Table 4.
Maintenance and consolidation studies with bortezomib in combination with thalidomide or prednisone
| Study group | Median age, y (no. of patients) | Induction therapy | Maintenance dose, duration of treatment | Improvement in quality of response | EFS or PFS* | OS* | Tolerance |
|---|---|---|---|---|---|---|---|
| PETHEMA: Mateos et al44 (2011) | 73 (N = 260) | VMP vs VTP | (A) VT: bortezomib 1.3 mg/m2, days 1, 4, 8, and 11 every 12 wks for 3 y; thalidomide 50 mg/d for 3 y | CR IF (A) 24%-46% | PFS (A) 39 mo | (A) not reached | G3 and G4 PNP (A) 9% (B) 3% |
| (B) VP: bortezomib 1.3 mg/m2, days 1, 4, 8, and 11 every 12 wks for 3 y; prednisone 50 mg every 2 d for 3 y | (B) 24%-39% | (B) 32 mo P = .1 | (B) 60 mo P = .1 | Discontinuation because of AEs (A) 13% (B) 9% | |||
| GIMEMA: Palumbo et al45 (2010) | 71 (N = 511) | VMPT-VT | Bortezomib 1.3 mg/m2, days 1 and 15, every 4 wks; thalidomide 50 mg/d until PD or intolerance | CR (A) 38% | 3-y PFS (A) 60% | 3-y OS (A) 88.8% | G3 and G4 Neutropenia (A) 38% (B) 28.1% |
| Cardiologic | |||||||
| VMP | (B) 24% | (B) 42% | (B) 89.2% | (A) 10.4% | |||
| P = .0008 | P < .07 | P = .9 | (B) 5.5% | ||||
| HOVON/GMMG: Sonneveld et al46 (2010) | 57 (N = 613) | PAD | Bortezomib 1.3 mg/m2, biweekly, for 2 y; thalidomide 50 mg/d for 2 y | (A) CR/nCR 50% | 3-y PFS | 3-y OS | G3 and G4 PNP |
| ≥ VGPR 65% | (A) 48% | (A) 78% | (A) 16% | ||||
| VAD | (B) CR/nCR 38% | (B) 42% | (B) 71% | (B) 7% | |||
| ≥ VGPR 61% | P = .047 | P = .048 |
*
Data are median values unless otherwise stated.