Difference between revisions of "Osteosarcoma, pediatric"
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===References=== | ===References=== | ||
#'''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. [https://doi.org/10.1016/s1470-2045(16)30214-5 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5052459/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/27569442/ PubMed] NCT00134030 | #'''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. [https://doi.org/10.1016/s1470-2045(16)30214-5 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5052459/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/27569442/ PubMed] NCT00134030 | ||
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+ | [[Category:Pediatric solid tumors]] |
Revision as of 16:40, 22 January 2022
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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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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