Table 4.
Comparisons with previously published real-life experience in patients with relapsed and refractory CLL treated with ibrutinib.
| Ibrutinib as 2nd Line Onward | |||||
|---|---|---|---|---|---|
| This Study | Winqvist 2016 (14) | Ysebaert 2017 (15) | Pula 2020 (16) | van der Straten 2020 (17) | |
| N | 36 | 95 | 428 | 171 | 155 |
| Median age | 62 | 69 | 70 | 64 | 70 |
| TP53 mut | 3% | 63% (*) | 45% (*) | NA | 6% |
| del(17p) | 14% | 25% | 17% | ||
| IGHV unmut | 33% | NA | NA | NA | NA |
| Best ORR | 97% | 84% | 89% | 77% | 67% |
| Best CR rate | 3% (**) | 3% | NA | 18% | 13% |
| Follow-up | 26 mos | 10 mos | 3 mos | 40 mos | 14 mos |
| PFS | Median 21 mos 87% at 1 year 44% at 2 years |
Median NR 77% at 10 mos |
NA | Median NR 61% at 4 years |
Median NR 73% at 1 year |
| OS | Median 59 mos 100% at 1 year 92% at 2 years |
Median NR 83% at 10 mos |
NA | Median NR 65% at 4 years |
Median NR 77% at 1 year |
(*) data collected together for del(17p) and TP53mut; (**) strictly negative computed tomography scan and bone marrow biopsy. NA, not reported in the paper or not assessed; CR, complete response; mos, months; NR, not reached; ORR, overall response rate; PFS, progression-free survival; OS, overall survival.