Difference between revisions of "Ewing sarcoma, pediatric - historical"
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+ | ''Protocol A is a standard protocol consisting of 14 21-day cycles'' | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Induction=== | ===Induction=== | ||
− | |||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy, VDC portion==== | ====Chemotherapy, VDC portion==== | ||
Line 49: | Line 49: | ||
**Cycles 1 & 3: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | **Cycles 1 & 3: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | ||
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | |||
====Chemotherapy, IE portion==== | ====Chemotherapy, IE portion==== | ||
*[[Ifosfamide (Ifex)]] as follows: | *[[Ifosfamide (Ifex)]] as follows: | ||
Line 65: | Line 64: | ||
**Cycles 2 & 4: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 6 | **Cycles 2 & 4: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 6 | ||
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | '''21-day cycle''' | + | '''21-day cycle for 4 cycles, followed by:''' |
</div></div><br> | </div></div><br> | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
Line 71: | Line 70: | ||
*At week 13 patients either underwent surgery, received radiation, or both | *At week 13 patients either underwent surgery, received radiation, or both | ||
*Radiation coincided with cycle 5 | *Radiation coincided with 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==== | ||
Line 91: | Line 91: | ||
**Cycle 5 & 9: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | **Cycle 5 & 9: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | ||
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | |||
====Chemotherapy, IE portion==== | ====Chemotherapy, IE portion==== | ||
*[[Ifosfamide (Ifex)]] as follows: | *[[Ifosfamide (Ifex)]] as follows: | ||
Line 107: | Line 106: | ||
**Cycle 6, 8, 10, 12, & 14: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 6 | **Cycle 6, 8, 10, 12, & 14: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 6 | ||
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 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> (Surgery Only)==== | ====Chemotherapy, VDC portion Regimen A<sub>1</sub> (Surgery Only)==== | ||
*[[Vincristine (Oncovin)]] as follows: | *[[Vincristine (Oncovin)]] as follows: | ||
Line 126: | Line 124: | ||
**Cycle 7: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | **Cycle 7: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | ||
**ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | **ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | |||
====Chemotherapy, VC portion Regimen A<sub>2</sub> & A<sub>3</sub> (Radiation w/ or w/o Surgery)==== | ====Chemotherapy, VC portion Regimen A<sub>2</sub> & A<sub>3</sub> (Radiation w/ or w/o Surgery)==== | ||
*[[Vincristine (Oncovin)]] as follows: | *[[Vincristine (Oncovin)]] as follows: | ||
Line 142: | Line 139: | ||
**Cycle 7: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | **Cycle 7: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | ||
**ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | **ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | |||
====Chemotherapy, VC portion Regimen A<sub>1</sub> (Surgery Only)==== | ====Chemotherapy, VC portion Regimen A<sub>1</sub> (Surgery Only)==== | ||
*[[Vincristine (Oncovin)]] as follows: | *[[Vincristine (Oncovin)]] as follows: | ||
Line 158: | Line 154: | ||
**Cycle 11: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | **Cycle 11: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | ||
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | |||
====Chemotherapy, VDC portion Regimen A<sub>2</sub> & A<sub>3</sub> (Radiation w/ or w/o Surgery)==== | ====Chemotherapy, VDC portion Regimen A<sub>2</sub> & A<sub>3</sub> (Radiation w/ or w/o Surgery)==== | ||
*[[Vincristine (Oncovin)]] as follows: | *[[Vincristine (Oncovin)]] as follows: | ||
Line 177: | Line 172: | ||
**Cycle 11: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | **Cycle 11: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | ||
**ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | **ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | |||
====Chemotherapy, VC portion==== | ====Chemotherapy, VC portion==== | ||
*[[Vincristine (Oncovin)]] as follows: | *[[Vincristine (Oncovin)]] as follows: | ||
Line 193: | Line 187: | ||
**Cycle 13: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | **Cycle 13: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | ||
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | '''21-day cycle''' | + | '''21-day cycle for 9 cycles (13 cycles total)''' |
</div></div></div> | </div></div></div> | ||
===References=== | ===References=== | ||
Line 213: | Line 207: | ||
|- | |- | ||
|} | |} | ||
