CCG treatment schema
| Standard therapy (CCG-BFM) . | Augmented BFM therapy . | ||
|---|---|---|---|
| Treatment . | Dose . | Treatment . | Dose . |
| Consolidation phase (5 wk) | Consolidation phase (9 wk) | ||
| Prednisone | 7.5 mg/m2, d 0; 3.75 mg/m2, d 1, 2 | Cyclophosphamide | 1000 mg/m2 IV, d 0, 28 |
| Cyclophosphamide | 1000 mg/m2 IV, d 0, 14 | Cytarabine | 75 mg/m2 SC or IV, d 1-4, 8-11, 29-32, 36-39 |
| Mercaptopurine | 60 mg/m2 PO, d 0-27 | Mercaptopurine | 60 mg/m2 PO, d 0-13, 28-41 |
| Vincristine | 1.5 mg/m2 IV, d 14, 21, 42, 49 | Vincristine | 1.5 mg/m2 IV, d 14, 21, 42, 49 |
| Cytarabine | 75 mg/m2 IV, d 1-4, 8-11, 15-18, 22-25 | Asparaginase | 6000 U/m2 IM, d 14,16, 18, 21, 23, 25, 42, 44, 46, 49, 51, 53 |
| Intrathecal methotrexate* | 12 mg, d 1, 8, 15, 22 | Intrathecal methotrexate* | 12 mg, d 1, 8, 15, 22 |
| Radiotherapy† | Cranial, 1800 cGy; cranial, 2400 cGy, and spinal, 600 cGy | Radiotherapy† | Cranial, 1800 cGy; cranial, 2400 cGy, and spinal, 600 cGy; testicular, 2400 cGy |
| Interim maintenance phase (8 wk) | Interim maintenance phase (8 wk) | ||
| Mercaptopurine | 60 mg/m2 PO, d 0-41 | Vincristine | 1.5 mg/m2 IV, d 0, 10, 20, 30, 40 |
| Methotrexate | 15 mg/m2 PO, d 0, 7, 14, 21, 28, 35 | Methotrexate | 100 mg/mg2 IV, d 0, 10, 20, 30, 40 (escalate by 50 mg/m2 per dose) |
| Asparaginase | 15 000 IU/m2 IM, d 1, 11, 21, 31, 41 | ||
| Delayed intensification phase (7 wk) | Delayed intensification I phase (8 wk) | ||
| Reinduction phase (4 wk) | Reinduction phase (4 wk) | ||
| Dexamethasone | 10 mg/m2 PO, d 0-20, then taper for 7 d | Dexamethasone | 10 mg/m2 PO, d 0-20, then taper for 7 d |
| Vincristine | 1.5 mg/m2 IV, d 0,14, 21 | Vincristine | 1.5 mg/m2 IV, d 0, 14, 21 |
| Doxorubicin | 25 mg/m2 IV, d 0, 7, 14 | Doxorubicin | 25 mg/m2 IV, d 0, 7, 14 |
| Reconsolidation phase (3 wk) | Reconsolidation phase (4 wk) | ||
| l-Asparaginase | 6000 IU/m2 IM, d 3, 5, 7, 10, 12, 14 | l-Asparaginase | 6000 /m2 IM, d 3, 5, 7, 10, 12, 14 |
| Vincristine | 1.5 mg/m2 IV, d 42, 29 | Vincristine | 1.5 mg/m2 IV, d 42, 49 |
| Cyclophosphamide | 1000 mg/m2 IV, d 28 | Cyclophosphamide | 1000 mg/m2 IV, d 28 |
| Thioguanine | 60 mg/m2 PO, d 28-41 | Thioguanine | 60 mg/m2 PO, d 28-41 |
| Cytarabine | 75 mg/m2 SC or IV, d 29-32, 36-39 | Cytarabine | 75 mg/m2/d SC or IV, d 29-32, 36-39 |
| Intrathecal methotrexate* | 12 mg, d 29, 36 | Intrathecal methotrexate* | 12 mg, d 29, 36 |
| l-asparaginase | 6000 IU/m2 IV, d 42, 44, 46, 49, 51,53 | ||
| Interim maintenance II phase (8 wk) | |||
| Vincristine | 1.5 mg/m2 IV, d 0, 10, 20, 30, 40 | ||
| Methotrexate | 100 mg/m2 IV, d 0, 10, 20, 30, 40 (escalate by 50 mg/m2 per dose) | ||
