Background
Methods
Study design and participants
Statistical analysis
Results
Patient characteristics
LOT1 (n = 889) | LOT ≥ 2 (n = 605) | |||||
---|---|---|---|---|---|---|
Characteristics | < 75 years | ≥ 75 years |
p valuea,b
| < 75 years | ≥ 75 years |
p valuea,b
|
(n = 630) | (n = 259) | (n = 409) | (n = 196) | |||
Age, years | ||||||
Mean | 62.4 | 80.4 | 63.9 | 80.8 | ||
SD | 8.26 | 4.33 | 7.67 | 4.37 | ||
Median | 63.0 | 80.0 | 65.0 | 80.0 | ||
Range | 22–74 | 75–99 | 34–74 | 75–96 | ||
Sex, n (%) | ||||||
Male | 411 (65.2) | 155 (59.8) |
0.1288
| 281 (68.7) | 106 (54.1) |
0.0005
|
Female | 219 (34.8) | 104 (40.2) | 128 (31.3) | 90 (45.9) | ||
Duration of CLL from diagnosis to registry enrollment, years | ||||||
Median | 1.4 | 1.8 |
0.2912
| 7.0 | 7.2 |
0.7074
|
Range | 0–29 | 0–32 | 0–32 | 0–30 | ||
Time from diagnosis to first LOT, years | ||||||
Median | 1.4 | 1.8 |
0.2593
| 1.4 | 2.3 |
0.0139
|
Range | 0–29 | 0–32 | 0–32 | 0–20 | ||
Race, n (%)c,d
| ||||||
White | 561 (92.3) | 237 (92.9) |
0.7211
| 352 (90.0) | 183 (96.3) |
0.0076
|
Black | 40 (6.6) | 16 (6.3) | 37 (9.5) | 5 (2.6) | ||
American Indian/Alaskan native | 0 | 0 | 1 (0.3) | 0 | ||
Asian | 3 (0.5) | 0 | 1 (0.3) | 0 | ||
Other | 4 (0.7) | 2 (0.8) | 0 | 2 (1.1) | ||
Geographic region, n (%)c,d
| ||||||
Northeast | 75 (12.0) | 37 (14.3) |
0.2029
| 58 (14.3) | 37 (19.0) |
0.016
|
Midwest | 207 (33.2) | 70 (27.1) | 137 (33.7) | 45 (23.1) | ||
South | 249 (40.0) | 103 (39.9) | 162 (39.8) | 77 (39.5) | ||
West | 92 (14.8) | 48 (18.6) | 50 (12.3) | 36 (18.5) | ||
Institution type, n (%) | ||||||
Academic | 74 (11.7) | 12 (4.6) | 57 (13.9) | 12 (6.1) | ||
Community | 545 (86.5) | 242 (93.4) | 343 (83.9) | 181 (92.3) | ||
Government | 11 (1.7) | 5 (1.9) | 9 (2.2) | 3 (1.5) | ||
Insurance, n (%)e
| ||||||
Medicare | 283 (44.9) | 229 (88.4) | 227 (55.5) | 175 (89.3) | ||
Medicaid | 28 (4.4) | 14 (5.4) | 16 (3.9) | 7 (3.6) | ||
Supplemental coverage | 86 (13.7) | 92 (35.5) | 81 (19.8) | 67 (34.2) | ||
Private coverage | 357 (56.7) | 46 (17.8) | 189 (46.2) | 35 (17.9) | ||
HMO | 88 (14.0) | 16 (6.2) | 56 (13.7) | 13 (6.6) | ||
PPO | 206 (32.7) | 26 (10.0) | 103 (25.2) | 14 (7.1) | ||
Other | 64 (10.2) | 4 (1.5) | 33 (8.1) | 8 (4.1) | ||
Military | 10 (1.6) | 5 (1.9) | 5 (1.2) | 6 (3.1) | ||
Self-pay | 13 (2.1) | 0 | 6 (1.5) | 0 | ||
