01.12.2017 | Research article | Ausgabe 1/2017 Open Access

Characterizing and prognosticating chronic lymphocytic leukemia in the elderly: prospective evaluation on 455 patients treated in the United States
- Zeitschrift:
- BMC Cancer > Ausgabe 1/2017
Electronic supplementary material
Background
Methods
Study design and participants
Statistical analysis
Results
Patient characteristics
LOT1 (
n = 889)
|
LOT ≥ 2 (
n = 605)
|
|||||
---|---|---|---|---|---|---|
Characteristics
|
< 75 years
|
≥ 75 years
|
p value
a,b
|
< 75 years
|
≥ 75 years
|
p value
a,b
|
(
n = 630)
|
(
n = 259)
|
(
n = 409)
|
(
n = 196)
|
|||
Age, years
|
||||||
Mean
|
62.4
|
80.4
|
63.9
|
80.8
|
||
SD
|
8.26
|
4.33
|
7.67
|
4.37
|
||
Median
|
63.0
|
80.0
|
65.0
|
80.0
|
||
Range
|
22–74
|
75–99
|
34–74
|
75–96
|
||
Sex, n (%)
|
||||||
Male
|
411 (65.2)
|
155 (59.8)
|
0.1288
|
281 (68.7)
|
106 (54.1)
|
0.0005
|
Female
|
219 (34.8)
|
104 (40.2)
|
128 (31.3)
|
90 (45.9)
|
||
Duration of CLL from diagnosis to registry enrollment, years
|
||||||
Median
|
1.4
|
1.8
|
0.2912
|
7.0
|
7.2
|
0.7074
|
Range
|
0–29
|
0–32
|
0–32
|
0–30
|
||
Time from diagnosis to first LOT, years
|
||||||
Median
|
1.4
|
1.8
|
0.2593
|
1.4
|
2.3
|
0.0139
|
Range
|
0–29
|
0–32
|
0–32
|
0–20
|
||
Race, n (%)
c,d
|
||||||
White
|
561 (92.3)
|
237 (92.9)
|
0.7211
|
352 (90.0)
|
183 (96.3)
|
0.0076
|
Black
|
40 (6.6)
|
16 (6.3)
|
37 (9.5)
|
5 (2.6)
|
||
American Indian/Alaskan native
|
0
|
0
|
1 (0.3)
|
0
|
||
Asian
|
3 (0.5)
|
0
|
1 (0.3)
|
0
|
||
Other
|
4 (0.7)
|
2 (0.8)
|
0
|
2 (1.1)
|
||
Geographic region, n (%)
c,d
|
||||||
Northeast
|
75 (12.0)
|
37 (14.3)
|
0.2029
|
58 (14.3)
|
37 (19.0)
|
0.016
|
Midwest
|
207 (33.2)
|
70 (27.1)
|
137 (33.7)
|
45 (23.1)
|
||
South
|
249 (40.0)
|
103 (39.9)
|
162 (39.8)
|
77 (39.5)
|
||
West
|
92 (14.8)
|
48 (18.6)
|
50 (12.3)
|
36 (18.5)
|
||
Institution type, n (%)
|
||||||
Academic
|
74 (11.7)
|
12 (4.6)
|
57 (13.9)
|
12 (6.1)
|
||
Community
|
545 (86.5)
|
242 (93.4)
|
343 (83.9)
|
181 (92.3)
|
||
Government
|
11 (1.7)
|
5 (1.9)
|
9 (2.2)
|
3 (1.5)
|
||
Insurance, n (%)
e
|
||||||
Medicare
|
283 (44.9)
|
229 (88.4)
|
227 (55.5)
|
175 (89.3)
|
||
Medicaid
|
28 (4.4)
|
14 (5.4)
|
16 (3.9)
|
7 (3.6)
|
||
Supplemental coverage
|
86 (13.7)
|
92 (35.5)
|
81 (19.8)
|
67 (34.2)
|
||
Private coverage
|
357 (56.7)
|
46 (17.8)
|
189 (46.2)
|
35 (17.9)
|
||
HMO
|
88 (14.0)
|
16 (6.2)
|
56 (13.7)
|
13 (6.6)
|
||
PPO
|
206 (32.7)
|
26 (10.0)
