Difference between revisions of "Ewing sarcoma, pediatric - historical"
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===Induction=== | ===Induction=== | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
| − | ====Chemotherapy, VDC portion==== | + | ====Chemotherapy, VDC portion (cycles 1 & 3)==== |
| − | *[[Vincristine (Oncovin)]] | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once on day 1 |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | + | *[[Doxorubicin (Adriamycin)]] 75 mg/m<sup>2</sup> IV continuous infusion over 48 hours, started on day 1 | |
| − | *[[Doxorubicin (Adriamycin)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | *[[Cyclophosphamide (Cytoxan)]] 1200 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | *[[Cyclophosphamide (Cytoxan)]] | + | ====Supportive therapy, VDC portion (cycles 1 & 3)==== |
| − | + | *[[Mesna (Mesnex)]] 720 mg/m<sup>2</sup> IV continuous infusion on day 1 | |
| − | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m<sup>2</sup> | |
| − | ====Supportive therapy, VDC portion==== | + | **Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion |
| − | *[[Mesna (Mesnex)]] | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2 |
| − | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | |
| − | + | ====Chemotherapy, IE portion (cycles 2 & 4)==== | |
| − | ** | + | *[[Ifosfamide (Ifex)]] 1800 mg/m<sup>2</sup> IV infusion over 1 hour once per day on days 1 to 5 |
| − | *[[Filgrastim (Neupogen)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | *[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV infusion over 1 to 2 hours once per day on days 1 to 5 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | ====Chemotherapy, IE portion==== | + | ====Supportive therapy, IE portion (cycles 2 & 4)==== |
| − | *[[Ifosfamide (Ifex)]] | + | *[[Mesna (Mesnex)]] 1080 mg/m<sup>2</sup> IV continuous infusion on day 1 |
| − | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of ifosfamide m<sup>2</sup> | |
| − | + | **Ccontinuous infusion should be started at the same time as the ifosfamide and remain until at least 8 hours after the end of the ifosfamide infusion | |
| − | *[[Etoposide (Vepesid)]] | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 6 |
| − | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | |
| − | |||
| − | ====Supportive therapy, IE portion==== | ||
| − | *[[Mesna (Mesnex)]] | ||
| − | |||
| − | |||
| − | ** | ||
| − | *[[Filgrastim (Neupogen)]] | ||
| − | |||
| − | |||
'''21-day cycle for 4 cycles, followed by:''' | '''21-day cycle for 4 cycles, followed by:''' | ||
</div></div><br> | </div></div><br> | ||
| Line 72: | Line 63: | ||
''Note: the cycle count for this phase starts at cycle 5.'' | ''Note: the cycle count for this phase starts at cycle 5.'' | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
| − | ====Chemotherapy, VDC portion==== | + | ====Chemotherapy, VDC portion (cycles 5 & 9)==== |
Cycle 5 begins on week 15 in patients receiving surgery and on week 13 in Regimen A<sub>2</sub> | Cycle 5 begins on week 15 in patients receiving surgery and on week 13 in Regimen A<sub>2</sub> | ||
| − | *[[Vincristine (Oncovin)]] | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once on day 1 |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | + | *[[Doxorubicin (Adriamycin)]] 75 mg/m<sup>2</sup> IV continuous infusion over 48 hours, started on day 1 | |
| − | *[[Doxorubicin (Adriamycin)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | *[[Cyclophosphamide (Cytoxan)]] 1200 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | *[[Cyclophosphamide (Cytoxan)]] | + | ====Supportive medication, VDC portion (cycles 5 & 9)==== |
| − | + | *[[Mesna (Mesnex)]] 720 mg/m<sup>2</sup> IV continuous infusion on day 1 | |
| − | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m<sup>2</sup> | |
| − | ====Supportive medication, VDC portion==== | + | **Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion |
| − | *[[Mesna (Mesnex)]] | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2 |
| − | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | |
| − | + | ====Chemotherapy, IE portion (cycles 6, 8, 10, 12, 14)==== | |
