Summary of studies with upfront bortezomib-based therapy in systemic AL amyloidosis
| Bortezomib-containing regimen . | Newly diagnosed patients treated with bortezomib, n . | Stage III patients, % . | Median follow-up, mo . | ITT ORR, % . | ITT CR, % . | Organ response . | Median OS . | Median PFS or TNT . |
|---|---|---|---|---|---|---|---|---|
| Current cohort (primarily CyBorD) | 915 | 51.3 | 23 mo in all patients; 32 mo in living patients. | 65 | 15 | ITT: | 72 mo | Median TNT not reached (55% had not progressed to next treatment at 7 y) |
| Cardiac 32.5% | ||||||||
| Renal 15.4% | ||||||||
| Liver 30% | ||||||||
| CyBorD5 | 60 | 100 | 11.8 | 68 | 17 | Cardiac 32% | 1-y OS, 57%. | Not documented |
| Renal 23% | ||||||||
| Liver 25% | ||||||||
| CyBorD18 | 69 | 58 | 12.7 | 71 | 40.6 | Evaluable responses: | 1-y OS, 65.2%. | Median PFS, 28 mo. |
| Cardiac 35% | ||||||||
| Renal 43% | ||||||||
| Liver 53% | ||||||||
| Bortezomib, dexamethasone24 | 49 treated with bortezomib-dexamethasone (26 with twice-weekly bortezomib, 23 with once-weekly bortezomib). | 28 (twice-weekly bortezomib), 48 (once-weekly bortezomib). | 57 | 77 | 39 | Cardiac 45% | 1-y OS, 67%; 4-y OS, 43%. | 1-y PFS, 58%; 4-y PFS, 26%. |
| Renal 53% | ||||||||
| CyBorD4 | 230 | 49 | 25 (living patients) | 62 | 21 | Cardiac 17% | 5-y OS, 55%. | Median PFS, 13 mo. |
| Renal 25% | ||||||||
| Liver 32% | ||||||||
| BMDex19 | 53 | 15 | 25 (living patients) | 81 | 64 (CR/VGPR) | Cardiac 38% | 1-y OS, 80%. | Not documented |
| Bortezomib-containing regimen . | Newly diagnosed patients treated with bortezomib, n . | Stage III patients, % . | Median follow-up, mo . | ITT ORR, % . | ITT CR, % . | Organ response . | Median OS . | Median PFS or TNT . |
|---|---|---|---|---|---|---|---|---|
| Current cohort (primarily CyBorD) | 915 | 51.3 | 23 mo in all patients; 32 mo in living patients. | 65 | 15 | ITT: | 72 mo | Median TNT not reached (55% had not progressed to next treatment at 7 y) |
| Cardiac 32.5% | ||||||||
| Renal 15.4% | ||||||||
| Liver 30% | ||||||||
| CyBorD5 | 60 | 100 | 11.8 | 68 | 17 | Cardiac 32% | 1-y OS, 57%. | Not documented |
| Renal 23% | ||||||||
| Liver 25% | ||||||||
| CyBorD18 | 69 | 58 | 12.7 | 71 | 40.6 | Evaluable responses: | 1-y OS, 65.2%. | Median PFS, 28 mo. |
| Cardiac 35% | ||||||||
| Renal 43% | ||||||||
| Liver 53% | ||||||||
| Bortezomib, dexamethasone24 | 49 treated with bortezomib-dexamethasone (26 with twice-weekly bortezomib, 23 with once-weekly bortezomib). | 28 (twice-weekly bortezomib), 48 (once-weekly bortezomib). | 57 | 77 | 39 | Cardiac 45% | 1-y OS, 67%; 4-y OS, 43%. | 1-y PFS, 58%; 4-y PFS, 26%. |
| Renal 53% | ||||||||
| CyBorD4 | 230 | 49 | 25 (living patients) | 62 | 21 | Cardiac 17% | 5-y OS, 55%. | Median PFS, 13 mo. |
| Renal 25% | ||||||||
| Liver 32% | ||||||||
| BMDex19 | 53 | 15 | 25 (living patients) | 81 | 64 (CR/VGPR) | Cardiac 38% | 1-y OS, 80%. | Not documented |