Demographic and clinical characteristics at baseline for IC-treated population, analysis population (total and according to 1L treatment received), P-L population, POLARIX R-CHOP treatment arm, S-L population, and SENIOR trial
| . | IC-treated population N = 697 . | Analysis population N = 645 . | REALYSA P-L population n = 320 . | POLARIX R-CHOP arm23 n = 439 . | REALYSA S-L population n = 59 . | SENIOR R-miniCHOP arm24 n = 127 . | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Total n = 645 . | R–high-dose anthracycline n = 62 (9.6%) . | R-CHOP n = 482 (74.7%) . | R-miniCHOP n = 86 (13.3%) . | R–nonanthracycline-based chemotherapy n = 15 (2.3%) . | ||||||
| Male sex | 371 (53.2%) | 344 (53.3%) | 33 (53.2%) | 260 (53.9%) | 40 (46.5%) | 11 (73.3%) | 174 (54.4%) | 234 (53.3%) | 32 (54.2%) | 56 (44.0%) |
| Median age at diagnosis (min-max), y | 67.0 (19-98) | 66.3 (19-98) | 40.1 (19-67) | 65.2 (20-90) | 82.5 (71-95) | 82.3 (60-98) | 67.4 (24-80) | 66.0 (19-80) | 83.4 (80-95) | 83.0 (80-96)∗ |
| Age at diagnosis, y | ||||||||||
| ≤60 | 238 (34.1%) | 235 (36.4%) | 61 (98.4%) | 173 (35.9%) | 0 (0.0%) | 1 (6.7%) | 78 (24.4%) | 131 (29.8%) | 0 (0.0%) | 0 (0.0%) |
| 60 to 80 | 373 (53.5%) | 325 (50.4%) | 1 (1.6%) | 301 (62.4%) | 18 (20.9%) | 5 (33.3%) | 242 (75.6%) | 308 (70.2%) | 0 (0.0%) | 0 (0.0%) |
| >80 | 86 (12.3%) | 85 (13.2%) | 0 (0.0%) | 8 (1.7%) | 68 (79.1%) | 9 (60.0%) | 0 (0.0%) | 308 (70.2%) | 59 (100.0%)† | 127 (100.0%)† |
| ECOG PS‡ | ||||||||||
| Data available | 680 (97.6%) | 628 (97.3%) | 61 (98.4%) | 470 (97.5%) | 84 (97.7%) | 13 (86.7%) | 320 (100.0%) | 439 (100.0%) | 59 (100.0%) | 127 (100.0%) |
| 2 to 4 | 128 (18.8%) | 125 (19.9%) | 7 (11.5%) | 79 (16.8%) | 33 (39.3%) | 6 (46.2%) | 56 (17.5%) | 75 (17.1%) | 17 (28.8%) | 36 (28.0%) |
| Main histological subtypes | ||||||||||
| DLBCL | 521 (74.7%) | 480 (74.4%) | 32 (51.6%) | 369 (76.6%) | 69 (80.2%) | 10 (66.7%) | 244 (76.3%) | 367 (83.6%) | 47 (79.7%) | NA |
| PMBL | 46 (6.6%) | 45 (7.0%) | 21 (33.9%) | 24 (5.0%) | 0 (0.0%) | 0 (0.0%) | 9 (2.8%) | 0 (0.0%) | 0 (0.0%) | |
| HGBL | 85 (12.2%) | 81 (12.6%) | 5 (8.1%) | 61 (12.7%) | 11 (12.8%) | 4 (26.7%) | 45 (14.1%) | 50 (11.4%) | 9 (15.2%) | |
| Other large B-cell lymphoma | 45 (6.5%) | 39 (6.0%) | 4 (6.4%) | 28 (5.8%) | 6 (7.0%) | 1 (6.7%) | 22 (6.8%) | 22 (5.0%) | 3 (5.1%) | |
| Low grade component at diagnosis | 42 (6.0%) | 41 (6.4%) | 2 (3.2%) | 31 (6.4%) | 7 (8.1%) | 1 (6.7%) | 20 (6.3%) | NA | 5 (8.5%) | NA |
| PETscan performed at diagnosis | ||||||||||
| Data available | 694 (99.6%) | 642 (99.5%) | 62 (100.0%) | 480 (99.6%) | 85 (98.8%) | 15 (100.0%) | 318 (99.4%) | NA | 58 (98.3%) | NA |
