Reasons for discontinuation in patients with CLL and/or SLL treated with acalabrutinib or ibrutinib (from unstructured data on or after 1 January 2018)
| . | Original sample . | ||
|---|---|---|---|
| Acalabrutinib cohort∗ . | Ibrutinib cohort without subsequent acalabrutinib† . | Ibrutinib cohort with subsequent acalabrutinib‡ . | |
| Total patients . | n = 212 . | n = 194 . | n = 59 . |
| Patients who discontinued treatment, n (%) . | 54 (25.5) . | 79 (40.7) . | 59 (100.0) . |
| Reasons for discontinuation§ | |||
| Toxic effect of therapy/MEOI | 27 (12.7) | 37 (19.1) | 53 (89.8) |
| Cytopenia | 9 (4.2) | 4 (2.1) | 4 (6.8) |
| Arthralgia/myalgia/arthritis | 3 (1.4) | 3 (1.5) | 12 (20.3) |
| Gastrointestinal toxicity | 3 (1.4) | 3 (1.5) | 4 (6.8) |
| Headache | 3 (1.4) | 1 (0.5) | 2 (3.4) |
| Atrial fibrillation | 3 (1.4) | 5 (2.6) | 7 (11.9) |
| Bleeding episodes | 2 (0.9) | 8 (4.1) | 8 (13.6) |
| Cardiac toxicity | 2 (0.9) | 1 (0.5) | 5 (8.5) |
| Fatigue | 2 (0.9) | 10 (5.2) | 3 (5.1) |
| Rash | 3 (1.4) | 4 (2.1) | 8 (13.6) |
| Diarrhea | 1 (0.5) | 3 (1.5) | 4 (6.8) |
| Edema | 1 (0.5) | 2 (1.0) | 5 (8.5) |
| Infection | 1 (0.5) | 2 (1.0) | 0 (0.0) |
| Pulmonary toxicity / pneumonitis | 0 (0.0) | 2 (1.0) | 1 (1.7) |
| Hypertension | 0 (0.0) | 0 (0.0) | 1 (1.7) |
| Other | 2 (0.9) | 7 (3.6) | 5 (8.5) |
| Progression | 7 (3.3) | 5 (2.6) | 3 (5.1) |
| Noncancer-related medical issue | 4 (1.9) | 5 (2.6) | 2 (3.4) |
| Insufficient response | 3 (1.4) | 4 (2.1) | 3 (5.1) |
| Planned regimen change | 2 (0.9) | 2 (1.0) | 1 (1.7) |
| Cancer-related symptoms not due to therapy | 1 (0.5) | 2 (1.0) | 0 (0.0) |
| Sufficient disease control | 0 (0.0) | 2 (1.0) | 0 (0.0) |
| Patient request | 0 (0.0) | 1 (0.5) | 0 (0.0) |
| Other | 3 (1.4) | 5 (2.6) | 0 (0.0) |
| Unknown | 8 (3.8) | 17 (8.8) | 0 (0.0) |
| . | Original sample . | ||
|---|---|---|---|
| Acalabrutinib cohort∗ . | Ibrutinib cohort without subsequent acalabrutinib† . | Ibrutinib cohort with subsequent acalabrutinib‡ . | |
| Total patients . | n = 212 . | n = 194 . | n = 59 . |
| Patients who discontinued treatment, n (%) . | 54 (25.5) . | 79 (40.7) . | 59 (100.0) . |
| Reasons for discontinuation§ | |||
| Toxic effect of therapy/MEOI | 27 (12.7) | 37 (19.1) | 53 (89.8) |
| Cytopenia | 9 (4.2) | 4 (2.1) | 4 (6.8) |
| Arthralgia/myalgia/arthritis | 3 (1.4) | 3 (1.5) | 12 (20.3) |
| Gastrointestinal toxicity | 3 (1.4) | 3 (1.5) | 4 (6.8) |
| Headache | 3 (1.4) | 1 (0.5) | 2 (3.4) |
| Atrial fibrillation | 3 (1.4) | 5 (2.6) | 7 (11.9) |
| Bleeding episodes | 2 (0.9) | 8 (4.1) | 8 (13.6) |
| Cardiac toxicity | 2 (0.9) | 1 (0.5) | 5 (8.5) |
| Fatigue | 2 (0.9) | 10 (5.2) | 3 (5.1) |
| Rash | 3 (1.4) | 4 (2.1) | 8 (13.6) |
| Diarrhea | 1 (0.5) | 3 (1.5) | 4 (6.8) |
| Edema | 1 (0.5) | 2 (1.0) | 5 (8.5) |
| Infection | 1 (0.5) | 2 (1.0) | 0 (0.0) |
| Pulmonary toxicity / pneumonitis | 0 (0.0) | 2 (1.0) | 1 (1.7) |
| Hypertension | 0 (0.0) | 0 (0.0) | 1 (1.7) |
| Other | 2 (0.9) | 7 (3.6) | 5 (8.5) |
| Progression | 7 (3.3) | 5 (2.6) | 3 (5.1) |
| Noncancer-related medical issue | 4 (1.9) | 5 (2.6) | 2 (3.4) |
| Insufficient response | 3 (1.4) | 4 (2.1) | 3 (5.1) |
| Planned regimen change | 2 (0.9) | 2 (1.0) | 1 (1.7) |
| Cancer-related symptoms not due to therapy | 1 (0.5) | 2 (1.0) | 0 (0.0) |
| Sufficient disease control | 0 (0.0) | 2 (1.0) | 0 (0.0) |
| Patient request | 0 (0.0) | 1 (0.5) | 0 (0.0) |
| Other | 3 (1.4) | 5 (2.6) | 0 (0.0) |
| Unknown | 8 (3.8) | 17 (8.8) | 0 (0.0) |
MEOI, medical events of interest.
Patients in the acalabrutinib cohort might have received ibrutinib in any line of therapy. One patient in the acalabrutinib cohort discontinued treatment because of atrial fibrillation, and 1 patient in the ibrutinib cohort discontinued treatment because of arthralgia/myalgia + headache on the index date (ie, initiation of acalabrutinib or ibrutinib). These patients were excluded from the analysis.
Patients who received both acalabrutinib monotherapy and ibrutinib monotherapy on or after 1 January 2018 were excluded from this cohort.
Patients in this cohort received ibrutinib monotherapy on or after 1 January 2018, followed by acalabrutinib monotherapy in a later line; 4 patients received acalabrutinib monotherapy before ibrutinib monotherapy, and were removed from this cohort.
Reasons for discontinuation were abstracted via a review of unstructured data. Patients might have had ≥1 reasons for discontinuation. See Appendix 5 for descriptions of each reason for discontinuation per the Flatiron Analytic Guide.