Difference between revisions of "Osteosarcoma, pediatric"
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| − | + | <big>''This page contains studies that were specific to pediatric populations. For the more general osteosarcoma page, follow [[Osteosarcoma|this link]].</big> | |
| − | =COG AOST0331 | + | =All lines of therapy= |
| − | == | + | ==MAP [COG AOST0331]== |
| + | <div class="toccolours" style="background-color:#c8a2c8"> | ||
| + | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| + | !style="width: 20%"|Study | ||
| + | !style="width: 20%"|Years of enrollment | ||
| + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | !style="width: 20%"|Comparator | ||
| + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
| + | |- | ||
| + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5052459/ Marina et al. 2016 (EURAMOS-1 poor response)] | ||
| + | |2005-2011 | ||
| + | |style="background-color:#1a9851"|Phase 3 (C) | ||
| + | |[[#MAPIE|MAPIE]] | ||
| + | | style="background-color:#ffffbf" |Did not meet primary endpoint of EFS | ||
| + | |- | ||
| + | |} | ||
| + | <div class="toccolours" style="background-color:#eeeeee"> | ||
| + | ===Neoadjuvant therapy=== | ||
Received by all patients and consists of 2 cycles of MAP. | Received by all patients and consists of 2 cycles of MAP. | ||
| − | ===Chemotherapy=== | + | <div class="toccolours" style="background-color:#b3e2cd"> |
| + | ====Chemotherapy==== | ||
*[[Cisplatin (Platinol)]] 60 mg/m<sup>2</sup> IV infusion over 4 hours, started on day 1 of weeks 1, 6 | *[[Cisplatin (Platinol)]] 60 mg/m<sup>2</sup> IV infusion over 4 hours, started on day 1 of weeks 1, 6 | ||
*[[Doxorubicin (Adriamycin)]] 37.5 mg/m<sup>2</sup> (total dose is 75 mg/m<sup>2</sup> given as a 48 hour infusion) on days 1 to 2 of Weeks 1, 6 | *[[Doxorubicin (Adriamycin)]] 37.5 mg/m<sup>2</sup> (total dose is 75 mg/m<sup>2</sup> given as a 48 hour infusion) on days 1 to 2 of Weeks 1, 6 | ||
| Line 21: | Line 39: | ||
'''10 Week course''' | '''10 Week course''' | ||
| − | + | </div></div><br> | |
| − | === | + | <div class="toccolours" style="background-color:#eeeeee"> |
| − | + | ===Adjuvant therapy=== | |
| − | + | MAP Cycles 3-4: Good Responders and Poor Responders | |
| − | ==MAP Cycles 3-4 | + | <div class="toccolours" style="background-color:#b3e2cd"> |
| − | Good Responders and Poor Responders | + | ====Chemotherapy==== |
| − | |||
| − | ===Chemotherapy=== | ||
*[[Cisplatin (Platinol)]] 60 mg/m<sup>2</sup> IV infusion over 4 hours, started on day 1 of weeks 12, 17 | *[[Cisplatin (Platinol)]] 60 mg/m<sup>2</sup> IV infusion over 4 hours, started on day 1 of weeks 12, 17 | ||
*[[Doxorubicin (Adriamycin)]] 37.5 mg/m<sup>2</sup> (total dose is 75 mg/m<sup>2</sup> given as a 48 hour infusion) on days 1 to 2 of Weeks 12, 17 | *[[Doxorubicin (Adriamycin)]] 37.5 mg/m<sup>2</sup> (total dose is 75 mg/m<sup>2</sup> given as a 48 hour infusion) on days 1 to 2 of Weeks 12, 17 | ||
| Line 35: | Line 51: | ||
'''10 Week course''' | '''10 Week course''' | ||
| − | + | </div></div><br> | |
| − | === | + | <div class="toccolours" style="background-color:#eeeeee"> |
| − | + | ===Consolidation=== | |
| − | + | MAP Cycles 5-6: Good Responders and Poor Responders | |
| − | ==MAP Cycles 5-6 | + | <div class="toccolours" style="background-color:#b3e2cd"> |
| − | Good Responders and Poor Responders | + | ====Chemotherapy==== |
| − | |||
| − | ===Chemotherapy=== | ||
*[[Doxorubicin (Adriamycin)]] 37.5 mg/m<sup>2</sup> (total dose is 75 mg/m<sup>2</sup> given as a 48 hour infusion) on days 1 to 2 of Weeks 22, 26 | *[[Doxorubicin (Adriamycin)]] 37.5 mg/m<sup>2</sup> (total dose is 75 mg/m<sup>2</sup> given as a 48 hour infusion) on days 1 to 2 of Weeks 22, 26 | ||
*[[Methotrexate (MTX)]] 12 g/m<sup>2</sup> (maximum dose of 20 grams) IV over 4 hours once on day 1 of weeks 24, 25, 28, 29 | *[[Methotrexate (MTX)]] 12 g/m<sup>2</sup> (maximum dose of 20 grams) IV over 4 hours once on day 1 of weeks 24, 25, 28, 29 | ||
| Line 48: | Line 62: | ||
'''10 Week course''' | '''10 Week course''' | ||
| − | + | </div></div></div> | |
===References=== | ===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. [https://doi.org/10.1200/JCO.2014.60.0734 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4486345/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26033801 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. [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 dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/27569442 PubMed] NCT00134030 | ||
=Relapsed Refractory= | =Relapsed Refractory= | ||
Revision as of 13:55, 4 March 2023
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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 | Years 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 infusion over 4 hours, started on day 1 of weeks 1, 6
- Doxorubicin (Adriamycin) 37.5 mg/m2 (total dose is 75 mg/m2 given as a 48 hour infusion) on days 1 to 2 of Weeks 1, 6
- Methotrexate (MTX) 12 g/m2 (maximum dose of 20 g) IV over 4 hours once on day 1 of weeks 4, 5, 9, 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
Adjuvant therapy
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, 17
- Doxorubicin (Adriamycin) 37.5 mg/m2 (total dose is 75 mg/m2 given as a 48 hour infusion) on days 1 to 2 of Weeks 12, 17
- Methotrexate (MTX) 12 g/m2 (maximum dose of 20 g) IV over 4 hours once on day 1 of weeks 15, 16, 20, 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
Consolidation
MAP Cycles 5-6: Good Responders and Poor Responders
Chemotherapy
- Doxorubicin (Adriamycin) 37.5 mg/m2 (total dose is 75 mg/m2 given as a 48 hour infusion) on days 1 to 2 of Weeks 22, 26
- Methotrexate (MTX) 12 g/m2 (maximum dose of 20 grams) IV over 4 hours once on day 1 of weeks 24, 25, 28, 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
- 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 contains dosing details in manuscript PubMed NCT00134030