Ibrutinib dose reductions and discontinuation
| Ibrutinib dose reductions . | |
|---|---|
| Events | n = 42 |
| Days to event, median (range), d | 62 (5-589) |
| Reasons for reduction | |
| Muscle cramps (myalgia) | 10 (24%) |
| GI toxicity | 7 (17%) |
| Bleeding/bruising | 5 (12%) |
| Drug interaction | 5 (12%) |
| Cytopenias | 3 (7.3%) |
| Fatigue/others | 3 (7.3%) |
| Fatigue | 2 (4.9%) |
| Headache | 1 (2.4%) |
| Hypertension | 1 (2.4%) |
| Infection | 1 (2.4%) |
| Oral lesions | 1 (2.4%) |
| Skin rash | 1 (2.4%) |
| Skin nodules | 1 (2.4%) |
| Ibrutinib discontinuation | |
| Events | n = 183 |
| Days to event, median, (range), d | 154 (0-1254) |
| Discontinuation category | |
| Progressive cGVHD | 81 (44%) |
| Therapy toxicity | 76 (42%) |
| Responsive cGVHD | 20 (11%) |
| Other | 6 (3.3%) |
| Toxicity leading to discontinuation | |
| Muscle cramps (myalgia) | 14 (21%) |
| GI toxicity | 11 (16%) |
| Bleeding/bruising | 10 (15%) |
| Infection | 8 (12%) |
| Fatigue/others | 6 (9%) |
| Cytopenias | 3 (4.5%) |
| Skin rash | 3 (4.5%) |
| Skin nodules | 3 (4.5%) |
| Cardiac (arrhythmia) | 2 (3%) |
| Cardiac (ejection fraction decrease) | 2 (3%) |
| Fatigue | 2 (3%) |
| Headache | 2 (3%) |
| Oral ulcers | 1 (1.5%) |
| Ibrutinib dose reductions . | |
|---|---|
| Events | n = 42 |
| Days to event, median (range), d | 62 (5-589) |
| Reasons for reduction | |
| Muscle cramps (myalgia) | 10 (24%) |
| GI toxicity | 7 (17%) |
| Bleeding/bruising | 5 (12%) |
| Drug interaction | 5 (12%) |
| Cytopenias | 3 (7.3%) |
| Fatigue/others | 3 (7.3%) |
| Fatigue | 2 (4.9%) |
| Headache | 1 (2.4%) |
| Hypertension | 1 (2.4%) |
| Infection | 1 (2.4%) |
| Oral lesions | 1 (2.4%) |
| Skin rash | 1 (2.4%) |
| Skin nodules | 1 (2.4%) |
| Ibrutinib discontinuation | |
| Events | n = 183 |
| Days to event, median, (range), d | 154 (0-1254) |
| Discontinuation category | |
| Progressive cGVHD | 81 (44%) |
| Therapy toxicity | 76 (42%) |
| Responsive cGVHD | 20 (11%) |
| Other | 6 (3.3%) |
| Toxicity leading to discontinuation | |
| Muscle cramps (myalgia) | 14 (21%) |
| GI toxicity | 11 (16%) |
| Bleeding/bruising | 10 (15%) |
| Infection | 8 (12%) |
| Fatigue/others | 6 (9%) |
| Cytopenias | 3 (4.5%) |
| Skin rash | 3 (4.5%) |
| Skin nodules | 3 (4.5%) |
| Cardiac (arrhythmia) | 2 (3%) |
| Cardiac (ejection fraction decrease) | 2 (3%) |
| Fatigue | 2 (3%) |
| Headache | 2 (3%) |
| Oral ulcers | 1 (1.5%) |
Of 8 patients with infection as primary toxicity leading to ibrutinib discontinuation, 4 had additional data on the type of infection, and it included COVID-19 (n = 1), pneumonia (n = 1), and invasive fungal infection (n = 2).