Baseline characteristics of 59 adult lymphoma patients enrolled in the Siesta trial
| . | ALN (n =30), n (%) . | Placebo (n = 29), n (%) . | P . |
|---|---|---|---|
| Age, mean (SD) | 66 (9.2) | 65 (11.2) | 1.000 |
| Sex | 1.000 | ||
| Male | 22 (73.3) | 22 (75.9) | |
| Female | 8 (26.7) | 7 (24.1) | |
| Postmenopausal | 8 (100.0) | 7 (100.0) | 1.000 |
| Performance status | .212 | ||
| 0 | 21 (70.0) | 24 (85.7) | |
| >0 | 9 (30.0) | 4 (14.3) | |
| BMI, mean (range) | 29 (19-43) | 27 (22-37) | .088 |
| Subtype | .301 | ||
| DLBCL | 18 (60.0) | 18 (62.1) | |
| FL | 6 (20.0) | 9 (31.0) | |
| Other (marginal zone lymphoma, Hodgkin lymphoma, T-cell lymphoma, unspecified low grade lymphoma) | 6 (20.0) | 2 (6.9) | |
| Bone marrow involvement | 9 (30.0) | 5 (17.2) | .360 |
| Ann Arbor stage | .037 | ||
| 1 to 2 | 9 (30.0) | 17 (58.6) | |
| 3 to 4 | 21 (70.0) | 12 (41.4) | |
| LDH | .438 | ||
| Normal | 18 (60.0) | 14 (48.3) | |
| Elevated | 12 (40.0) | 15 (51.7) | |
| Treatment line | 1.000 | ||
| First-line | 28 (93.3) | 27 (93.1) | |
| Second- or later-lines | 2 (6.7) | 2 (6.9) | |
| Chemotherapy | 1.000 | ||
| R-CHOP | 15 (50.0) | 14 (48.3) | |
| R-CVP | 10 (33.3) | 10 (34.5) | |
| Other | 5 (16.6) | 5 (17.2) | |
| CNS prophylaxis with high doses MTX | .472 | ||
| No | 24 (80.0) | 26 (89.7) | |
| Yes | 6 (20.0) | 3 (10.3) | |
| Total prednisolone doses, mean (range) | 3291 (2400-4400) | 3398 (2000-4000) | .400 |
| T-score (lumbar spine) | |||
| Available | 25 (83.3) | 27 (93.1) | .424 |
| Lumbar spine, median (range) | −0.6 (−3.1 to 3.8) | 1.0 (−3.2 to 2.7) | .073 |
| T-score (hip/femoral neck) | |||
| Available | 26 (86.7) | 25 (86.2) | 1.000 |
| Total hip, median (range) | −0.2(−2.5 to 1.5) | 0.0 (−3.5 to 1.6) | .784 |
| Femoral neck, median (range) | −0.8(−3.0 to 1.5) | −0.6(−3.2 to 1.0) | .734 |
| Completion status | .289 | ||
| Completed | 22 (73.3) | 23 (79.3) | |
| Dead | 0 (0.0) | 1 (3.4) | |
| Withdrawal | 5 (16.7) | 1 (3.4) | |
| Drop-out | 3 (10.0) | 4 (13.8) | |
| . | ALN (n =30), n (%) . | Placebo (n = 29), n (%) . | P . |
|---|---|---|---|
| Age, mean (SD) | 66 (9.2) | 65 (11.2) | 1.000 |
| Sex | 1.000 | ||
| Male | 22 (73.3) | 22 (75.9) | |
| Female | 8 (26.7) | 7 (24.1) | |
| Postmenopausal | 8 (100.0) | 7 (100.0) | 1.000 |
| Performance status | .212 | ||
| 0 | 21 (70.0) | 24 (85.7) | |
| >0 | 9 (30.0) | 4 (14.3) | |
| BMI, mean (range) | 29 (19-43) | 27 (22-37) | .088 |
| Subtype | .301 | ||
| DLBCL | 18 (60.0) | 18 (62.1) | |
| FL | 6 (20.0) | 9 (31.0) | |
| Other (marginal zone lymphoma, Hodgkin lymphoma, T-cell lymphoma, unspecified low grade lymphoma) | 6 (20.0) | 2 (6.9) | |
| Bone marrow involvement | 9 (30.0) | 5 (17.2) | .360 |
| Ann Arbor stage | .037 | ||
| 1 to 2 | 9 (30.0) | 17 (58.6) | |
| 3 to 4 | 21 (70.0) | 12 (41.4) | |
| LDH | .438 | ||
| Normal | 18 (60.0) | 14 (48.3) | |
| Elevated | 12 (40.0) | 15 (51.7) | |
| Treatment line | 1.000 | ||
| First-line | 28 (93.3) | 27 (93.1) | |
| Second- or later-lines | 2 (6.7) | 2 (6.9) | |
| Chemotherapy | 1.000 | ||
| R-CHOP | 15 (50.0) | 14 (48.3) | |
| R-CVP | 10 (33.3) | 10 (34.5) | |
| Other | 5 (16.6) | 5 (17.2) | |
| CNS prophylaxis with high doses MTX | .472 | ||
| No | 24 (80.0) | 26 (89.7) | |
| Yes | 6 (20.0) | 3 (10.3) | |
| Total prednisolone doses, mean (range) | 3291 (2400-4400) | 3398 (2000-4000) | .400 |
| T-score (lumbar spine) | |||
| Available | 25 (83.3) | 27 (93.1) | .424 |
| Lumbar spine, median (range) | −0.6 (−3.1 to 3.8) | 1.0 (−3.2 to 2.7) | .073 |
| T-score (hip/femoral neck) | |||
| Available | 26 (86.7) | 25 (86.2) | 1.000 |
| Total hip, median (range) | −0.2(−2.5 to 1.5) | 0.0 (−3.5 to 1.6) | .784 |
| Femoral neck, median (range) | −0.8(−3.0 to 1.5) | −0.6(−3.2 to 1.0) | .734 |
| Completion status | .289 | ||
| Completed | 22 (73.3) | 23 (79.3) | |
| Dead | 0 (0.0) | 1 (3.4) | |
| Withdrawal | 5 (16.7) | 1 (3.4) | |
| Drop-out | 3 (10.0) | 4 (13.8) | |
Performance status, CNS, central nervous system; Eastern Cooperative Oncology Group performance status (ECOG); LDH, lactate dehydrogenase; MTX, high-dose Methotrexate.