Table 1.
Response to Lenalidomide in relapsed/refractory diffuse large B-cell lymphomas.
| Lenalidomide | Monotherapy | Association | ||
|---|---|---|---|---|
| Name of the protocol | NHL002 [52] | NHL003 [53] | Lenalidomide and rituximab [54] | |
| Year of publication | 2008 | 2011 | 2011 | |
| Type of study | Multicentric | International | Multicentric | |
| Phase | Phase II | Phase II | Phase II | |
| Treatment | Lenalidomide | Lenalidomide | Lenalidomide and rituximab | |
| Dose of lenalidomide: | 25 mg/d, D1–21 | 25 mg/d, D1–21 | 20 mg/d, D1–21 | |
| every 28 days | every 28 days | every 28 days | ||
| Duration or treatment or No. of cycles |
52 weeks | — | 4 cycles + maintenance (n = 10 pts) |
|
| No. of patients | 49 | 267 | 23 | |
| No. of DLBCL | 26 | 108 | 23 | |
| Response* | Induction | Complete therapy | ||
| ORR n, (%) | 5 (19) | 30 (28) | 8 (35) | 8 (35) |
| CR n, (%) | 1 (3) | 8 (7) | 7 (31) | 8 (35) |
| CRU n, (%) | 2 (8) | — | — | |
| PR n, (%) | 2 (8) | 22 (20) | 1 (4) | 0 (0) |
| Stable disease n, (%) | 7 (27) | 23 (21) | 2 (8) | 2 (8) |
| Progression n, (%) | 14 (54) | 40 (37) | 13 (57) | |
| Followup | 9.2 | 16 | ||
| Median time to response (month) | PR: 1.9 (1.2–3.7) CR: 4.3 (1.9–10.5) |
1.9 (1.4–11.5) | — | |
| Median response duration (month) | 6.2 (0–12.8) | 1.6 | — | |
| PFS, Median (month) | 4 | 2.7 | 1-year DFS 34.8% | |
ORR: overall response rate, CR: complete response, CRU: complete response unconfirmed, PR: partial response, PFS: progression free survival.
NHL002: the results of response are specifically reported for DLBCL.
NHL003: the results of response are specifically reported for DLBCL.