Table 2 Demographics and baseline disease characteristics for patients with or without a detectable clonal marker, and all baseline-evaluable patients
No marker detected | Marker detected, with/without RQ-PCR assay | Total | |
---|---|---|---|
(n = 91) | (n = 228) | (n = 319) | |
Median age, years (range) | 63 (34–87) | 63 (34–87) | 63 (34–87) |
Male, n (%) | 49 (53.8) | 129 (57) | 178 (55.8) |
ECOG PS, n (%) | (n = 91) | (n = 227) | (n = 318) |
0–1 | 89 (97.8) | 214 (94) | 303 (95.3) |
2 | 2 (2.2) | 13 (6) | 15 (4.7) |
Ann Arbor stage,a n (%) | |||
I | 11 (12.9) | 7 (3) | 18 (6.0) |
II | 13 (15.3) | 22 (10) | 35 (11.6) |
III | 30 (35.3) | 45 (21) | 75 (24.8) |
IV | 31 (36.5) | 143 (66) | 174 (57.6) |
Unknown | 6 | 11 | 17 |
FLIPI, 1 adverse factors risk category,a n (%) | (n = 91) | (n = 227) | (n = 318) |
Low (0–1) | 35 (40.7) | 41 (19) | 76 (24.9) |
Intermediate (2) | 26 (30.2) | 78 (36) | 104 (34.1) |
High (≥3) | 25 (29.1) | 100 (46) | 125 (41.0) |
Unknown | 5 | 8 | 13 |
Bone marrow involvement,a n (%) | (n = 87) | (n = 218) | (n = 305) |
Positive | 9 (10.3) | 83 (38) | 92 (30.2) |
Negative | 74 (85.1) | 127 (58) | 201 (65.9) |
Insufficient sample | 3 (3.4) | 5 (2) | 8 (2.6) |
Other | 1 (1.1) | 3 (1) | 4 (1.3) |
Extranodal involvement,a n (%) | |||
Yes | 37 (46.3) | 120 (55) | 157 (52.9) |
No | 43 (53.8) | 97 (45) | 140 (47.1) |
Unknown | 11 | 11 | 22 |
Time from initial diagnosis to randomization (months)a | |||
Mean (SD) | 50.6 (41.3) | 51.9 (53.9) | 51.5 (50.6) |
Median (range) | 39.8 (3.8–215.6) | 34.6 (3.1–384.8) | 36.2 (3.1–384.8) |
Time from last regimen to randomization (months)a | |||
Mean (SD) | 5.8 (6.03) | 8.0 (13.3) | 7.4 (11.7) |
Median (range) | 3.7 (0.7–37.5) | 3.9 (0.7–128.4) | 3.8 (0.7–128.4) |