Multivariate models in trials 2003-33 and 2006-66 linked to OS, EFS, CR rate, and CRD
| Variable . | 2003-33 . | 2006-66 . | ||||
|---|---|---|---|---|---|---|
| n/N (%) . | HR (95% CI) . | P . | n/N (%) . | HR (95% CI) . | P . | |
| OS | ||||||
| GEP high-risk | 40/275 (15) | 2.43 (1.40-4.19) | .001 | 36/159 (23) | 3.00 (1.23-7.31) | .016* |
| Cytogenetic abnormalities | 95/275 (35) | 1.99 (1.19-3.34) | .009 | 66/159 (42) | 1.72 (0.73-4.02) | .213 |
| LDH > 190 U/L | 74/275 (27) | 1.78 (1.07-2.95) | .025 | 40/159 (25) | 1.25 (0.55-2.84) | .590 |
| B2M > 5.5 mg/L | 59/275 (21) | 2.24 (1.35-3.74) | .002 | 48/159 (30) | 1.28 (0.56-2.92) | .553 |
| EFS | ||||||
| GEP high-risk | 40/275 (15) | 2.57 (1.54-4.31) | < .001 | 36/159 (23) | 2.77 (1.18-6.45) | .019* |
| Cytogenetic abnormalities | 95/275 (35) | 1.80 (1.12-2.90) | .016 | 66/159 (42) | 1.17 (0.53-2.56) | .696 |
| LDH > 190 U/L | 74/275 (27) | 2.34 (1.46-3.74) | < .001 | 40/159 (25) | 1.54 (0.72-3.26) | .264 |
| Creatinine > 2 mg/dL | 21/275 (8) | 3.30 (1.86-5.85) | < .001 | 11/159 (7) | 0.61 (0.16-2.32) | .469 |
| Albumin < 3.5 g/dL | 76/275 (28) | 2.00 (1.25-3.22) | .004 | 71/159 (45) | 1.62 (0.74-3.55) | .226 |
| CR rate | ||||||
| GEP CD-1 subgroup | 15/275 (5) | 8.43 (1.08-65.84) | .042 | 18/165 (11) | 12.56 (1.62-97.30) | .015* |
| Creatinine > 2 mg/dL | 21/275 (8) | 0.28 (0.11-0.74) | .010 | 11/165 (7) | 1.76 (0.44-7.12) | .427 |
| Albumin < 3.5 g/dL | 76/275 (28) | 0.47 (0.27-0.82) | .008 | 74/165 (45) | 0.59 (0.31-1.13) | .110 |
| CRD | ||||||
| GEP high-risk | 23/172 (13) | 7.58 (3.28-17.50) | < .001 | 21/100 (21) | 5.87 (1.80-19.07) | .003* |
| GEP CD-1 subgroup | 14/172 (8) | 2.93 (0.81-10.56) | .100 | 17/100 (17) | 2.96 (0.92-9.59) | .070 |
| Creatinine > 2 mg/dL | 7/172 (4) | 4.23 (1.50-11.93) | .006 | 8/100 (8) | 0.61 (0.07-5.13) | .648 |
| Variable . | 2003-33 . | 2006-66 . | ||||
|---|---|---|---|---|---|---|
| n/N (%) . | HR (95% CI) . | P . | n/N (%) . | HR (95% CI) . | P . | |
| OS | ||||||
| GEP high-risk | 40/275 (15) | 2.43 (1.40-4.19) | .001 | 36/159 (23) | 3.00 (1.23-7.31) | .016* |
| Cytogenetic abnormalities | 95/275 (35) | 1.99 (1.19-3.34) | .009 | 66/159 (42) | 1.72 (0.73-4.02) | .213 |
| LDH > 190 U/L | 74/275 (27) | 1.78 (1.07-2.95) | .025 | 40/159 (25) | 1.25 (0.55-2.84) | .590 |
| B2M > 5.5 mg/L | 59/275 (21) | 2.24 (1.35-3.74) | .002 | 48/159 (30) | 1.28 (0.56-2.92) | .553 |
| EFS | ||||||
| GEP high-risk | 40/275 (15) | 2.57 (1.54-4.31) | < .001 | 36/159 (23) | 2.77 (1.18-6.45) | .019* |
| Cytogenetic abnormalities | 95/275 (35) | 1.80 (1.12-2.90) | .016 | 66/159 (42) | 1.17 (0.53-2.56) | .696 |
| LDH > 190 U/L | 74/275 (27) | 2.34 (1.46-3.74) | < .001 | 40/159 (25) | 1.54 (0.72-3.26) | .264 |
| Creatinine > 2 mg/dL | 21/275 (8) | 3.30 (1.86-5.85) | < .001 | 11/159 (7) | 0.61 (0.16-2.32) | .469 |
| Albumin < 3.5 g/dL | 76/275 (28) | 2.00 (1.25-3.22) | .004 | 71/159 (45) | 1.62 (0.74-3.55) | .226 |
| CR rate | ||||||
| GEP CD-1 subgroup | 15/275 (5) | 8.43 (1.08-65.84) | .042 | 18/165 (11) | 12.56 (1.62-97.30) | .015* |
| Creatinine > 2 mg/dL | 21/275 (8) | 0.28 (0.11-0.74) | .010 | 11/165 (7) | 1.76 (0.44-7.12) | .427 |
| Albumin < 3.5 g/dL | 76/275 (28) | 0.47 (0.27-0.82) | .008 | 74/165 (45) | 0.59 (0.31-1.13) | .110 |
| CRD | ||||||
| GEP high-risk | 23/172 (13) | 7.58 (3.28-17.50) | < .001 | 21/100 (21) | 5.87 (1.80-19.07) | .003* |
| GEP CD-1 subgroup | 14/172 (8) | 2.93 (0.81-10.56) | .100 | 17/100 (17) | 2.96 (0.92-9.59) | .070 |
| Creatinine > 2 mg/dL | 7/172 (4) | 4.23 (1.50-11.93) | .006 | 8/100 (8) | 0.61 (0.07-5.13) | .648 |
Multivariate model uses stepwise selection with entry level 0.1 and variable remains if meets the 0.05 level. A multivariate P value greater than .05 indicates variable forced into model with significant variables chosen using stepwise selection. P value for HR from the Wald χ2 test in Cox regression. Variables considered for the models included: age > 65 years, female, albumin < 3.5 g/dL, B2M > 3.5 mg/L, B2M > 5.5 mg/L, ISS stage 1, ISS stage 3, creatinine > 2 mg/dL, CRP > 8 mg/L, Hb < 10 g/dL, LDH > 190 U/L, cytogenetic abnormalities (any time before enrollment), GEP high-risk, GEP CD-1 subgroup, GEP CD-2 subgroup, GEP hyperdiploidy subgroup, GEP low bone disease subgroup, GEP MAF/MAFB subgroup, GEP MMSET/FGFR3 subgroup, GEP myeloid subgroup, GEP proliferation subgroup, and GEP TP53 deletion.
HR indicates hazard ratio; OS, overall survival; EFS, event-free survival; CI, confidence interval; LDH, lactate dehydrogenase; B2M, β-2-microglobulin; ISS, International Staging System; CR, complete response; CRD, complete response duration; and GEP, gene expression profiling.
Statistically significant at P < .05.