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.