+ | ''Note: Protocol B is a consolidated regimen consisting of 14-day cycles.'' | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Induction=== | ===Induction=== | ||
− | |||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy, VDC portion==== | ====Chemotherapy, VDC portion==== | ||
*[[Vincristine (Oncovin)]] as follows: | *[[Vincristine (Oncovin)]] as follows: | ||
− | **Cycles 1, 3, | + | **Cycles 1, 3, 5: 2 mg/m<sup>2</sup> IV push once on day 1 (maximum dose of 2 mg) |
***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 | ||
*[[Doxorubicin (Adriamycin)]] as follows: | *[[Doxorubicin (Adriamycin)]] as follows: | ||
− | **Cycles 1, 3, | + | **Cycles 1, 3, 5: 75 mg/m<sup>2</sup> IV infusion over 48 hours 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 | ***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)]] as follows: | *[[Cyclophosphamide (Cytoxan)]] as follows: | ||
− | **Cycles 1, 3, | + | **Cycles 1, 3, 5: 1200 mg/m<sup>2</sup> IV over 1 hour on Days 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 | ***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==== | ====Supportive therapy, VDC portion==== | ||
*[[Mesna (Mesnex)]] as follows: | *[[Mesna (Mesnex)]] as follows: | ||
− | **Cycles 1, 3, | + | **Cycles 1, 3, 5: 720 mg/m<sup>2</sup> IV continuous infusion on day 1 |
***NOTE: Protocol states that [[Mesna (Mesnex)]] should be dosed as AT LEAST 60% of [[Cyclophosphamide (Cytoxan)]] m<sup>2</sup> | ***NOTE: Protocol states that [[Mesna (Mesnex)]] should be dosed as AT LEAST 60% of [[Cyclophosphamide (Cytoxan)]] m<sup>2</sup> | ||
***[[Mesna (Mesnex)]] continuous infusion should be started at the same time as the [[Cyclophosphamide (Cytoxan)]] and remain until at least 8 hours after the end of the [[Cyclophosphamide (Cytoxan)]] infusion | ***[[Mesna (Mesnex)]] continuous infusion should be started at the same time as the [[Cyclophosphamide (Cytoxan)]] and remain until at least 8 hours after the end of the [[Cyclophosphamide (Cytoxan)]] infusion | ||
*[[Filgrastim (Neupogen)]] as follows: | *[[Filgrastim (Neupogen)]] as follows: | ||
− | **Cycles 1, 3, | + | **Cycles 1, 3, 5: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 |
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | |||
====Chemotherapy, IE portion==== | ====Chemotherapy, IE portion==== | ||
*[[Ifosfamide (Ifex)]] as follows: | *[[Ifosfamide (Ifex)]] as follows: | ||
− | ** | + | **Cycles 2, 4, 6: 1800 mg/m<sup>2</sup> IV infusion over 1 hour once on day 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 | ***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)]] as follows: | *[[Etoposide (Vepesid)]] as follows: | ||
− | ** | + | **Cycles 2, 4, 6: 100 mg/m<sup>2</sup> IV infusion over 1 to 2 hours once 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 | ***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, IE portion==== | ====Supportive therapy, IE portion==== | ||
*[[Mesna (Mesnex)]] as follows: | *[[Mesna (Mesnex)]] as follows: | ||
− | ** | + | **Cycles 2, 4, 6: 1080 mg/m<sup>2</sup> IV continuous infusion on day 1 |
***NOTE: Protocol states that [[Mesna (Mesnex)]] should be dosed as AT LEAST 60% of [[Ifosfamide (Ifex)]] m<sup>2</sup> | ***NOTE: Protocol states that [[Mesna (Mesnex)]] should be dosed as AT LEAST 60% of [[Ifosfamide (Ifex)]] m<sup>2</sup> | ||
***[[Mesna (Mesnex)]] continuous infusion should be started at the same time as the [[Ifosfamide (Ifex)]] and remain until at least 8 hours after the end of the [[Ifosfamide (Ifex)]] infusion | ***[[Mesna (Mesnex)]] continuous infusion should be started at the same time as the [[Ifosfamide (Ifex)]] and remain until at least 8 hours after the end of the [[Ifosfamide (Ifex)]] infusion | ||
*[[Filgrastim (Neupogen)]] as follows: | *[[Filgrastim (Neupogen)]] as follows: | ||
− | ** | + | **Cycles 2, 4, 6: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 6 |
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | '''14-day cycle''' | + | '''14-day cycle for 6 cycles, followed by:''' |
</div></div><br> | </div></div><br> | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
Line 257: | Line 250: | ||
*At week 13 patients either underwent surgery, received radiation, or both | *At week 13 patients either underwent surgery, received radiation, or both | ||
*Radiation coincided with cycle 7 | *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 B<sub>2</sub>.'' | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy, VDC portion==== | ====Chemotherapy, VDC portion==== | ||
− | |||
*[[Vincristine (Oncovin)]] as follows: | *[[Vincristine (Oncovin)]] as follows: | ||
**Cycle 7: 2 mg/m<sup>2</sup> IV push once on day 1 (maximum dose of 2 mg) | **Cycle 7: 2 mg/m<sup>2</sup> IV push once on day 1 (maximum dose of 2 mg) | ||
Line 277: | Line 270: | ||
**Cycle 7: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | **Cycle 7: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | ||
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | |||
