Table 1.
Characteristics of the 22 Patients Who Were Treated.*
| Characteristic | All Patients (N = 22) |
Patients with DLBCL (N = 15) |
Patients with Follicular Lymphoma (N = 7) |
|---|---|---|---|
| Median age (range) — yr | 59 (44–82) | 60 (44–82) | 59 (44–75) |
| Sex — no. (%) | |||
| Male | 12 (55) | 7 (47) | 5 (71) |
| Female | 10 (45) | 8 (53) | 2 (29) |
| Median no. of previous therapies (range) | 4 (2–10) | 4 (2–10) | 4 (2–9) |
| ECOG performance-status score — no. (%)† | |||
| 0 | 7 (32) | 3 (20) | 4 (57) |
| 1 | 14 (64) | 11 (73) | 3 (43) |
| 2 | 1 (5) | 1 (7) | 0 |
| Lugano stage at diagnosis — no. (%)‡ | |||
| I or II | 4 (18) | 3 (20) | 1 (14) |
| III or IV | 15 (68) | 11 (73) | 4 (57) |
| Unknown | 3 (14) | 1 (7) | 2 (29) |
| Disease refractory to previous rituximab regimen — no. (%) | 21 (95) | 14 (93) | 7 (100) |
| Disease refractory to most recent regimen — no. (%) | 14 (64) | 9 (60) | 5 (71) |
| Previous autologous stem-cell transplantation — no. (%) | 4 (18) | 2 (13) | 2 (29) |
| 5F9 maintenance dose level — no. (%) | |||
| 10 mg/kg | 3 (14) | 2 (13) | 1 (14) |
| 20 mg/kg | 6 (27) | 6 (40) | 0 |
| 30 mg/kg | 13 (59) | 7 (47) | 6 (86) |
*
A total of 15 patients (68%) in this study of Hu5F9-G4 (5F9) had received a diagnosis of diffuse large B-cell lymphoma (DLBCL) and 7 (32%) had received a diagnosis of follicular lymphoma.
†
Scores for the Eastern Cooperative Oncology Group (ECOG) performance status are assessed on a 5-point scale, with higher numbers indicating greater disability.
‡
A Lugano stage of I indicates disease involving one lymph node or a group of adjacent nodes, II two or more nodal groups on the same side of the diaphragm, III nodes on both sides of the diaphragm or nodes above the diaphragm with spleen involvement, and IV additional noncontiguous extralymphatic involvement.18