Patient characteristics
| Characteristic . | Unfit . | Fit . | Total . | P value . | |||
|---|---|---|---|---|---|---|---|
| n . | % . | n . | % . | n . | % . | ||
| All patients, N | 228 | 181 | 409 | ||||
| CLL13 | 46 | 20.2 | 181 | 100 | 227 | 55.5 | <.001 |
| CLL14 | 182 | 79.8 | 0 | 0 | 182 | 44.5 | |
| Age, y | 228 | 181 | 409 | ||||
| Median | 72 | 58 | 67 | <.001 | |||
| IQR | 66-76 | 53-66 | 58-73 | ||||
| ≤65 | 48 | 21.1 | 136 | 75.1 | 184 | 45.0 | <.001 |
| >65 and ≤70 | 57 | 25.0 | 24 | 13.3 | 81 | 19.8 | |
| >70 and ≤75 | 60 | 26.3 | 16 | 8.8 | 76 | 18.6 | |
| >75 and ≤80 | 39 | 17.1 | 5 | 2.8 | 44 | 10.8 | |
| >80 | 24 | 10.5 | 0 | 0 | 24 | 5.9 | |
| Sex | 228 | 181 | 409 | ||||
| Female | 92 | 40.4 | 31 | 17.1 | 123 | 30.1 | <.001 |
| Male | 136 | 59.6 | 150 | 82.9 | 286 | 69.9 | |
| ECOG status | 228 | 181 | 409 | ||||
| Median | 1 | 0 | 0 | <.001 | |||
| IQR | 0-1 | 0-1 | 0-1 | ||||
| Total CIRS score | 228 | 181 | 409 | ||||
| Median | 8 | 2 | 5 | <.001 | |||
| IQR | 5-10 | 1-3 | 2-8 | ||||
| >3 | 197 | 86.4 | 43 | 23.8 | 240 | 58.7 | <.001 |
| >4 | 188 | 82.5 | 24 | 13.3 | 212 | 51.8 | <.001 |
| >5 | 171 | 75.0 | 16 | 8.8 | 187 | 45.7 | <.001 |
| >6 | 158 | 69.3 | 0 | 0 | 158 | 38.6 | <.001 |
| Binet stage | 228 | 181 | 409 | ||||
| A | 56 | 24.6 | 43 | 23.8 | 99 | 24.2 | .452 |
| B | 80 | 35.1 | 74 | 40.9 | 154 | 37.7 | |
| C | 92 | 40.4 | 64 | 35.4 | 156 | 38.1 | |
| Time from diagnosis to study entry, mo | 228 | 181 | 409 | ||||
| Median | 36.4 | 24 | 31.9 | <.001 | |||
| IQR | 15.9-67.5 | 6.1-50.1 | 10.4-64.2 | ||||
| Constitutional symptoms | 228 | 180 | 408 | ||||
| No | 121 | 53.1 | 116 | 64.4 | 237 | 58.1 | .026 |
| Yes | 107 | 46.9 | 64 | 35.6 | 171 | 41.9 | |
| Missing information | 0 | 0 | 1 | 0.6 | 1 | 0.2 | |
| Creatinine clearance, mL/min | 227 | 181 | 408 | ||||
| Median | 63.5 | 91.9 | 78.5 | <.001 | |||
| IQR | 53.0-77.2 | 81.6-114.5 | 60.9-96.0 | ||||
| <70 | 155 | 68.3 | 0 | 0 | 155 | 38.0 | <.001 |
| <60 | 98 | 43.2 | 0 | 0 | 98 | 24.0 | <.001 |
| <50 | 38 | 16.7 | 0 | 0 | 38 | 9.3 | <.001 |
| del(17p) | 228 | 181 | 409 | ||||
| Yes | 0 | 0 | 0 | 0 | 0 | 0 | NA |
| del(11q) | 228 | 181 | 409 | ||||
| Yes | 37 | 16.2 | 39 | 21.5 | 76 | 18.6 | .201 |
| Trisomy 12 | 228 | 181 | 409 | ||||
| Yes | 52 | 22.8 | 38 | 21 | 90 | 22 | .719 |
| del(13q) | 228 | 181 | 409 | ||||
| Yes | 123 | 53.9 | 100 | 55.2 | 223 | 54.5 | .842 |
| IGHV mutational status | 217 | 172 | 389 | ||||
| Unmutated | 122 | 56.2 | 108 | 62.8 | 230 | 59.1 | .213 |
| Mutated | 95 | 43.8 | 64 | 37.2 | 159 | 40.9 | |
