Phase 3 trials of bortezomib-based regimens in preparation for ASCT
Regimen . | N . | After induction . | After ASCT . | PFS . | OS . | Reference . | ||
---|---|---|---|---|---|---|---|---|
CR + PR, % . | CR/ ≥ VGPR, % . | CR + PR, % . | CR/ ≥ VGPR, % . | |||||
VD vs | 223 | 78.5 | 6 (15)*/38 | 80 | 16 (35)*/54 | median, 36 mo | 3-yr, 81% | 53 |
VAD | 218 | 63 | 1 (6)*/15 | 77 | 9 (18)*/37 | median, 30 mo | 3-yr, 77% | |
(P = .06) | (P = .5) | |||||||
VTD vs | 236 | 93 | 19 (31)*/62 | 93 | 42 (55)*/82 | 3-yr, 68% | 3-yr, 86% | 61 |
TD | 238 | 79 | 5 (11)*/28 | 84 | 30 (41)*/64 | 3-yr, 56% | 3-yr, 84% | |
(P = .005) | (P = .3) | |||||||
VBMCP/VBAD + V vs | 129 | 75 | 21/36 | 73 | 38/51 | 38 mo | NR | 62 |
VTD vs | 130 | 85 | 35/60 | 77 | 46/65 | 27 mo | NR | |
TD | 127 | 62 | 14/29 | 58 | 24/40 | Not reached | NR | |
(P = .006) | ||||||||
PAD vs | 371 | 78 | NR (11)*/42 | 88 | NR (30)*/61 | 3-yr, 36% | 3-yr, 78% | 55 |
VAD | 373 | 55 | NR (5)*/15 | 77 | NR (15)*/36 | 3-yr, 27% | 3-yr, 70% | |
(P = .01) | (P = .02) | |||||||
VD vs | 99 | 81 | 12 (22)*/35 | 84 | 33 (54)*/59 | NR | NR | 63 |
vTD | 100 | 90 | 13 (32)*/51 | 90 | 30 (61)*/73 | NR | NR |
Regimen . | N . | After induction . | After ASCT . | PFS . | OS . | Reference . | ||
---|---|---|---|---|---|---|---|---|
CR + PR, % . | CR/ ≥ VGPR, % . | CR + PR, % . | CR/ ≥ VGPR, % . | |||||
VD vs | 223 | 78.5 | 6 (15)*/38 | 80 | 16 (35)*/54 | median, 36 mo | 3-yr, 81% | 53 |
VAD | 218 | 63 | 1 (6)*/15 | 77 | 9 (18)*/37 | median, 30 mo | 3-yr, 77% | |
(P = .06) | (P = .5) | |||||||
VTD vs | 236 | 93 | 19 (31)*/62 | 93 | 42 (55)*/82 | 3-yr, 68% | 3-yr, 86% | 61 |
TD | 238 | 79 | 5 (11)*/28 | 84 | 30 (41)*/64 | 3-yr, 56% | 3-yr, 84% | |
(P = .005) | (P = .3) | |||||||
VBMCP/VBAD + V vs | 129 | 75 | 21/36 | 73 | 38/51 | 38 mo | NR | 62 |
VTD vs | 130 | 85 | 35/60 | 77 | 46/65 | 27 mo | NR | |
TD | 127 | 62 | 14/29 | 58 | 24/40 | Not reached | NR | |
(P = .006) | ||||||||
PAD vs | 371 | 78 | NR (11)*/42 | 88 | NR (30)*/61 | 3-yr, 36% | 3-yr, 78% | 55 |
VAD | 373 | 55 | NR (5)*/15 | 77 | NR (15)*/36 | 3-yr, 27% | 3-yr, 70% | |
(P = .01) | (P = .02) | |||||||
VD vs | 99 | 81 | 12 (22)*/35 | 84 | 33 (54)*/59 | NR | NR | 63 |
vTD | 100 | 90 | 13 (32)*/51 | 90 | 30 (61)*/73 | NR | NR |
PAD indicates bortezomib, doxorubicin, dexamethasone; V, bortezomib; TD, thalidomide-dexamethasone; VAD, vincristine, doxorubicin, dexamethasone; VBAD, vincristine, carmustine, doxorubicin, dexamethasone; VBMCP, vincristine, carmustine, melphalan, cyclophosphamide, prednisone; VD, bortezomib, dexamethasone; VTD, bortezomib (1.3 mg/m2), thalidomide, dexamethasone; vTD, bortezomib (1.0 mg/m2), thalidomide, dexamethasone; and NR, not reported.
At least near CR.