Table 2.
Comparison of response and toxicity between the Con-ibr and No-ibr cohorts
Con-ibr cohort | No-ibr cohort | P* | |
---|---|---|---|
Response at 4 wk | |||
iwCLL 2018, CR/CRi/PR† | 15/18 (83) | 10/18 (56) | .15 |
iwCLL 2018 CT response, CR/PR‡ | 10/14 (71) | 9/17 (53) | .46 |
Marrow CR by flow cytometry | 13/18 (72) | 12/18 (67) | 1 |
Marrow CR by IGH sequencing§ | 11/13 (85) | 6/10 (60) | .34 |
Toxicity | |||
CRS grade | |||
Median (range) | 1 (0-2) | 2 (0-5) | .04 |
Any grade CRS | 14/19 (74) | 18/19 (95) | .49 |
Grade ≥3 CRS | 0/19 (0) | 2/19 (11) | .18 |
Neurotoxicity grade | |||
Median (range) | 0 (0-3) | 0 (0-5) | .33 |
Any grade neurotoxicity | 5/19 (26) | 8/19 (42) | .49 |
Grade ≥3 neurotoxicity | 5/19 (26) | 7/19 (37) | .73 |
Grade 5 (fatal) events | Presumed ibrutinib-related cardiac arrhythmia (n = 1) | CRS and neurotoxicity (n =1) | Not applicable |
Unless otherwise noted, data are n/N (%).
Two-sided P values calculated using the Fisher’s exact test.
Two patients were not evaluable for response (early death before first disease restaging).
In patients with measurable nodal disease by CT.
In patients with no detectable disease by flow cytometry and with a trackable clone.