Table 1.
Demographics and characteristics of patients at enrollment to therapy
| 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 | ||
a p values (bold text) calculated using a Chi-square test. b p values of interest are shown. cData are missing. dRounding of numbers may cause totals to be =, <, or > 100%. eMore than one answer permitted. fPercentages calculated based on the number of patients tested
ALC absolute lymphocyte count, CLL chronic lymphocytic leukemia, ECOG Eastern Cooperative Oncology Group, FISH fluorescence in-situ hybridization, HMO health maintenance organization, LOT1 first line of therapy, LOT ≥ 2 second line of therapy or greater, PPO preferred provider organization, SD standard deviation