| − | ** | + | *[[Ifosfamide (Ifex)]] 1800 mg/m<sup>2</sup> IV infusion over 1 hour once per day on days 1 to 5 |
| − | *[[Filgrastim (Neupogen)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | *[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV infusion over 1 to 2 hours once per day on days 1 to 5 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | ====Chemotherapy, IE portion==== | + | ====Supportive therapy, IE portion (cycles 6, 8, 10, 12, 14)==== |
| − | *[[Ifosfamide (Ifex)]] | + | *[[Mesna (Mesnex)]] 1080 mg/m<sup>2</sup> IV continuous infusion on day 1 |
| − | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of ifosfamide m<sup>2</sup> | |
| − | + | **Continuous infusion should be started at the same time as the ifosfamide and remain until at least 8 hours after the end of the ifosfamide infusion | |
| − | *[[Etoposide (Vepesid)]] | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 6 |
| − | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | |
| − | + | ====Chemotherapy, VDC portion Regimen A<sub>1</sub> (cycle 7; Surgery Only)==== | |
| − | ====Supportive therapy, IE portion==== | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once on day 1 |
| − | *[[Mesna (Mesnex)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | *[[Doxorubicin (Adriamycin)]] 75 mg/m<sup>2</sup> IV continuous infusion over 48 hours, started on day 1 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | ** | + | *[[Cyclophosphamide (Cytoxan)]] 1200 mg/m<sup>2</sup> IV over 60 minutes once on day 1 |
| − | *[[Filgrastim (Neupogen)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | ====Supportive therapy, VDC portion Regimen A<sub>1</sub> (cycle 7; Surgery Only)==== | |
| − | + | *[[Mesna (Mesnex)]] 720 mg/m<sup>2</sup> IV continuous infusion on day 1 | |
| − | ====Chemotherapy, VDC portion Regimen A<sub>1</sub> (Surgery Only)==== | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m<sup>2</sup> |
| − | *[[Vincristine (Oncovin)]] | + | **Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion |
| − | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2 | |
| − | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | |
| − | *[[Doxorubicin (Adriamycin)]] | + | ====Chemotherapy, VC portion Regimen A<sub>2</sub> & A<sub>3</sub> (cycle 7; Radiation w/ or w/o Surgery)==== |
| − | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once on day 1 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | *[[Cyclophosphamide (Cytoxan)]] | + | *[[Cyclophosphamide (Cytoxan)]] 1200 mg/m<sup>2</sup> IV over 60 minutes once on day 1 |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | + | ====Supportive therapy, VC portion Regimen A<sub>2</sub> & A<sub>3</sub> (cycle 7; Radiation w/ or w/o Surgery)==== | |
| − | ====Supportive therapy, VDC portion Regimen A<sub>1</sub> (Surgery Only)==== | + | *[[Mesna (Mesnex)]] 720 mg/m<sup>2</sup> IV continuous infusion on day 1 |
| − | *[[Mesna (Mesnex)]] | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m<sup>2</sup> |
| − | + | **Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion | |
| − | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2 | |
| − | ** | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF |
| − | *[[Filgrastim (Neupogen)]] | + | ====Chemotherapy, VC portion Regimen A<sub>1</sub> (cycle 11; Surgery Only)==== |
| − | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once on day 1 | |
| − | **ANC | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | ====Chemotherapy, VC portion Regimen A<sub>2</sub> & A<sub>3</sub> (Radiation w/ or w/o Surgery)==== | + | *[[Cyclophosphamide (Cytoxan)]] 1200 mg/m<sup>2</sup> IV over 60 minutes once on day 1 |
| − | *[[Vincristine (Oncovin)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | ====Supportive therapy, VC portion Regimen A<sub>1</sub> (cycle 11; Surgery Only)==== | |
| − | + | *[[Mesna (Mesnex)]] 720 mg/m<sup>2</sup> IV continuous infusion on day 1 | |
| − | *[[Cyclophosphamide (Cytoxan)]] | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m<sup>2</sup> |
| − | + | **Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion | |
| − | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2 | |
