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Safety of obinutuzumab with/without chemotherapy in CLL
loss to follow up (n=9, 0.9%), investigator decision (n=4, 0.4%) and other (n=4, 0.4%).
In the ITT population, median age was 66.0 (range 33-90) years, 63.5% of patients were male, 59.6%/36.9%/3.5% had an ECOG performance status of
0/1/2, 79.2% had a CIRS score of ≤6 and 61.0% had CrCl ≥70 mL/min (Table 1). Binet stage distribution at screening was 25.3% stage A, 41.2% stage B, 32.9% stage C and 0.6% missing. Five hundred and thirty-three (54.8%) patients had a high tumor burden (with nodes ≥10 cm, or
Table 1. Demographics and baseline disease characteristics according to line of therapy and fitness of patients (intent-to-treat population).
Characteristic
Median age, (range) years Age ≥65 years, n (%) Age ≥75 years, n (%)
Male, n (%)
ECOG performance status, n(%)
0 1 2
Binet stage, n(%) A
B
C Missing
B symptoms, n (%)*
Bulky disease (≥5 cm), n(%)
Lymphocytes ≥25x109/L, n(%) Total CIRS score, n(%)
>6
CrCl at screening, n(%)
Negative Positive Missing
CD38 expression, n(%)
Negative Positive Missing
Cytogenetics, n(%) 17p deletion
11q deletion
12q trisomy
13q deletion Other
No abnormality Missing
IgVH mutation status, n (%)
Mutated Unmutated Missing
First-line fit (n=339)
59.0 (33-82) 102 (30.1) 15 (4.4) 233 (68.7)
237 (69.9) 98 (28.9) 4 (1.2)
97 (28.6) 161 (47.5) 81 (23.9) 0
120 (35.4)
240 (70.8) 259 (76.4)
339 (100) 0
0
339 (100)
87 (25.7) 189 (55.8) 63 (18.6)
140 (41.3) 134 (39.5) 65 (19.2)
14 (4.1) 55 (16.2) 45 (13.3) 106 (31.3) 18 (5.3) 58 (17.1) 43 (12.7)
101 (29.8) 181 (53.4) 57 (16.8)
First-line unfit (n=292)
72.0 (45-87) 223 (76.4) 114 (39.0) 166 (56.8)
154 (52.7) 127 (43.5) 11 (3.8)
72 (24.7) 112 (38.4) 108 (37.0) 0
87 (29.8)
149 (51.0) 230 (78.8)
172 (58.9) 120 (41.1)
230 (78.8)
62 (21.2)
72 (24.7) 146 (50.0) 74 (25.3)
104 (35.6) 115 (39.4) 73 (25.0)
20 (6.8) 33 (11.3) 48 (16.4) 97 (33.2) 7 (2.4) 43 (14.7) 44 (15.1)
90 (30.8) 146 (50.0) 56 (19.2)
First-line all (n=631)
65.0 (33-87) 325 (51.5) 129 (20.4) 399 (63.2)
391 (62.0) 225 (35.7) 15 (2.4)
169 (26.8) 273 (43.3) 189 (30.0) 0
207 (32.8)
389 (61.6) 489 (77.5)
511 (81.0) 120 (19.0)
230 (36.5)
401 (63.5)
159 (25.2) 335 (53.1) 137 (21.7)
244 (38.7) 249 (39.5) 138 (21.9)
34 (5.4) 88 (13.9) 93 (14.7) 203 (32.2) 25 (4.0) 101 (16.0) 87 (13.8)
191 (30.3) 327 (51.8) 113 (17.9)
R/R (n=341)
68.0 (33-90) 213 (62.5) 98 (28.7) 218 (63.9)
188 (55.1) 134 (39.3) 19 (5.6)
77 (22.6) 127 (37.2) 131 (38.4) 6 (1.8) 114 (33.4)
210 (61.6) 214 (62.8)
259 (76.0) 82 (24.0)
149 (43.7)
192 (56.3)
84 (24.6) 160 (46.9) 97 (28.4)
93 (27.3) 153 (44.9) 95 (27.9)
46 (13.5) 67 (19.6) 33 (9.7) 79 (23.2) 16 (4.7) 33 (9.7) 67 (19.6)
64 (18.8) 188 (55.1) 89 (26.1)
Total (n=972)
66.0 (33-90) 538 (55.3) 277 (28.5) 617 (63.5)
579 (59.6) 359 (36.9) 34 (3.5)
246 (25.3) 400 (41.2) 320 (32.9) 6 (0.6) 321 (33.0)
599 (61.6) 703 (72.3)
770 (79.2) 202 (20.8)
379 (39.0)
593 (61.0)
243 (25.0) 495 (50.9) 234 (24.1)
337 (34.7) 402 (41.4) 233 (24.0)
80 (8.2) 155 (15.9) 126 (13.0) 282 (29.0) 41 (4.2) 134 (13.8) 154 (15.8)
255 (26.2) 515 (53.0) 202 (20.8)
≤6
<70 mL/min
≥70 mL/min
ZAP-70 expression, n(%)
R/R: relapsed/refractory; ECOG: Eastern Cooperative Oncology Group; CIRS: Cumulative Illness Rating Scale; CrCl: creatinine clearance; n: number; min: minute. *Patients with at least one B symptom (unexplained fever >38°C, drenching night sweats >1 month or weight loss >10% of body mass in preceding 6 months).
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