|
103 (25.2)
|
14 (7.1)
|
||
Other
|
64 (10.2)
|
4 (1.5)
|
33 (8.1)
|
8 (4.1)
|
||
Military
|
10 (1.6)
|
5 (1.9)
|
5 (1.2)
|
6 (3.1)
|
||
Self-pay
|
13 (2.1)
|
0
|
6 (1.5)
|
0
|
||
Other Insurance
|
10 (1.6)
|
3 (1.2)
|
8 (2.0)
|
3 (1.5)
|
||
Not specified
|
15 (2.4)
|
5 (1.9)
|
19 (4.6)
|
2 (1.0)
|
||
ECOG score and status, n (%)
c,d
|
||||||
0 - Fully active
|
276 (57.4)
|
70 (33.7)
|
<0.001
|
138 (46.8)
|
42 (30.7)
|
0.0105
|
1 - Restricted in strenuous activity only
|
180 (37.4)
|
116 (55.8)
|
138 (46.8)
|
79 (57.7)
|
||
2 - Ambulatory, but unable to work
|
22 (4.6)
|
19 (9.1)
|
17 (5.8)
|
14 (10.2)
|
||
3 - Capable of only limited self-care
|
2 (0.4)
|
3 (1.4)
|
2 (0.7)
|
2 (1.5)
|
||
4 - Completely disabled
|
1 (0.2)
|
0
|
0
|
0
|
||
Rai staging system score, n (%)
c,d
|
||||||
Stage 0
|
112 (23.7)
|
60 (28.4)
|
0.0219
|
63 (25.2)
|
46 (32.6)
|
0.1728
|
Stage I
|
143 (30.2)
|
48 (22.7)
|
58 (23.2)
|
39 (27.7)
|
||
Stage II
|
83 (17.5)
|
25 (11.8)
|
43 (17.2)
|
16 (11.3)
|
||
Stage III
|
71 (15.0)
|
36 (17.1)
|
44 (17.6)
|
24 (17.0)
|
||
Stage IV
|
64 (13.5)
|
42 (19.9)
|
42 (16.8)
|
16 (11.3)
|
||
Constitutional symptoms, n (%)
|
397 (63.0)
|
183 (71.8)
|
0.0192
|
264 (65.0)
|
126 (64.3)
|
0.977
|
Fatigue
f
|
328 (82.6)
|
152 (83.1)
|
212 (80.3)
|
114 (90.5)
|
||
Fever
|
44 (11.1)
|
16 (8.7)
|
22 (8.3)
|
5 (4.0)
|
||
Night sweats
|
164 (41.3)
|
62 (33.9)
|
85 (32.2)
|
27 (21.4)
|
||
Other
|
69 (17.4)
|
44 (24.0)
|
54 (20.5)
|
25 (19.8)
|
||
Weight loss
|
97 (24.4)
|
60 (32.8)
|
71 (26.9)
|
37 (29.4)
|
||
Metaphase cytogenetic analysis, n (%)
e
|
||||||
Yes
|
254 (40.3)
|
93 (35.9)
|
148 (36.2)
|
46 (23.5)
|
||
Abnormalities found
f
|
110 (43.3)
|
48 (51.6)
|
81 (54.7)
|
23 (50.0)
|
||
del(11q)
|
24 (9.4)
|
12 (12.9)
|
18 (12.2)
|
5 (10.9)
|
||
del(13q)
|
36 (14.2)
|
11 (11.8)
|
23 (15.5)
|
7 (15.2)
|
||
Trisomy 12
|
41 (16.1)
|
16 (17.2)
|
30 (20.3)
|
8 (17.4)
|
||
del(17p)
|
13 (5.1)
|
6 (6.5)
|
12 (8.1)
|
3 (6.5)
|
||
Other
|
35 (13.8)
|
18 (19.4)
|
36 (24.3)
|
10 (21.7)
|
||
FISH analysis, n (%)
e
|
||||||
Yes
|
377 (59.8)
|
136 (52.5)
|
157 (38.4)
|
67 (34.2)
|
||
Abnormalities found
f
|
281 (74.5)
|
99 (72.8)
|
116 (73.9)
|
44 (65.7)
|
||
del(11q)
|
64 (17.0)
|
26 (19.1)
|
31 (19.7)
|
14 (20.9)
|
||
del(13q)
|
179 (47.5)
|
59 (43.4)
|
69 (43.9)
|
30 (44.8)
|
||
Trisomy 12
|
74 (19.6)
|
31 (22.8)
|
38 (24.2)
|
10 (14.9)
|
||
del(17p)
|
33 (8.8)
|
18 (13.2)
|
28 (17.8)
|
9 (13.4)
|
||
Other
|