====Chemotherapy, IE portion==== | ====Chemotherapy, IE portion==== | ||
*[[Ifosfamide (Ifex)]] as follows: | *[[Ifosfamide (Ifex)]] as follows: | ||
− | ** | + | **Cycles 8, 10, 12, 14: 1800 mg/m<sup>2</sup> IV infusion over 1 hour once on day 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 | ***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)]] as follows: | *[[Etoposide (Vepesid)]] as follows: | ||
− | ** | + | **Cycles 8, 10, 12, 14: 100 mg/m<sup>2</sup> IV infusion over 1 to 2 hours once 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 | ***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, IE portion==== | ====Supportive therapy, IE portion==== | ||
*[[Mesna (Mesnex)]] as follows: | *[[Mesna (Mesnex)]] as follows: | ||
− | ** | + | **Cycles 8, 10, 12, 14: 1080 mg/m<sup>2</sup> IV continuous infusion on day 1 |
***NOTE: Protocol states that [[Mesna (Mesnex)]] should be dosed as AT LEAST 60% of [[Ifosfamide (Ifex)]] m<sup>2</sup> | ***NOTE: Protocol states that [[Mesna (Mesnex)]] should be dosed as AT LEAST 60% of [[Ifosfamide (Ifex)]] m<sup>2</sup> | ||
***[[Mesna (Mesnex)]] continuous infusion should be started at the same time as the [[Ifosfamide (Ifex)]] and remain until at least 8 hours after the end of the [[Ifosfamide (Ifex)]] infusion | ***[[Mesna (Mesnex)]] continuous infusion should be started at the same time as the [[Ifosfamide (Ifex)]] and remain until at least 8 hours after the end of the [[Ifosfamide (Ifex)]] infusion | ||
*[[Filgrastim (Neupogen)]] as follows: | *[[Filgrastim (Neupogen)]] as follows: | ||
− | ** | + | **Cycles 8, 10, 12, 14: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 6 |
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 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> (Surgery Only)==== | ====Chemotherapy, VDC portion Regimen B<sub>1</sub> (Surgery Only)==== | ||
*[[Vincristine (Oncovin)]] as follows: | *[[Vincristine (Oncovin)]] as follows: | ||
Line 312: | Line 303: | ||
**Cycle 9: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | **Cycle 9: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | ||
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | |||
====Chemotherapy, VC portion Regimen B<sub>2</sub> & B<sub>3</sub> (Radiation w/ or w/o Surgery)==== | ====Chemotherapy, VC portion Regimen B<sub>2</sub> & B<sub>3</sub> (Radiation w/ or w/o Surgery)==== | ||
*[[Vincristine (Oncovin)]] as follows: | *[[Vincristine (Oncovin)]] as follows: | ||
Line 328: | Line 318: | ||
**Cycle 9: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | **Cycle 9: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | ||
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | |||
====Chemotherapy, VC portion==== | ====Chemotherapy, VC portion==== | ||
*[[Vincristine (Oncovin)]] as follows: | *[[Vincristine (Oncovin)]] as follows: | ||
Line 344: | Line 333: | ||
**Cycle 11: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | **Cycle 11: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | ||
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | |||
====Chemotherapy, VC portion Regimen B<sub>1</sub> (Surgery Only)==== | ====Chemotherapy, VC portion Regimen B<sub>1</sub> (Surgery Only)==== | ||
*[[Vincristine (Oncovin)]] as follows: | *[[Vincristine (Oncovin)]] as follows: | ||
Line 360: | Line 348: | ||
**Cycle 13: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | **Cycle 13: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | ||
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 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> (Radiation w/ or w/o Surgery)==== | ====Chemotherapy, VDC portion Regimen B<sub>2</sub> & B<sub>3</sub> (Radiation w/ or w/o Surgery)==== | ||
*[[Vincristine (Oncovin)]] as follows: | *[[Vincristine (Oncovin)]] as follows: | ||
Line 379: | Line 366: | ||
**Cycle 13: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | **Cycle 13: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2 | ||
***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ***ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF | ||
− | '''14-day cycle''' | + | '''14-day cycle for 8 cycles (14 cycles total)''' |
</div></div></div> | </div></div></div> | ||
===References=== | ===References=== |
Revision as of 18:34, 3 May 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
|
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
- Vincristine (Oncovin) as follows:
- Cycles 1 & 3: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- 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
- Cycles 1 & 3: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- Doxorubicin (Adriamycin) as follows:
- Cycles 1 & 3: 75 mg/m2 IV infusion over 48 hours 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
- Cycles 1 & 3: 75 mg/m2 IV infusion over 48 hours once on day 1