Other Insurance | 10 (1.6) | 3 (1.2) | 8 (2.0) | 3 (1.5) | ||
Not specified | 15 (2.4) | 5 (1.9) | 19 (4.6) | 2 (1.0) | ||
ECOG score and status, n (%)c,d
| ||||||
0 - Fully active | 276 (57.4) | 70 (33.7) |
<0.001
| 138 (46.8) | 42 (30.7) |
0.0105
|
1 - Restricted in strenuous activity only | 180 (37.4) | 116 (55.8) | 138 (46.8) | 79 (57.7) | ||
2 - Ambulatory, but unable to work | 22 (4.6) | 19 (9.1) | 17 (5.8) | 14 (10.2) | ||
3 - Capable of only limited self-care | 2 (0.4) | 3 (1.4) | 2 (0.7) | 2 (1.5) | ||
4 - Completely disabled | 1 (0.2) | 0 | 0 | 0 | ||
Rai staging system score, n (%)c,d
| ||||||
Stage 0 | 112 (23.7) | 60 (28.4) |
0.0219
| 63 (25.2) | 46 (32.6) |
0.1728
|
Stage I | 143 (30.2) | 48 (22.7) | 58 (23.2) | 39 (27.7) | ||
Stage II | 83 (17.5) | 25 (11.8) | 43 (17.2) | 16 (11.3) | ||
Stage III | 71 (15.0) | 36 (17.1) | 44 (17.6) | 24 (17.0) | ||
Stage IV | 64 (13.5) | 42 (19.9) | 42 (16.8) | 16 (11.3) | ||
Constitutional symptoms, n (%) | 397 (63.0) | 183 (71.8) |
0.0192
| 264 (65.0) | 126 (64.3) |
0.977
|
Fatiguef
| 328 (82.6) | 152 (83.1) | 212 (80.3) | 114 (90.5) | ||
Fever | 44 (11.1) | 16 (8.7) | 22 (8.3) | 5 (4.0) | ||
Night sweats | 164 (41.3) | 62 (33.9) | 85 (32.2) | 27 (21.4) | ||
Other | 69 (17.4) | 44 (24.0) | 54 (20.5) | 25 (19.8) | ||
Weight loss | 97 (24.4) | 60 (32.8) | 71 (26.9) | 37 (29.4) | ||
Metaphase cytogenetic analysis, n (%)e
| ||||||
Yes | 254 (40.3) | 93 (35.9) | 148 (36.2) | 46 (23.5) | ||
Abnormalities foundf
| 110 (43.3) | 48 (51.6) | 81 (54.7) | 23 (50.0) | ||
del(11q) | 24 (9.4) | 12 (12.9) | 18 (12.2) | 5 (10.9) | ||
del(13q) | 36 (14.2) | 11 (11.8) | 23 (15.5) | 7 (15.2) | ||
Trisomy 12 | 41 (16.1) | 16 (17.2) | 30 (20.3) | 8 (17.4) | ||
del(17p) | 13 (5.1) | 6 (6.5) | 12 (8.1) | 3 (6.5) | ||
Other | 35 (13.8) | 18 (19.4) | 36 (24.3) | 10 (21.7) | ||
FISH analysis, n (%)e
| ||||||
Yes | 377 (59.8) | 136 (52.5) | 157 (38.4) | 67 (34.2) | ||
Abnormalities foundf
| 281 (74.5) | 99 (72.8) | 116 (73.9) | 44 (65.7) | ||
del(11q) | 64 (17.0) | 26 (19.1) | 31 (19.7) | 14 (20.9) | ||
del(13q) | 179 (47.5) | 59 (43.4) | 69 (43.9) | 30 (44.8) | ||
Trisomy 12 | 74 (19.6) | 31 (22.8) | 38 (24.2) | 10 (14.9) | ||
del(17p) | 33 (8.8) | 18 (13.2) | 28 (17.8) | 9 (13.4) | ||
Other | 24 (6.4) | 14 (10.3) | 11 (7.0) | 6 (9.0) | ||
ALC (×109/L) | 263 | 106 | 179 | 79 | ||