| − | ====Supportive therapy, VC portion Regimen A<sub>2</sub> & A<sub>3</sub> (Radiation w/ or w/o Surgery)==== | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF |
| − | *[[Mesna (Mesnex)]] | + | ====Chemotherapy, VDC portion Regimen A<sub>2</sub> & A<sub>3</sub> (cycle 11; Radiation w/ or w/o Surgery)==== |
| − | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once on day 1 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | ** | + | *[[Doxorubicin (Adriamycin)]] 75 mg/m<sup>2</sup> IV continuous infusion over 48 hours, started on day 1 |
| − | *[[Filgrastim (Neupogen)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | *[[Cyclophosphamide (Cytoxan)]] 1200 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | |
| − | **ANC | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | ====Chemotherapy, VC portion Regimen A<sub>1</sub> (Surgery Only)==== | + | ====Supportive therapy, VDC portion Regimen A<sub>2</sub> & A<sub>3</sub> (cycle 11; Radiation w/ or w/o Surgery)==== |
| − | *[[Vincristine (Oncovin)]] | + | *[[Mesna (Mesnex)]] 720 mg/m<sup>2</sup> IV continuous infusion on day 1 |
| − | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m<sup>2</sup> | |
| − | + | **Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion | |
| − | *[[Cyclophosphamide (Cytoxan)]] | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2 |
| − | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | |
| − | + | ====Chemotherapy, VC portion (cycle 13)==== | |
| − | ====Supportive therapy, VC portion Regimen A<sub>1</sub> (Surgery Only)==== | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once on day 1 |
| − | *[[Mesna (Mesnex)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | *[[Cyclophosphamide (Cytoxan)]] 1200 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | ** | + | ====Supportive therapy, VC portion (cycle 13)==== |
| − | *[[Filgrastim (Neupogen)]] | + | *[[Mesna (Mesnex)]] 720 mg/m<sup>2</sup> IV continuous infusion on day 1 |
| − | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m<sup>2</sup> | |
| − | + | **Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion | |
| − | ====Chemotherapy, VDC portion Regimen A<sub>2</sub> & A<sub>3</sub> (Radiation w/ or w/o Surgery)==== | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2 |
| − | *[[Vincristine (Oncovin)]] | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF |
| − | |||
| − | |||
| − | *[[Doxorubicin (Adriamycin)]] | ||
| − | |||
| − | |||
| − | *[[Cyclophosphamide (Cytoxan)]] | ||
| − | |||
| − | |||
| − | ====Supportive therapy, VDC portion Regimen A<sub>2</sub> & A<sub>3</sub> (Radiation w/ or w/o Surgery)==== | ||
| − | *[[Mesna (Mesnex)]] | ||
| − | |||
| − | |||
| − | ** | ||
| − | *[[Filgrastim (Neupogen)]] | ||
| − | |||
| − | **ANC | ||
| − | ====Chemotherapy, VC portion==== | ||
| − | *[[Vincristine (Oncovin)]] | ||
| − | |||
| − | |||
| − | *[[Cyclophosphamide (Cytoxan)]] | ||
| − | |||
| − | |||
| − | ====Supportive therapy, VC portion==== | ||
| − | *[[Mesna (Mesnex)]] | ||
| − | |||
| − | |||
| − | ** | ||
| − | *[[Filgrastim (Neupogen)]] | ||
| − | |||
| − | |||
'''21-day cycle for 9 cycles (13 cycles total)''' | '''21-day cycle for 9 cycles (13 cycles total)''' | ||
</div></div></div> | </div></div></div> | ||
| Line 211: | Line 171: | ||
===Induction=== | ===Induction=== | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
| − | ====Chemotherapy, VDC portion==== | + | ====Chemotherapy, VDC portion (cycles 1, 3, 5)==== |
| − | *[[Vincristine (Oncovin)]] | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once on day 1 |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | + | *[[Doxorubicin (Adriamycin)]] 75 mg/m<sup>2</sup> IV continuous infusion over 48 hours, started on day 1 | |
| − | *[[Doxorubicin (Adriamycin)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | *[[Cyclophosphamide (Cytoxan)]] 1200 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | *[[Cyclophosphamide (Cytoxan)]] | + | ====Supportive therapy, VDC portion (cycles 1, 3, 5)==== |
| − | + | *[[Mesna (Mesnex)]] 720 mg/m<sup>2</sup> IV continuous infusion on day 1 | |
| − | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m<sup>2</sup> | |
