Table 1.
Baseline Demographic and Disease Characteristics (Intention-to-Treat Population)
| Qualifying for Radiotherapy (n = 467) | Not Qualifying for Radiotherapy (n = 228) | |||||
|---|---|---|---|---|---|---|
| R-CHOP-21 (n = 81) |
R-CHOP-14 (n = 81) |
R-CHOP-21 + Radiotherapy (n = 155) |
R-CHOP-14 + Radiotherapy (n = 150) |
R-CHOP-21 (n=114) |
R-CHOP-14 (n=114) |
|
| Male | 49 (60%) | 43 (53%) | 86 (55%) | 83 (55%) | 71 (62%) | 71 (62%) |
| Female | 32 (40%) | 38 (47%) | 69 (45%) | 67 (45%) | 43 (38%) | 43 (38%) |
| Age, median (range) | 43 (20–60) | 45 (20–60) | 46 (18–60) | 44 (18–60) | 50 (18–60) | 49 (20–60) |
| LDH > ULN | 36 (44%) | 37 (46%) | 71 (46%) | 67 (45%) | 40 (35%) | 42 (37%) |
| ECOG > 1 | 1 (1%) | 1 (1%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (1%) |
| Stage III/ IV | 30 (37%) | 28 (35%) | 55 (35%) | 52 (35%) | 64 (56%) | 67 (59%) |
| aaIPI | ||||||
| 0a | 14 (17%) | 16 (20%) | 33 (21%) | 31 (21%) | 12 (11%) | 5 (4%) |
| 1 | 67 (83%) | 64 (79%) | 118 (76%) | 119 (79%) | 100 (88%) | 108 (95%) |
| 2 | 0 (0%) | 1 (1%) | 4 (3%) | 0 (0%) | 2 (2%) | 1 (1%) |
| Stage | ||||||
| I | 28 (35%) | 20 (25%) | 43 (28%) | 31 (21%) | 18 (16%) | 19 (17%) |
| II | 23 (28%) | 33 (41%) | 57 (37%) | 67 (45%) | 32 (28%) | 28 (25%) |
| III | 9 (11%) | 7 (9%) | 15 (10%) | 16 (11%) | 36 (32%) | 41 (36%) |
| IV | 21 (26%) | 21 (26%) | 40 (26%) | 36 (24%) | 28 (25%) | 26 (23%) |
| Extralymph. involv. | 45 (56%) | 37 (46%) | 80 (52%) | 80 (53%) | 43 (38%) | 39 (34%) |
| Extralymph. involv. > 1 | 14 (17%) | 18 (22%) | 33 (21%) | 23 (15%) | 14 (12%) | 11 (10%) |
| Bulk ≥ 7.5 cm | 59 (73%) | 60 (74%) | 121 (78%) | 117 (78%) | 22 (19%) | 17 (15%) |
| B symptomsb | 23 (28%) | 19 (23%) | 35 (23%) | 41 (28%) | 22 (19%) | 12 (11%) |
| BM involvement | 3 (4%) | 5 (6%) | 8 (5%) | 6 (4%) | 13 (11%) | 6 (5%) |
| Reference pathology available | 79 (98%) | 74 (91%) | 150 (97%) | 146 (97%) | 105 (92%) | 101 (89%) |
| DLBCL | 69 (87%) | 62 (84%) | 133 (89%) | 132 (90%) | 80 (76%) | 81 (80%) |
| PMBCLc | 27 (34%) | 22 (30%) | 43 (29%) | 39 (27%) | 2 (2%) | 3 (3%) |
| Follicular lymphoma III°b | 3 (4%) | 2 (3%) | 3 (2%) | 1 (1%) | 7 (7%) | 3 (3%) |
| Follicular lymphoma III°+DLBCL | 2 (2%) | 3 (4%) | 3 (2%) | 6 (4%) | 11 (10%) | 11 (11%) |
| Burkitt‘s lymphoma | 2 (2%) | 0 (0%) | 1 (1%) | 0 (0%) | 2 (2%) | 1 (1%) |
| Burkitt-like | 0 (0%) | 1 (1%) | 2 (1%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Aggressive marginal zone lymphoma | 1 (1%) | 0 (0%) | 0 (0%) | 0 (0%) | 3 (3%) | 1 (1%) |
| Grey zone lymphoma | 0 (0%) | 1 (1%) | 1 (1%) | 1 (1%) | 0 (0%) | 0 (0%) |
| B-cell, NOS | 0 (0%) | 1 (1%) | 0 (0%) | 0 (0%) | 1 (1%) | 1 (1%) |
| B-cell, unclassified (techn. insufficient mat.) | 0 (0%) | 1 (1%) | 3 (2%) | 3 (2%) | 0 (0%) | 0 (0%) |
| Other, not B-cell | 2 (2%) | 3 (4%) | 4 (3%) | 3 (2%) | 1 (1%) | 3 (3%) |
Bone marrow is counted as extralymphatic; spleen and waldeyers ring are counted as lymphathic DLBCL.
a10 (0/2/1/1/4/2) IPI = 0 without bulk.
b4 (0/0/2/1/0/1) missing values.
cSubtype of DLBCL.
aaIPI = age-adjusted International Prognostic Index; BM = bone marrow; DLBCL = diffuse large B-cell lymphoma; ECOG = Eastern Cooperative Oncology Group; LDH = lactate dehydrogenase; NOS = not otherwise specified; PMBCL = primary mediastinal B-cell lymphoma; R-CHOP = rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; ULN = upper limit of normal.