Selected studies evaluating first-line treatments in MZLs
| Study . | Phase . | MZL subtype . | N pts . | Regimen . | ORR, % (CR) . | 5-y PFS, % . | Notes . |
|---|---|---|---|---|---|---|---|
| IESLG1956 | 3 | EMZL | 401 (171 gastric) | Chlorambucil alone R-chlorambucil R alone | 85.5 (73.4) 94.7 (78.8) 78.3 (55.8) | 59 72 57 | All regimens well tolerated. |
| MALT2008-0177 | 2 | EMZL | 57 (19 gastric) | R-bendamustine (4 to 6 cycles)a | 100 (98) | 92.8 (7-y) | |
| Alderuccio et al78 | Retrospective | EMZL | 237 (41 gastric) | R-bendamustine (+ R-maintenance in 48) | 93.2 (81) | 80.5 (94.4 vs 81.1) | OS not impacted by R maintenance. |
| IELSG3858 | 2 | EMZL | 112 (36 gastric) | R-chlorambucil +2 years of R-maintenance (sc) | (65) | 87 | No new safety signals. 5-y PFS compare favorably with IELSG19. |
| Kalpadakis et al61 | Retrospective | SMZL | 108 | R × 6 weekly doses (+ R-maintenance in 48) | 92 (65) | 71 (79 vs 52b ) | |
| IELSG36 (BRISMA)62 | 2 | SMZL | 56 | R-bendamustine (4 to 6 cycles)a | 91 (73) | 90 (3-y) | Grade ≥3 AEs 68%; grade ≥3 infections 5.4%. |
| STiL NHL7-08 (MAINTAIN)79 | 3 | SMZL, NMZL | 119 | R-bendamustine (6 cycles +2 R) +2 y of R-maintenance vs WW | 91 (19) | NR vs 92.2 mo (median) | OS not impacted by R-maintenance. |
| GALLIUM59 | 3 | EMZL, SMZL, NMZL | 195 (61 EMZL, 68 SMZL, 66 NMZL) | O-chemo + O-maintenance vs R-chemo + R-maintenance (chemo: B, CHOP, COP) | 81.8 (17.7) vs 81.3 (17.2) | 72.6 vs 64.1 (4-y)c |
| Study . | Phase . | MZL subtype . | N pts . | Regimen . | ORR, % (CR) . | 5-y PFS, % . | Notes . |
|---|---|---|---|---|---|---|---|
| IESLG1956 | 3 | EMZL | 401 (171 gastric) | Chlorambucil alone R-chlorambucil R alone | 85.5 (73.4) 94.7 (78.8) 78.3 (55.8) | 59 72 57 | All regimens well tolerated. |
| MALT2008-0177 | 2 | EMZL | 57 (19 gastric) | R-bendamustine (4 to 6 cycles)a | 100 (98) | 92.8 (7-y) | |
| Alderuccio et al78 | Retrospective | EMZL | 237 (41 gastric) | R-bendamustine (+ R-maintenance in 48) | 93.2 (81) | 80.5 (94.4 vs 81.1) | OS not impacted by R maintenance. |
| IELSG3858 | 2 | EMZL | 112 (36 gastric) | R-chlorambucil +2 years of R-maintenance (sc) | (65) | 87 | No new safety signals. 5-y PFS compare favorably with IELSG19. |
| Kalpadakis et al61 | Retrospective | SMZL | 108 | R × 6 weekly doses (+ R-maintenance in 48) | 92 (65) | 71 (79 vs 52b ) | |
| IELSG36 (BRISMA)62 | 2 | SMZL | 56 | R-bendamustine (4 to 6 cycles)a | 91 (73) | 90 (3-y) | Grade ≥3 AEs 68%; grade ≥3 infections 5.4%. |
| STiL NHL7-08 (MAINTAIN)79 | 3 | SMZL, NMZL | 119 | R-bendamustine (6 cycles +2 R) +2 y of R-maintenance vs WW | 91 (19) | NR vs 92.2 mo (median) | OS not impacted by R-maintenance. |
| GALLIUM59 | 3 | EMZL, SMZL, NMZL | 195 (61 EMZL, 68 SMZL, 66 NMZL) | O-chemo + O-maintenance vs R-chemo + R-maintenance (chemo: B, CHOP, COP) | 81.8 (17.7) vs 81.3 (17.2) | 72.6 vs 64.1 (4-y)c |
4 cycles if CR after 3 cycles, 6 cycles if PR.
FFP not different if R-maintenance 1 and 2y.
Not significantly different (not powered to detect PFS difference in MZL). Grade ≥3 toxicity higher in O arm.
B, bendamustine; chemo, chemotherapy; CHOP, rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone; COP, rituximab, cyclophosphamide, vincristine, prednisone; FFP, freedom from progression; NR, not reached; O, obinutuzumab; R, rituximab; sc, subcute; WW, watch and wait.