Baseline characteristics of patients from the ITT set and according to long-term follow-up program enrolment
| . | Patients enrolled in the LTFU program . | All (ITT set) n = 600 . | ||
|---|---|---|---|---|
| No (center not participating in LTFU) n = 125 . | No (patients dead at cutoff date of primary analysis or refused data collection) n = 219 . | Yes n = 256 . | ||
| Treatment received, n (%) | ||||
| R-CHOP14 | 66 (52.8) | 108 (49.3) | 130 (50.8) | 304 (50.7) |
| R-CHOP21 | 59 (47.2) | 111 (50.7) | 126 (49.2) | 296 (49.3) |
| Sex, n (%) | ||||
| Male | 62 (49.6) | 127 (58.0) | 143 (55.9) | 332 (55.3) |
| Female | 63 (50.4) | 92 (42.0) | 113 (44.1) | 268 (44.7) |
| Age, yr | ||||
| n | 125 | 219 | 256 | 600 |
| Missing | 0 | 0 | 0 | 0 |
| Mean (SD) | 70 (4.94) | 71 (5.01) | 69 (4.96) | 70 (5.09) |
| Median | 70 | 72 | 69 | 70 |
| Q1;Q3 | 67;74 | 67;76 | 65;73 | 66;74 |
| Min;max | 60;79 | 59;80 | 60;79 | 59;80 |
| ECOG in class, n (%) | ||||
| 0-1 | 109 (87.2) | 147 (67.1) | 209 (81.6) | 465 (77.5) |
| ≥2 | 16 (12.8) | 72 (32.9) | 47 (18.4) | 135 (22.5) |
| Ann Arbor stage in class, n (%) | ||||
| 1-2 | 21 (16.8) | 20 (9.1) | 29 (11.3) | 70 (11.7) |
| 3-4 | 104 (83.2) | 199 (90.9) | 227 (88.7) | 530 (88.3) |
| LDH, n (%) | ||||
| ≤normal | 46 (36.8) | 47 (21.5) | 96 (37.5) | 189 (31.5) |
| >normal | 79 (63.2) | 172 (78.5) | 160 (62.5) | 411 (68.5) |
| Number of extranodal sites in class, n (%) | ||||
| 0-1 | 65 (52.0) | 94 (42.9) | 135 (52.7) | 294 (49.0) |
| ≥2 | 60 (48.0) | 125 (57.1) | 121 (47.3) | 306 (51.0) |
| Bone marrow biopsy, n (%) | ||||
| Not involved | 96 (76.8) | 145 (66.2) | 197 (77.0) | 438 (73.0) |
| Involved | 20 (16.0) | 60 (27.4) | 48 (18.8) | 128 (21.3) |
| Unspecified | 3 (2.4) | 4 (1.8) | 5 (2.0) | 12 (2.0) |
| Not done | 6 (4.8) | 10 (4.6) | 6 (2.3) | 22 (3.7) |
| IPI in class, n (%) | ||||
| 0-2 | 40 (32.0) | 35 (16.0) | 73 (28.5) | 148 (24.7) |
| 3 | 41 (32.8) | 68 (31.1) | 92 (35.9) | 201 (33.5) |
| 4-5 | 44 (35.2) | 116 (53.0) | 91 (35.5) | 251 (41.8) |
| Bulky mass >10 cm, n (%) | ||||
| No | 105 (84.0) | 176 (80.4) | 215 (84.0) | 496 (82.7) |
| Yes | 20 (16.0) | 43 (19.6) | 41 (16.0) | 104 (17.3) |
| B symptoms | ||||
| No | 80 (64.0) | 124 (56.6) | 173 (67.6) | 377 (62.8) |
| Yes | 45 (36.0) | 95 (43.4) | 83 (32.4) | 223 (37.2) |
| . | Patients enrolled in the LTFU program . | All (ITT set) n = 600 . | ||
|---|---|---|---|---|
| No (center not participating in LTFU) n = 125 . | No (patients dead at cutoff date of primary analysis or refused data collection) n = 219 . | Yes n = 256 . | ||
| Treatment received, n (%) | ||||
| R-CHOP14 | 66 (52.8) | 108 (49.3) | 130 (50.8) | 304 (50.7) |
| R-CHOP21 | 59 (47.2) | 111 (50.7) | 126 (49.2) | 296 (49.3) |
| Sex, n (%) | ||||
| Male | 62 (49.6) | 127 (58.0) | 143 (55.9) | 332 (55.3) |
| Female | 63 (50.4) | 92 (42.0) | 113 (44.1) | 268 (44.7) |
| Age, yr | ||||
| n | 125 | 219 | 256 | 600 |
| Missing | 0 | 0 | 0 | 0 |
| Mean (SD) | 70 (4.94) | 71 (5.01) | 69 (4.96) | 70 (5.09) |
| Median | 70 | 72 | 69 | 70 |
| Q1;Q3 | 67;74 | 67;76 | 65;73 | 66;74 |
| Min;max | 60;79 | 59;80 | 60;79 | 59;80 |
| ECOG in class, n (%) | ||||
| 0-1 | 109 (87.2) | 147 (67.1) | 209 (81.6) | 465 (77.5) |
| ≥2 | 16 (12.8) | 72 (32.9) | 47 (18.4) | 135 (22.5) |
| Ann Arbor stage in class, n (%) | ||||
| 1-2 | 21 (16.8) | 20 (9.1) | 29 (11.3) | 70 (11.7) |
| 3-4 | 104 (83.2) | 199 (90.9) | 227 (88.7) | 530 (88.3) |
| LDH, n (%) | ||||
| ≤normal | 46 (36.8) | 47 (21.5) | 96 (37.5) | 189 (31.5) |
| >normal | 79 (63.2) | 172 (78.5) | 160 (62.5) | 411 (68.5) |
| Number of extranodal sites in class, n (%) | ||||
| 0-1 | 65 (52.0) | 94 (42.9) | 135 (52.7) | 294 (49.0) |
| ≥2 | 60 (48.0) | 125 (57.1) | 121 (47.3) | 306 (51.0) |
| Bone marrow biopsy, n (%) | ||||
| Not involved | 96 (76.8) | 145 (66.2) | 197 (77.0) | 438 (73.0) |
| Involved | 20 (16.0) | 60 (27.4) | 48 (18.8) | 128 (21.3) |
| Unspecified | 3 (2.4) | 4 (1.8) | 5 (2.0) | 12 (2.0) |
| Not done | 6 (4.8) | 10 (4.6) | 6 (2.3) | 22 (3.7) |
| IPI in class, n (%) | ||||
| 0-2 | 40 (32.0) | 35 (16.0) | 73 (28.5) | 148 (24.7) |
| 3 | 41 (32.8) | 68 (31.1) | 92 (35.9) | 201 (33.5) |
| 4-5 | 44 (35.2) | 116 (53.0) | 91 (35.5) | 251 (41.8) |
| Bulky mass >10 cm, n (%) | ||||
| No | 105 (84.0) | 176 (80.4) | 215 (84.0) | 496 (82.7) |
| Yes | 20 (16.0) | 43 (19.6) | 41 (16.0) | 104 (17.3) |
| B symptoms | ||||
| No | 80 (64.0) | 124 (56.6) | 173 (67.6) | 377 (62.8) |
| Yes | 45 (36.0) | 95 (43.4) | 83 (32.4) | 223 (37.2) |
ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; LTFU, long-term follow-up; PS, performance status.