Response by pretreatment characteristics
| Patient characteristic . | N . | NCI-WG response . | |||||
|---|---|---|---|---|---|---|---|
| CR/CRi . | % . | P . | OR . | % . | P . | ||
| All | 60 | 9 | 15 | 39 | 65 | ||
| Age, y | |||||||
| 65-71 | 32 | 6 | 19 | 23 | 72 | ||
| 72+ | 28 | 3 | 11 | .48 | 16 | 57 | .28 |
| Sex | |||||||
| Female | 26 | 2 | 8 | 17 | 65 | ||
| Male | 34 | 7 | 21 | .28 | 22 | 65 | 1.0 |
| Rai stage | |||||||
| 0-II | 42 | 7 | 16 | 29 | 69 | ||
| III-IV | 18 | 2 | 12 | .71 | 10 | 56 | .38 |
| Lymph node size* | |||||||
| < 5 cm | 50 | 7 | 14 | 34 | 68 | ||
| ≥ 5 cm | 10 | 2 | 20 | .64 | 5 | 50 | .30 |
| ALC, ×109/L | |||||||
| 0-100 | 40 | 5 | 13 | 28 | 70 | ||
| > 100 | 20 | 4 | 20 | .46 | 11 | 55 | .27 |
| β2-microglobulin, mg/L | |||||||
| < 4 | 32 | 6 | 23 | 18 | 69 | ||
| ≥ 4 | 28 | 3 | 9 | .48 | 21 | 62 | .18 |
| CD38 flow, % | |||||||
| < 30 | 29 | 3 | 10 | 16 | 55 | ||
| > 30 | 30 | 6 | 20 | .47 | 22 | 73 | .18 |
| Zap-70 flow, % | |||||||
| < 20 | 14 | 1 | 7 | 8 | 57 | ||
| > 20 | 17 | 3 | 18 | .61 | 11 | 65 | .72 |
| ND | 29 | 5 | 17 | 20 | 69 | ||
| IGHV genes (ND = 5) | |||||||
| Mutated | 22 | 1 | 5 | 11 | 50 | ||
| Unmutated | 33 | 8 | 24 | .070 | 25 | 76 | .08 |
| FISH hierarchy† | |||||||
| 13q deletion | 15 | 4 | 27 | 11 | 73 | ||
| Negative | 12 | 1 | 8 | 6 | 50 | ||
| Trisomy 12 | 13 | 1 | 8 | 13 | 100 | ||
| 11q deletion | 14 | 3 | 21 | 9 | 64 | ||
| 17p deletion | 6 | 0 | 0 | .58 | 0 | 0 | .0011‡ |
| Mean dose cycles 1-6 | |||||||
| < 5 mg | 26 | 0 | 0 | 11 | 42 | ||
| ≥ 5 mg | 34 | 9 | 26 | .0038 | 28 | 82 | .0023 |
| Tumor flare | |||||||
| No | 29 | 1 | 3 | 15 | 52 | ||
| Yes | 31 | 8 | 26 | .03 | 24 | 77 | .058 |
| Patient characteristic . | N . | NCI-WG response . | |||||
|---|---|---|---|---|---|---|---|
| CR/CRi . | % . | P . | OR . | % . | P . | ||
| All | 60 | 9 | 15 | 39 | 65 | ||
| Age, y | |||||||
| 65-71 | 32 | 6 | 19 | 23 | 72 | ||
| 72+ | 28 | 3 | 11 | .48 | 16 | 57 | .28 |
| Sex | |||||||
| Female | 26 | 2 | 8 | 17 | 65 | ||
| Male | 34 | 7 | 21 | .28 | 22 | 65 | 1.0 |
| Rai stage | |||||||
| 0-II | 42 | 7 | 16 | 29 | 69 | ||
| III-IV | 18 | 2 | 12 | .71 | 10 | 56 | .38 |
| Lymph node size* | |||||||
| < 5 cm | 50 | 7 | 14 | 34 | 68 | ||
| ≥ 5 cm | 10 | 2 | 20 | .64 | 5 | 50 | .30 |
| ALC, ×109/L | |||||||
| 0-100 | 40 | 5 | 13 | 28 | 70 | ||
| > 100 | 20 | 4 | 20 | .46 | 11 | 55 | .27 |
| β2-microglobulin, mg/L | |||||||
| < 4 | 32 | 6 | 23 | 18 | 69 | ||
| ≥ 4 | 28 | 3 | 9 | .48 | 21 | 62 | .18 |
| CD38 flow, % | |||||||
| < 30 | 29 | 3 | 10 | 16 | 55 | ||
| > 30 | 30 | 6 | 20 | .47 | 22 | 73 | .18 |
| Zap-70 flow, % | |||||||
| < 20 | 14 | 1 | 7 | 8 | 57 | ||
| > 20 | 17 | 3 | 18 | .61 | 11 | 65 | .72 |
| ND | 29 | 5 | 17 | 20 | 69 | ||
| IGHV genes (ND = 5) | |||||||
| Mutated | 22 | 1 | 5 | 11 | 50 | ||
| Unmutated | 33 | 8 | 24 | .070 | 25 | 76 | .08 |
| FISH hierarchy† | |||||||
| 13q deletion | 15 | 4 | 27 | 11 | 73 | ||
| Negative | 12 | 1 | 8 | 6 | 50 | ||
| Trisomy 12 | 13 | 1 | 8 | 13 | 100 | ||
| 11q deletion | 14 | 3 | 21 | 9 | 64 | ||
| 17p deletion | 6 | 0 | 0 | .58 | 0 | 0 | .0011‡ |
| Mean dose cycles 1-6 | |||||||
| < 5 mg | 26 | 0 | 0 | 11 | 42 | ||
| ≥ 5 mg | 34 | 9 | 26 | .0038 | 28 | 82 | .0023 |
| Tumor flare | |||||||
| No | 29 | 1 | 3 | 15 | 52 | ||
| Yes | 31 | 8 | 26 | .03 | 24 | 77 | .058 |
NCI-WG indicates NCI-sponsored CLL working group criteria for response; ALC, absolute lymphocyte count; IGHV, immunoglobulin variable heavy chain; CD38 flow, CD38 expression by flow cytometry on CD19+ lymphocytes in bone marrow aspirate; Zap-70 flow, Zap-70 expression by flow cytometry on peripheral blood; and ND, not done.
Lymph node size: ≥ 5 cm by examination or computed tomography.
FISH hierarchy according to Döhner classification system listed from lowest to highest risk genomic abnormality present.
P value: 17p− versus other FISH results.