Difference between revisions of "Osteosarcoma - null regimens"

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. While not clinically relevant, these references provide further insight into the historical development of the treatment landscape. See the [[Osteosarcoma|main osteosarcoma page]] for current regimens.
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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the [[Osteosarcoma|main osteosarcoma page]] for regimens that include active anticancer treatment.
  
 
{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
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==Observation==
 
==Observation==
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{| class="wikitable" style="float:right; margin-left: 5px;"
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<div class="toccolours" style="background-color:#eeeeee">
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
 
===Regimen===
 
===Regimen===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
−
!style="width: 20%"|Years of enrollment
+
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
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|}
 
|}
 
''No further treatment.''
 
''No further treatment.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
−
*[[Osteosarcoma#M-BCD|Neoadjuvant M-BCD]], then [[Surgery#Surgical_resection|surgery]], with good response
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*Neoadjuvant [[Osteosarcoma#M-BCD|M-BCD]], then [[Surgery#Surgical_resection|surgery]], with good response
 +
</div></div>
 
===References===
 
===References===
−
# Eilber F, Giuliano A, Eckardt J, Patterson K, Moseley S, Goodnight J. Adjuvant chemotherapy for osteosarcoma: a randomized prospective trial. J Clin Oncol. 1987 Jan;5(1):21-6. [https://doi.org/10.1200/JCO.1987.5.1.21 link to original article] [https://pubmed.ncbi.nlm.nih.gov/3543236 PubMed]
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# Eilber F, Giuliano A, Eckardt J, Patterson K, Moseley S, Goodnight J. Adjuvant chemotherapy for osteosarcoma: a randomized prospective trial. J Clin Oncol. 1987 Jan;5(1):21-6. [https://doi.org/10.1200/JCO.1987.5.1.21 link to original article] [https://pubmed.ncbi.nlm.nih.gov/3543236/ PubMed]
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## '''Update:''' Bernthal NM, Federman N, Eilber FR, Nelson SD, Eckardt JJ, Eilber FC, Tap WD. Long-term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high-grade, operable osteosarcoma. Cancer. 2012 Dec 1;118(23):5888-93. Epub 2012 May 30. [https://onlinelibrary.wiley.com/doi/full/10.1002/cncr.27651 link to original article] [https://pubmed.ncbi.nlm.nih.gov/22648705 PubMed]
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## '''Update:''' Bernthal NM, Federman N, Eilber FR, Nelson SD, Eckardt JJ, Eilber FC, Tap WD. Long-term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high-grade, operable osteosarcoma. Cancer. 2012 Dec 1;118(23):5888-93. Epub 2012 May 30. [https://doi.org/10.1002/cncr.27651 link to original article] [https://pubmed.ncbi.nlm.nih.gov/22648705/ PubMed]
  
 
=Maintenance after upfront therapy=
 
=Maintenance after upfront therapy=
  
 
==Observation==
 
==Observation==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
<div class="toccolours" style="background-color:#eeeeee">
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
 
===Regimen===
 
===Regimen===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
−
!style="width: 20%"|Years of enrollment
+
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
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|2005-2011
 
|2005-2011
 
| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
−
|[[#Inteferon_alfa-2b_monotherapy_99|Interferon alfa-2b]]
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|[[#Interferon_alfa-2b_monotherapy_999|Interferon alfa-2b]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of EFS
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of EFS
 
|-
 
|-
 
|}
 
|}
 
''No further treatment.''
 
''No further treatment.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
−
*[[Osteosarcoma#MAP|Neoadjuvant MAP]] x 2, then [[Surgery#Surgical_resection|surgery]], then adjuvant [[Osteosarcoma#MAP_2|MAP]] x 2, then [[Osteosarcoma#MA_2|MA]] x 2
+
*Neoadjuvant [[Osteosarcoma#MAP|MAP]] x 2, then [[Surgery#Surgical_resection|surgery]], then adjuvant [[Osteosarcoma#MAP_2|MAP]] x 2, then adjuvant [[Osteosarcoma#MA_2|MA]] x 2
 +
</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]
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# '''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]
  
 
=Relapsed, refractory, or metastatic, subsequent lines=
 
=Relapsed, refractory, or metastatic, subsequent lines=
 
==Placebo==
 
==Placebo==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
<div class="toccolours" style="background-color:#eeeeee">
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
 
===Regimen===
 
===Regimen===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
−
!style="width: 20%"|Years of enrollment
+
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7799443/ Davis et al. 2019 (SARC024)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7799443/ Davis et al. 2019 (SARC024)]
 
|2014-2018
 
|2014-2018
 
| style="background-color:#1a9851" |Randomized Phase 2 (C)
 
| style="background-color:#1a9851" |Randomized Phase 2 (C)
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|}
 
|}
 
''No active antineoplastic treatment.''
 
