Table 1.
Characteristics of the Patients at Baseline. *
| Characteristic | Ibrutinib (N = 195) | Ofatumumab (N = 196) |
|---|---|---|
| Patients with small lymphocytic lymphoma — no. (%) | 10 (5) | 8 (4) |
| Median age (range) — yr | 67 (30–86) | 67 (37–88) |
| Male sex — no. (%) | 129 (66) | 137 (70) |
| Cumulative Illness Rating Scale score >6 — no. (%)† | 38 (32) | 39 (32) |
| Creatinine clearance <60 ml/min — no. (%) | 62 (32) | 61 (31) |
| Median hemoglobin (range) — g/dl | 11 (7–16) | 11 (6–16) |
| Median platelet count (range) — per mm3 | 116,500 (20,000–441,000) | 122,000 (23,000–345,000) |
| Median lymphocyte count (range) — per mm3 | 29,470 (90–467,700) | 29,930 (290–551,030) |
| ECOG performance status — no. (%)‡ | ||
| 0 | 79 (41) | 80 (41) |
| 1 | 116 (59) | 116 (59) |
| Bulky disease ≥5 cm — no. (%)§ | 124 (64) | 101 (52) |
| Interphase cytogenetic abnormalities — no. (%) | ||
| Chromosome 11q22.3 deletion | 63 (32) | 59 (30) |
| Chromosome 17p13.1 deletion ¶ | 63 (32) | 64 (33) |
| β2-microglobulin >3.5 mg/liter — no. (%) | 153 (78) | 145 (74) |
| Previous therapies | ||
| Median no. (range) | 3 (1–12) | 2 (1–13) |
| ≥3 — no. (%) | 103 (53) | 90 (46) |
| Type of therapy — no. (%) | ||
| Alkylator | 181 (93) | 173 (88) |
| Bendamustine | 84 (43) | 73 (37) |
| Purine analogue | 166 (85) | 151 (77) |
| Anti-CD20 | 183 (94) | 176 (90) |
| Alemtuzumab | 40 (21) | 33 (17) |
| Allogeneic transplantation | 3 (2) | 1 (1) |
| Median time from last therapy (range) — mo | 8 (1–140) | 12 (0–184) |
| Resistance to purine analogues — no. (%)|| | 87 (45) | 88 (45) |
There were no significant differences between the two groups at baseline, except with respect to the presence of bulky disease of 5 cm or more (P = 0.04) and the median time from last therapy (P = 0.02).
Scores on the Cumulative Illness Rating Scale range from 0 to 52, with higher scores indicating worse health status. Scores on this test were required only for patients 65 years of age or older, and coexisting illnesses were not included in the scoring.
Scores on the Eastern Cooperative Oncology Group (ECOG) performance status range from 0 to 5, with higher scores indicating greater disability.
Measurement was based on the largest diameter of the longest lymph node at screening, according to the assessment of the independent review committee.
Patients were stratified at randomization according to the presence or absence of this genetic abnormality.
Resistance was defined as no response or a relapse within 12 months after the last dose of a CD20-based chemoimmunotherapy regimen that included a purine analogue.