Nilotinib cross-intolerance in patients with imatinib-intolerance: nonhematologic adverse events
| . | Reason for imatinib intolerance . | |||||
|---|---|---|---|---|---|---|
| Nonhematologic AE . | Rash/skin . | Fluid retention . | Diarrhea . | ALT/AST elevation . | Myalgia/arthralgia . | |
| CML-CP (n = 95) | ||||||
| Imatinib-intolerant* grade 3/4 AE or persistent grade 2 AE, n (%) | 60 (63) | 28 (29) | 18 (19) | 12 (13) | 3 (3)/4 (4) | 10 (11) |
| Grade 3/4 AE or persistent grade 2 AE on nilotinib, n† | 4 | 0 | 0 | 3 | 1/0 | 0 |
| Grade 3/4 AE on nilotinib, n‡ | 1 | 0 | 0 | 1 | 0/0 | 0 |
| AE that led to dose reduction on nilotinib, n | 0 | 0 | 0 | 0 | 0/0 | 0 |
| Discontinuation on nilotinib attributable to AE, n | 0 | 0 | 0 | 0 | 0/0 | 0 |
| CML-AP (n = 27) | ||||||
| Imatinib-intolerant* grade 3/4 AE or persistent grade 2 AE, n (%) | 15 (56) | 5 (19) | 5 (19) | 1 (4) | 1 (4)/0 (0) | 2 (7) |
| Grade 3/4 AE or persistent grade 2 AE on nilotinib, n† | 0 | 0 | 0 | 0 | 0/0 | 0 |
| Grade 3/4 AE on nilotinib, n‡ | 0 | 0 | 0 | 0 | 0/0 | 0 |
| AE that led to dose reduction on nilotinib, n | 0 | 0 | 0 | 0 | 0/0 | 0 |
| Discontinuation on nilotinib attributable to AE, n | 0 | 0 | 0 | 0 | 0/0 | 0 |
| All patients (n = 122) | ||||||
| Imatinib-intolerant* grade 3/4 AE or persistent grade 2 AE, n (%) | 75 (61) | 33 (27) | 23 (19) | 13 (11) | 4 (3)/4 (3) | 12 (10) |
| Grade 3/4 AE or persistent grade 2 AE on nilotinib, n† | 4 | 0 | 0 | 3 | 1/0 | 0 |
| Grade 3/4 AE on nilotinib, n‡ | 1 | 0 | 0 | 1 | 0/0 | 0 |
| AE that led to dose reduction on nilotinib, n | 0 | 0 | 0 | 0 | 0/0 | 0 |
| Discontinuation on nilotinib attributable to AE, n | 0 | 0 | 0 | 0 | 0/0 | 0 |
| . | Reason for imatinib intolerance . | |||||
|---|---|---|---|---|---|---|
| Nonhematologic AE . | Rash/skin . | Fluid retention . | Diarrhea . | ALT/AST elevation . | Myalgia/arthralgia . | |
| CML-CP (n = 95) | ||||||
| Imatinib-intolerant* grade 3/4 AE or persistent grade 2 AE, n (%) | 60 (63) | 28 (29) | 18 (19) | 12 (13) | 3 (3)/4 (4) | 10 (11) |
| Grade 3/4 AE or persistent grade 2 AE on nilotinib, n† | 4 | 0 | 0 | 3 | 1/0 | 0 |
| Grade 3/4 AE on nilotinib, n‡ | 1 | 0 | 0 | 1 | 0/0 | 0 |
| AE that led to dose reduction on nilotinib, n | 0 | 0 | 0 | 0 | 0/0 | 0 |
| Discontinuation on nilotinib attributable to AE, n | 0 | 0 | 0 | 0 | 0/0 | 0 |
| CML-AP (n = 27) | ||||||
| Imatinib-intolerant* grade 3/4 AE or persistent grade 2 AE, n (%) | 15 (56) | 5 (19) | 5 (19) | 1 (4) | 1 (4)/0 (0) | 2 (7) |
| Grade 3/4 AE or persistent grade 2 AE on nilotinib, n† | 0 | 0 | 0 | 0 | 0/0 | 0 |
| Grade 3/4 AE on nilotinib, n‡ | 0 | 0 | 0 | 0 | 0/0 | 0 |
| AE that led to dose reduction on nilotinib, n | 0 | 0 | 0 | 0 | 0/0 | 0 |
| Discontinuation on nilotinib attributable to AE, n | 0 | 0 | 0 | 0 | 0/0 | 0 |
| All patients (n = 122) | ||||||
| Imatinib-intolerant* grade 3/4 AE or persistent grade 2 AE, n (%) | 75 (61) | 33 (27) | 23 (19) | 13 (11) | 4 (3)/4 (3) | 12 (10) |
| Grade 3/4 AE or persistent grade 2 AE on nilotinib, n† | 4 | 0 | 0 | 3 | 1/0 | 0 |
| Grade 3/4 AE on nilotinib, n‡ | 1 | 0 | 0 | 1 | 0/0 | 0 |
| AE that led to dose reduction on nilotinib, n | 0 | 0 | 0 | 0 | 0/0 | 0 |
| Discontinuation on nilotinib attributable to AE, n | 0 | 0 | 0 | 0 | 0/0 | 0 |
AE indicates adverse event; ALT, alanine aminotransferase; AP, accelerated phase; AST, aspartate aminotransferase; CML, chronic myeloid leukemia; and CP, chronic phase.
Patients with multiple reasons for imatinib intolerance are counted in each category.
Number of imatinib-intolerant patients who experienced any grade 3/4 AE or grade 2 AE that persisted for > 30 days during nilotinib therapy and was the same corresponding reason for imatinib intolerance.
Number of imatinib-intolerant patients who experienced any grade 3/4 AE during nilotinib therapy that was the same corresponding reason for imatinib intolerance.