''No active antineoplastic treatment.''
−
 
+
</div>
 
===References===
 
===References===
−
#'''SARC024:''' Davis LE, Bolejack V, Ryan CW, Ganjoo KN, Loggers ET, Chawla S, Agulnik M, Livingston MB, Reed D, Keedy V, Rushing D, Okuno S, Reinke DK, Riedel RF, Attia S, Mascarenhas L, Maki RG. Randomized Double-Blind Phase II Study of Regorafenib in Patients With Metastatic Osteosarcoma. J Clin Oncol. 2019 Jun 1;37(16):1424-1431. Epub 2019 Apr 23. [https://doi.org/10.1200/jco.18.02374 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7799443/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31013172/ PubMed] NCT02048371
+
#'''SARC024:''' Davis LE, Bolejack V, Ryan CW, Ganjoo KN, Loggers ET, Chawla S, Agulnik M, Livingston MB, Reed D, Keedy V, Rushing D, Okuno S, Reinke DK, Riedel RF, Attia S, Mascarenhas L, Maki RG. Randomized Double-Blind Phase II Study of Regorafenib in Patients With Metastatic Osteosarcoma. J Clin Oncol. 2019 Jun 1;37(16):1424-1431. Epub 2019 Apr 23. [https://doi.org/10.1200/jco.18.02374 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7799443/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31013172/ PubMed] [https://clinicaltrials.gov/study/NCT02048371 NCT02048371]
  
 
[[Category:Osteosarcoma regimens]]
 
[[Category:Osteosarcoma regimens]]

Latest revision as of 17:31, 14 April 2024

The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main osteosarcoma page for regimens that include active anticancer treatment.


Adjuvant therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Eilber et al. 1987 1981-1984 Randomized (C) M-BCD Seems to have inferior OS

No further treatment.

Preceding treatment

References

  1. Eilber F, Giuliano A, Eckardt J, Patterson K, Moseley S, Goodnight J. Adjuvant chemotherapy for osteosarcoma: a randomized prospective trial. J Clin Oncol. 1987 Jan;5(1):21-6. link to original article PubMed
    1. Update: Bernthal NM, Federman N, Eilber FR, Nelson SD, Eckardt JJ, Eilber FC, Tap WD. Long-term results (>25 years) of a randomized, prospective clinical trial evaluating chemotherapy in patients with high-grade, operable osteosarcoma. Cancer. 2012 Dec 1;118(23):5888-93. Epub 2012 May 30. link to original article PubMed

Maintenance after upfront therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Bielack et al. 2015 (EURAMOS-1 good response) 2005-2011 Phase 3 (C) Interferon alfa-2b Did not meet primary endpoint of EFS

No further treatment.

Preceding treatment

  • Neoadjuvant MAP x 2, then surgery, then adjuvant MAP x 2, then adjuvant MA x 2

References

  1. 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

Relapsed, refractory, or metastatic, subsequent lines

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Davis et al. 2019 (SARC024) 2014-2018 Randomized Phase 2 (C) Regorafenib Inferior PFS

No active antineoplastic treatment.

References

  1. SARC024: Davis LE, Bolejack V, Ryan CW, Ganjoo KN, Loggers ET, Chawla S, Agulnik M, Livingston MB, Reed D, Keedy V, Rushing D, Okuno S, Reinke DK, Riedel RF, Attia S, Mascarenhas L, Maki RG. Randomized Double-Blind Phase II Study of Regorafenib in Patients With Metastatic Osteosarcoma. J Clin Oncol. 2019 Jun 1;37(16):1424-1431. Epub 2019 Apr 23. link to original article link to PMC article PubMed NCT02048371
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