Table 2.
Randomized Phase III trials comparing maintenance rituximab versus observation after induction therapy in follicular lymphoma
| Study | Disease setting | n | Induction regimen | MR schedule | MR duration | EFS/PFS MR versus OB | OS MR versus OB |
|---|---|---|---|---|---|---|---|
| Ghielmini et al54 | Untreated/relapsed FL | 202 | R wk ×4 | Once every 2 m | 8 m | 9.5-y EFS | 9.5-y |
| Martinelli et al15 | 24 versus 13 ma | 68% versus 54% | |||||
| Hochster et al55 | Untreated FL | 282 | CVP ×6–8 | Once wk ×4every 6 m | 2 y | 3-y PFS 64% versus 33%a |
3-y 91% versus 86% |
| Salles et al56,57 | Untreated FL | 1,217 | R-CVP ×8 R-CHOP ×6 R-FCM ×6 |
Once every 2 m | 2 y | 6-y PFS 59% versus 43%a |
6-y 89% versus 87% |
| Vitolo et al58 | Untreated FL | 234 | R-FND ×4 followed by R wk ×4 |
Once every 2 m | 8 m | 2-y PFS 81% versus 69% |
3-y whole series 89% |
| Forstpointner et al59,62 | Relapsed FL/MCL | 319b | R-FCM ×4 FCM ×4 |
Once wk ×4 at 3 and 9 m | 9 m | 2-y PFSc nr versus 26 ma |
3-y 77% versus 57% |
| van Oers et al60,61 | Relapsed FL | 466 | R-CHOP ×6 CHOP ×6 |
Once every 3 m | 2 y | 3.7 y versus 1.3 ya | 5-y 74% versus 64% |
Notes:
a
Indicates statistically significant differences;
b
113 FL randomized to MR versus OB;
c
data for FL patients only.
Abbreviations: CHOP, cyclophosphamide, doxorubicin, vincristine, and prednisone; CVP, cyclophosphamide, vincristine, and prednisone; EFS, event-free survival; FCM, fludarabine, cyclophosphamide, and mitoxantrone; FL, follicular lymphoma; FND, fludarabine, mitoxantrone, and dexamethasone; m, months; MCL, mantle cell lymphoma; MR, maintenance rituximab; n, number of patients; nr, not reached; OB, observation; OS, overall survival; PFS, progression-free survival; R, rituximab; wk, weekly; y, years.