Osteosarcoma, pediatric
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This page contains studies that were specific to pediatric populations. For the more general osteosarcoma page, follow this link.
All lines of therapy
MAP [COG AOST0331]
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Marina et al. 2016 (EURAMOS-1 poor response) | 2005-2011 | Phase 3 (C) | MAPIE | Did not meet primary endpoint of EFS |
Neoadjuvant therapy
Received by all patients and consists of 2 cycles of MAP.
Chemotherapy
- Cisplatin (Platinol) 60 mg/m2 IV over 4 hours once on day 1
- Doxorubicin (Adriamycin) 37.5 mg/m2/day IV continuous infusion over 48 hours, started on day 1 (total dose per cycle: 75 mg/m2)
- Methotrexate (MTX) 12,000 mg/m2 (maximum dose of 20,000 mg) IV over 4 hours once per day on days 22 & 29
Supportive therapy
- Leucovorin (Folinic acid) 15 mg/m2 PO or IV every 6 hours, beginning 24 hours after the beginning of each methotrexate infusion and continuing until the serum methotrexate level is less than 0.1 μM
35-day cycle for 2 cycles, followed by surgery
Definitive
Local therapy
- Surgical resection
Adjuvant therapy
MAP Cycles 3-4: Good Responders and Poor Responders; treatment starts 2 weeks after surgery (i.e., week 12 overall)
Chemotherapy
- Cisplatin (Platinol) 60 mg/m2 IV infusion over 4 hours once on day 1
- Doxorubicin (Adriamycin) 37.5 mg/m2/day IV continuous infusion over 48 hours, started on day 1 (total dose per cycle: 75 mg/m2)
- Methotrexate (MTX) 12,000 mg/m2 (maximum dose of 20,000 mg) IV over 4 hours once per day on days 22 & 29
Supportive therapy
- Leucovorin (Folinic acid) 15 mg/m2 PO or IV every 6 hours, beginning 24 hours after the beginning of each methotrexate infusion and continuing until the serum methotrexate level is less than 0.1 μM
35-day cycle for 2 cycles
Consolidation
MAP Cycles 5-6: Good Responders and Poor Responders
Chemotherapy
- Doxorubicin (Adriamycin) as follows:
- Weeks 22 & 26: 37.5 mg/m2/day IV continuous infusion over 48 hours, started on day 1 (total dose per infusion: 75 mg/m2)
- Methotrexate (MTX) 12,000 mg/m2 (maximum dose of 20,000 mg) IV over 4 hours once on day 1 of weeks 24, 25, 28, 29
- Leucovorin (Folinic acid) 15 mg/m2 PO or IV every 6 hours beginning 24 hours after the beginning of the methotrexate infusion and continuing until the serum methotrexate level is less than 0.1 μM
10 Week course
References
- EURAMOS-1 good response: Bielack SS, Smeland S, Whelan JS, Marina N, Jovic G, Hook JM, Krailo MD, Gebhardt M, Pápai Z, Meyer J, Nadel H, Randall RL, Deffenbaugh C, Nagarajan R, Brennan B, Letson GD, Teot LA, Goorin A, Baumhoer D, Kager L, Werner M, Lau CC, Sundby Hall K, Gelderblom H, Meyers P, Gorlick R, Windhager R, Helmke K, Eriksson M, Hoogerbrugge PM, Schomberg P, Tunn PU, Kühne T, Jürgens H, van den Berg H, Böhling T, Picton S, Renard M, Reichardt P, Gerss J, Butterfass-Bahloul T, Morris C, Hogendoorn PC, Seddon B, Calaminus G, Michelagnoli M, Dhooge C, Sydes MR, Bernstein M; EURAMOS-1 investigators. Methotrexate, doxorubicin, and cisplatin (MAP) plus maintenance pegylated interferon alfa-2b versus MAP alone in patients with resectable high-grade osteosarcoma and good histologic response to preoperative map: first results of the EURAMOS-1 good response randomized controlled trial. J Clin Oncol. 2015 Jul 10;33(20):2279-87. Epub 2015 Jun 1. link to original article link to PMC article PubMed
- EURAMOS-1 poor response: Marina NM, Smeland S, Bielack SS, Bernstein M, Jovic G, Krailo MD, Hook JM, Arndt C, van den Berg H, Brennan B, Brichard B, Brown KL, Butterfass-Bahloul T, Calaminus G, Daldrup-Link HE, Eriksson M, Gebhardt MC, Gelderblom H, Gerss J, Goldsby R, Goorin A, Gorlick R, Grier HE, Hale JP, Hall KS, Hardes J, Hawkins DS, Helmke K, Hogendoorn PC, Isakoff MS, Janeway KA, Jürgens H, Kager L, Kühne 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 MC, 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, randomised controlled trial. Lancet Oncol. 2016 Oct;17(10):1396-1408. Epub 2016 Aug 25. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT00134030