24 (6.4)
|
14 (10.3)
|
11 (7.0)
|
6 (9.0)
|
||
ALC (×10
9/L)
|
263
|
106
|
179
|
79
|
||
Mean (×10
9/L)
|
68.5
|
58.4
|
52.7
|
54.2
|
||
SD
|
75.7
|
62.9
|
64.5
|
51.9
|
||
Median (×10
9/L)
|
46.1
|
34.6
|
25.6
|
40.1
|
||
Range (×10
9/L)
|
0–564.0
|
1.3–275.4
|
0.1–306.0
|
0.8–271.1
|
Treatment patterns
Regimen
|
LOT1 (
n = 889)
|
LOT ≥ 2 (
n = 605)
|
||||
---|---|---|---|---|---|---|
< 75 years
|
≥ 75 years
|
p value
a,b
|
< 75 years
|
≥ 75 years
|
p value
a,b
|
|
(
n = 630)
|
(
n = 259)
|
(
n = 409)
|
(
n = 196)
|
|||
Rituximab monotherapy, n (%)
|
54 (8.6)
|
50 (19.3)
|
<0.0001
|
52 (12.7)
|
30 (15.3)
|
0.3834
|
Combinations with rituximab, n (%)
|
482 (76.5)
|
139 (53.7)
|
<0.0001
|
243 (59.4)
|
90 (45.92)
|
0.0018
|
Bendamustine/rituximab
|
126 (20.0)
|
61 (23.6)
|
0.2377
|
125 (30.6)
|
43 (21.9)
|
0.0267
|
Bendamustine/dexamethasone/rituximab
|
5 (0.8)
|
4 (1.5)
|
5 (1.2)
|
0
|
||
Chlorambucil/rituximab
|
0
|
4 (1.5)
|
0
|
0
|
||
Cyclophosphamide/rituximab
|
0
|
0
|
0
|
3 (1.5)
|
||
Cyclophosphamide/fludarabine/dexamethasone/rituximab
|
8 (1.3)
|
0
|
0
|
0
|
||
Cyclophosphamide/lenalidomide/rituximab
|
0
|
0
|
4 (1.0)
|
0
|
||
Cyclophosphamide/pentostatin/rituximab
|
21 (3.3)
|
3 (1.2)
|
13 (3.2)
|
0
|
||
Cyclophosphamide/vincristine/prednisone/rituximab
|
14 (2.2)
|
9 (3.5)
|
8 (2.0)
|
6 (3.1)
|
||
Fludarabine/cyclophosphamide/rituximab
|
212 (33.7)
|
18 (6.9)
|
<0.0001
|
41 (10.0)
|
11 (5.6)
|
0.0700
|
Fludarabine/rituximab
|
33 (5.2)
|
22 (8.5)
|
14 (3.4)
|
11 (5.6)
|
||
Lenalidomide/rituximab
|
10 (1.6)
|
0
|
0
|
0
|
||
Prednisone/rituximab
|
0
|
4 (1.5)
|
0
|
3 (1.5)
|
||
Investigational product/rituximab
|
14 (2.2)
|
0
|
0
|
0
|
||
Chemotherapy alone, n (%)
|
65 (10.3)
|
52 (20.1)
|
<0.0001
|
45 (11.0)
|
50 (25.5)
|
<0.0001
|
Bendamustine
|
23 (3.7)
|
8 (3.1)
|
24 (5.9)
|
21 (10.7)
|
||
Chlorambucil
|
18 (2.9)
|
22 (8.5)
|
6 (1.5)
|
12 (6.1)
|
||
Chlorambucil/prednisone
|
0
|
12 (4.6)
|
0
|
3 (1.5)
|
||
Cyclophosphamide
|
0
|
4 (1.5)
|
0
|
0
|
||
Cyclophosphamide/fludarabine
|
11 (1.7)
|
0
|
0
|
2 (1.0)
|
||
Cyclophosphamide/vincristine/prednisone
|
0
|
0
|
5 (1.2)
|
0
|
||
Fludarabine
|
9 (1.4)
|
0
|
5 (1.2)
|
10 (5.1)
|
||
Other, n (%)
|
14 (2.2)
|
16 (6.2)
|
0.0030
|
46 (11.3)
|
18 (9.2)
|
0.4400
|
Alemtuzumab
|
0
|
0
|
14 (3.4)
|
6 (3.1)
|
||
Lenalidomide
|
0
|
4 (1.5)
|
0
|
0
|
||
Ofatumumab
|
0
|
0
|
17 (4.2)
|
8 (4.1)
|
||
Investigational product
|
6 (1.0)
|
7 (2.7)
|
13 (3.2)
|
4 (2.0)
|