Baseline characteristics efficacy group (47 patients)
| . | ALN (n = 23), n (%) . | Placebo (n = 24), n (%) . | P . |
|---|---|---|---|
| Age, mean (SD) | 66 (7.8) | 64 (10.3) | .617 |
| Sex | 1.000 | ||
| Male | 17 (73.9) | 18 (75.0) | |
| Female | 6 (26.1) | 6 (25.0) | |
| Postmenopausal | 6 (100.0) | 6 (100.0) | 1.000 |
| Performance status | .188 | ||
| 0 | 19 (82.6) | 23 (95.8) | |
| >0 | 4 (17.4) | 1 (4.2) | |
| BMI, mean (range) | 28 (19-38) | 27 (22-37) | .441 |
| Subtype | .311 | ||
| DLBCL | 13 (56.5) | 13 (54.2) | |
| FL | 5 (21.7) | 9 (37.5) | |
| Other (marginal zone lymphoma, Hodgkin lymphoma, T-cell lymphoma) | 5 (21.7) | 2 (8.3) | |
| Bone marrow involvement | 7 (30.4) | 5 (20.8) | .517 |
| Ann Arbor stage | .041 | ||
| 1 to 2 | 7 (30.4) | 15 (62.5) | |
| 3 to 4 | 16 (69.6) | 9 (37.5) | |
| LDH | .147 | ||
| Normal | 15 (65.2) | 10 (41.7) | |
| Elevated | 8 (34.8) | 14 (58.3) | |
| Treatment line | 1.000 | ||
| First-line | 21 (91.3) | 22 (91.7) | |
| Second- or later-lines | 2 (8.7) | 2 (8.3) | |
| Chemotherapy | 1.000 | ||
| R-CHOP | 11 (47.8) | 10 (41.7) | |
| R-CVP | 9 (39.1) | 10 (41.7) | |
| Other | 3 (13.1) | 4 (16.6) | |
| CNS prophylaxis with high-dose MTX | .287 | ||
| No | 17 (73.9) | 21 (87.5) | |
| Yes | 6 (26.1) | 3 (12.5) | |
| Total prednisolone doses, mean (range) | 3291 (2400-4400) | 3398 (2000-4000) | .400 |
| T-score (lumbar spine) | |||
| Available | 22 (95.7) | 24 (100.0) | .489 |
| Lumbar spine, median (range) | −0.8 (−3.1 to 3.8) | 1.0 (−3.2 to 2.7) | .097 |
| T-score (hip/femoral neck) | |||
| Available | 23 (100.0) | 23 (95.8) | 1.000 |
| Total hip, median (range) | −0.2 (−2.5 to 1.5) | 0.1 (−2.3 to 1.6) | .322 |
| Femoral neck, median (range) | −0.9 (−3.0 to 1.5) | −0.4 (−3.1 to 1.0) | .475 |
| Completion status | 1.000 | ||
| Completed | 22 (95.7) | 23 (95.8) | |
| Dead | 0 (0.0) | 0 (0.0) | |
| Withdrawal | 0 (0.0) | 0 (0.0) | |
| Drop-out | 1 (4.3) | 1 (4.2) | |
| . | ALN (n = 23), n (%) . | Placebo (n = 24), n (%) . | P . |
|---|---|---|---|
| Age, mean (SD) | 66 (7.8) | 64 (10.3) | .617 |
| Sex | 1.000 | ||
| Male | 17 (73.9) | 18 (75.0) | |
| Female | 6 (26.1) | 6 (25.0) | |
| Postmenopausal | 6 (100.0) | 6 (100.0) | 1.000 |
| Performance status | .188 | ||
| 0 | 19 (82.6) | 23 (95.8) | |
| >0 | 4 (17.4) | 1 (4.2) | |
| BMI, mean (range) | 28 (19-38) | 27 (22-37) | .441 |
| Subtype | .311 | ||
| DLBCL | 13 (56.5) | 13 (54.2) | |
| FL | 5 (21.7) | 9 (37.5) | |
| Other (marginal zone lymphoma, Hodgkin lymphoma, T-cell lymphoma) | 5 (21.7) | 2 (8.3) | |
| Bone marrow involvement | 7 (30.4) | 5 (20.8) | .517 |
| Ann Arbor stage | .041 | ||
| 1 to 2 | 7 (30.4) | 15 (62.5) | |
| 3 to 4 | 16 (69.6) | 9 (37.5) | |
| LDH | .147 | ||
| Normal | 15 (65.2) | 10 (41.7) | |
| Elevated | 8 (34.8) | 14 (58.3) | |
| Treatment line | 1.000 | ||
| First-line | 21 (91.3) | 22 (91.7) | |
| Second- or later-lines | 2 (8.7) | 2 (8.3) | |
| Chemotherapy | 1.000 | ||
| R-CHOP | 11 (47.8) | 10 (41.7) | |
| R-CVP | 9 (39.1) | 10 (41.7) | |
| Other | 3 (13.1) | 4 (16.6) | |
| CNS prophylaxis with high-dose MTX | .287 | ||
| No | 17 (73.9) | 21 (87.5) | |
| Yes | 6 (26.1) | 3 (12.5) | |
| Total prednisolone doses, mean (range) | 3291 (2400-4400) | 3398 (2000-4000) | .400 |
| T-score (lumbar spine) | |||
| Available | 22 (95.7) | 24 (100.0) | .489 |
| Lumbar spine, median (range) | −0.8 (−3.1 to 3.8) | 1.0 (−3.2 to 2.7) | .097 |
| T-score (hip/femoral neck) | |||
| Available | 23 (100.0) | 23 (95.8) | 1.000 |
| Total hip, median (range) | −0.2 (−2.5 to 1.5) | 0.1 (−2.3 to 1.6) | .322 |
| Femoral neck, median (range) | −0.9 (−3.0 to 1.5) | −0.4 (−3.1 to 1.0) | .475 |
| Completion status | 1.000 | ||
| Completed | 22 (95.7) | 23 (95.8) | |
| Dead | 0 (0.0) | 0 (0.0) | |
| Withdrawal | 0 (0.0) | 0 (0.0) | |
| Drop-out | 1 (4.3) | 1 (4.2) | |
See Table 1 for definitions.