| − | ====Supportive therapy, VDC portion==== | + | **Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion |
| − | *[[Mesna (Mesnex)]] | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2 |
| − | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | |
| − | + | ====Chemotherapy, IE portion (cycles 2, 4, 6)==== | |
| − | ** | + | *[[Ifosfamide (Ifex)]] 1800 mg/m<sup>2</sup> IV infusion over 1 hour once per day on days 1 to 5 |
| − | *[[Filgrastim (Neupogen)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | *[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV infusion over 1 to 2 hours once per day on days 1 to 5 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | ====Chemotherapy, IE portion==== | + | ====Supportive therapy, IE portion (cycles 2, 4, 6)==== |
| − | *[[Ifosfamide (Ifex)]] | + | *[[Mesna (Mesnex)]] 1080 mg/m<sup>2</sup> IV continuous infusion on day 1 |
| − | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of ifosfamide m<sup>2</sup> | |
| − | + | **Continuous infusion should be started at the same time as the ifosfamide and remain until at least 8 hours after the end of the ifosfamide infusion | |
| − | *[[Etoposide (Vepesid)]] | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 6 |
| − | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | |
| − | |||
| − | ====Supportive therapy, IE portion==== | ||
| − | *[[Mesna (Mesnex)]] | ||
| − | |||
| − | |||
| − | ** | ||
| − | *[[Filgrastim (Neupogen)]] | ||
| − | |||
| − | |||
'''14-day cycle for 6 cycles, followed by:''' | '''14-day cycle for 6 cycles, followed by:''' | ||
</div></div><br> | </div></div><br> | ||
| Line 252: | Line 203: | ||
''Note: The counting starts at cycle 7, which begins on week 15 in patients receiving surgery and on week 13 in Regimen B<sub>2</sub>.'' | ''Note: The counting starts at cycle 7, which begins on week 15 in patients receiving surgery and on week 13 in Regimen B<sub>2</sub>.'' | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
| − | ====Chemotherapy, VDC portion==== | + | ====Chemotherapy, VDC portion (cycle 7)==== |
| − | *[[Vincristine (Oncovin)]] | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once on day 1 |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | + | *[[Doxorubicin (Adriamycin)]] 75 mg/m<sup>2</sup> IV continuous infusion over 48 hours, started on day 1 | |
| − | *[[Doxorubicin (Adriamycin)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | *[[Cyclophosphamide (Cytoxan)]] 1200 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | *[[Cyclophosphamide (Cytoxan)]] | + | ====Supportive therapy, VDC portion (cycle 7)==== |
| − | + | *[[Mesna (Mesnex)]] 720 mg/m<sup>2</sup> IV continuous infusion on day 1 | |
| − | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m<sup>2</sup> | |
| − | ====Supportive therapy, VDC portion==== | + | **Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion |
| − | *[[Mesna (Mesnex)]] | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2 |
| − | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | |
| − | + | ====Chemotherapy, IE portion (cycles 8, 10, 12, 14)==== | |
| − | ** | + | *[[Ifosfamide (Ifex)]] 1800 mg/m<sup>2</sup> IV infusion over 1 hour once per day on days 1 to 5 |
| − | *[[Filgrastim (Neupogen)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | *[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV infusion over 1 to 2 hours once per day on days 1 to 5 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | ====Chemotherapy, IE portion==== | + | ====Supportive therapy, IE portion (cycles 8, 10, 12, 14)==== |
| − | *[[Ifosfamide (Ifex)]] | + | *[[Mesna (Mesnex)]] 1080 mg/m<sup>2</sup> IV continuous infusion on day 1 |
| − | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of ifosfamide m<sup>2</sup> | |
| − | + | **Continuous infusion should be started at the same time as the ifosfamide and remain until at least 8 hours after the end of the ifosfamide infusion | |
| − | *[[Etoposide (Vepesid)]] | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 6 |
| − | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | |
| − | + | ====Chemotherapy, VDC portion Regimen B<sub>1</sub> (cycle 9; Surgery Only)==== | |