| Yes | 658 (94.8%) | 606 (94.4%) | 62 (100.0%) | 464 (96.7%) | 70 (82.4%) | 10 (66.7%) | 308 (96.9%) | 47 (81.0%) | ||
| Ann-Arbor stage‡ | ||||||||||
| Data available | 696 (99.9%) | 644 (99.8%) | 62 (100.0%) | 481 (99.8%) | 86 (100.0%) | 15 (100.0%) | 320 (100.0%) | 439 (100.0%) | 59 (100.0%) | 127 (100.0%) |
| III to IV | 518 (74.4%) | 472 (73.3%) | 41 (66.1%) | 350 (72.8%) | 70 (81.4%) | 11 (73.3%) | 291 (90.9%) | 387 (88.2%) | 52 (88.1%) | 105 (83.0%) |
| IPI class‡ | ||||||||||
| Data available | 671 (96.3%) | 619 (96.0%) | 60 (96.8%) | 466 (96.7%) | 81 (94.2%) | 12 (80.0%) | 320 (100.0%) | 439 (100.0%) | 57 (96.6%) | 126 (99.2%) |
| 0 to 1 | 155 (23.1%) | 152 (24.6%) | 23 (38.3%) | 121 (26.0%) | 7 (8.6%) | 1 (8.3%) | 0 (0.0%) | 0 (0.0%) | 3 (5.3%) | 32 (25.0%) |
| 2 | 153 (22.8%) | 141 (22.8%) | 15 (25.0%) | 110 (23.6%) | 12 (14.8%) | 4 (33.3%) | 110 (34.3%) | 167 (38.0%) | 9 (15.8%) | 32 (25.0%) |
| 3 | 167 (24.9%) | 148 (23.9%) | 18 (30.0%) | 110 (23.6%) | 19 (23.5%) | 1 (8.3%) | 210 (65.7%) | 272 (62.0%) | 16 (28.1%) | 94 (75.0%) |
| 4-5 | 196 (29.2%) | 178 (28.8%) | 4 (6.7%) | 125 (26.8%) | 43 (53.1%) | 6 (50.0%) | 210 (65.7%) | 272 (62.0%) | 29 (50.9%) | 94 (75.0%) |
| aaIPI | ||||||||||
| Data available | 662 (95.0%) | 610 (94.6%) | 59 (95.2%) | 458 (95.0%) | 81 (94.2%) | 12 (80.0%) | 315 (98.4%) | NA | 57 (96.6%) | NA |
| 0 | 77 (11.6%) | 76 (12.5%) | 2 (3.4%) | 66 (14.4%) | 8 (9.9%) | 0 (0.0%) | 0 (0.0%) | 4 (7.0%) | ||
| 1 | 213 (32.2%) | 197 (32.3%) | 22 (37.3%) | 153 (33.4%) | 17 (21.0%) | 5 (41.7%) | 102 (32.4%) | 14 (24.6%) | ||
| 2 | 277 (41.8%) | 244 (40.0%) | 30 (50.8%) | 181 (39.5%) | 30 (37.0%) | 3 (25.0%) | 173 (54.9%) | 25 (43.9%) | ||
| 3 | 95 (14.4%) | 93 (15.2%) | 5 (8.5%) | 58 (12.7%) | 26 (32.1%) | 4 (33.3%) | 40 (12.7%) | 14 (24.6%) | ||
| Extranodal involvement§ | 540 (77.5%) | 499 (77.4%) | 39 (62.9%) | 372 (77.2%) | 75 (87.2%) | 13 (86.7%) | 276 (86.3%) | NA | 53 (89.8%) | NA |
| Elevated LDH level at baseline | ||||||||||
| Data available | 680 (97.6%) | 628 (97.4%) | 60 (96.8%) | 471 (97.7%) | 83 (96.5%) | 14 (93.3%) | 315 (98.4%) | 438 (99.8%) | 57 (96.6%) | NA |
| Yes | 441 (64.9%) | 402 (64.0%) | 52 (86.7%) | 284 (60.3%) | 58 (69.9%) | 8 (57.1%) | 226 (71.7%) | 284 (64.8%) | 39 (68.4%) | |
| . | IC-treated population N = 697 . | Analysis population N = 645 . | REALYSA P-L population n = 320 . | POLARIX R-CHOP arm23 n = 439 . | REALYSA S-L population n = 59 . | SENIOR R-miniCHOP arm24 n = 127 . | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Total n = 645 . | R–high-dose anthracycline n = 62 (9.6%) . | R-CHOP n = 482 (74.7%) . | R-miniCHOP n = 86 (13.3%) . | R–nonanthracycline-based chemotherapy n = 15 (2.3%) . | ||||||