Mean (×109/L) | 68.5 | 58.4 | 52.7 | 54.2 | ||
SD | 75.7 | 62.9 | 64.5 | 51.9 | ||
Median (×109/L) | 46.1 | 34.6 | 25.6 | 40.1 | ||
Range (×109/L) | 0–564.0 | 1.3–275.4 | 0.1–306.0 | 0.8–271.1 |
Treatment patterns
Regimen | LOT1 (n = 889) | LOT ≥ 2 (n = 605) | ||||
---|---|---|---|---|---|---|
< 75 years | ≥ 75 years |
p valuea,b
| < 75 years | ≥ 75 years |
p valuea,b
| |
(n = 630) | (n = 259) | (n = 409) | (n = 196) | |||
Rituximab monotherapy, n (%) | 54 (8.6) | 50 (19.3) |
<0.0001
| 52 (12.7) | 30 (15.3) |
0.3834
|
Combinations with rituximab, n (%) | 482 (76.5) | 139 (53.7) |
<0.0001
| 243 (59.4) | 90 (45.92) |
0.0018
|
Bendamustine/rituximab | 126 (20.0) | 61 (23.6) |
0.2377
| 125 (30.6) | 43 (21.9) |
0.0267
|
Bendamustine/dexamethasone/rituximab | 5 (0.8) | 4 (1.5) | 5 (1.2) | 0 | ||
Chlorambucil/rituximab | 0 | 4 (1.5) | 0 | 0 | ||
Cyclophosphamide/rituximab | 0 | 0 | 0 | 3 (1.5) | ||
Cyclophosphamide/fludarabine/dexamethasone/rituximab | 8 (1.3) | 0 | 0 | 0 | ||
Cyclophosphamide/lenalidomide/rituximab | 0 | 0 | 4 (1.0) | 0 | ||
Cyclophosphamide/pentostatin/rituximab | 21 (3.3) | 3 (1.2) | 13 (3.2) | 0 | ||
Cyclophosphamide/vincristine/prednisone/rituximab | 14 (2.2) | 9 (3.5) | 8 (2.0) | 6 (3.1) | ||
Fludarabine/cyclophosphamide/rituximab | 212 (33.7) | 18 (6.9) |
<0.0001
| 41 (10.0) | 11 (5.6) |
0.0700
|
Fludarabine/rituximab | 33 (5.2) | 22 (8.5) | 14 (3.4) | 11 (5.6) | ||
Lenalidomide/rituximab | 10 (1.6) | 0 | 0 | 0 | ||
Prednisone/rituximab | 0 | 4 (1.5) | 0 | 3 (1.5) | ||
Investigational product/rituximab | 14 (2.2) | 0 | 0 | 0 | ||
Chemotherapy alone, n (%) | 65 (10.3) | 52 (20.1) |
<0.0001
| 45 (11.0) | 50 (25.5) |
<0.0001
|
Bendamustine | 23 (3.7) | 8 (3.1) | 24 (5.9) | 21 (10.7) | ||
Chlorambucil | 18 (2.9) | 22 (8.5) | 6 (1.5) | 12 (6.1) | ||
Chlorambucil/prednisone | 0 | 12 (4.6) | 0 | 3 (1.5) | ||
Cyclophosphamide | 0 | 4 (1.5) | 0 | 0 | ||
Cyclophosphamide/fludarabine | 11 (1.7) | 0 | 0 | 2 (1.0) | ||
Cyclophosphamide/vincristine/prednisone | 0 | 0 | 5 (1.2) | 0 | ||
Fludarabine | 9 (1.4) | 0 | 5 (1.2) | 10 (5.1) | ||
Other, n (%) | 14 (2.2) | 16 (6.2) |
0.0030
| 46 (11.3) | 18 (9.2) |
0.4400
|
Alemtuzumab | 0 | 0 | 14 (3.4) | 6 (3.1) | ||
Lenalidomide | 0 | 4 (1.5) | 0 | 0 | ||
Ofatumumab | 0 | 0 | 17 (4.2) | 8 (4.1) | ||
Investigational product | 6 (1.0) | 7 (2.7) | 13 (3.2) | 4 (2.0) |