Results of the univariate and multivariate Cox regression analyses on survival after relapse in patients with pB-ALL and prednisone good-response according to randomization arm (as assigned) and other characteristics
| . | Relapses by assigned randomization arm . | Survival after relapse . | |||||||
|---|---|---|---|---|---|---|---|---|---|
| . | DXM . | PDN . | . | Univariate analysis . | Multivariate analysis . | ||||
| . | N (%) . | N (%) . | P . | Hazard ratio . | 95% CI . | P . | Hazard ratio . | 95% CI . | P . |
| Randomization arm in frontline treatment | |||||||||
| Prednisone | NA | 248 | 1 | 1 | |||||
| Dexamethasone | 173 | NA | 1.54 | 1.14-2.09 | .0053 | 1.13 | 0.80-1.59 | .50 | |
| Risk group in relapse* | |||||||||
| S1/S2 | 117 (67.6) | 184 (74.2) | 1 | 1 | |||||
| S3/S4 | 56 (32.4) | 64 (25.8) | .14 | 3.65 | 2.69-4.96 | <.0001 | 3.49 | 2.46-4.94 | <.0001 |
| ETV6-RUNX1 | |||||||||
| Positive | 19 (12.7) | 51 (21.8) | 0.40 | 0.23-0.70 | .0012 | 0.44 | 0.24-0.81 | .0077 | |
| Negative | 131 (87.3) | 183 (78.2) | .023 | 1 | 1 | ||||
| MRD on day 78 of frontline treatment | |||||||||
| <5 × 10−4 | 136 (86.6) | 213 (91.8) | 1 | 1 | |||||
| ≥5 × 10−4 | 21 (13.4) | 19 (8.2) | .098 | 4.22 | 2.87-6.21 | <.0001 | 3.00 | 1.98-4.54 | <.0001 |
| . | Relapses by assigned randomization arm . | Survival after relapse . | |||||||
|---|---|---|---|---|---|---|---|---|---|
| . | DXM . | PDN . | . | Univariate analysis . | Multivariate analysis . | ||||
| . | N (%) . | N (%) . | P . | Hazard ratio . | 95% CI . | P . | Hazard ratio . | 95% CI . | P . |
| Randomization arm in frontline treatment | |||||||||
| Prednisone | NA | 248 | 1 | 1 | |||||
| Dexamethasone | 173 | NA | 1.54 | 1.14-2.09 | .0053 | 1.13 | 0.80-1.59 | .50 | |
| Risk group in relapse* | |||||||||
| S1/S2 | 117 (67.6) | 184 (74.2) | 1 | 1 | |||||
| S3/S4 | 56 (32.4) | 64 (25.8) | .14 | 3.65 | 2.69-4.96 | <.0001 | 3.49 | 2.46-4.94 | <.0001 |
| ETV6-RUNX1 | |||||||||
| Positive | 19 (12.7) | 51 (21.8) | 0.40 | 0.23-0.70 | .0012 | 0.44 | 0.24-0.81 | .0077 | |
| Negative | 131 (87.3) | 183 (78.2) | .023 | 1 | 1 | ||||
| MRD on day 78 of frontline treatment | |||||||||
| <5 × 10−4 | 136 (86.6) | 213 (91.8) | 1 | 1 | |||||
| ≥5 × 10−4 | 21 (13.4) | 19 (8.2) | .098 | 4.22 | 2.87-6.21 | <.0001 | 3.00 | 1.98-4.54 | <.0001 |
Risk groups in relapsed patients with pB-ALL are defined as follows: S1, late (ie, >6 mo after cessation of frontline treatment) isolated extramedullary relapse; S3, early (ie, >18 mo after initial diagnosis and before 6 mo after cessation of frontline treatment) isolated bone marrow relapse; S4, very early (ie, within 18 mo after initial diagnosis) isolated or combined bone marrow relapse; S2, all others.16
CI, confidence interval; DXM, dexamethasone; MRD, minimal residual disease; NA, not applicable; PDN, prednisone.