- Cyclophosphamide (Cytoxan) as follows:
- Cycles 1 & 3: 1200 mg/m2 IV over 1 hour on Days 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
- Cycles 1 & 3: 1200 mg/m2 IV over 1 hour on Days 1
Supportive therapy, VDC portion
- Mesna (Mesnex) as follows:
- Cycles 1 & 3: 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Cyclophosphamide (Cytoxan) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Cyclophosphamide (Cytoxan) and remain until at least 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion
- Cycles 1 & 3: 720 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycles 1 & 3: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycles 1 & 3: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
Chemotherapy, IE portion
- Ifosfamide (Ifex) as follows:
- Cycles 2 & 4: 1800 mg/m2 IV infusion over 1 hour once on day 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
- Cycles 2 & 4: 1800 mg/m2 IV infusion over 1 hour once on day 1 to 5
- Etoposide (Vepesid) as follows:
- Cycles 2 & 4: 100 mg/m2 IV infusion over 1 to 2 hours once 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
- Cycles 2 & 4: 100 mg/m2 IV infusion over 1 to 2 hours once on days 1 to 5
Supportive therapy, IE portion
- Mesna (Mesnex) as follows:
- Cycles 2 & 4: 1080 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Ifosfamide (Ifex) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Ifosfamide (Ifex) and remain until at least 8 hours after the end of the Ifosfamide (Ifex) infusion
- Cycles 2 & 4: 1080 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycles 2 & 4: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 6
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycles 2 & 4: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 6
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
Cycle 5 begins on week 15 in patients receiving surgery and on week 13 in Regimen A2
- Vincristine (Oncovin) as follows:
- Cycle 5 & 9: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- 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
- Cycle 5 & 9: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- Doxorubicin (Adriamycin) as follows:
- Cycle 5 & 9: 75 mg/m2 IV infusion over 48 hours 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
- Cycle 5 & 9: 75 mg/m2 IV infusion over 48 hours once on day 1
- Cyclophosphamide (Cytoxan) as follows:
- Cycle 5 & 9: 1200 mg/m2 IV over 1 hour on Days 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
- Cycle 5 & 9: 1200 mg/m2 IV over 1 hour on Days 1
Supportive medication, VDC portion
- Mesna (Mesnex) as follows:
- Cycle 5 & 9: 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Cyclophosphamide (Cytoxan) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Cyclophosphamide (Cytoxan) and remain until at least 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion
- Cycle 5 & 9: 720 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycle 5 & 9: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycle 5 & 9: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
Chemotherapy, IE portion
- Ifosfamide (Ifex) as follows:
- Cycle 6, 8, 10, 12, & 14: 1800 mg/m2 IV infusion over 1 hour once on day 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
- Cycle 6, 8, 10, 12, & 14: 1800 mg/m2 IV infusion over 1 hour once on day 1 to 5
- Etoposide (Vepesid) as follows:
- Cycle 6, 8, 10, 12, & 14: 100 mg/m2 IV infusion over 1 to 2 hours once 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
- Cycle 6, 8, 10, 12, & 14: 100 mg/m2 IV infusion over 1 to 2 hours once on days 1 to 5
Supportive therapy, IE portion
- Mesna (Mesnex) as follows:
- Cycle 6, 8, 10, 12, & 14: 1080 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Ifosfamide (Ifex) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Ifosfamide (Ifex) and remain until at least 8 hours after the end of the Ifosfamide (Ifex) infusion
- Cycle 6, 8, 10, 12, & 14: 1080 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycle 6, 8, 10, 12, & 14: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 6
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycle 6, 8, 10, 12, & 14: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 6
Chemotherapy, VDC portion Regimen A1 (Surgery Only)
- Vincristine (Oncovin) as follows:
- Cycle 7: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- 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
- Cycle 7: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- Doxorubicin (Adriamycin) as follows:
- Cycle 7: 75 mg/m2 IV infusion over 48 hours 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
- Cycle 7: 75 mg/m2 IV infusion over 48 hours once on day 1
- Cyclophosphamide (Cytoxan) as follows:
- Cycle 7: 1200 mg/m2 IV over 1 hour on Days 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
- Cycle 7: 1200 mg/m2 IV over 1 hour on Days 1
Supportive therapy, VDC portion Regimen A1 (Surgery Only)
- Mesna (Mesnex) as follows:
