TABLE 1.
Baseline characteristics and treatment history of patients with relapsed/refractory MCL treated with lenalidomide
| Characteristic, n (%) | NHL-002/NHL-003 (n = 72) | MCL-001 (n = 134) | Post-bortezomib (n = 157) | All MCL patients (N = 206) |
|---|---|---|---|---|
| Age, years | ||||
| Median (range) | 68 (33–84) | 67 (43–83) | 68 (43–84) | 67 (33–84) |
| ≥65 years, n (%) | 45 (63) | 85 (63) | 99 (63) | 130 (63) |
| Male | 52 (72) | 108 (81) | 124 (79) | 160 (78) |
| MCL stage disease | ||||
| I/II | 8 (11) | 10 (7) | 12 (8) | 18 (9) |
| III/IV | 63 (88) | 124 (93) | 144 (92) | 187 (91) |
| Missing | 1 (1) | 0 | 1 (1) | 1 (<1) |
| ECOG performance status | ||||
| 0–1 | 65 (90) | 116 (87) | 135 (86) | 181 (88) |
| ≥2 | 7 (10) | 18 (13) | 22 (14) | 25 (12) |
| MIPI score | ||||
| High (≥ 6.2) | 32 (44) | 39 (29) | 54 (34) | 71 (34) |
| Intermediate (5.7–<6.2) | 24 (33) | 51 (38) | 55 (35) | 75 (36) |
| Low (<5.7) | 14 (19) | 39 (29) | 42 (27) | 53 (26) |
| Missing | 2 (3) | 5 (4) | 6 (4) | 7 (3) |
| Elevated LDH (>250 U/L) | ||||
| Yes | 40 (56) | 47 (35) | 62 (39) | 87 (42) |
| No | 31 (43) | 84 (63) | 92 (59) | 115 (56) |
| Missing | 1 (1) | 3 (2) | 3 (2) | 4 (2) |
| Baseline WBC group (109/L) | ||||
| <6.7 | 44 (61) | 67 (50) | 81 (52) | 111 (54) |
| 6.7–<10 | 15 (21) | 41 (31) | 46 (29) | 56 (27) |
| 10–<15 | 5 (7) | 9 (7) | 10 (6) | 14 (7) |
| ≥15 | 8 (11) | 12 (9) | 15 (10) | 20 (10) |
| Missing | 0 | 5 (4) | 5 (3) | 5 (2) |
| Tumor burdena | ||||
| High | 30 (42) | 78 (58) | 90 (57) | 108 (52) |
| Low | 33 (46) | 54 (40) | 61 (39) | 87 (42) |
| Missing | 9 (13) | 2 (1) | 6 (4) | 11 (5) |
| Bulky diseaseb | ||||
| Yes | 18 (25) | 44 (33) | 53 (34) | 62 (30) |
| No | 45 (63) | 88 (66) | 98 (62) | 133 (65) |
| Missing | 9 (13) | 2 (1) | 6 (4) | 11 (5) |
| Renal groupc | ||||
| Normal | 40 (56) | 99 (74) | 110 (70) | 139 (67) |
| Moderate | 16 (22) | 28 (21) | 35 (22) | 44 (21) |
| Severe | 1 (1) | 1 (1) | 1 (1) | 2 (1) |
| Missing | 15 (21) | 6 (4) | 11 (7) | 21 (10) |
| Prior treatment regimens | ||||
| Median (range) | 3 (1–13) | 4 (2–10) | 4 (2–13) | 4 (1–13) |
| Number of regimens | 11 (15) | 0 | 0 | 11 (5) |
| 1 | 12 (17) | 29 (22) | 30 (19) | 41 (20) |
| 2 | 15 (21) | 35 (26) | 41 (26) | 50 (24) |
| 3 | 34 (47) | 70 (52) | 86 (55) | 104 (50) |
| 4 | ||||
| Median time from last prior therapy (range) | 4.1 (0–58.5) | 3.1 (0.3–37.7) | 2.9 (0.1–37.7) | 3.3 (0–58.5) |
| Best response to last prior therapy | ||||
| CR | 22 (31) | 21 (16) | 26 (17) | 43 (21) |
| Cru | 0 | 1 (1) | 1(1) | 1 (<1) |
| PR | 18 (25) | 30 (22) | 31 (20) | 48 (23) |
| SD | 12 (17) | 27 (20) | 33 (21) | 39 (19) |
| PD | 12 (17) | 48 (36) | 55 (35) | 60 (29) |
| Missing | 8 (11) | 7 (5) | 11 (7) | 15 (7) |
| Prior lines of therapy | ||||
| <3 | 23 (32) | 29 (22) | 30 (19) | 52 (25) |
| ≥3 | 49 (68) | 105 (78) | 127 (81) | 154 (75) |
| Relapsed after vs. refractory to last prior therapy | ||||
| Relapsed | 40 (56) | 52 (39) | 58 (37) | 92 (45) |
| Refractory | 26 (36) | 75 (56) | 90 (57) | 101 (49) |
| Missing | 6 (8) | 7 (5) | 9 (6) | 13 (6) |
| Prior therapies | ||||
| Anthracycline-containing | 65 (90) | 133 (99) | 155 (99) | 198 (96) |
| Bortezomib | 23 (32) | 134 (100) | 157 (100) | 157 (76) |
| Rituximab | 67 (93) | 134 (100) | 156 (99) | 201 (98) |
| Relapsed after vs. refractory to prior bortezomib | ||||
| Relapsed | 10 (14) | 51 (38) | 61 (39) | 61 (30) |
| Refractory | 13 (18) | 81 (60) | 94 (60) | 94 (46) |
| Received prior HDT or DITd | 23 (32) | 44 (33) | 49 (31) | 67 (33) |
| Time from last prior systemic anti-lymphoma therapy | ||||
| <6 months | 40 (56) | 96 (72) | 114 (73) | 136 (66) |
| ≥6 months | 32 (44) | 38 (28) | 43 (27) | 70 (34) |
Abbreviations: CR, complete response; CRu, unconfirmed complete response; ECOG, Eastern Cooperative Oncology Group; hyperCVAD, fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone; LDH, lactate dehydrogenase; MIPI, MCL International Prognostic Index; N/A, not applicable; PD, progressive disease; PR, partial response; R, rituximab; SD, stable disease; WBC, white blood cells.
High tumor burden was defined by at least 1 lesion ≥5 cm in diameter or at least 3 lesions ≥3 cm in diameter.
Bulky disease was defined at least 1 lesion ≥7 cm in longest diameter.
Creatinine clearance: normal ≥60 mL/min; moderate ≥30 to <60 mL/min; severe <30 mL/min.
High-dose therapy (HDT) or dose-intensive therapy (DIT) included stem cell transplant, hyperCVAD, or R-hyperCVAD.