Contemporary MCL first-line treatment
| Regimen . | Trial name or sponsor . | Phase . | N . | Median age, y (range) . | ORR (%) . | CR (%) . | EFS/PFS/TTF . | OS . | Predictive biomarkers . | MRD negativity . | References . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Intensive chemotherapy | |||||||||||
| R-hyperCVAD/R-MA | MD Anderson Cancer Center | 2 | 97 | 61 (41-80) | 97 | 87 | Median EFS, 4.8 y | Median OS, 10.7 y | MIPI | N/R | 17 |
| Maxi-CHOP/HDAC/rituximab → ASCT | Nordic MCL2 | 2 | 160 | 56 (32-65) | 96 | 54 | Median PFS, 8.5 y | Median OS, 12.7 y | MIPI, MIPI-B, MIPI-B-miR, MRD TP53 mutation | ASCT: 49% | 20 |
| R-CHOP/R-DHAP → ASCT | Groupe d’Etude des Lymphomes de l’Adulte (GELA) | 2 | 60 | 57.5 (40-66) | 95 | 57 | Median EFS, 83 mo | 5-y OS rate, 75% | N/R | N/R | 18 |
| R-CHOP/R-DHAP → ASCT | MCL Younger | 3 | 232 | 56 (50-60) | EOI, 94; ASCT, 98 | EOI, 55; ASCT, 83 | Median TTF, 9.1 y | Median OS, 9.8 y | MIPI, Ki-67, MRD CDKN2A/TP53 deletions | EOI: PB, 79%; BM, 61%; ASCT: PB, 85%; BM, 79% | 6, 19 |
| R-DHAP/R-CHOP → ASCT → rituximab maintenance | LYSA | 3 | 120 | 57 (27-65) | EOI, 99; ASCT, 100 | EOI, 85; ASCT, 94 | 4-y PFS rate, 83% | 4-y OS rate, 89% | MIPI | N/R | 21 |
| Outpatient chemotherapy | |||||||||||
| Rituximab-bendamustine | StiL | 3 | 46 | 64 (34-83) | 93 | 40 | Median PFS, 35 mo | N/R | N/R | N/R | 24 |
| Rituximab-bendamustine | BRIGHT | 3 | 36 | 60 (28-84) | 94 | 50 | 5-y PFS rate, 40% | 5-y OS rate, 59% | N/R | N/R | 25 |
| R-CHOP/rituximab maintenance | MCL Elderly | 3 | 267 | 70 (60-87) | 86 | 34 | 4-y PFS rate, 57% | 4-y OS rate, 87% | MIPI, MRD | PB, 48% | 23 |
| VR-CAP | 3 | 243 | 65 (26-88) | 92 | 53 | Median PFS, 25 mo | 4-y OS rate, 64% | MIPI-B, Ki-67 | N/R | 22 | |
| R-BAC | Fondazione Italiana Linformi | 2 | 57 | 71 (67-75) | 91 | 91 | 3-y PFS rate, 76% | N/R | MIPI, Ki-67, blastoid | PB, 78%; BM, 54% | 26 |
| RiBVD | LYSA | 2 | 74 | 73 (64-83) | 84 | 75.5 | 4-y PFS rate, 58% | 4-y OS rate, 71% | MRD | PB, 87% | 27 |
| Lenalidomide-bendamustine-rituximab | NLG/MCL4 | 1/2 | 51 | 71 (62-84) | 80 | 64 | Median PFS, 42 mo | 3-y OS rate, 73% | N/R | PB, 68%; BM, 56% | 28 |
| Novel agents | |||||||||||
| Rituximab-lenalidomide | 2 | 38 | 65 (42-86) | 92 | 64 | 5-y PFS rate, 64% | 5-y OS rate, 77% | MIPI correlates with OS | PB, 80% | 46,47 |