- Cycle 7: 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Cyclophosphamide (Cytoxan) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Cyclophosphamide (Cytoxan) and remain until at least 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion
- Cycle 7: 720 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycle 7: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, VC portion Regimen A2 & A3 (Radiation w/ or w/o Surgery)
- Vincristine (Oncovin) as follows:
- Cycle 7: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- 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
- Cycle 7: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- Cyclophosphamide (Cytoxan) as follows:
- Cycle 7: 1200 mg/m2 IV over 1 hour on Days 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
- Cycle 7: 1200 mg/m2 IV over 1 hour on Days 1
Supportive therapy, VC portion Regimen A2 & A3 (Radiation w/ or w/o Surgery)
- Mesna (Mesnex) as follows:
- Cycle 7: 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Cyclophosphamide (Cytoxan) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Cyclophosphamide (Cytoxan) and remain until at least 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion
- Cycle 7: 720 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycle 7: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, VC portion Regimen A1 (Surgery Only)
- Vincristine (Oncovin) as follows:
- Cycle 11: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- 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
- Cycle 11: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- Cyclophosphamide (Cytoxan) as follows:
- Cycle 11: 1200 mg/m2 IV over 1 hour on Days 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
- Cycle 11: 1200 mg/m2 IV over 1 hour on Days 1
Supportive therapy, VC portion Regimen A1 (Surgery Only)
- Mesna (Mesnex) as follows:
- Cycle 11: 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Cyclophosphamide (Cytoxan) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Cyclophosphamide (Cytoxan) and remain until at least 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion
- Cycle 11: 720 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycle 11: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycle 11: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
Chemotherapy, VDC portion Regimen A2 & A3 (Radiation w/ or w/o Surgery)
- Vincristine (Oncovin) as follows:
- Cycle 11: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- 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
- Cycle 11: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- Doxorubicin (Adriamycin) as follows:
- Cycle 11: 75 mg/m2 IV infusion over 48 hours 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
- Cycle 11: 75 mg/m2 IV infusion over 48 hours once on day 1
- Cyclophosphamide (Cytoxan) as follows:
- Cycle 11: 1200 mg/m2 IV over 1 hour on Days 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
- Cycle 11: 1200 mg/m2 IV over 1 hour on Days 1
Supportive therapy, VDC portion Regimen A2 & A3 (Radiation w/ or w/o Surgery)
- Mesna (Mesnex) as follows:
- Cycle 11: 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Cyclophosphamide (Cytoxan) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Cyclophosphamide (Cytoxan) and remain until at least 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion
- Cycle 11: 720 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycle 11: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
Chemotherapy, VC portion
- Vincristine (Oncovin) as follows:
- Cycle 13: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- 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
- Cycle 13: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- Cyclophosphamide (Cytoxan) as follows:
- Cycle 13: 1200 mg/m2 IV over 1 hour on Days 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
- Cycle 13: 1200 mg/m2 IV over 1 hour on Days 1
Supportive therapy, VC portion
- Mesna (Mesnex) as follows:
- Cycle 13: 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Cyclophosphamide (Cytoxan) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Cyclophosphamide (Cytoxan) and remain until at least 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion
- Cycle 13: 720 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycle 13: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycle 13: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
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
- Vincristine (Oncovin) as follows:
- Cycles 1, 3, 5: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- 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
- Cycles 1, 3, 5: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- Doxorubicin (Adriamycin) as follows:
- Cycles 1, 3, 5: 75 mg/m2 IV infusion over 48 hours 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
