Table 3.
Clinical trials with consolidative, frontline autologous hematopoietic-stem cell transplantation (ASCT) in patients with mantle cell lymphoma.
| Reference | Study design | n | Induction and conditioning regimen | Response prior to ASCT | Comparison chemotherapy | Median follow up (months) | Overall survival | Event/failure/progression/disease-free survival | Risk stratification |
|---|---|---|---|---|---|---|---|---|---|
| Dreyling et al. [2005] | Prospective | 122 | 4–6 cycles CHOP,DEXA-BEAM/Cy/TBI | CR: 35% PR: 65% |
8 cycles CHOP like, then interferon α maintenance | 25 | 3 years, 83% with ASCT versus 77% control (p = 0.18) | 3 years, PFS 54% with ASCT versus 25% control (p = 0.01) | IPI ASCT: 11% intermediate–high, 7% high risk; control: 11% intermediate–high, 4% high risk |
| Khouri et al. [1998] | Prospective | 25 | HyperCVAD/Ara-C-MTX,Cy/TBI | CR/PR | Historical controls with CHOP-like regimen (n = 25) | 25 | 3 years, 92% with ASCT versus 56% control (p = 0.05) | 3 years, EFS 72% with ASCT versus 28% control (p = 0.0001) | Stage IV 88% with ASCT, 84% control |
| Dreger et al. [2000] | Prospective | 46 | DEXA-BEAM/TBI | CR/PR | ASCT at relapse | 24 | 2 years, 100% for frontline ASCT versus 54% relapse ASCT (p = 0.002) | 2 years, EFS 77% for frontline ASCT versus 30% relapse ASCT (p = 0.0007) | All stage III/IV disease |
| Andersen et al. [2003] | Prospective | 41 | 4 cycles CHOP then BEAM/BEAC | CR/PR | NA | 34 | 4 years, 51% | 4 years, failure-free survival 15% with ASCT | IPI 15% intermediate–high, 15% high risk |
| Geisler et al. [2008] | Prospective | 160 | 3 cycles maxi-R-CHOP-21 alternating with 2 cycles high-dose-cytarabine/BEAM | CR: 54% PR: 42% |
NA | 46 | 4 years, 81% | 4 years, EFS 63% with ASCT | 65% low risk 35% intermediate or high risk |
| Van’t Veer et al. [2009] | Prospective | 87 | 3 cycles R-CHOP + high-dose Ara-C BEAM | CR: 92% PR: 8% |
NA | 42 | 4 years, 66% | 4 years, PFS 44% with ASCT | 51% low risk 49% intermediate or high risk |
| Damon et al. [2009] | Prospective | 78 | 2–3 cycles CHOP, EAR and cyclophosphamide, carmustine, etoposide | CR/PR | NA | 56 | 5 years, 64% | 5 years, PFS 56% with ASCT | ASCT53% low risk 46% intermediate or high risk |
| Delarue et al. [2013] | Prospective | 60 | 3 cycles of R-CHOP, then 3 cycles of rituximab cisplatin, cytarabine, DEXA-BEAM | CR: 96% PR: 4% |
NA | 67 | 5 years, 75% | 5 years, EFS 64% with ASCT | 55% low risk 32% intermediate risk13% high risk |
| LaCasce et al. [2012] | Retrospective | 167 | R-CHOP/BEAM (n = 55) | CR/PR | R-CHOP (n = 112) | 33 | 3 years, 87% with ASCT versus 69–85% control (p = NS) | 3 years, PFS 55–56% with ASCT versus 18% R-CHOP (p < 0.001)/versus 58% (p = NS) | ASCT 18% intermediate–high, 2% high risk; control: 25% intermediate–risk, 8% high risk |
Ara-C, cytarabine arabinoside; BEAC, carmustine, etoposide, cytarabine, cyclophosphamide; CHOP, cyclophosphamide, doxorubicin, vincristine, prednisone; CR, complete response; Cy/TBI, cyclophosphamide/total body irradiation; DEXA-BEAM, dexamethasone, carmustine, etoposide, cytarabine, melphalan; EAR, etoposide, cytarabine, rituximab; EFS, event-free survival; HyperCVAD, cyclophosphamide, vincristine, adriamycin, dexamethasone; IPI, international prognostic index; MTX, methotrexate; NA, not applicable; NS, nonsignificant; PFS, progression-free survival; PR, partial response.