Events
| . | Randomization group as assigned . | . | . | |||
|---|---|---|---|---|---|---|
| . | DXM (n = 1853) . | PDN (n = 1867) . | . | . | ||
| . | N . | %† . | N . | %† . | P§ . | HR (95% CI) . |
| Death before CR | 37 | 2.0 | 15 | 0.8 | .0019 | 2.49 (1.36-4.53) |
| Non-response | 3 | 0.2 | 6 | 0.3 | .51 | 0.50 (0.13-2.02) |
| Death in 1st CR | 42 | 2.3 | 32 | 1.7 | .24 | 1.33 (0.84-2.11) |
| Related to induction chemotherapy | 10 | 0.5 | 2 | 0.1 | .022 | 5.09 (1.1-23.3) |
| Related to post-induction chemotherapy | 17 | 0.9 | 15 | 0.8 | .73 | 1.15 (0.57-2.31) |
| Related to alloHSCT* | 12 | 0.6 | 14 | 0.7 | .84 | 0.87 (0.40-1.87) |
| Other | 3 | 0.2 | 1 | 0.1 | .37 | 2.98 (0.31-28.74) |
| All relapses | 229 | 10.8 (0.7) | 323 | 15.6 (0.8) | <.0001 | 0.70 (0.59-0.83) |
| Isolated BM | 158 | 7.6 (0.6) | 204 | 9.7 (0.7) | .013 | 0.77 (0.62-0.95) |
| Isolated CNS | 19 | 0.9 (0.2) | 37 | 1.9 (0.3) | .019 | 0.51 (0.30-0.90) |
| Isolated testes | 9 | 0.4 (0.1) | 23 | 1.1 (0.2) | .016 | 0.39 (0.18-0.84) |
| Combined CNS/BM involved | 15 | 0.7 (0.2) | 30 | 1.5 (0.3) | .027 | 0.50 (0.27-0.92) |
| Combined BM/other (w/o CNS) | 17 | 0.8 (0.2) | 21 | 1.0 (0.2) | .52 | 0.80 (0.42-1.52) |
| Other relapses | 11 | 0.4 (0.1) | 8 | 0.4 (0.1) | .47 | 1.37 (0.55-3.41) |
| Secondary neoplasms | 30 | 1.0 (0.2) | 25 | 0.8 (0.2) | .47 | 1.18 (0.70-2.01) |
| All events | 341 | 16.1 (0.9) | 401 | 19.2 (0.9) | .024 | 0.85 (0.73-0.98) |
| . | Randomization group as assigned . | . | . | |||
|---|---|---|---|---|---|---|
| . | DXM (n = 1853) . | PDN (n = 1867) . | . | . | ||
| . | N . | %† . | N . | %† . | P§ . | HR (95% CI) . |
| Death before CR | 37 | 2.0 | 15 | 0.8 | .0019 | 2.49 (1.36-4.53) |
| Non-response | 3 | 0.2 | 6 | 0.3 | .51 | 0.50 (0.13-2.02) |
| Death in 1st CR | 42 | 2.3 | 32 | 1.7 | .24 | 1.33 (0.84-2.11) |
| Related to induction chemotherapy | 10 | 0.5 | 2 | 0.1 | .022 | 5.09 (1.1-23.3) |
| Related to post-induction chemotherapy | 17 | 0.9 | 15 | 0.8 | .73 | 1.15 (0.57-2.31) |
| Related to alloHSCT* | 12 | 0.6 | 14 | 0.7 | .84 | 0.87 (0.40-1.87) |
| Other | 3 | 0.2 | 1 | 0.1 | .37 | 2.98 (0.31-28.74) |
| All relapses | 229 | 10.8 (0.7) | 323 | 15.6 (0.8) | <.0001 | 0.70 (0.59-0.83) |
| Isolated BM | 158 | 7.6 (0.6) | 204 | 9.7 (0.7) | .013 | 0.77 (0.62-0.95) |
| Isolated CNS | 19 | 0.9 (0.2) | 37 | 1.9 (0.3) | .019 | 0.51 (0.30-0.90) |
| Isolated testes | 9 | 0.4 (0.1) | 23 | 1.1 (0.2) | .016 | 0.39 (0.18-0.84) |
| Combined CNS/BM involved | 15 | 0.7 (0.2) | 30 | 1.5 (0.3) | .027 | 0.50 (0.27-0.92) |
| Combined BM/other (w/o CNS) | 17 | 0.8 (0.2) | 21 | 1.0 (0.2) | .52 | 0.80 (0.42-1.52) |
| Other relapses | 11 | 0.4 (0.1) | 8 | 0.4 (0.1) | .47 | 1.37 (0.55-3.41) |
| Secondary neoplasms | 30 | 1.0 (0.2) | 25 | 0.8 (0.2) | .47 | 1.18 (0.70-2.01) |
| All events | 341 | 16.1 (0.9) | 401 | 19.2 (0.9) | .024 | 0.85 (0.73-0.98) |
alloHSCT, allogeneic hematopoietic stem cell transplantation; BM, bone marrow; CI, confidence interval; CNS, central nervous system; CR, complete remission; DXM, dexamethasone; HR, hazard ratio; PDN, prednisone.
112 patients in the prednisone and 88 patients in the dexamethasone arm underwent allogeneic stem cell transplantation in first CR.
Percentages are presented for deaths and resistant disease; 5-year cumulative incidences (standard error in parentheses) were calculated for relapses, secondary neoplasms, and the total number of events.
Fisher exact test was used for deaths and resistant disease and Gray test was used for relapses and secondary neoplasms.