- Cycles 1, 3, 5: 75 mg/m2 IV infusion over 48 hours once on day 1
- Cyclophosphamide (Cytoxan) as follows:
- Cycles 1, 3, 5: 1200 mg/m2 IV over 1 hour on Days 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
- Cycles 1, 3, 5: 1200 mg/m2 IV over 1 hour on Days 1
Supportive therapy, VDC portion
- Mesna (Mesnex) as follows:
- Cycles 1, 3, 5: 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Cyclophosphamide (Cytoxan) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Cyclophosphamide (Cytoxan) and remain until at least 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion
- Cycles 1, 3, 5: 720 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycles 1, 3, 5: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycles 1, 3, 5: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
Chemotherapy, IE portion
- Ifosfamide (Ifex) as follows:
- Cycles 2, 4, 6: 1800 mg/m2 IV infusion over 1 hour once on day 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
- Cycles 2, 4, 6: 1800 mg/m2 IV infusion over 1 hour once on day 1 to 5
- Etoposide (Vepesid) as follows:
- Cycles 2, 4, 6: 100 mg/m2 IV infusion over 1 to 2 hours once 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
- Cycles 2, 4, 6: 100 mg/m2 IV infusion over 1 to 2 hours once on days 1 to 5
Supportive therapy, IE portion
- Mesna (Mesnex) as follows:
- Cycles 2, 4, 6: 1080 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Ifosfamide (Ifex) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Ifosfamide (Ifex) and remain until at least 8 hours after the end of the Ifosfamide (Ifex) infusion
- Cycles 2, 4, 6: 1080 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycles 2, 4, 6: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 6
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycles 2, 4, 6: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 6
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
- Vincristine (Oncovin) as follows:
- Cycle 7: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- 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
- Cycle 7: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- Doxorubicin (Adriamycin) as follows:
- Cycle 7: 75 mg/m2 IV infusion over 48 hours 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
- Cycle 7: 75 mg/m2 IV infusion over 48 hours once on day 1
- Cyclophosphamide (Cytoxan) as follows:
- Cycle 7: 1200 mg/m2 IV over 1 hour on Days 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
- Cycle 7: 1200 mg/m2 IV over 1 hour on Days 1
Supportive therapy, VDC portion
- Mesna (Mesnex) as follows:
- Cycle 7: 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Cyclophosphamide (Cytoxan) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Cyclophosphamide (Cytoxan) and remain until at least 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion
- Cycle 7: 720 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycle 7: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycle 7: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
Chemotherapy, IE portion
- Ifosfamide (Ifex) as follows:
- Cycles 8, 10, 12, 14: 1800 mg/m2 IV infusion over 1 hour once on day 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
- Cycles 8, 10, 12, 14: 1800 mg/m2 IV infusion over 1 hour once on day 1 to 5
- Etoposide (Vepesid) as follows:
- Cycles 8, 10, 12, 14: 100 mg/m2 IV infusion over 1 to 2 hours once 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
- Cycles 8, 10, 12, 14: 100 mg/m2 IV infusion over 1 to 2 hours once on days 1 to 5
Supportive therapy, IE portion
- Mesna (Mesnex) as follows:
- Cycles 8, 10, 12, 14: 1080 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Ifosfamide (Ifex) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Ifosfamide (Ifex) and remain until at least 8 hours after the end of the Ifosfamide (Ifex) infusion
- Cycles 8, 10, 12, 14: 1080 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycles 8, 10, 12, 14: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 6
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycles 8, 10, 12, 14: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 6
Chemotherapy, VDC portion Regimen B1 (Surgery Only)
- Vincristine (Oncovin) as follows:
- Cycle 9: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- 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
- Cycle 9: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- Doxorubicin (Adriamycin) as follows:
- Cycle 9: 75 mg/m2 IV infusion over 48 hours 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
- Cycle 9: 75 mg/m2 IV infusion over 48 hours once on day 1
- Cyclophosphamide (Cytoxan) as follows:
- Cycle 9: 1200 mg/m2 IV over 1 hour on Days 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
- Cycle 9: 1200 mg/m2 IV over 1 hour on Days 1
Supportive therapy, VDC portion Regimen B1 (Surgery Only)
- Mesna (Mesnex) as follows:
