Table 1.
Patient demographics and clinical characteristics for the SEP (GOYA), the EP and the non-EP
|
Safety-evaluable (GOYA) (N = 1407) |
EP (N = 1268) |
Non-EP (N = 139) |
|
|---|---|---|---|
| Treatment, n (%) | |||
| G-CHOP | 704 (50) | 636 (50) | 68 (49) |
| R-CHOP | 703 (50) | 632 (50) | 71 (51) |
| Age, years | |||
| Mean | 59 | 59 | 58 |
| Median | 62 | 62 | 60 |
| Min–max | 18–86 | 18–86 | 19–81 |
| Sex, n (%) | |||
| Female | 663 (47) | 595 (47) | 68 (49) |
| Male | 744 (53) | 673 (53) | 71 (51) |
| IPI at baseline, n (%) | |||
| 0–2 | 781 (56) | 709 (56) | 72 (52) |
| 3–5 | 626 (44) | 559 (44) | 67 (48) |
| ECOG PS, n (%) | |||
| 0–1 | 1222 (87) | 1110 (88) | 112 (81) |
| ≥ 2 | 184 (13) | 157 (12) | 27 (19) |
| Missing | 1 (0) | 1 (0) | 0 |
| Serum LDH at baseline, n (%) | |||
| Elevated | 811 (58) | 724 (57) | 87 (63) |
| Normal | 592 (42) | 540 (43) | 52 (37) |
| Missing | 4 (0) | 4 (0) | 0 |
| Hemoglobin, n (%) | |||
| < LLN | 702 (50) | 627 (49) | 64 (46) |
| ≥ LLN | 705 (50) | 641 (51) | 75 (54) |
| Ann Arbor stage, n (%) | |||
| I–II | 339 (24) | 302 (24) | 37 (27) |
| III–IV | 1068 (76) | 966 (76) | 102 (73) |
| Extranodal involvement, n (%) | |||
| ≤ 1 | 910 (65) | 815 (64) | 95 (68) |
| > 1 | 497 (35) | 453 (36) | 44 (32) |
ECOG PS Eastern Cooperative Oncology Group performance status, EP Evaluable population, G-CHOP Obinutuzumab plus cyclophosphamide, doxorubicin, vincristine and prednisone; obinutuzumab, IPI International Prognostic Index, LDH lactate dehydrogenase, LLN lower limit of normal, R-CHOP Rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone, SEP Safety-evaluable population