Table 2.
Phase | Treatment | n | Median age, years (range) | OR, % (CR) | Survival | TRM | Reference |
III randomized | R-Bendamustine vs R-CHOP | 46 vs 48 | 70 (65–74) | 93 (40)* vs 91 (30)* | median PFS: 35.4 months vs 22.1 months | 0.4%* vs 2.0%* | Rummel et al. 201327 |
III randomized | R-Bendamustine vs R-CHOP/R-CVP | 34 vs 33 | 60 (28–84)* vs 58 (25–86)* | 94 (50) vs 85 (27) | NA | 0.5%* vs 0.5%* | Flinn et al. 201428 |
II two-center | R-Bendamustine + HDA + ASCT | 23 | 57 (42–69) | 96 (96) | 1-year PFS: 96%, OS: 96% | 0% | Armand et al. 201630 |
II randomized, closed prematurely | R-HCVAD/MA + ASCT vs R-Bendamustine + ASCT | 17 vs 35 | 59 (44–66) vs 57 (33–64) | 94 (35) vs 83 (40) | 2-year PFS: 82% vs. 81%, OS: 88% vs. 87% | NA | Chen et al. 201729 |
II multicenter | R-Bendamustine + low-dose cytarabine (RBAC500) | 57 | 71 (61–79) | 91 (91) | 2-year PFS: 81%, OS: 86% | 0% | Visco et al. 201731 |
*not restricted to MCL.
ASCT, autologous stem cell transplantation; CHOP, cyclophosphamide, doxorubicin, vincristine, and prednisone; CR, complete response rate; CVP, cyclophosphamide, vincristine, and prednisone; HDA, high-dose cytarabine; HCVAD/MA, hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose cytarabine and methotrexate; MCL, mantle cell lymphoma; n, number of patients; NA, not available; OR, overall response rate; OS, overall survival; PFS, progression-free survival; R, rituximab; TRM, treatment-related mortality.