| − | ====Supportive therapy, IE portion==== | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once on day 1 |
| − | *[[Mesna (Mesnex)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | *[[Doxorubicin (Adriamycin)]] 75 mg/m<sup>2</sup> IV continuous infusion over 48 hours, started on day 1 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | ** | + | *[[Cyclophosphamide (Cytoxan)]] 1200 mg/m<sup>2</sup> IV over 60 minutes once on day 1 |
| − | *[[Filgrastim (Neupogen)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | ====Supportive therapy, VDC portion Regimen B<sub>1</sub> (cycle 9; Surgery Only)==== | |
| − | + | *[[Mesna (Mesnex)]] 720 mg/m<sup>2</sup> IV continuous infusion on day 1 | |
| − | ====Chemotherapy, VDC portion Regimen B<sub>1</sub> (Surgery Only)==== | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m<sup>2</sup> |
| − | *[[Vincristine (Oncovin)]] | + | **Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion |
| − | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2 | |
| − | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | |
| − | *[[Doxorubicin (Adriamycin)]] | + | ====Chemotherapy, VC portion Regimen B<sub>2</sub> & B<sub>3</sub> (cycle 9; Radiation w/ or w/o Surgery)==== |
| − | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once on day 1 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | *[[Cyclophosphamide (Cytoxan)]] | + | *[[Cyclophosphamide (Cytoxan)]] 1200 mg/m<sup>2</sup> IV over 60 minutes once on day 1 |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | + | ====Supportive therapy, VC portion Regimen B<sub>2</sub> & B<sub>3</sub> (cycle 9; Radiation w/ or w/o Surgery)==== | |
| − | ====Supportive therapy, VDC portion Regimen B<sub>1</sub> (Surgery Only)==== | + | *[[Mesna (Mesnex)]] 720 mg/m<sup>2</sup> IV continuous infusion on day 1 |
| − | *[[Mesna (Mesnex)]] | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m<sup>2</sup> |
| − | + | **Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion | |
| − | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2 | |
| − | ** | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF |
| − | *[[Filgrastim (Neupogen)]] | + | ====Chemotherapy, VC portion (cycle 11)==== |
| − | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once on day 1 | |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | ====Chemotherapy, VC portion Regimen B<sub>2</sub> & B<sub>3</sub> (Radiation w/ or w/o Surgery)==== | + | *[[Cyclophosphamide (Cytoxan)]] 1200 mg/m<sup>2</sup> IV over 60 minutes once on day 1 |
| − | *[[Vincristine (Oncovin)]] | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | ====Supportive therapy, VC portion (cycle 11)==== | |
| − | + | *[[Mesna (Mesnex)]] 720 mg/m<sup>2</sup> IV continuous infusion on day 1 | |
| − | *[[Cyclophosphamide (Cytoxan)]] | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m<sup>2</sup> |
| − | + | **Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion | |
| − | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2 | |
| − | ====Supportive therapy, VC portion Regimen B<sub>2</sub> & B<sub>3</sub> (Radiation w/ or w/o Surgery)==== | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF |
| − | *[[Mesna (Mesnex)]] | + | ====Chemotherapy, VC portion Regimen B<sub>1</sub> (cycle 13; Surgery Only)==== |
| − | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once on day 1 | |
| − | |||
| − | ** | ||
| − | *[[Filgrastim (Neupogen)]] | ||
| − | |||
| − | |||
| − | ====Chemotherapy, VC portion==== | ||
| − | *[[Vincristine (Oncovin)]] | ||
| − | |||
| − | |||
| − | *[[Cyclophosphamide (Cytoxan)]] | ||
| − | |||
| − | |||
| − | ====Supportive therapy, VC portion==== | ||
| − | *[[Mesna (Mesnex)]] | ||
| − | |||
| − | |||
| − | ** | ||
| − | *[[Filgrastim (Neupogen)]] | ||
| − | |||
| − | |||
| − | ====Chemotherapy, VC portion Regimen B<sub>1</sub> (Surgery Only)==== | ||
| − | *[[Vincristine (Oncovin)]] | ||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
| − | |||
***Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | ***Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | ||
| − | *[[ | + | *[[Cyclophosphamide (Cytoxan)]] 1200 mg/m<sup>2</sup> IV over 60 minutes once on day 1 |
| − | ** | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | + | ====Supportive therapy, VC portion Regimen B<sub>1</sub> (cycle 13; Surgery Only)==== | |
| − | *[[Cyclophosphamide (Cytoxan)]] | + | *[[Mesna (Mesnex)]] 720 mg/m<sup>2</sup> IV continuous infusion on day 1 |
| − | + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m<sup>2</sup> | |
| − | + | **Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion | |
| − | ====Supportive therapy, VDC portion Regimen B<sub>2</sub> & B<sub>3</sub> (Radiation w/ or w/o Surgery)==== | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2 |
| − | *[[Mesna (Mesnex)]] | + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF |
| − | + | ====Chemotherapy, VDC portion Regimen B<sub>2</sub> & B<sub>3</sub> (cycle 13; Radiation w/ or w/o Surgery)==== | |
| − | + | *[[Vincristine (Oncovin)]] 2 mg/m<sup>2</sup> (maximum dose of 2 mg) IV push once on day 1 | |
| − | ** | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated |
| − | *[[Filgrastim (Neupogen)]] | + | *[[Doxorubicin (Adriamycin)]] 75 mg/m<sup>2</sup> IV continuous infusion over 48 hours, started on day 1 |
| − | + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | |
| − | + | *[[Cyclophosphamide (Cytoxan)]] 1200 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | |
| + | **Treat with 50% doses calculated on a m<sup>2</sup> basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated | ||
| + | ====Supportive therapy, VDC portion Regimen B<sub>2</sub> & B<sub>3</sub> (cycle 13; Radiation w/ or w/o Surgery)==== | ||
| + | *[[Mesna (Mesnex)]] 720 mg/m<sup>2</sup> IV continuous infusion on day 1 | ||
| + | **NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m<sup>2</sup> | ||
| + | **Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion | ||
| + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2 | ||
| + | **ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
'''14-day cycle for 8 cycles (14 cycles total)''' | '''14-day cycle for 8 cycles (14 cycles total)''' | ||
</div></div></div> | </div></div></div> | ||
Revision as of 03:40, 18 July 2023
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the NCCN Guidelines. Is there a regimen missing from this list? See the main pediatric Ewing sarcoma page for current regimens.
0 regimens on this page
0 variants on this page
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Upfront therapy, localized disease
COG AEWS0031 Protocol A
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Womer et al. 2012 (COG AEWS0031) | 5/2001-8/2005 | Phase 3 (C) | Intensified treatment | Seems to have inferior EFS |
Protocol A is a standard protocol consisting of 14 21-day cycles
Induction
Chemotherapy, VDC portion (cycles 1 & 3)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV push once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Doxorubicin (Adriamycin) 75 mg/m2 IV continuous infusion over 48 hours, started on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV over 60 minutes once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, VDC portion (cycles 1 & 3)
- Mesna (Mesnex) 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m2
- Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, IE portion (cycles 2 & 4)
- Ifosfamide (Ifex) 1800 mg/m2 IV infusion over 1 hour once per day on days 1 to 5
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Etoposide (Vepesid) 100 mg/m2 IV infusion over 1 to 2 hours once per day on days 1 to 5
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, IE portion (cycles 2 & 4)
- Mesna (Mesnex) 1080 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of ifosfamide m2
- Ccontinuous infusion should be started at the same time as the ifosfamide and remain until at least 8 hours after the end of the ifosfamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 6
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
21-day cycle for 4 cycles, followed by:
Continuation
- At week 13 patients either underwent surgery, received radiation, or both
- Radiation coincided with cycle 5
Note: the cycle count for this phase starts at cycle 5.