| Missing information | 11 | 4.8 | 9 | 5 | 20 | 4.9 | |
| TP53 status | 228 | 181 | 409 | ||||
| None | 228 | 100 | 181 | 100 | 409 | 100 | NA |
| Mutation and/or deletion | 0 | 0 | 0 | 0 | 0 | 0 | |
| Serum β2-microglobulin, mg/L | 219 | 179 | 398 | ||||
| Median | 4.1 | 3.9 | 3.9 | .069 | |||
| IQR | 3.0-5.7 | 3.1-4.7 | 3.1-5.2 | ||||
| Serum thymidine kinase, U/L | 212 | 176 | 388 | ||||
| Median | 27.6 | 39.2 | 31.5 | <.001 | |||
| IQR | 14.6-46.6 | 20.6-76.7 | 16.9-62.4 | ||||
| Platelets, ×109/L | 228 | 181 | 409 | ||||
| Median | 139 | 146 | 143 | .306 | |||
| IQR | 100.0-195.5 | 108.0-197.0 | 105.0-196.5 | ||||
| Leukocytes, ×109/L | 228 | 181 | 409 | ||||
| Median | 72.8 | 88.2 | 76.5 | .092 | |||
| IQR | 33.7-141.7 | 35.7-200.0 | 35.3-164.3 | ||||
| Lymphocytes, ×109/L | 227 | 180 | 407 | ||||
| Median | 60.4 | 75.9 | 64.1 | .139 | |||
| IQR | 24.0-124.3 | 31.0-170.3 | 25.2-146.7 | ||||
| Neutrophils, ×109/L | 227 | 180 | 407 | ||||
| Median | 4 | 4.4 | 4.2 | .830 | |||
| IQR | 2.5-6.3 | 2.5-6.6 | 2.5-6.5 | ||||
| LDH, U/L | 228 | 177 | 405 | ||||
| Median | 264.5 | 261 | 262 | .439 | |||
| IQR | 200.5-360.3 | 213.0-320.0 | 205.0-344.0 | ||||
| Characteristic . | Unfit . | Fit . | Total . | P value . | |||
|---|---|---|---|---|---|---|---|
| n . | % . | n . | % . | n . | % . | ||
| All patients, N | 228 | 181 | 409 | ||||
| CLL13 | 46 | 20.2 | 181 | 100 | 227 | 55.5 | <.001 |
| CLL14 | 182 | 79.8 | 0 | 0 | 182 | 44.5 | |
| Age, y | 228 | 181 | 409 | ||||
| Median | 72 | 58 | 67 | <.001 | |||
| IQR | 66-76 | 53-66 | 58-73 | ||||
| ≤65 | 48 | 21.1 | 136 | 75.1 | 184 | 45.0 | <.001 |
| >65 and ≤70 | 57 | 25.0 | 24 | 13.3 | 81 | 19.8 | |
| >70 and ≤75 | 60 | 26.3 | 16 | 8.8 | 76 | 18.6 | |
| >75 and ≤80 | 39 | 17.1 | 5 | 2.8 | 44 | 10.8 | |
| >80 | 24 | 10.5 | 0 | 0 | 24 | 5.9 | |
| Sex | 228 | 181 | 409 | ||||
| Female | 92 | 40.4 | 31 | 17.1 | 123 | 30.1 | <.001 |
| Male | 136 | 59.6 | 150 | 82.9 | 286 | 69.9 | |
| ECOG status | 228 | 181 | 409 | ||||
| Median | 1 | 0 | 0 | <.001 | |||
| IQR | 0-1 | 0-1 | 0-1 | ||||
| Total CIRS score | 228 | 181 | 409 | ||||
| Median | 8 | 2 | 5 | <.001 | |||
| IQR | 5-10 | 1-3 | 2-8 | ||||
| >3 | 197 | 86.4 | 43 | 23.8 | 240 | 58.7 | <.001 |
| >4 | 188 | 82.5 | 24 | 13.3 | 212 | 51.8 | <.001 |
| >5 | 171 | 75.0 | 16 | 8.8 | 187 | 45.7 | <.001 |
| >6 | 158 | 69.3 | 0 | 0 | 158 | 38.6 | <.001 |
| Binet stage | 228 | 181 | 409 | ||||
| A | 56 | 24.6 | 43 | 23.8 | 99 | 24.2 | .452 |
| B | 80 | 35.1 | 74 | 40.9 | 154 | 37.7 | |
| C | 92 | 40.4 | 64 | 35.4 | 156 | 38.1 | |
| Time from diagnosis to study entry, mo | 228 | 181 | 409 | ||||
