Table 1.
Characteristics of the Patients at Baseline (Intention-to-Treat Population).*
| Characteristic | Ibrutinib-Rituximab Group (N = 354) | Chemoimmunotherapy Group (N = 175) | Total (N = 529) |
|---|---|---|---|
| Age | |||
| Mean | 56.7±7.5 | 56.7±7.2 | 56.7±7.4 |
| ≥60 yr — no. (%) | 145 (41.0) | 70 (40.0) | 215 (40.6) |
| Sex — no. (%) | |||
| Female | 118 (33.3) | 55 (31.4) | 173 (32.7) |
| Male | 236 (66.7) | 120 (68.6) | 356 (67.3) |
| Rai stage — no. (%) | |||
| Low risk, 0 | 11 (3.1) | 9 (5.1) | 20 (3.8) |
| Intermediate risk, I or II | 187 (52.8) | 94 (53.7) | 281 (53.1) |
| High risk, III or IV | 156 (44.1) | 72 (41.1) | 228 (43.1) |
| ECOG performance-status score — no. (%)† | |||
| 0 | 226 (63.8) | 109 (62.3) | 335 (63.3) |
| 1 | 119 (33.6) | 63 (36.0) | 182 (34.4) |
| 2 | 9 (2.5) | 3 (1.7) | 12 (2.3) |
| Beta2 microglobulin — mg/liter | |||
| Mean | 4.0±2.1 | 4.0±1.9 | 4.0±2.0 |
| Median | 3.6 | 3.4 | 3.6 |
| Interquartile range | 2.6–4.6 | 2.7–4.8 | 2.6–4.7 |
| Dohner classification — no. (%) | |||
| Chromosome 17p13 deletion‡ | 2 (0.6) | 0 | 2 (0.4) |
| Chromosome 11q22.3 deletion | 78 (22.0) | 39 (22.3) | 117 (22.1) |
| Trisomy 12 | 70 (19.8) | 27 (15.4) | 97 (18.3) |
| Normal | 69 (19.5) | 37 (21.1) | 106 (20.0) |
| Chromosome 13q deletion | 121 (34.2) | 58 (33.1) | 179 (33.8) |
| Other | 14 (4.0) | 14 (8.0) | 28 (5.3) |
| IGHV mutation status — no./total no. (%)§ | |||
| Mutated | 70/280 (25.0) | 44/115 (38.3) | 114/395 (28.9) |
| Unmutated | 210/280 (75.0) | 71/115 (61.7) | 281/395 (71.1) |
Plus–minus values are means ±SD. Patients were randomly assigned to receive ibrutinib–rituximab or chemoimmunotherapy with fludarabine–cyclophosphamide–rituximab. Data include patients with small lymphocytic lymphoma (SLL); overall, 11.4% of the patients (11.7% in the ibrutinib–rituximab group and 10.9% in the chemoimmunotherapy group) had the SLL subtype of chronic lymphocytic lymphoma. Percentages may not total 100 because of rounding. More detailed information regarding the characteristics of the patients at baseline is provided in Table S1 in the Supplementary Appendix.
Eastern Cooperative Oncology Group (ECOG) performance-status scores are assessed on a 5-point scale, with higher scores indicating greater disability.
Two patients with chromosome 17p13 deletion were enrolled and randomly assigned to the ibrutinib–rituximab group but were later found to be ineligible on the basis of fluorescence in situ hybridization analysis.
Immunoglobulin heavy-chain variable region (IGHV) mutation status was tested in the 436 patients (82.4% of the overall population) who agreed to participate in the correlative study component of the trial and who provided a research sample. Among the 436 patients who underwent testing, IGHV status could be determined in 395.