| Regimen . | Trial name or sponsor . | Phase . | N . | Median age, y (range) . | ORR (%) . | CR (%) . | EFS/PFS/TTF . | OS . | Predictive biomarkers . | MRD negativity . | References . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Intensive chemotherapy | |||||||||||
| R-hyperCVAD/R-MA | MD Anderson Cancer Center | 2 | 97 | 61 (41-80) | 97 | 87 | Median EFS, 4.8 y | Median OS, 10.7 y | MIPI | N/R | 17 |
| Maxi-CHOP/HDAC/rituximab → ASCT | Nordic MCL2 | 2 | 160 | 56 (32-65) | 96 | 54 | Median PFS, 8.5 y | Median OS, 12.7 y | MIPI, MIPI-B, MIPI-B-miR, MRD TP53 mutation | ASCT: 49% | 20 |
| R-CHOP/R-DHAP → ASCT | Groupe d’Etude des Lymphomes de l’Adulte (GELA) | 2 | 60 | 57.5 (40-66) | 95 | 57 | Median EFS, 83 mo | 5-y OS rate, 75% | N/R | N/R | 18 |
| R-CHOP/R-DHAP → ASCT | MCL Younger | 3 | 232 | 56 (50-60) | EOI, 94; ASCT, 98 | EOI, 55; ASCT, 83 | Median TTF, 9.1 y | Median OS, 9.8 y | MIPI, Ki-67, MRD CDKN2A/TP53 deletions | EOI: PB, 79%; BM, 61%; ASCT: PB, 85%; BM, 79% | 6, 19 |
| R-DHAP/R-CHOP → ASCT → rituximab maintenance | LYSA | 3 | 120 | 57 (27-65) | EOI, 99; ASCT, 100 | EOI, 85; ASCT, 94 | 4-y PFS rate, 83% | 4-y OS rate, 89% | MIPI | N/R | 21 |
| Outpatient chemotherapy | |||||||||||
| Rituximab-bendamustine | StiL | 3 | 46 | 64 (34-83) | 93 | 40 | Median PFS, 35 mo | N/R | N/R | N/R | 24 |
| Rituximab-bendamustine | BRIGHT | 3 | 36 | 60 (28-84) | 94 | 50 | 5-y PFS rate, 40% | 5-y OS rate, 59% | N/R | N/R | 25 |
| R-CHOP/rituximab maintenance | MCL Elderly | 3 | 267 | 70 (60-87) | 86 | 34 | 4-y PFS rate, 57% | 4-y OS rate, 87% | MIPI, MRD | PB, 48% | 23 |
| VR-CAP | 3 | 243 | 65 (26-88) | 92 | 53 | Median PFS, 25 mo | 4-y OS rate, 64% | MIPI-B, Ki-67 | N/R | 22 | |
| R-BAC | Fondazione Italiana Linformi | 2 | 57 | 71 (67-75) | 91 | 91 | 3-y PFS rate, 76% | N/R | MIPI, Ki-67, blastoid | PB, 78%; BM, 54% | 26 |
| RiBVD | LYSA | 2 | 74 | 73 (64-83) | 84 | 75.5 | 4-y PFS rate, 58% | 4-y OS rate, 71% | MRD | PB, 87% | 27 |
| Lenalidomide-bendamustine-rituximab | NLG/MCL4 | 1/2 | 51 | 71 (62-84) | 80 | 64 | Median PFS, 42 mo | 3-y OS rate, 73% | N/R | PB, 68%; BM, 56% | 28 |
| Novel agents | |||||||||||
| Rituximab-lenalidomide | 2 | 38 | 65 (42-86) | 92 | 64 | 5-y PFS rate, 64% | 5-y OS rate, 77% | MIPI correlates with OS | PB, 80% | 46,47 |
EOI, end of induction; HDAC, high-dose cytarabine; miR, microRNA; N/R, not reported; RiBVD, rituximab plus bendamustine, bortezomib, and dexamethasone; R-MA, rituximab, methotrexate, and cytarabine; TTF, time-to-treatment failure.