| Median | 36.4 | 24 | 31.9 | <.001 | |||
| IQR | 15.9-67.5 | 6.1-50.1 | 10.4-64.2 | ||||
| Constitutional symptoms | 228 | 180 | 408 | ||||
| No | 121 | 53.1 | 116 | 64.4 | 237 | 58.1 | .026 |
| Yes | 107 | 46.9 | 64 | 35.6 | 171 | 41.9 | |
| Missing information | 0 | 0 | 1 | 0.6 | 1 | 0.2 | |
| Creatinine clearance, mL/min | 227 | 181 | 408 | ||||
| Median | 63.5 | 91.9 | 78.5 | <.001 | |||
| IQR | 53.0-77.2 | 81.6-114.5 | 60.9-96.0 | ||||
| <70 | 155 | 68.3 | 0 | 0 | 155 | 38.0 | <.001 |
| <60 | 98 | 43.2 | 0 | 0 | 98 | 24.0 | <.001 |
| <50 | 38 | 16.7 | 0 | 0 | 38 | 9.3 | <.001 |
| del(17p) | 228 | 181 | 409 | ||||
| Yes | 0 | 0 | 0 | 0 | 0 | 0 | NA |
| del(11q) | 228 | 181 | 409 | ||||
| Yes | 37 | 16.2 | 39 | 21.5 | 76 | 18.6 | .201 |
| Trisomy 12 | 228 | 181 | 409 | ||||
| Yes | 52 | 22.8 | 38 | 21 | 90 | 22 | .719 |
| del(13q) | 228 | 181 | 409 | ||||
| Yes | 123 | 53.9 | 100 | 55.2 | 223 | 54.5 | .842 |
| IGHV mutational status | 217 | 172 | 389 | ||||
| Unmutated | 122 | 56.2 | 108 | 62.8 | 230 | 59.1 | .213 |
| Mutated | 95 | 43.8 | 64 | 37.2 | 159 | 40.9 | |
| Missing information | 11 | 4.8 | 9 | 5 | 20 | 4.9 | |
| TP53 status | 228 | 181 | 409 | ||||
| None | 228 | 100 | 181 | 100 | 409 | 100 | NA |
| Mutation and/or deletion | 0 | 0 | 0 | 0 | 0 | 0 | |
| Serum β2-microglobulin, mg/L | 219 | 179 | 398 | ||||
| Median | 4.1 | 3.9 | 3.9 | .069 | |||
| IQR | 3.0-5.7 | 3.1-4.7 | 3.1-5.2 | ||||
| Serum thymidine kinase, U/L | 212 | 176 | 388 | ||||
| Median | 27.6 | 39.2 | 31.5 | <.001 | |||
| IQR | 14.6-46.6 | 20.6-76.7 | 16.9-62.4 | ||||
| Platelets, ×109/L | 228 | 181 | 409 | ||||
| Median | 139 | 146 | 143 | .306 | |||
| IQR | 100.0-195.5 | 108.0-197.0 | 105.0-196.5 | ||||
| Leukocytes, ×109/L | 228 | 181 | 409 | ||||
| Median | 72.8 | 88.2 | 76.5 | .092 | |||
| IQR | 33.7-141.7 | 35.7-200.0 | 35.3-164.3 | ||||
| Lymphocytes, ×109/L | 227 | 180 | 407 | ||||
| Median | 60.4 | 75.9 | 64.1 | .139 | |||
| IQR | 24.0-124.3 | 31.0-170.3 | 25.2-146.7 | ||||
| Neutrophils, ×109/L | 227 | 180 | 407 | ||||
| Median | 4 | 4.4 | 4.2 | .830 | |||
| IQR | 2.5-6.3 | 2.5-6.6 | 2.5-6.5 | ||||
| LDH, U/L | 228 | 177 | 405 | ||||
| Median | 264.5 | 261 | 262 | .439 | |||
| IQR | 200.5-360.3 | 213.0-320.0 | 205.0-344.0 | ||||
Patient characteristics for total study population and according to unfit or fit status. For comparisons of metric variables, Mann Whitney U test was used; for comparisons of categorical variables, χ2 test was used.
IGHV, immunoglobulin heavy chain region; LDH, lactate dehydrogenase; NA, not applicable; y, years.