Table 3.
Efficacy analysis by biological risk groups.
| Characteristic | N | ORa | 90% CI (Clopper Pearson) | N | ORa | 90% CI (Clopper Pearson) |
|---|---|---|---|---|---|---|
| ORR (combination) | ||||||
| Ki67 (<30 vs. >30) | 24 | 23 (96%) | 82%, 100% | 28 | 19 (68%) | 51%, 82% |
| Blastoid/pleomorphic (no vs. yes) | 46 | 40 (87%) | 76%, 94% | 9 | 5 (56%) | 25%, 83% |
| Normal vs. aberrant p53 status | 23 | 20 (87%) | 70%, 96% | 16 | 13 (81%) | 58%, 95% |
| Any of the above (no vs. yes) | 11 | 10 (91%) | 64%, 100% | 34 | 25 (74%) | 58%, 85% |
| ORR (maintenance) | ||||||
| Ki67 (<30 vs. >30) | 24 | 23 (96%) | 82%, 100% | 28 | 22 (79%) | 62%, 90% |
| Blastoid/pleomorphic (no vs. yes) | 46 | 42 (91%) | 81%, 97% | 9 | 6 (67%) | 34%, 90% |
| Normal vs. aberrant p53 status | 23 | 22 (96%) | 81%, 100% | 16 | 13 (81%) | 58%, 95% |
| Any of the above (no vs. yes) | 11 | 10 (91%) | 64%, 100% | 34 | 28 (82%) | 68%, 92% |
Reported separately at the end of the combination therapy with bortezomib and ibrutinib (above), and during the maintenance with ibrutinib (maintenance, below).
ORR, overall response rate; N, number.
a
n (%); CI, confidence interval.