) | 8.9 (0.1-298.9) | 13 (0.1-299) |
| Median CrCl, mL/min (range) | 67 (31-156) | 81 (36-213) | 79 (31-213) |
| <60 mL/min, n (%) | 9 (29) | 20 (20) | 29 (22) |
| Median prior therapy, n (range) | — | 4 (1-12) | |
| Number of prior therapies, n (%) | |||
| 1-2 | — | 27 (27) | |
| 3 | — | 14 (14) | |
| ≥4 | — | 60 (59) | |
| Prior systemic therapy, n (%) | |||
| Chemotherapy | — | 101 (100) | |
| Nucleoside analog | — | 97 (96) | |
| Alkylator (including bendamustine) | — | 92 (91) | |
| Any anti-CD20–based therapy | — | 99 (98) | |
| Anti-CD20–based chemoimmunotherapy | — | 97 (96) | |
| Anti-CD52–based therapy (alemtuzumab) | — | 23 (23) | |
| Idelalisib | — | 6 (6) |
| . | TN ≥65 years (n = 31) . | R/R (n = 101) . | All patients (N = 132) . |
|---|---|---|---|
| Median age, years (range) | 71 (65-84) | 64 (37-82) | 68 (37-84) |
| ≥70 y, n (%) | 23 (74) | 34 (34) | 57 (43) |
| Sex, n (%) | |||
| Male | 19 (61) | 79 (78) | 98 (74) |
| Female | 12 (39) | 22 (22) | 34 (26) |
| ECOG PS, n (%) | |||
| 0 | 23 (74) | 43 (43) | 66 (50) |
| 1 | 8 (26) | 54 (53) | 62 (47) |
| 2 | 0 (0) | 4 (4) | 4 (3) |
| Bulky disease, n (%) | |||
| ≥5 cm | 6 (19) | 55 (54) | 61 (46) |
| ≥10 cm | 0 | 15 (15) | 15 (11) |
| Baseline Rai stage, n (%) | |||
| 0-II | 13 (42) | 38 (38) | 51 (39) |
| III-IV | 17 (55) | 58 (57) | 75 (57) |
| Unknown | 1 (3) | 5 (5) | 6 (5) |
| Cytogenetics/FISH, n (%) | |||
| Del(17p) | 2 (6) | 34 (34) | 36 (27) |
| Del(11q) | 1 (3) | 35 (35) | 36 (27) |
| Trisomy 12 | 8 (26) | 12 (12) | 20 (15) |
| Del(13q) | 17 (55) | 47 (47) | 64 (49) |
| β2-microglobulin level >3 mg/L, n (%) | 8 (26) | 49 (49) | 57 (43) |
| Unmutated IGHV, n (%) | 15 (48) | 79 (78) | 94 (71) |
| Median ANC, × 109/L (range) | 3.9 (0-19.4) | 2.5 (0-19) | 2.6 (0-19.4) |
| ANC ≤1.5 × 109/L | 1 (3) | 34 (34) | 35 (27) |
| Median hemoglobin, g/L (range) | 122 (77-157) | 115 (62-176) | 117 (62-176) |
| ≤11 g/dL, n (%) | 11 (35) | 42 (42) | 53 (40) |
| Median platelets, × 109/L (range) | 113 (32-217) | 105 (2-310) | 105 (2-310) |
| ≤100 × 109/L, n (%) | 12 (39) | 49 (49) | 61 (46) |
| Hemoglobin ≤11 g/dL or platelets ≤100 × 109/L, n (%) | 20 (65) | 61 (60) | 81 (61) |
| Median ALC, × 109/L (range) | 41.1 (0.3-240.2) | 8.9 (0.1-298.9) | 13 (0.1-299) |
| Median CrCl, mL/min (range) | 67 (31-156) | 81 (36-213) | 79 (31-213) |
| <60 mL/min, n (%) | 9 (29) | 20 (20) | 29 (22) |
| Median prior therapy, n (range) | — | 4 (1-12) | |
| Number of prior therapies, n (%) | |||
| 1-2 | — | 27 (27) | |
| 3 | — | 14 (14) | |
| ≥4 | — | 60 (59) | |
| Prior systemic therapy, n (%) | |||
| Chemotherapy | — | 101 (100) | |
| Nucleoside analog | — | 97 (96) | |
| Alkylator (including bendamustine) | — | 92 (91) | |
| Any anti-CD20–based therapy | — | 99 (98) | |
| Anti-CD20–based chemoimmunotherapy | — | 97 (96) | |
| Anti-CD52–based therapy (alemtuzumab) | — | 23 (23) | |
| Idelalisib | — | 6 (6) |
CrCl, creatinine clearance; FISH, fluorescence in situ hybridization.