Osteosarcoma, pediatric

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COG AOST0331 MAP Group

Induction

Received by all patients and consists of 2 cycles of MAP.

Chemotherapy

• Cisplatin (Platinol) 60 mg/m² IV infusion over 4 hours, started on day 1 of weeks 1 and 6
• Doxorubicin (Adriamycin) 37.5 mg/m²/day (total dose is 75 mg/m² given as a 48 hour infusion) on days 1 to 2 of Weeks 1 and 6
• Methotrexate (MTX) 12 g/m² (MAX DOSE = 20 grams) IV over 4 hours once on day 1 of weeks 4, 5, 9, and 10.
• Folinic acid (Leucovorin) 15 mg/m² PO or IV every 6 hours beginning 24 hours after the beginning of the Methotrexate (MTX) infusion and continuing until the serum Methotrexate (MTX) level is less than 0.1 μM.

10 Week Course

References

1. COG AOST0331: Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier H, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, JAneway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international randomized controlled trial. J Clin Oncol. 2020 Fe1b 20;38(6):602-62. Epub 2019 Dec 11. link to original article link to PMC article contains verified protocol PubMed NCT00134030

MAP Cycles 3-4

Good Responders and Poor Responders

Chemotherapy

• Cisplatin (Platinol) 60 mg/m² IV infusion over 4 hours, started on day 1 of weeks 12 and 17
• Doxorubicin (Adriamycin) 37.5 mg/m²/day (total dose is 75 mg/m² given as a 48 hour infusion) on days 1 to 2 of Weeks 12 and 17.
• Methotrexate (MTX) 12 g/m² (MAX DOSE = 20 grams) IV over 4 hours once on day 1 of weeks 15, 16, 20, and 21.
• Folinic acid (Leucovorin) 15 mg/m² PO or IV every 6 hours beginning 24 hours after the beginning of the Methotrexate (MTX) infusion and continuing until the serum Methotrexate (MTX) level is less than 0.1 μM.

10 Week Course

References

1. COG AOST0331: Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier H, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, JAneway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international randomized controlled trial. J Clin Oncol. 2020 Feb 20;38(6):602-612. Epub 2019 Dec 11. link to original article link to PMC article contains verified protocol PubMed NCT00134030

MAP Cycles 5-6

Good Responders and Poor Responders

Chemotherapy

• Doxorubicin (Adriamycin) 37.5 mg/m²/day (total dose is 75 mg/m² given as a 48 hour infusion) on days 1 to 2 of Weeks 22 and 26.
• Methotrexate (MTX) 12 g/m² (MAX DOSE = 20 grams) IV over 4 hours once on day 1 of weeks 24, 25, 28, and 29.
• Folinic acid (Leucovorin) 15 mg/m² PO or IV every 6 hours beginning 24 hours after the beginning of the Methotrexate (MTX) infusion and continuing until the serum Methotrexate (MTX) level is less than 0.1 μM.

10 Week Course

References

1. COG AOST0331: Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier H, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, JAneway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international randomized controlled trial. J Clin Oncol. 2020 Feb 20;38(6):602-612. Epub 2019 Dec 11. link to original article link to PMC article contains verified protocol PubMed NCT00134030

COG AOST0331 MAPifn Group

Induction

Received by all patients and consists of 2 cycles of MAP.

Chemotherapy

• Cisplatin (Platinol) 60 mg/m² IV infusion over 4 hours, started on day 1 of weeks 1 and 6
• Doxorubicin (Adriamycin) 37.5 mg/m²/day (total dose is 75 mg/m² given as a 48 hour infusion) on days 1 to 2 of Weeks 1 and 6
• Methotrexate (MTX) 12 g/m² (MAX DOSE = 20 grams) IV over 4 hours once on day 1 of weeks 4, 5, 9, and 10.
• Folinic acid (Leucovorin) 15 mg/m² PO or IV every 6 hours beginning 24 hours after the beginning of the Methotrexate (MTX) infusion and continuing until the serum Methotrexate (MTX) level is less than 0.1 μM.