- Cycle 9: 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Cyclophosphamide (Cytoxan) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Cyclophosphamide (Cytoxan) and remain until at least 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion
- Cycle 9: 720 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycle 9: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycle 9: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
Chemotherapy, VC portion Regimen B2 & B3 (Radiation w/ or w/o Surgery)
- Vincristine (Oncovin) as follows:
- Cycle 9: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- 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
- Cycle 9: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- Cyclophosphamide (Cytoxan) as follows:
- Cycle 9: 1200 mg/m2 IV over 1 hour on Days 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
- Cycle 9: 1200 mg/m2 IV over 1 hour on Days 1
Supportive therapy, VC portion Regimen B2 & B3 (Radiation w/ or w/o Surgery)
- Mesna (Mesnex) as follows:
- Cycle 9: 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Cyclophosphamide (Cytoxan) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Cyclophosphamide (Cytoxan) and remain until at least 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion
- Cycle 9: 720 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycle 9: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycle 9: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
Chemotherapy, VC portion
- Vincristine (Oncovin) as follows:
- Cycle 11: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- 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
- Cycle 11: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- Cyclophosphamide (Cytoxan) as follows:
- Cycle 11: 1200 mg/m2 IV over 1 hour on Days 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
- Cycle 11: 1200 mg/m2 IV over 1 hour on Days 1
Supportive therapy, VC portion
- Mesna (Mesnex) as follows:
- Cycle 11: 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Cyclophosphamide (Cytoxan) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Cyclophosphamide (Cytoxan) and remain until at least 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion
- Cycle 11: 720 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycle 11: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycle 11: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
Chemotherapy, VC portion Regimen B1 (Surgery Only)
- Vincristine (Oncovin) as follows:
- Cycle 13: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- 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
- Cycle 13: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- Cyclophosphamide (Cytoxan) as follows:
- Cycle 13: 1200 mg/m2 IV over 1 hour on Days 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
- Cycle 13: 1200 mg/m2 IV over 1 hour on Days 1
Supportive therapy, VC portion Regimen B1 (Surgery Only)
- Mesna (Mesnex) as follows:
- Cycle 13: 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Cyclophosphamide (Cytoxan) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Cyclophosphamide (Cytoxan) and remain until at least 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion
- Cycle 13: 720 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycle 13: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycle 13: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
Chemotherapy, VDC portion Regimen B2 & B3 (Radiation w/ or w/o Surgery)
- Vincristine (Oncovin) as follows:
- Cycle 13: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- 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
- Cycle 13: 2 mg/m2 IV push once on day 1 (maximum dose of 2 mg)
- Doxorubicin (Adriamycin) as follows:
- Cycle 13: 75 mg/m2 IV infusion over 48 hours 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
- Cycle 13: 75 mg/m2 IV infusion over 48 hours once on day 1
- Cyclophosphamide (Cytoxan) as follows:
- Cycle 13: 1200 mg/m2 IV over 1 hour on Days 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
- Cycle 13: 1200 mg/m2 IV over 1 hour on Days 1
Supportive therapy, VDC portion Regimen B2 & B3 (Radiation w/ or w/o Surgery)
- Mesna (Mesnex) as follows:
- Cycle 13: 720 mg/m2 IV continuous infusion on day 1
- NOTE: Protocol states that Mesna (Mesnex) should be dosed as AT LEAST 60% of Cyclophosphamide (Cytoxan) m2
- Mesna (Mesnex) continuous infusion should be started at the same time as the Cyclophosphamide (Cytoxan) and remain until at least 8 hours after the end of the Cyclophosphamide (Cytoxan) infusion
- Cycle 13: 720 mg/m2 IV continuous infusion on day 1
- Filgrastim (Neupogen) as follows:
- Cycle 13: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
- ANC ≥ 750/μl on or before day 7 of the cycle is not sufficient for discontinuing G-CSF
- Cycle 13: 5 mcg/kg SC for at least 7 days, or until ANC ≥ 750/μl, beginning on day 2
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