Patient demographics and baseline characteristics
| Characteristic . | FC . | FCR . | P value . |
|---|---|---|---|
| All patients (ITT), N | 409 | 408 | |
| Age | N = 409 | N = 408 | |
| Median, years | 61 | 61 | |
| Range, years | 36-81 | 30-80 | |
| ≥65 years, no. (%) | 119 (29) | 126 (31) | |
| ≥75 years, no. (%) | 37 (9) | 44 (11) | |
| Sex, no. (%) | N = 409 | N = 408 | |
| Male | 304 (74) | 303 (74) | |
| Binet stage, no. (%) | N = 407 | N = 407 | |
| A | 22 (5) | 18 (4) | |
| B | 259 (64) | 263 (64) | |
| C | 126 (31) | 126 (31) | |
| Presence of B symptoms, no. (%) | N = 406 | N = 407 | |
| Yes | 197 (49) | 167 (41) | |
| Cumulative illness rating scale | N = 409 | N = 408 | |
| Median | 1 | 1 | |
| Range | 0-8 | 0-7 | |
| ECOG performance status, no. (%) | N = 390 | N = 395 | |
| 0 | 226 (58) | 221 (56) | |
| Cytogenetic abnormalities, no. (%) | N = 305 | N = 311 | |
| 17p deletion | 29 (10) | 22 (7) | |
| 11q deletion | 62 (20) | 80 (26) | |
| Trisomy 12 | 37 (12) | 24 (8) | |
| Normal | 58 (19) | 80 (26) | |
| 13q deletion | 119 (39) | 105 (34) | |
| IGHV mutational status, no. (%) | N = 312 | N = 310 | |
| UNM | 195 (63) | 197 (64) | |
| MUT | 117 (37) | 113 (37) | |
| NOTCH1 mutation, no. (%) | N = 312 | N = 310 | |
| Mutated | 32 (10) | 30 (10) | |
| Wild type | 280 (90) | 280 (90) | |
| SF3B1 mutation, no. (%) | N = 312 | N = 310 | |
| Mutated | 59 (19) | 55 (18) | |
| Wild type | 253 (91) | 254 (82) | |
| Serum thymidine kinase level, no. (%) | N = 288 | N = 303 | |
| ≥10.0 U/L | 225 (78) | 222 (73) | |
| Serum β2- microglobulin level, no. (%) | N = 288 | N = 303 | |
| ≥3.5 mg/L | 95 (33) | 102 (34) | |
| Response to treatment, no. (%) | |||
| Complete response | 88 (22) | 180 (44) | <.001 |
| Overall response | 328 (80) | 369 (90) | <.001 |
| Missing response | 38 (9) | 20 (5) |
| Characteristic . | FC . | FCR . | P value . |
|---|---|---|---|
| All patients (ITT), N | 409 | 408 | |
| Age | N = 409 | N = 408 | |
| Median, years | 61 | 61 | |
| Range, years | 36-81 | 30-80 | |
| ≥65 years, no. (%) | 119 (29) | 126 (31) | |
| ≥75 years, no. (%) | 37 (9) | 44 (11) | |
| Sex, no. (%) | N = 409 | N = 408 | |
| Male | 304 (74) | 303 (74) | |
| Binet stage, no. (%) | N = 407 | N = 407 | |
| A | 22 (5) | 18 (4) | |
| B | 259 (64) | 263 (64) | |
| C | 126 (31) | 126 (31) | |
| Presence of B symptoms, no. (%) | N = 406 | N = 407 | |
| Yes | 197 (49) | 167 (41) | |
| Cumulative illness rating scale | N = 409 | N = 408 | |
| Median | 1 | 1 | |
| Range | 0-8 | 0-7 | |
| ECOG performance status, no. (%) | N = 390 | N = 395 | |
| 0 | 226 (58) | 221 (56) | |
| Cytogenetic abnormalities, no. (%) | N = 305 | N = 311 | |
| 17p deletion | 29 (10) | 22 (7) | |
| 11q deletion | 62 (20) | 80 (26) | |
| Trisomy 12 | 37 (12) | 24 (8) | |
| Normal | 58 (19) | 80 (26) | |
| 13q deletion | 119 (39) | 105 (34) | |
| IGHV mutational status, no. (%) | N = 312 | N = 310 | |
| UNM | 195 (63) | 197 (64) | |
| MUT | 117 (37) | 113 (37) | |
| NOTCH1 mutation, no. (%) | N = 312 | N = 310 | |
| Mutated | 32 (10) | 30 (10) | |
| Wild type | 280 (90) | 280 (90) | |
| SF3B1 mutation, no. (%) | N = 312 | N = 310 | |
| Mutated | 59 (19) | 55 (18) | |
| Wild type | 253 (91) | 254 (82) | |
| Serum thymidine kinase level, no. (%) | N = 288 | N = 303 | |
| ≥10.0 U/L | 225 (78) | 222 (73) | |
| Serum β2- microglobulin level, no. (%) | N = 288 | N = 303 | |
| ≥3.5 mg/L | 95 (33) | 102 (34) | |
| Response to treatment, no. (%) | |||
| Complete response | 88 (22) | 180 (44) | <.001 |
| Overall response | 328 (80) | 369 (90) | <.001 |
| Missing response | 38 (9) | 20 (5) |