| Male sex | 371 (53.2%) | 344 (53.3%) | 33 (53.2%) | 260 (53.9%) | 40 (46.5%) | 11 (73.3%) | 174 (54.4%) | 234 (53.3%) | 32 (54.2%) | 56 (44.0%) |
| Median age at diagnosis (min-max), y | 67.0 (19-98) | 66.3 (19-98) | 40.1 (19-67) | 65.2 (20-90) | 82.5 (71-95) | 82.3 (60-98) | 67.4 (24-80) | 66.0 (19-80) | 83.4 (80-95) | 83.0 (80-96)∗ |
| Age at diagnosis, y | ||||||||||
| ≤60 | 238 (34.1%) | 235 (36.4%) | 61 (98.4%) | 173 (35.9%) | 0 (0.0%) | 1 (6.7%) | 78 (24.4%) | 131 (29.8%) | 0 (0.0%) | 0 (0.0%) |
| 60 to 80 | 373 (53.5%) | 325 (50.4%) | 1 (1.6%) | 301 (62.4%) | 18 (20.9%) | 5 (33.3%) | 242 (75.6%) | 308 (70.2%) | 0 (0.0%) | 0 (0.0%) |
| >80 | 86 (12.3%) | 85 (13.2%) | 0 (0.0%) | 8 (1.7%) | 68 (79.1%) | 9 (60.0%) | 0 (0.0%) | 308 (70.2%) | 59 (100.0%)† | 127 (100.0%)† |
| ECOG PS‡ | ||||||||||
| Data available | 680 (97.6%) | 628 (97.3%) | 61 (98.4%) | 470 (97.5%) | 84 (97.7%) | 13 (86.7%) | 320 (100.0%) | 439 (100.0%) | 59 (100.0%) | 127 (100.0%) |
| 2 to 4 | 128 (18.8%) | 125 (19.9%) | 7 (11.5%) | 79 (16.8%) | 33 (39.3%) | 6 (46.2%) | 56 (17.5%) | 75 (17.1%) | 17 (28.8%) | 36 (28.0%) |
| Main histological subtypes | ||||||||||
| DLBCL | 521 (74.7%) | 480 (74.4%) | 32 (51.6%) | 369 (76.6%) | 69 (80.2%) | 10 (66.7%) | 244 (76.3%) | 367 (83.6%) | 47 (79.7%) | NA |
| PMBL | 46 (6.6%) | 45 (7.0%) | 21 (33.9%) | 24 (5.0%) | 0 (0.0%) | 0 (0.0%) | 9 (2.8%) | 0 (0.0%) | 0 (0.0%) | |
| HGBL | 85 (12.2%) | 81 (12.6%) | 5 (8.1%) | 61 (12.7%) | 11 (12.8%) | 4 (26.7%) | 45 (14.1%) | 50 (11.4%) | 9 (15.2%) | |
| Other large B-cell lymphoma | 45 (6.5%) | 39 (6.0%) | 4 (6.4%) | 28 (5.8%) | 6 (7.0%) | 1 (6.7%) | 22 (6.8%) | 22 (5.0%) | 3 (5.1%) | |
| Low grade component at diagnosis | 42 (6.0%) | 41 (6.4%) | 2 (3.2%) | 31 (6.4%) | 7 (8.1%) | 1 (6.7%) | 20 (6.3%) | NA | 5 (8.5%) | NA |
| PETscan performed at diagnosis | ||||||||||
| Data available | 694 (99.6%) | 642 (99.5%) | 62 (100.0%) | 480 (99.6%) | 85 (98.8%) | 15 (100.0%) | 318 (99.4%) | NA | 58 (98.3%) | NA |
| Yes | 658 (94.8%) | 606 (94.4%) | 62 (100.0%) | 464 (96.7%) | 70 (82.4%) | 10 (66.7%) | 308 (96.9%) | 47 (81.0%) | ||
| Ann-Arbor stage‡ | ||||||||||
| Data available | 696 (99.9%) | 644 (99.8%) | 62 (100.0%) | 481 (99.8%) | 86 (100.0%) | 15 (100.0%) | 320 (100.0%) | 439 (100.0%) | 59 (100.0%) | 127 (100.0%) |
| III to IV | 518 (74.4%) | 472 (73.3%) | 41 (66.1%) | 350 (72.8%) | 70 (81.4%) | 11 (73.3%) | 291 (90.9%) | 387 (88.2%) | 52 (88.1%) | 105 (83.0%) |
| IPI class‡ | ||||||||||
| Data available | 671 (96.3%) | 619 (96.0%) | 60 (96.8%) | 466 (96.7%) | 81 (94.2%) | 12 (80.0%) | 320 (100.0%) | 439 (100.0%) | 57 (96.6%) | 126 (99.2%) |