Chemotherapy, VDC portion (cycles 5 & 9)
Cycle 5 begins on week 15 in patients receiving surgery and on week 13 in Regimen A2
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV push once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Doxorubicin (Adriamycin) 75 mg/m2 IV continuous infusion over 48 hours, started on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV over 60 minutes once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive medication, VDC portion (cycles 5 & 9)
- Mesna (Mesnex) 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m2
- Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, IE portion (cycles 6, 8, 10, 12, 14)
- Ifosfamide (Ifex) 1800 mg/m2 IV infusion over 1 hour once per day on days 1 to 5
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Etoposide (Vepesid) 100 mg/m2 IV infusion over 1 to 2 hours once per day on days 1 to 5
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, IE portion (cycles 6, 8, 10, 12, 14)
- Mesna (Mesnex) 1080 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of ifosfamide m2
- Continuous infusion should be started at the same time as the ifosfamide and remain until at least 8 hours after the end of the ifosfamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 6
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, VDC portion Regimen A1 (cycle 7; Surgery Only)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV push once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Doxorubicin (Adriamycin) 75 mg/m2 IV continuous infusion over 48 hours, started on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV over 60 minutes once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, VDC portion Regimen A1 (cycle 7; Surgery Only)
- Mesna (Mesnex) 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m2
- Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, VC portion Regimen A2 & A3 (cycle 7; Radiation w/ or w/o Surgery)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV push once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV over 60 minutes once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, VC portion Regimen A2 & A3 (cycle 7; Radiation w/ or w/o Surgery)
- Mesna (Mesnex) 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m2
- Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, VC portion Regimen A1 (cycle 11; Surgery Only)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV push once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV over 60 minutes once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, VC portion Regimen A1 (cycle 11; Surgery Only)
- Mesna (Mesnex) 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m2
- Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, VDC portion Regimen A2 & A3 (cycle 11; Radiation w/ or w/o Surgery)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV push once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Doxorubicin (Adriamycin) 75 mg/m2 IV continuous infusion over 48 hours, started on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV over 60 minutes once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, VDC portion Regimen A2 & A3 (cycle 11; Radiation w/ or w/o Surgery)
- Mesna (Mesnex) 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m2
- Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, VC portion (cycle 13)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV push once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV over 60 minutes once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, VC portion (cycle 13)
- Mesna (Mesnex) 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m2
- Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
21-day cycle for 9 cycles (13 cycles total)
References
- COG AEWS0031: Womer RB, West DC, Krailo MD, Dickman PS, Pawel BR, Grier HE, Marcus K, Sailer S, Healey JH, Dormans JP, and Weiss AR. Randomized Controlled Trial of Interval-Compressed Chemotherapy for the Treatment of Localized Ewing Sarcoma: A Report From the Children's Oncology Group. J Clin Oncol. 2012 Nov 20;30(33):4148-4154. Epub 2012 Oct 22. link to original article link to PMC article PubMed NCT00006734
COG AEWS0031 Protocol B
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Womer et al. 2012 (COG AEWS0031) | 5/2001-8/2005 | Phase 3 (E-esc) | Standard treatment | Seems to have superior EFS (primary endpoint) EFS60: 73% vs 65% (HR 0.74, 95% CI 0.54-0.99) Seems to have superior OS (secondary endpoint) OS60: 83% vs 77% (HR 0.69, 95% CI 0.47-1.00) |
Note: Protocol B is a consolidated regimen consisting of 14-day cycles.
