Table 2.
Results of first-line randomised trials in younger/fit patients. * FCR and FCM-miniR analysed together. BR, bendamustine + rituximab; FCR, fludarabine + cyclophosphamide + rituximab; CrCl, creatinine clearance; ORR/CR, response rate/complete responses; CIRS, Cumulative Illness Rating Scale; PFS, progression-free survival; NR, not reported; IGHV, variable region of immunoglobulin heavy chain; FISH, fluorescent in situ hybridisation.
| Variable | BR CLL10 | FCR CLL8 | FCR CLL10 | FCR ARCTIC | FCR ECOG/ACRIN | IR ECOG/ACRIN |
|---|---|---|---|---|---|---|
| n | 279 | 408 | 282 | 100 | 175 | 354 |
| Median age | 61 | 61 | 62 | 63 | 57 (mean) | 57 (mean) |
| Median CrCl (mL/min) | 86 | NR | 87 | NR | NR | NR |
| Median CIRS | 2 | 1 | 2 | NR | NR | NR |
| Unmutated IGHV, % | 68 | 63 | 55 | 52 | 62 | 75 |
| FISH del 11q, % | 23 | 22 | 24 | 10 | 22 | 22 |
| FISH del 17p, % | 0 | 10 | 0 | 4 | 0 | 1 |
| ORR/CR, % | 96/31 | 90/44 | 95/40 | 94/68 | 81/30 | 96/17 |
| Median PFS, months | 42 | 52 | 58 | 58 | not reached, 73% at 3y | not reached, 89% at 3y |
| Median PFS, M-IGHV | 69 | not reached, 67% at 5y | not reached, 65% at 5y | not reached, 68% at 5y * | not reached, 88% at 3y | not reached, 88% at 3y |
| Neutropenia grade 3–4 | 59 | 34 | 85 | 14 | 45 | 26 |
| Infections grade 3–5 | 26 | 25 | 40 | 58 | 20 | 11 |
| Reference | Eichhorst, 2016; Kutsch, 2020 | Hallek, 2010; Fischer, 2016 | Eichhorst, 2016; Kutsch, 2020 | Howard, 2017 | Shanafelt, 2019 | Shanafelt, 2019 |