Table 1:
Characteristics of the patients at baseline, intention-to-treat population
| Acalabrutinib-obinutuzumab (n=179) | Acalabrutinib monotherapy (n=179) | Obinutuzumab-chlorambucil (n=177) | |
|---|---|---|---|
| Age (years) | |||
| Median (IQR) | 70·0 (65·0–75·0) | 70·0 (66·0–75·0) | 71·0 (67·0–76·0) |
| ≥75 | 53 (29·6%) | 50 (27·9%) | 52 (29·4%) |
| ≥65 | 144 (80·4%) | 151 (84·4%) | 153 (86·4%) |
| <65* | 35 (19·6%) | 28 (15·6%) | 24 (13·6%) |
| Creatinine clearance 30–69 mL/min† | 2 (1·1%) | 4 (2·2%) | 7 (4·0%) |
| CIRS-G >6† | 30 (16·8%) | 21 (11·7%) | 15 (8·5%) |
| Any of the above† | 31 (17·3%) | 24 (13·4%) | 20 (11·3%) |
| Sex | |||
| Female | 68 (38·0%) | 68 (38·0%) | 71 (40·1%) |
| Male | 111 (62·0%) | 111 (62·0%) | 106 (59·9%) |
| ECOG PS | |||
| 0–1 | 169 (94·4%) | 165 (92·2%) | 167 (94·4%) |
| 2 | 10 (5·6%) | 14 (7·8%) | 10 (5·6%) |
| CLL-IPI score | |||
| 0–1 (low risk) | 9 (5·0%) | 4 (2·2%) | 5 (2·8%) |
| 2–3 (intermediate risk) | 27 (15·1%) | 18 (10·1%) | 25 (14·1%) |
| 4–6 (high risk) | 115 (64·2%) | 134 (74·9%) | 119 (67·2%) |
| 7–10 (very high risk) | 23 (12·8%) | 20 (11·2%) | 23 (13·0%) |
| Rai stage | |||
| 0 | 3 (1·7%) | 0 | 1 (0·6%) |
| I | 54 (30·2%) | 48 (26·8%) | 50 (28·2%) |
| II | 36 (20·1%) | 44 (24·6%) | 48 (27·1%) |
| III | 48 (26·8%) | 50 (27·9%) | 40 (22·6%) |
| IV | 38 (21·2%) | 37 (20·7%) | 38 (21·5) |
| High-risk features | |||
| Chromosome 17p13·1 deletion | 17 (9·5%) | 16 (8·9%) | 16 (9·0%) |
| Chromosome 11q22·3 deletion | 31 (17·3%) | 31 (17·3%) | 33 (18·6%) |
| Unmutated IGHV | 103 (57·5%) | 119 (66·5%) | 116 (65·5%) |
| Mutated TP53 | 21 (11·7%) | 19 (10·6%) | 21 (11·9%) |
| Complex karyotype | 29 (16·2%) | 31 (17·3%) | 32 (18·1%) |
| Including chromosome 17p13·1 deletion | 8 (4·5%) | 8 (4·5%) | 7 (4·0%) |
| Without chromosome 17p13·1 deletion | 21 (11·7%) | 23 (12·8%) | 25 (14·1%) |
| Chromosome 17p13·1 deletion and/or mutated TP53 | 25 (14·0%) | 23 (12·8%) | 25 (14·1%) |
| Chromosome 17p13·1 deletion and mutated TP53 | 13 (7·3%) | 12 (6·7%) | 12 (6·8%) |
| Any cytopenia at baseline | 93 (52·0%) | 85 (47·5%) | 77 (43·5%) |
| Haemoglobin ≤11·0 g/dL | 67 (37·4%) | 68 (38·0%) | 69 (39·0%) |
| Platelet count ≤100 000/μL | 44 (24·6%) | 33 (18·4%) | 34 (19·2%) |
| Absolute neutrophil count ≤1500 μL | 9 (5·0%) | 10 (5·6%) | 5 (2·8%) |
| CIRS-G score‡ | |||
| n, median (IQR) | 117, 6·0 (3·0–8·0) | 115, 6·0 (3·0–8·0) | 118, 5·5 (4·0–8·0) |
| Creatinine clearance (mL/min) | |||
| Median (IQR) | 76·5 (59·0–92·5) | 75·0 (58·0–98·0) | 70·0 (55·0–90·0) |
| <60 mL/min | 45 (25·1%) | 48 (26·8%) | 56 (31·6%) |
| Time from initial diagnosis (months) | |||
| Median (IQR) | 30·5 (9·4–70·7) | 24·4 (7·0–70·3) | 30·7 (9·4–64·2) |
Data are n (%) unless otherwise specified. CIRS-G=Cumulative Illness Rating Scale for Geriatrics. CLL-IPI=chronic lymphocytic leukaemia international prognostic index. ECOG PS=Eastern Cooperative Oncology Group performance status. IGHV=immunoglobulin heavy-chain variable gene. TP53=cellular tumour antigen p53 gene.
*
Twelve patients did not meet eligibility criteria of being younger than 65 years and having a CIRS-G score higher than 6 or creatinine clearance of 30–69 mL/min.
†
Percentages are for the total population in the treatment group.
‡
CIRS-G reporting was not required for all patients.