Risk group, therapy, and second malignant neoplasms in NOPHO ALL-92 protocol
| . | SR-ALL (n = 562)* . | IR-ALL (n = 590)† . | HR-ALL (n = 239)‡ . | VHR-ALL (n = 223)§ . |
|---|---|---|---|---|
| Doxorubicin/daunomycin‖ | 120 | 240 | 280 | 400 |
| Cyclophosphamide‖ | 0 | 3.000 | 3.000 | 6.600 |
| Cranial irradiation | No | No | No | Yes |
| 6MP/MTX (weeks) | 117 | 72 | 41 | 0-8 |
| Dead in CR1/relapse/SMN¶ | 7/85/12 | 9/106/4 | 8/80/2 | 10/64/2 |
| pEFS/pOS¶ | 0.81/0.90 | 0.79/0.90 | 0.62/0.74 | 0.66/0.74 |
| AML/MDS/solid tumor | 5/7/0 | 1/1/2 | 2#/0/0 | 0/0/2#¶ |
| 12-year pSMN, mean ± SE (%)** | 2.4 ± 0.7 | 1.2 ± 0.7 | 1.2 ± 0.8 | 1.1 ± 0.8 |
| . | SR-ALL (n = 562)* . | IR-ALL (n = 590)† . | HR-ALL (n = 239)‡ . | VHR-ALL (n = 223)§ . |
|---|---|---|---|---|
| Doxorubicin/daunomycin‖ | 120 | 240 | 280 | 400 |
| Cyclophosphamide‖ | 0 | 3.000 | 3.000 | 6.600 |
| Cranial irradiation | No | No | No | Yes |
| 6MP/MTX (weeks) | 117 | 72 | 41 | 0-8 |
| Dead in CR1/relapse/SMN¶ | 7/85/12 | 9/106/4 | 8/80/2 | 10/64/2 |
| pEFS/pOS¶ | 0.81/0.90 | 0.79/0.90 | 0.62/0.74 | 0.66/0.74 |
| AML/MDS/solid tumor | 5/7/0 | 1/1/2 | 2#/0/0 | 0/0/2#¶ |
| 12-year pSMN, mean ± SE (%)** | 2.4 ± 0.7 | 1.2 ± 0.7 | 1.2 ± 0.8 | 1.1 ± 0.8 |
AML indicates acute myeloid leukemia; CNS, central nervous system; dead in CR1, dead in first remission; M2/3 BM, greater than 5%/25% leukemic blasts in bone marrow; MDS, myelodysplastic syndrome; 6MP/MTX, duration of oral 6MP/MTX maintenance therapy in weeks; pEFS/pOS, the 12-year probability of event-free survival and overall survival, respectively; SNM, second malignant neoplasm; SR/IR/HR/VHR, standard/intermediate/high/very high risk of acute lymphoblastic leukemia; and WBC, white blood cell.
Risk criteria were age of 2.0 to 9.9 years, WBC count less than 10 × 109/L, and no HR/VHR criteria.
Risk criteria were age of 1.0 to 1.9 year (or older than 10.0 years) or WBC count of 10 to 49 × 109/L, and no HR/VHR criteria.
Risk criteria were WBC count at least 50 × 109/L; T-cell, mediastinal, CNS, testicular, or lymphomatous disease; t(4;11) or t(9;22); M3 d15 or M2/3 d29; and no VHR criteria.
Risk criteria were HR-ALL at diagnosis and at least 5 years of age and (1) CNS leukemia, or (2) lymphomatous leukemia, or (3) d15 M3 or a d29 M2/3 BM, or (4) T-ALL with 1 or more other HR features.
Cumulative dose in mg/m2.
Twelve-year probability of event-free survival and overall survival.
Three of the 4 SMNs occurred after stem cell transplantation in first remission.
Twelve-year probability of developing an SMN.