10 Week Course

References

1. COG AOST0331: Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier H, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, JAneway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international randomized controlled trial. J Clin Oncol. 2020 Feb 20;38(6):602-612. Epub 2019 Dec 11. link to original article link to PMC article contains verified protocol PubMed NCT00134030

MAPifn Cycles 3-4

Good Responders

Chemotherapy

• Cisplatin (Platinol) 60 mg/m² IV infusion over 4 hours, started on day 1 of weeks 12 and 17
• Doxorubicin (Adriamycin) 37.5 mg/m²/day (total dose is 75 mg/m² given as a 48 hour infusion) on days 1 to 2 of Weeks 12 and 17.
• Methotrexate (MTX) 12 g/m² (MAX DOSE = 20 grams) IV over 4 hours once on day 1 of weeks 15, 16, 20, and 21.
• Folinic acid (Leucovorin) 15 mg/m² PO or IV every 6 hours beginning 24 hours after the beginning of the Methotrexate (MTX) infusion and continuing until the serum Methotrexate (MTX) level is less than 0.1 μM.

10 Week Course

References

1. COG AOST0331: Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier H, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, JAneway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international randomized controlled trial. J Clin Oncol. 2020 Feb 20;38(6):602-612. Epub 2019 Dec 11. link to original article link to PMC article contains verified protocol PubMed NCT00134030

MAPifn Cycles 5-6

Good Responders

Chemotherapy

• Doxorubicin (Adriamycin) 37.5 mg/m²/day (total dose is 75 mg/m² given as a 48 hour infusion) on days 1 to 2 of Weeks 22 and 26.
• Methotrexate (MTX) 12 g/m² (MAX DOSE = 20 grams) IV over 4 hours once on day 1 of weeks 24, 25, 28, and 29.
• Folinic acid (Leucovorin) 15 mg/m² PO or IV every 6 hours beginning 24 hours after the beginning of the Methotrexate (MTX) infusion and continuing until the serum Methotrexate (MTX) level is less than 0.1 μM.

10 Week Course

References

1. COG AOST0331: Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier H, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, JAneway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international randomized controlled trial. J Clin Oncol. 2020 Feb 20;38(6):602-612. Epub 2019 Dec 11. link to original article link to PMC article contains verified protocol PubMed NCT00134030

MAPifn Weeks 30-104

Good Responders

Chemotherapy

• Peginterferon alfa-2b (PegIntron) 0.5 μg/kg/day (MAX DOSE = 50 μg) subcutaneously on day 1 of Weeks 30, 31, 32, and 33.
  • If well tolerated during first 4 weeks of therapy, escalate dose.
• Peginterferon alfa-2b (PegIntron) 1 μg/kg/day (MAX DOSE = 100 μg) subcutaneously on day 1 of Weeks 34 through 104.

75 Week Course

References

1. COG AOST0331: Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier H, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, JAneway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international randomized controlled trial. J Clin Oncol. 2020 Feb 20;38(6):602-612. Epub 2019 Dec 11. link to original article link to PMC article contains verified protocol PubMed NCT00134030

COG AOST0331 MAPIE Group

Induction

Received by all patients and consists of 2 cycles of MAP.

Chemotherapy

• Cisplatin (Platinol) 60 mg/m² IV infusion over 4 hours, started on day 1 of weeks 1 and 6
• Doxorubicin (Adriamycin) 37.5 mg/m²/day (total dose is 75 mg/m² given as a 48 hour infusion) on days 1 to 2 of Weeks 1 and 6
• Methotrexate (MTX) 12 g/m² (MAX DOSE = 20 grams) IV over 4 hours once on day 1 of weeks 4, 5, 9, and 10.
• Folinic acid (Leucovorin) 15 mg/m² PO or IV every 6 hours beginning 24 hours after the beginning of the Methotrexate (MTX) infusion and continuing until the serum Methotrexate (MTX) level is less than 0.1 μM.

10 Week Course

References

1. COG AOST0331: Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier H, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, JAneway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international randomized controlled trial. J Clin Oncol. 2020 Feb 20;38(6):602-612. Epub 2019 Dec 11. link to original article link to PMC article contains verified protocol PubMed NCT00134030

MAPIE Cycles 3 and 7

Poor Responders

Chemotherapy

• Cisplatin (Platinol) 60 mg/m² IV infusion over 4 hours, started on day 1 of weeks 12 and 28
• Doxorubicin (Adriamycin) 37.5 mg/m²/day (total dose is 75 mg/m² given as a 48 hour infusion) on days 1 to 2 of Weeks 12 and 28.
• Methotrexate (MTX) 12 g/m² (MAX DOSE = 20 grams) IV over 4 hours once on day 1 of weeks 15 and 31.
• Folinic acid (Leucovorin) 15 mg/m² PO or IV every 6 hours beginning 24 hours after the beginning of the Methotrexate (MTX) infusion and continuing until the serum Methotrexate (MTX) level is less than 0.1 μM.

