Table 1.
Demographic data of patients in the per-protocol group in the titration study and the embedded, randomised cohort
| Patients in the titration study (n=1287) | Patients in the embedded, randomised cohort (n=892) | Patients randomly assigned to COPP (n=444) | Patients randomly assigned to COPDAC (n=448) | |
|---|---|---|---|---|
| Age, years | ||||
| ≥13 years | 934 (73%) | 652 (73%) | 317 (71%) | 335 (75%) |
| <13 years | 353 (27%) | 240 (27%) | 127 (29%) | 113 (25%) |
| Median (IQR) | 14·8 (12·8–16·2) | 14·8 (12·8–16·3) | 14·7 (12·6–16·1) | 15·0 (12·9–16·3) |
| Sex | ||||
| Male | 717 (56%) | 494 (55%) | 244 (55%) | 250 (56%) |
| Female | 570 (44%) | 398 (45%) | 200 (45%) | 198 (44%) |
| Combined stage* | ||||
| 2A | 3 (<1%) | 1 (<1%) | 1 (<1%) | 0 |
| 2AE | 93 (7%) | 66 (7%) | 30 (7%) | 36 (8%) |
| 2B | 194 (15%) | 140 (16%) | 73 (16%) | 67 (15%) |
| 2BE | 114 (9%) | 85 (10%) | 49 (11%) | 36 (8%) |
| 3A | 157 (12%) | 112 (13%) | 56 (13%) | 56 (13%) |
| 3AE | 30 (2%) | 20 (2%) | 8 (2%) | 12 (3%) |
| 3B | 148 (11%) | 97 (11%) | 51 (11%) | 46 (10%) |
| 3BE | 54 (4%) | 41 (5%) | 20 (5%) | 21 (5%) |
| 4A | 167 (13%) | 112 (13%) | 49 (11%) | 63 (14%) |
| 4AE | 44 (3%) | 26 (3%) | 17 (4%) | 9 (2%) |
| 4B | 189 (15%) | 130 (15%) | 61 (14%) | 69 (15%) |
| 4BE | 94 (7%) | 62 (7%) | 29 (7%) | 33 (7%) |
| Ann Arbor stage | ||||
| 2 | 404 (31%) | 292 (33%) | 153 (34%) | 139 (31%) |
| 3 | 389 (30%) | 270 (30%) | 135 (30%) | 135 (30%) |
| 4 | 494 (38%) | 330 (37%) | 156 (35%) | 174 (39%) |
| B symptoms | ||||
| No | 494 (38%) | 337 (38%) | 161 (36%) | 176 (39%) |
| Yes | 793 (62%) | 555 (62%) | 283 (64%) | 272 (61%) |
| Bulky disease† | ||||
| No | 635 (49%) | 429 (48%) | 222 (50%) | 207 (46%) |
| Yes | 602 (47%) | 422 (47%) | 201 (45%) | 221 (49%) |
| Response group | ||||
| Adequate response | 514 (40%) | 349 (39%) | 189 (43%) | 160 (36%) |
| Inadequate response | 773 (60%) | 543 (61%) | 255 (57%) | 288 (64%) |
| Treatment group and ERA response | ||||
| TG 2 adequate response | 215 (17%) | 156 (17%) | 85 (19%) | 71 (16%) |
| TG 2 inadequate response | 220 (17%) | 154 (17%) | 69 (16%) | 85 (19%) |
| TG 3 adequate response | 299 (23%) | 193 (22%) | 104 (23%) | 89 (20%) |
| TG 3 inadequate response | 553 (43%) | 389 (44%) | 186 (42%) | 203 (45%) |
Data are n (%). COPP=cyclophosphamide, vincristine, prednisone, and procarbazine. COPDAC=cyclophosphamide, vincristine, prednisone, and dacarbazine. ERA=early-response assessment. TG2=treatment group 2. TG3=treatment group 3.
*
Combined stage consists of the Ann Arbor stage combined with B symptoms (ie, unexplained fever >38.5°C, weight loss of 10% during the past 6 months, and drenching night sweats) and E stage (ie, lymphoma with contiguous invasion of neighbouring organs or tissue).
†
Bulky disease is defined as a contiguous tumour volume of at least 200 mL.