| [SCAP]L[R]-asparaginase | 15 000 IU/m2 IM, d 1, 11, 21, 31, 41 | ||
| Intrathecal methotrexate* | 12 mg, d 0, 20, 40 | ||
| Delayed intensification II phase (8 wk) | Same as for delayed intensification I phase | ||
| Long-term maintenance phase (12 wk)‡ | Long-term maintenance phase (12 wk)‡ | ||
| Vincristine | 1.5 mg/m2 IV, d 0, 28, 56 | Vincristine | 1.5 mg/m2 IV, d 0, 28, 56 |
| Prednisone | 40 mg/m2 PO, d 0-4, 28-32, 56-60 | Prednisone | 60 mg/m2 PO, d 0-14, 28-32, 56-60 |
| Mercaptopurine | 75 mg/m2 PO, d 0-83 | Mercaptopurine | 75 mg/m2 PO, d 0-83 |
| Methotrexate | 20 mg/m2 PO, d 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77 | Methotrexate | 20 mg/m2 PO, d 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77 |
| Intrathecal methotrexate* | 12 mg, d 0 | Intrathecal methotrexate* | 12 mg, d 0 |
| Standard therapy (CCG-BFM) . | Augmented BFM therapy . | ||
|---|---|---|---|
| Treatment . | Dose . | Treatment . | Dose . |
| Consolidation phase (5 wk) | Consolidation phase (9 wk) | ||
| Prednisone | 7.5 mg/m2, d 0; 3.75 mg/m2, d 1, 2 | Cyclophosphamide | 1000 mg/m2 IV, d 0, 28 |
| Cyclophosphamide | 1000 mg/m2 IV, d 0, 14 | Cytarabine | 75 mg/m2 SC or IV, d 1-4, 8-11, 29-32, 36-39 |
| Mercaptopurine | 60 mg/m2 PO, d 0-27 | Mercaptopurine | 60 mg/m2 PO, d 0-13, 28-41 |
| Vincristine | 1.5 mg/m2 IV, d 14, 21, 42, 49 | Vincristine | 1.5 mg/m2 IV, d 14, 21, 42, 49 |
| Cytarabine | 75 mg/m2 IV, d 1-4, 8-11, 15-18, 22-25 | Asparaginase | 6000 U/m2 IM, d 14,16, 18, 21, 23, 25, 42, 44, 46, 49, 51, 53 |
| Intrathecal methotrexate* | 12 mg, d 1, 8, 15, 22 | Intrathecal methotrexate* | 12 mg, d 1, 8, 15, 22 |
| Radiotherapy† | Cranial, 1800 cGy; cranial, 2400 cGy, and spinal, 600 cGy | Radiotherapy† | Cranial, 1800 cGy; cranial, 2400 cGy, and spinal, 600 cGy; testicular, 2400 cGy |
| Interim maintenance phase (8 wk) | Interim maintenance phase (8 wk) | ||
| Mercaptopurine | 60 mg/m2 PO, d 0-41 | Vincristine | 1.5 mg/m2 IV, d 0, 10, 20, 30, 40 |
| Methotrexate | 15 mg/m2 PO, d 0, 7, 14, 21, 28, 35 | Methotrexate | 100 mg/mg2 IV, d 0, 10, 20, 30, 40 (escalate by 50 mg/m2 per dose) |
| Asparaginase | 15 000 IU/m2 IM, d 1, 11, 21, 31, 41 | ||
| Delayed intensification phase (7 wk) | Delayed intensification I phase (8 wk) | ||
| Reinduction phase (4 wk) | Reinduction phase (4 wk) | ||
| Dexamethasone | 10 mg/m2 PO, d 0-20, then taper for 7 d | Dexamethasone | 10 mg/m2 PO, d 0-20, then taper for 7 d |
| Vincristine | 1.5 mg/m2 IV, d 0,14, 21 | Vincristine | 1.5 mg/m2 IV, d 0, 14, 21 |
| Doxorubicin | 25 mg/m2 IV, d 0, 7, 14 | Doxorubicin | 25 mg/m2 IV, d 0, 7, 14 |
| Reconsolidation phase (3 wk) | Reconsolidation phase (4 wk) | ||
