Pretreatment characteristics of fludarabine-refractory patients by prior rituximab exposure and adverse events with ofatumumab treatment
| Characteristic . | Prior rituximab . | No prior rituximab . |
|---|---|---|
| No. of patients | 117 | 89 |
| Median age, y (range) | 63 (41-85) | 64 (44-87) |
| Median time since diagnosis, y (range) | 7.5 (0.7-20.0) | 5.3 (0.7-30.1) |
| Rai stage III or IV, n (%) | 83 (71) | 53 (60) |
| ECOG PS 1 or 2, n (%) | 69 (59)* | 64 (72)* |
| Palpable lymph nodes > 5 cm, n (%) | 40 (34) | 33 (37) |
| Median β2-microglobulin, mg/L (range) | 7.4 (3.1-19.0) | 6.7 (2.0-18.5) |
| FISH genomic abnormality, n (%)† | ||
| 17p del | 30 (26) | 15 (17) |
| 11q del | 37 (32) | 33 (37) |
| Trisomy 12 | 14 (12) | 4 (4) |
| No abnormality | 14 (12) | 19 (21) |
| 13q del (sole) | 16 (14) | 18 (20) |
| Alemtuzumab-refractory, n (%) | 56 (48) | 39 (44) |
| Median no. of prior treatment regimens (range) | 5 (1-16) | 4 (1-13) |
| Median no. of prior rituximab-containing regimens‡ (range) | 2 (1-7) | 0 |
| Median time from last rituximab dose, mo (range) | 10 (1.1-83.6) | NA |
| Median TTP from last rituximab regimen, mo (range) | 3 (0.0-76.1) | NA |
| Ofatumumab-related infusion reactions, n (%) | ||
| None | 31 (26) | 36 (40) |
| Grade 1 or 2 | 80 (68) | 45 (51) |
| Grades 3-5§ | 6 (5) | 8 (9) |
| Grade ≥ 3 hematologic toxicity on ofatumumab treatment, n (%) | ||
| Neutropenia | 19 (16) | 12 (13) |
| Thrombocytopenia | 5 (4) | 4 (4) |
| Anemia | 6 (5) | 8 (9) |
| Grade ≥ 3 nonhematologic toxicity (in ≥ 10% of patients) on ofatumumab treatment, n (%) | ||
| Infections | 36 (31) | 22 (25) |
| Pneumonia | 16 (14) | 6 (7) |
| Characteristic . | Prior rituximab . | No prior rituximab . |
|---|---|---|
| No. of patients | 117 | 89 |
| Median age, y (range) | 63 (41-85) | 64 (44-87) |
| Median time since diagnosis, y (range) | 7.5 (0.7-20.0) | 5.3 (0.7-30.1) |
| Rai stage III or IV, n (%) | 83 (71) | 53 (60) |
| ECOG PS 1 or 2, n (%) | 69 (59)* | 64 (72)* |
| Palpable lymph nodes > 5 cm, n (%) | 40 (34) | 33 (37) |
| Median β2-microglobulin, mg/L (range) | 7.4 (3.1-19.0) | 6.7 (2.0-18.5) |
| FISH genomic abnormality, n (%)† | ||
| 17p del | 30 (26) | 15 (17) |
| 11q del | 37 (32) | 33 (37) |
| Trisomy 12 | 14 (12) | 4 (4) |
| No abnormality | 14 (12) | 19 (21) |
| 13q del (sole) | 16 (14) | 18 (20) |
| Alemtuzumab-refractory, n (%) | 56 (48) | 39 (44) |
| Median no. of prior treatment regimens (range) | 5 (1-16) | 4 (1-13) |
| Median no. of prior rituximab-containing regimens‡ (range) | 2 (1-7) | 0 |
| Median time from last rituximab dose, mo (range) | 10 (1.1-83.6) | NA |
| Median TTP from last rituximab regimen, mo (range) | 3 (0.0-76.1) | NA |
| Ofatumumab-related infusion reactions, n (%) | ||
| None | 31 (26) | 36 (40) |
| Grade 1 or 2 | 80 (68) | 45 (51) |
| Grades 3-5§ | 6 (5) | 8 (9) |
| Grade ≥ 3 hematologic toxicity on ofatumumab treatment, n (%) | ||
| Neutropenia | 19 (16) | 12 (13) |
| Thrombocytopenia | 5 (4) | 4 (4) |
| Anemia | 6 (5) | 8 (9) |
| Grade ≥ 3 nonhematologic toxicity (in ≥ 10% of patients) on ofatumumab treatment, n (%) | ||
| Infections | 36 (31) | 22 (25) |
| Pneumonia | 16 (14) | 6 (7) |
ECOG PS indicates Eastern Cooperative Oncology Group Performance Status; FISH, fluorescence in situ hybridization; NA, not applicable; and TTP, time to progression.
P < .05. See text for details.
According to Dohner hierarchy.
Some patients received > 1 rituximab-containing regimen before study.
No grade 5 reactions were reported.