Table 1.
Induction therapy trials (excluding bortezomib) for mantle cell lymphoma listed in the order of age of patients at enrollment
| Study type | Induction therapy | Consolidation | Age | N | Median OS | Median PFS | ORR (%) | CR (%) |
|---|---|---|---|---|---|---|---|---|
| Phase III69 | R-CHOP vs R-CHOP | TBI + ASCT vs TBI + interferon-α | ≤65 | 62 vs 60 | 83% at 3 y vs 77% at 3 y | 3.3 y vs 1.4 y | 98 vs 99 | 81 vs 37 |
| Phase II70,a | R-CHOP + HD-AraC | ASCT | ≤65 | 87 | 66% at 4 y | 36% at 4 y (PFS) | 70 | 64 |
| Phase II71 | R-Maxi-CHOP alternating with R + HD-AraC | BEAM or BEAC ASCT | ≤65 | 160 | 58% at 10 y | 7.4 y (EFS) | 96 | 54 |
| Phase III15 | R-CHOP vs R-CHOP/R-DHAP + HD-AraC | Dexa BEAM ASCT vs ASCT | ≤65 | 455 | 6.8 y vs NR* | 3.8 y vs 7.3 y | 98 vs 97 | 63 vs 61 |
| Phase II17 | R-HyperCVAD | – | ≤66 | 60 | 73% at 5 y | 61% at 5 y | 83 | 72 |
| Phase II72 | R-CHOP/R-DHAP + HD-AraC | TAM6 or BEAM ASCT | ≤66 | 60 | 75% at 5 y | 6.9 y (EFS) | 100 | 96 |
| Phase II67 | R-CHOP + methotrexate + HD-AraC/etoposide | ASCT | ≤69 | 77 | 64% at 5 y | 56% at 5 y | 88 | 69 |
| Phase II18 | R-HyperCVAD | – | <70 | 49 | 6.8 y | 4.8 y | 86 | 55 |
| Phase II22 | R-Cbl | ≤74 | 14 | 2.1 y | 15 m | 64 | 36 | |
| Phase III14,b | R-CHOP vs CHOP | ≤78 | 112 | 76% vs 76% at 2 y | 21 m (TTF) vs 14 m* (TTF) | 94 vs 75* | 34 vs 7* | |
| Phase II73 | R-HyperCVAD | – | ≤80 | 97 | 82% at 3 y | 64% at 3 y | 97 | 87 |
| Phase III19 | R-CHOP vs R-B | ≤83 | 94 | NR vs NR | 22.1 m vs 35.4 m | 91 vs 93 | 30 vs 40 | |
| Phase II23 | R-Cbl | ≤84 | 20 | 95% 3 y | 84% 3 y | 95 | 90 | |
| Phase III20 | R-CHOP/CVP vs R-B | ≤86 | 74 | – | 85 vs 94 | 27 vs 50* | ||
| Phase II74 | R-CDA | ≤86 | 29 | NR | 43% 2 y | 66 | 52 | |
| Phase III13 | R-CHOP vs R-FC | 60–87 | 485 | 62% at 4 y vs 47% at 4 y* | 28 m (TTF) vs 26 m (TTF) | 86 vs 78 | 34 vs 40 |
Notes:
P<0.05,
One patient of 66 years was included in the study because of good performance status;
Patients ≤65 years of age who achieved a PR/CR underwent a second randomization to either myeloablative radiochemotherapy followed by ASCT or interferon-α maintenance.
Abbreviations: ASCT, autologous stem cell transplant; BEAM, BCNU, etoposide, cytarabine, melphalan; CHOP, cyclophosphamide, doxorubicin, vincristine, and prednisolone; CR, complete response; EFS, event-free survival; HD-AraC, high-dose cytarabine; m, months; N, number of patients; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression free survival; R-Cbl, rituximab plus chlorambucil; R-CHOP, rituximab plus CHOP; R-DHAP, rituximab, dexamethasone, cytarabine, and cisplatin; R-HyperCVAD, rituximab plus hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with methotrexate and cytarabine; TAM6, total body irradiation, cytarabine, and melphalan; TTF, time to treatment failure; y, years.