Table 3.
Results of first-line randomised trials in elderly/comorbid patients. G-CLB, obinutuzumab + chlorambucil; BR, bendamustine + rituximab; VG, venetoclax + obinutuzumab; CrCl, creatinine clearance; IGHV, variable region of immunoglobulin heavy chain; M, mutated; NA, not available; NR, not reached; FISH, fluorescent in situ hybridisation; ORR/CR, overall response rate/complete responses; CIRS, Cumulative Illness Rating Scale; PFS, progression-free survival.
| Variable | G-CLB CLL11 | G-CLB CLL14 | G-CLB ILLUMINATE |
G-CLB ELEVATE-TN |
BR MaBLe | BR ALLIANCE |
Ibrutinib ALLIANCE | G-ibrutinib ILLUMINATE |
Acalabrutinib ELEVATE-TN |
VG CLL14 |
|---|---|---|---|---|---|---|---|---|---|---|
| n | 238 | 216 | 116 | 177 | 121 | 113 | 182 | 113 | 179 | 216 |
| Median age | 74 | 71 | 72 | 71 | 72 | 70 | 71 | 70 | 70 | 72 |
| Median CrCl (mL/min) | 61 | 66 | 70 | 70 | NA | 67 | 69 | 72 | 75 | 65 |
| Median CIRS | 8 | 8 | 4 | 6 | 3 comorbidities | 2 comorbidities | 2 comorbidities | 4 | 6 | 9 |
| Unmutated IGHV, % | 61 | 59 | 53 | 66 | 60 | 58 | 63 | 62 | 58 | 59 |
| FISH del 11q, % | 16 | 18 | 19 | 19 | 20 | 18 | 19 | 12 | 17 | 17 |
| FISH del 17p, % | 8 | 7 | 16 | 9 | 8 | 8 | 5 | 12 | 10 | 8 |
| ORR/CR, % | 78/21 | 71/23 | 73/8 | 79/5 | 91/24 | 81/26 | 93/7 | 88/19 | 86/1 | 85/50 |
| Median PFS, months | 32 | 36 | 22 | 23 | 40 | 43 | NR; 87% at 2y | NR; 80% at 2y | NR; 87% at 2y | NR; 82% at 3y |
| Median PFS M-IGHV, months | NA | 43 | NR; 63% at 2y | NR; 68% at 3 y | NA | 51; 74% at 4y | NR; 83% at 4y | NR; 87% at 2y | NR; 80% at 3y | NR; 88% at 3y |
| Neutropenia grade 3–4 | 33 | 48 | 46 | 41 | 43 | 40 | 15 | 37 | 10 | 53 |
| Infections grade 3–5 | 12 | 15 | 11 | 8 | 19 | 15 | 20 | 16 | 14 | 17 |
| Reference | Goede 2014; Goede 2015 | Fischer 2019; Al-Sawaf 2020 | Moreno 2019 | Sharman 2020 | Michallet 2018 | Woyach 2018 | Woyach 2018 | Moreno 2019 | Sharman 2020 | Fischer 2019; Al-Sawaf 2020 |