| l-Asparaginase | 6000 IU/m2 IM, d 3, 5, 7, 10, 12, 14 | l-Asparaginase | 6000 /m2 IM, d 3, 5, 7, 10, 12, 14 |
| Vincristine | 1.5 mg/m2 IV, d 42, 29 | Vincristine | 1.5 mg/m2 IV, d 42, 49 |
| Cyclophosphamide | 1000 mg/m2 IV, d 28 | Cyclophosphamide | 1000 mg/m2 IV, d 28 |
| Thioguanine | 60 mg/m2 PO, d 28-41 | Thioguanine | 60 mg/m2 PO, d 28-41 |
| Cytarabine | 75 mg/m2 SC or IV, d 29-32, 36-39 | Cytarabine | 75 mg/m2/d SC or IV, d 29-32, 36-39 |
| Intrathecal methotrexate* | 12 mg, d 29, 36 | Intrathecal methotrexate* | 12 mg, d 29, 36 |
| l-asparaginase | 6000 IU/m2 IV, d 42, 44, 46, 49, 51,53 | ||
| Interim maintenance II phase (8 wk) | |||
| Vincristine | 1.5 mg/m2 IV, d 0, 10, 20, 30, 40 | ||
| Methotrexate | 100 mg/m2 IV, d 0, 10, 20, 30, 40 (escalate by 50 mg/m2 per dose) | ||
| [SCAP]L[R]-asparaginase | 15 000 IU/m2 IM, d 1, 11, 21, 31, 41 | ||
| Intrathecal methotrexate* | 12 mg, d 0, 20, 40 | ||
| Delayed intensification II phase (8 wk) | Same as for delayed intensification I phase | ||
| Long-term maintenance phase (12 wk)‡ | Long-term maintenance phase (12 wk)‡ | ||
| Vincristine | 1.5 mg/m2 IV, d 0, 28, 56 | Vincristine | 1.5 mg/m2 IV, d 0, 28, 56 |
| Prednisone | 40 mg/m2 PO, d 0-4, 28-32, 56-60 | Prednisone | 60 mg/m2 PO, d 0-14, 28-32, 56-60 |
| Mercaptopurine | 75 mg/m2 PO, d 0-83 | Mercaptopurine | 75 mg/m2 PO, d 0-83 |
| Methotrexate | 20 mg/m2 PO, d 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77 | Methotrexate | 20 mg/m2 PO, d 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77 |
| Intrathecal methotrexate* | 12 mg, d 0 | Intrathecal methotrexate* | 12 mg, d 0 |
Induction was as follows: vincristine, 1.5 mg/m2 per week for 4 weeks; daunomycin, 25 mg/m2 per week for 4 weeks; prednisone, 60 mg/m2 per day for 28 days; l-asparaginase, 6000 IU/m2 IM 3 times a week for 9 doses; intrathecal cytarabine on day 0; and intrathecal methotrexate on day 14.
IM indicates intramuscular.
Patients with CNS disease at diagnosis did not receive intrathecal methotrexate on days 15 and 22 of consolidation therapy.
During the first 2 weeks of consolidation therapy, patients without CNS disease at diagnosis received 1800 cGy of cranial radiotherapy in 10 fractions; patients with CNS disease at diagnosis received 2400 cGy to the cranial midplane in 12 fractions and 600 cGy to the spinal cord in 3 fractions. In the augmented therapy group, patients with testicular enlargement at diagnosis received 2400 cGy bilateral testicular radiation in 8 fractions.
The cycles of maintenance therapy were repeated until the total duration of therapy, beginning with the first interim maintenance period, reached 2 years for girls and 3 years for boys.