Induction
Chemotherapy, VDC portion (cycles 1, 3, 5)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV push once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Doxorubicin (Adriamycin) 75 mg/m2 IV continuous infusion over 48 hours, started on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV over 60 minutes once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, VDC portion (cycles 1, 3, 5)
- Mesna (Mesnex) 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m2
- Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, IE portion (cycles 2, 4, 6)
- Ifosfamide (Ifex) 1800 mg/m2 IV infusion over 1 hour once per day on days 1 to 5
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Etoposide (Vepesid) 100 mg/m2 IV infusion over 1 to 2 hours once per day on days 1 to 5
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, IE portion (cycles 2, 4, 6)
- Mesna (Mesnex) 1080 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of ifosfamide m2
- Continuous infusion should be started at the same time as the ifosfamide and remain until at least 8 hours after the end of the ifosfamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 6
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
14-day cycle for 6 cycles, followed by:
Continuation
- At week 13 patients either underwent surgery, received radiation, or both
- Radiation coincided with cycle 7
Note: The counting starts at cycle 7, which begins on week 15 in patients receiving surgery and on week 13 in Regimen B2.
Chemotherapy, VDC portion (cycle 7)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV push once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Doxorubicin (Adriamycin) 75 mg/m2 IV continuous infusion over 48 hours, started on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV over 60 minutes once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, VDC portion (cycle 7)
- Mesna (Mesnex) 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m2
- Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, IE portion (cycles 8, 10, 12, 14)
- Ifosfamide (Ifex) 1800 mg/m2 IV infusion over 1 hour once per day on days 1 to 5
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Etoposide (Vepesid) 100 mg/m2 IV infusion over 1 to 2 hours once per day on days 1 to 5
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, IE portion (cycles 8, 10, 12, 14)
- Mesna (Mesnex) 1080 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of ifosfamide m2
- Continuous infusion should be started at the same time as the ifosfamide and remain until at least 8 hours after the end of the ifosfamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 6
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, VDC portion Regimen B1 (cycle 9; Surgery Only)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV push once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Doxorubicin (Adriamycin) 75 mg/m2 IV continuous infusion over 48 hours, started on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV over 60 minutes once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, VDC portion Regimen B1 (cycle 9; Surgery Only)
- Mesna (Mesnex) 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m2
- Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, VC portion Regimen B2 & B3 (cycle 9; Radiation w/ or w/o Surgery)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV push once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV over 60 minutes once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, VC portion Regimen B2 & B3 (cycle 9; Radiation w/ or w/o Surgery)
- Mesna (Mesnex) 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m2
- Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, VC portion (cycle 11)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV push once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV over 60 minutes once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, VC portion (cycle 11)
- Mesna (Mesnex) 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m2
- Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, VC portion Regimen B1 (cycle 13; Surgery Only)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV push once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV over 60 minutes once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, VC portion Regimen B1 (cycle 13; Surgery Only)
- Mesna (Mesnex) 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m2
- Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, VDC portion Regimen B2 & B3 (cycle 13; Radiation w/ or w/o Surgery)
- Vincristine (Oncovin) 2 mg/m2 (maximum dose of 2 mg) IV push once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Doxorubicin (Adriamycin) 75 mg/m2 IV continuous infusion over 48 hours, started on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
- Cyclophosphamide (Cytoxan) 1200 mg/m2 IV over 60 minutes once on day 1
- Treat with 50% doses calculated on a m2 basis for children < 1 year, then consider increasing to 75% and then to 100 % of calculated dose if tolerated
Supportive therapy, VDC portion Regimen B2 & B3 (cycle 13; Radiation w/ or w/o Surgery)
- Mesna (Mesnex) 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that mesna should be dosed as AT LEAST 60% of cyclophosphamide m2
- Continuous infusion should be started at the same time as the cyclophosphamide and remain until at least 8 hours after the end of the cyclophosphamide infusion
- Filgrastim (Neupogen) 5 mcg/kg SC once per day for at least 7 days, or until ANC at least 750/μl, beginning on day 2
- ANC at least 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
14-day cycle for 8 cycles (14 cycles total)
References
- COG AEWS0031: Womer RB, West DC, Krailo MD, Dickman PS, Pawel BR, Grier HE, Marcus K, Sailer S, Healey JH, Dormans JP, and Weiss AR. Randomized Controlled Trial of Interval-Compressed Chemotherapy for the Treatment of Localized Ewing Sarcoma: A Report From the Children's Oncology Group. J Clin Oncol. 2012 Nov 20;30(33):4148-4154. Epub 2012 Oct 22. link to original article link to PMC article PubMed NCT00006734