Randomized trials evaluating the role of continued (maintenance) therapy with lenalidomide and bortezomib-based regimen in TNE patients
| Study group . | Age (median), y; no. of patients . | Induction therapy . | Maintenance dose, duration of TX . | Improvement in quality of response . | EFS or PFS* . | OS† . | Tolerance . |
|---|---|---|---|---|---|---|---|
| Mateos et al36 | 73; N = 260 | VMP or VTP | VT: bortezomib 1.3 mg/m2 days 1, 4, 8, 11 every 12 wk for 3 y; thalidomide 50 mg/d for 3 y | CR IFneg 23% ⇒ 44% | PFS 32 mo | OS at 2 y 86% | Grade 3 and 4 PNP |
| VT: 7% | |||||||
| VP: 2% | |||||||
| VP: bortezomib as above; prednisone 50 mg every 2 d for 3 y | 23% ⇒ 39% | 24 mo | 81% P = .7 | Discontinuation because of AEs | |||
| HR, 1.4; 95% CI, 0.8-2.1 | VT: 8% | ||||||
| P = .1 | VP: 5% | ||||||
| Palumbo et al35 | 71; N = 511 | VMPT-VT | Bortezomib 1.3 mg/m2 days 1 and 15 every 4 wk | CR | PFS at 3 y | OS at 3 y | Grade 3 and 4 neutropenia 38%, 28.1% |
| 38% | 60% | 88.8% | |||||
| VMP | Thalidomide 50 mg/d until PD or intolerance | 24% | 42% | 89.2% | Cardiologic 10.4%, 5.5% | ||
| P = .0008 | P < .07 | P = .9 | |||||
| Palumbo et al37 | 71; N = 355 | MPR-R | MP plus revlimid 10 mg, days 1-21, 9 cycles followed by revlimid 10 mg maintenance until PD or intolerance | CR: 9.9% | PFS: 31 mo | OS at 3 y 70% 62%, P = .81 | Grade 3 neutropenia 67%, 5% during maintenance |
| PR: 61.1% | Grade 3 neutropenia 64% | ||||||
| MPR | MP plus revlimid 10 mg, days 1-21, 9 cycles | CR: 3.3% | PFS: 14 mo P < .001 | ||||
| PR: 64.7% | |||||||
| Benboubker et al38 | 73; N = 535 | Ld continuous | Lenalidomide 25 mg, days 1-21; dexamethasone 40 mg once weekly | ORR: 75% | 25.5 mo | OS at 4 y 59% | Grade 3 and 4 AEs: 85% Grade 3 and 4 infections: 29% |
| N = 541 | Ld18 | Ld for 18 cycles | ORR:73% | 20.7 mo | 56% P = .31 | Grade 3 and 4 AEs: 80%; Grade 3 and 4 infections: 22% |
| Study group . | Age (median), y; no. of patients . | Induction therapy . | Maintenance dose, duration of TX . | Improvement in quality of response . | EFS or PFS* . | OS† . | Tolerance . |
|---|---|---|---|---|---|---|---|
| Mateos et al36 | 73; N = 260 | VMP or VTP | VT: bortezomib 1.3 mg/m2 days 1, 4, 8, 11 every 12 wk for 3 y; thalidomide 50 mg/d for 3 y | CR IFneg 23% ⇒ 44% | PFS 32 mo | OS at 2 y 86% | Grade 3 and 4 PNP |
| VT: 7% | |||||||
| VP: 2% | |||||||
| VP: bortezomib as above; prednisone 50 mg every 2 d for 3 y | 23% ⇒ 39% | 24 mo | 81% P = .7 | Discontinuation because of AEs | |||
| HR, 1.4; 95% CI, 0.8-2.1 | VT: 8% | ||||||
| P = .1 | VP: 5% | ||||||
| Palumbo et al35 | 71; N = 511 | VMPT-VT | Bortezomib 1.3 mg/m2 days 1 and 15 every 4 wk | CR | PFS at 3 y | OS at 3 y | Grade 3 and 4 neutropenia 38%, 28.1% |
| 38% | 60% | 88.8% | |||||
| VMP | Thalidomide 50 mg/d until PD or intolerance | 24% | 42% | 89.2% | Cardiologic 10.4%, 5.5% | ||
| P = .0008 | P < .07 | P = .9 | |||||
| Palumbo et al37 | 71; N = 355 | MPR-R | MP plus revlimid 10 mg, days 1-21, 9 cycles followed by revlimid 10 mg maintenance until PD or intolerance | CR: 9.9% | PFS: 31 mo | OS at 3 y 70% 62%, P = .81 | Grade 3 neutropenia 67%, 5% during maintenance |
| PR: 61.1% | Grade 3 neutropenia 64% | ||||||
| MPR | MP plus revlimid 10 mg, days 1-21, 9 cycles | CR: 3.3% | PFS: 14 mo P < .001 | ||||
| PR: 64.7% | |||||||
| Benboubker et al38 | 73; N = 535 | Ld continuous | Lenalidomide 25 mg, days 1-21; dexamethasone 40 mg once weekly | ORR: 75% | 25.5 mo | OS at 4 y 59% | Grade 3 and 4 AEs: 85% Grade 3 and 4 infections: 29% |
| N = 541 | Ld18 | Ld for 18 cycles | ORR:73% | 20.7 mo | 56% P = .31 | Grade 3 and 4 AEs: 80%; Grade 3 and 4 infections: 22% |
AE, adverse event; CI, confidence interval; EFS, event-free survival; FIRST, Frontline Investigation of Revlimid and Dexamethasone versus Standard Thalidomide; GIMEMA, Gruppo Italiano Malatti E Matologiche dell'Adulto; HR, hazard ratio; IFneg, negative immunofixation; Ld18, lenalidomide given over 18 cycles; ORR, objective response rate; PD, progression of disease; PETHEMA, Programa para el Tratamiento de Hemopatías Malignas; PNP, polyneuropathy; PR, partial response; TX, treatment; VTP, Velcade-thalidomide-prednisone.
Median unless otherwise stated.