Baseline patient characteristics and KI dosing
| Characteristic . | Result (range) . | Ibrutinib as first KI . | Idelalisib as first KI . | Total (n) . |
|---|---|---|---|---|
| Combined dataset . | ||||
| Median age at diagnosis | 60 y (33-89) | 60 (33-89) | 62 (43-79) | 178 |
| Median number prior therapies | 3.0 (0-11) | 3 (0-11) | 2 (0-8) | 178 |
| Elevated LDH at first KI | 63% | 67% | 50% | 125 |
| B symptoms present at first KI | 32% | 31% | 36% | 149 |
| Median WBC at first KI | 21 THO/μL (1-549) | 21.0 THO/μL (1359) | 24.3 THO/μL (2-549) | 143 |
| Median ALC at first KI | 18 THO/μL (0.1-359) | 18.4 THO/μL (0.1-359) | 17.5 THO/μL (0.7-267) | 129 |
| Median Hb at first KI | 11.5 g/dL (6-15.8) | 11.5 g/dL (6-15.8) | 11.2 g/dL (7.9-15.6) | 143 |
| Median Plt at first KI | 115 THO/μL (12-368) | 116 THO/μL (7-368) | 99 THO/μL (15-303) | 141 |
| del17p present (FISH)* | 34% | 37% | 24% | 155 |
| del11q present (FISH) | 33% | 37% | 26% | 152 |
| p53 mutation present1 | 27% | 33% | 14% | 95 |
| Complex karyotype present (≥3 abnormalities) | 29% | 33% | 18% | 128 |
| IGHV unmutated | 69% | 70% | 69% | 49 |
| Characteristic . | Result (range) . | Ibrutinib as first KI . | Idelalisib as first KI . | Total (n) . |
|---|---|---|---|---|
| Combined dataset . | ||||
| Median age at diagnosis | 60 y (33-89) | 60 (33-89) | 62 (43-79) | 178 |
| Median number prior therapies | 3.0 (0-11) | 3 (0-11) | 2 (0-8) | 178 |
| Elevated LDH at first KI | 63% | 67% | 50% | 125 |
| B symptoms present at first KI | 32% | 31% | 36% | 149 |
| Median WBC at first KI | 21 THO/μL (1-549) | 21.0 THO/μL (1359) | 24.3 THO/μL (2-549) | 143 |
| Median ALC at first KI | 18 THO/μL (0.1-359) | 18.4 THO/μL (0.1-359) | 17.5 THO/μL (0.7-267) | 129 |
| Median Hb at first KI | 11.5 g/dL (6-15.8) | 11.5 g/dL (6-15.8) | 11.2 g/dL (7.9-15.6) | 143 |
| Median Plt at first KI | 115 THO/μL (12-368) | 116 THO/μL (7-368) | 99 THO/μL (15-303) | 141 |
| del17p present (FISH)* | 34% | 37% | 24% | 155 |
| del11q present (FISH) | 33% | 37% | 26% | 152 |
| p53 mutation present1 | 27% | 33% | 14% | 95 |
| Complex karyotype present (≥3 abnormalities) | 29% | 33% | 18% | 128 |
| IGHV unmutated | 69% | 70% | 69% | 49 |
| Ibrutinib/idelalisib dosing information . | ||
|---|---|---|
| Number (patients) | 143 | 35 |
| Median time from CLL diagnosis to KI start | 84 mo | 81 mo |
| Median time on KI | 5 mo (0.25-41) | 5.5 mo (0.5-38) |
| Median starting dose | 420 mg daily | 150 mg bid |
| Proportion requiring dose modification | 18% (n = 141) | 35% (n = 34) |
| Proportion requiring dose interruption | 43% (n = 96) | 64% (n = 33) |
| KI administered as monotherapy | 85% | 20% |
| Ibrutinib/idelalisib dosing information . | ||
|---|---|---|
| Number (patients) | 143 | 35 |
| Median time from CLL diagnosis to KI start | 84 mo | 81 mo |
| Median time on KI | 5 mo (0.25-41) | 5.5 mo (0.5-38) |
| Median starting dose | 420 mg daily | 150 mg bid |
| Proportion requiring dose modification | 18% (n = 141) | 35% (n = 34) |
| Proportion requiring dose interruption | 43% (n = 96) | 64% (n = 33) |
| KI administered as monotherapy | 85% | 20% |
ALC, absolute lymphocyte count; FISH, fluorescence in situ hybridization; Hb, hemoglobin; IGHV, immunoglobulin variable heavy-chain; LDH, lactate dehydrogenase; Plt,platelet; THO, thousand; WBC, white blood cell.
Where data are available, patients with p53 mutations, 81% are occurring concomitantly with a del17p detected by FISH analysis and 19% are occurring without a concomitant p53 mutation present.