5-Week Courses

References

1. COG AOST0331: Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier H, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, JAneway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international randomized controlled trial. J Clin Oncol. 2020 Feb 20;38(6):602-612. Epub 2019 Dec 11. link to original article link to PMC article contains verified protocol PubMed NCT00134030

MAP Cycles 4, 6, and 8

Poor Responders

Chemotherapy

• Ifosfamide (Ifex) 2.8 g/m²/dose IV over 4 hours once per day on days 1 through 5 of weeks 16, 24, and 32.
• Etoposide (Vepesid) 100 mg/m²/dose IV over 60 minutes once per day on days 1 through 5 of weeks 16, 24, and 32.
• Mesna (Mesnex) 2.8 g/m²/24 hours IV continuous infusion over 24 hours on days 1 through 5 of weeks 16, 24, and 32.
• Methotrexate (MTX) 12 g/m² (MAX DOSE = 20 grams) IV over 4 hours once on day 1 of weeks 19, 27, and 35.
• Folinic acid (Leucovorin) 15 mg/m² PO or IV every 6 hours beginning 24 hours after the beginning of the Methotrexate (MTX) infusion and continuing until the serum Methotrexate (MTX) level is less than 0.1 μM.

5-Week Courses

References

1. COG AOST0331: Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier H, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, JAneway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international randomized controlled trial. J Clin Oncol. 2020 Feb 20;38(6):602-612. Epub 2019 Dec 11. link to original article link to PMC article contains verified protocol PubMed NCT00134030

MAP Cycle 5

Poor Responders

Chemotherapy

• Doxorubicin (Adriamycin) 37.5 mg/m²/day (total dose is 75 mg/m² given as a 48 hour infusion) on days 1 to 2 of Week 20.
• Ifosfamide (Ifex) 3 g/m²/dose IV over 4 hours once per day on days 1, 2, and 3 of weeks 20.
• Mesna (Mesnex) 3 g/m²/24 hours IV continuous infusion over 24 hours on days 1, 2, and 3 of weeks 20.
• Methotrexate (MTX) 12 g/m² (MAX DOSE = 20 grams) IV over 4 hours once on day 1 of weeks 23.
• Folinic acid (Leucovorin) 15 mg/m² PO or IV every 6 hours beginning 24 hours after the beginning of the Methotrexate (MTX) infusion and continuing until the serum Methotrexate (MTX) level is less than 0.1 μM.

5-Week Courses

References

1. COG AOST0331: Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier H, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, JAneway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international randomized controlled trial. J Clin Oncol. 2020 Feb 20;38(6):602-612. Epub 2019 Dec 11. link to original article link to PMC article contains verified protocol PubMed NCT00134030

MAP Cycle 9

Poor Responders

Chemotherapy

• Doxorubicin (Adriamycin) 37.5 mg/m²/day (total dose is 75 mg/m² given as a 48 hour infusion) on days 1 to 2 of Week 36.
• Ifosfamide (Ifex) 3 g/m²/dose IV over 4 hours once per day on days 1, 2, and 3 of weeks 36.
• Mesna (Mesnex) 3 g/m²/24 hours IV continuous infusion over 24 hours on days 1, 2, and 3 of weeks 36.
• Methotrexate (MTX) 12 g/m² (MAX DOSE = 20 grams) IV over 4 hours once on day 1 of weeks 39 and 40.
• Folinic acid (Leucovorin) 15 mg/m² PO or IV every 6 hours beginning 24 hours after the beginning of the Methotrexate (MTX) infusion and continuing until the serum Methotrexate (MTX) level is less than 0.1 μM.

5-Week Courses

References

1. COG AOST0331: Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, Berg H, Brennan B, Brichard B, Brown KLB, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier H, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PCW, Isakoff MS, JAneway KA, Jurgens H, Kager L, Kuhne T, Lau CC, Leavey PJ, Lessnick SL, Mascarenhas L, Meyers PA, Mottl H, Nathrath M, Papai Z, Randall RL, Reichardt P, Renard M, Safwat AA, Schwartz CL, Stevens MCG, Strauss SJ, Teot L, Werner M, Sydes MR, Whelan JS. Comparison of MAPIE versus MAP in patients with a poor response to preoperative chemotherapy for newly diagnosed high-grade osteosarcoma (EURAMOS-1): an open-label, international randomized controlled trial. J Clin Oncol. 2020 Feb 20;38(6):602-612. Epub 2019 Dec 11. link to original article link to PMC article contains verified protocol PubMed NCT00134030