| 0 to 1 | 155 (23.1%) | 152 (24.6%) | 23 (38.3%) | 121 (26.0%) | 7 (8.6%) | 1 (8.3%) | 0 (0.0%) | 0 (0.0%) | 3 (5.3%) | 32 (25.0%) |
| 2 | 153 (22.8%) | 141 (22.8%) | 15 (25.0%) | 110 (23.6%) | 12 (14.8%) | 4 (33.3%) | 110 (34.3%) | 167 (38.0%) | 9 (15.8%) | 32 (25.0%) |
| 3 | 167 (24.9%) | 148 (23.9%) | 18 (30.0%) | 110 (23.6%) | 19 (23.5%) | 1 (8.3%) | 210 (65.7%) | 272 (62.0%) | 16 (28.1%) | 94 (75.0%) |
| 4-5 | 196 (29.2%) | 178 (28.8%) | 4 (6.7%) | 125 (26.8%) | 43 (53.1%) | 6 (50.0%) | 210 (65.7%) | 272 (62.0%) | 29 (50.9%) | 94 (75.0%) |
| aaIPI | ||||||||||
| Data available | 662 (95.0%) | 610 (94.6%) | 59 (95.2%) | 458 (95.0%) | 81 (94.2%) | 12 (80.0%) | 315 (98.4%) | NA | 57 (96.6%) | NA |
| 0 | 77 (11.6%) | 76 (12.5%) | 2 (3.4%) | 66 (14.4%) | 8 (9.9%) | 0 (0.0%) | 0 (0.0%) | 4 (7.0%) | ||
| 1 | 213 (32.2%) | 197 (32.3%) | 22 (37.3%) | 153 (33.4%) | 17 (21.0%) | 5 (41.7%) | 102 (32.4%) | 14 (24.6%) | ||
| 2 | 277 (41.8%) | 244 (40.0%) | 30 (50.8%) | 181 (39.5%) | 30 (37.0%) | 3 (25.0%) | 173 (54.9%) | 25 (43.9%) | ||
| 3 | 95 (14.4%) | 93 (15.2%) | 5 (8.5%) | 58 (12.7%) | 26 (32.1%) | 4 (33.3%) | 40 (12.7%) | 14 (24.6%) | ||
| Extranodal involvement§ | 540 (77.5%) | 499 (77.4%) | 39 (62.9%) | 372 (77.2%) | 75 (87.2%) | 13 (86.7%) | 276 (86.3%) | NA | 53 (89.8%) | NA |
| Elevated LDH level at baseline | ||||||||||
| Data available | 680 (97.6%) | 628 (97.4%) | 60 (96.8%) | 471 (97.7%) | 83 (96.5%) | 14 (93.3%) | 315 (98.4%) | 438 (99.8%) | 57 (96.6%) | NA |
| Yes | 441 (64.9%) | 402 (64.0%) | 52 (86.7%) | 284 (60.3%) | 58 (69.9%) | 8 (57.1%) | 226 (71.7%) | 284 (64.8%) | 39 (68.4%) | |
ECOG PS, Eastern Cooperative Oncology Group-Performance Status; HGBL, high-grade B-cell lymphoma; NA, not applicable.
Median age of the whole trial population (ie, both arms, data not available for R-miniCHOP arm only). If “no data available” is not mentioned, it means that data were available for 100% of patients.
≥80 years of age.
When missing data are reported, the percentage of available data is reported, and the distribution of the variable is expressed as a percentage of available data; LDH; R-CHOP; R-mini-; R–nonanthracycline-based chemotherapy regimen: R-CEOP (cyclophosphamide, etoposide, vincristine, and prednisone), R-CEP (cyclophosphamide, etoposide, and prednisone), R-COP (cyclophosphamide, vincristine, and prednisone), R-COP + gemcitabine, R-CVP (cyclophosphamide, vincristine, and prednisone), R-CVP + gemcitabine, R-GEMOX (gemcitabin and oxaliplatin), R-ifosfamide, and etoposide.
Extranodal involvement includes spleen.