Patient characteristics in 2003-33 and 2006-66 trials
| Factor . | Overall, n/N (%) . | 2003-33, n/N (%) . | 2006-66, n/N (%) . | P . |
|---|---|---|---|---|
| Age > 65 y | 130/480 (27) | 84/303 (28) | 46/177 (26) | .680 |
| Female | 179/480 (37) | 110/303 (36) | 69/177 (39) | .558 |
| White | 432/480 (90) | 268/303 (88) | 164/177 (93) | .138 |
| Albumin < 3.5 g/dL* | 160/479 (33) | 80/303 (26) | 80/176 (45) | < .001 |
| B2M > 3.5 mg/L* | 235/477 (49) | 136/303 (45) | 99/174 (57) | .012 |
| B2M > 5.5 mg/L | 116/477 (24) | 65/303 (21) | 51/174 (29) | .054 |
| ISS stage 1* | 189/477 (40) | 137/303 (45) | 52/174 (30) | < .001 |
| ISS stage 3 | 116/477 (24) | 65/303 (21) | 51/174 (29) | .054 |
| Creatinine > 2 mg/dL | 34/479 (7) | 23/303 (8) | 11/176 (6) | .582 |
| CRP > 8 mg/L | 159/477 (33) | 100/302 (33) | 59/175 (34) | .893 |
| Hb < 10 g/dL | 151/479 (32) | 94/303 (31) | 57/176 (32) | .757 |
| LDH > 190 U/L | 124/479 (26) | 81/303 (27) | 43/176 (24) | .579 |
| Platelet count < 150 × 109/L | 63/479 (13) | 38/303 (13) | 25/176 (14) | .604 |
| Cytogenetic abnormalities (anytime before enrollment) | 170/475 (36) | 100/302 (33) | 70/173 (40) | .108 |
| GEP high-risk* | 77/441 (17) | 40/275 (15) | 37/166 (22) | .038 |
| GEP CD-1 subgroup* | 33/441 (7) | 15/275 (5) | 18/166 (11) | .037 |
| GEP CD-2 subgroup | 52/441 (12) | 27/275 (10) | 25/166 (15) | .098 |
| GEP HY subgroup | 129/441 (29) | 80/275 (29) | 49/166 (30) | .924 |
| GEP LB subgroup | 45/441 (10) | 33/275 (12) | 12/166 (7) | .109 |
| GEP MF subgroup | 31/441 (7) | 22/275 (8) | 9/166 (5) | .305 |
| GEP MS subgroup | 55/441 (12) | 33/275 (12) | 22/166 (13) | .700 |
| GEP MY subgroup* | 43/441 (10) | 38/275 (14) | 5/166 (3) | < .001 |
| GEP PR subgroup | 53/441 (12) | 27/275 (10) | 26/166 (16) | .067 |
| GEP TP53 deletion | 46/441 (10) | 33/275 (12) | 13/166 (8) | .165 |
| Factor . | Overall, n/N (%) . | 2003-33, n/N (%) . | 2006-66, n/N (%) . | P . |
|---|---|---|---|---|
| Age > 65 y | 130/480 (27) | 84/303 (28) | 46/177 (26) | .680 |
| Female | 179/480 (37) | 110/303 (36) | 69/177 (39) | .558 |
| White | 432/480 (90) | 268/303 (88) | 164/177 (93) | .138 |
| Albumin < 3.5 g/dL* | 160/479 (33) | 80/303 (26) | 80/176 (45) | < .001 |
| B2M > 3.5 mg/L* | 235/477 (49) | 136/303 (45) | 99/174 (57) | .012 |
| B2M > 5.5 mg/L | 116/477 (24) | 65/303 (21) | 51/174 (29) | .054 |
| ISS stage 1* | 189/477 (40) | 137/303 (45) | 52/174 (30) | < .001 |
| ISS stage 3 | 116/477 (24) | 65/303 (21) | 51/174 (29) | .054 |
| Creatinine > 2 mg/dL | 34/479 (7) | 23/303 (8) | 11/176 (6) | .582 |
| CRP > 8 mg/L | 159/477 (33) | 100/302 (33) | 59/175 (34) | .893 |
| Hb < 10 g/dL | 151/479 (32) | 94/303 (31) | 57/176 (32) | .757 |
| LDH > 190 U/L | 124/479 (26) | 81/303 (27) | 43/176 (24) | .579 |
| Platelet count < 150 × 109/L | 63/479 (13) | 38/303 (13) | 25/176 (14) | .604 |
| Cytogenetic abnormalities (anytime before enrollment) | 170/475 (36) | 100/302 (33) | 70/173 (40) | .108 |
| GEP high-risk* | 77/441 (17) | 40/275 (15) | 37/166 (22) | .038 |
| GEP CD-1 subgroup* | 33/441 (7) | 15/275 (5) | 18/166 (11) | .037 |
| GEP CD-2 subgroup | 52/441 (12) | 27/275 (10) | 25/166 (15) | .098 |
| GEP HY subgroup | 129/441 (29) | 80/275 (29) | 49/166 (30) | .924 |
| GEP LB subgroup | 45/441 (10) | 33/275 (12) | 12/166 (7) | .109 |
| GEP MF subgroup | 31/441 (7) | 22/275 (8) | 9/166 (5) | .305 |
| GEP MS subgroup | 55/441 (12) | 33/275 (12) | 22/166 (13) | .700 |
| GEP MY subgroup* | 43/441 (10) | 38/275 (14) | 5/166 (3) | < .001 |
| GEP PR subgroup | 53/441 (12) | 27/275 (10) | 26/166 (16) | .067 |
| GEP TP53 deletion | 46/441 (10) | 33/275 (12) | 13/166 (8) | .165 |
Molecular subgroups included CD-1 (CCND1 without CD20), CD-2 (CCND1 with CD20 expression), MS (MMSET/FGFR3), MF (MAF/MAFB), HY (hyperdiploidy), LB (low bone disease), MY (myeloid), and PR (proliferation).
B2M indicates β-2-microglobulin; ISS, International Staging System; CRP, C-reactive protein; Hb, hemoglobin; LDH, lactate dehydrogenase; and GEP, gene expression profiling.
Statistically significant at P < .05.