Difference between revisions of "Leiomyosarcoma - 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 [[Leiomyosarcoma|main LMS 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 [[Leiomyosarcoma|main LMS page]] for regimens that include active anticancer treatment.
  
 
{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
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=Adjuvant therapy=
 
=Adjuvant therapy=
 
==Observation==
 
==Observation==
{| 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" style="width: 100%; text-align:center;"  
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{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
!style="width: 20%"|Years of enrollment
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!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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|[https://doi.org/10.1093/annonc/mds545 Pautier et al. 2012 (SARCGYN)]
 
|[https://doi.org/10.1093/annonc/mds545 Pautier et al. 2012 (SARCGYN)]
 
|2001-2009
 
|2001-2009
| style="background-color:#1a9851" |Phase III (C)
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| style="background-color:#1a9851" |Phase 3 (C)
|API
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|[[#API_888|API]]
 
| style="background-color:#fc8d59" |Seems to have inferior DFS
 
| style="background-color:#fc8d59" |Seems to have inferior DFS
 
|-
 
|-
|[https://doi.org/10.1200/JCO.18.00454 Hensley et al. 2018 (GOG-0277)]
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6241678/ Hensley et al. 2018 (GOG-0277)]
 
|2012-2016
 
|2012-2016
| style="background-color:#1a9851" |Phase III (C)
+
| style="background-color:#1a9851" |Phase 3 (C)
|GD, then Doxorubicin
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|[[#Docetaxel_.26_Gemcitabine_999|GD]], then [[#Doxorubicin_monotherapy_999|Doxorubicin]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
|}
 
|}
 
''No further treatment.''
 
''No further treatment.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
 
*GOG-0277: [[Surgery#Hysterectomy|Hysterectomy]]
 
*GOG-0277: [[Surgery#Hysterectomy|Hysterectomy]]
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</div></div>
 
===References===
 
===References===
# '''SARCGYN:''' Pautier P, Floquet A, Gladieff L, Bompas E, Ray-Coquard I, Piperno-Neumann S, Selle F, Guillemet C, Weber B, Largillier R, Bertucci F, Opinel P, Duffaud F, Reynaud-Bougnoux A, Delcambre C, Isambert N, Kerbrat P, Netter-Pinon G, Pinto N, Duvillard P, Haie-Meder C, Lhommé C, Rey A; French Sarcoma Group. A randomized clinical trial of adjuvant chemotherapy with doxorubicin, ifosfamide, and cisplatin followed by radiotherapy versus radiotherapy alone in patients with localized uterine sarcomas (SARCGYN study). Ann Oncol. 2013 Apr;24(4):1099-104. Epub 2012 Nov 8. [https://doi.org/10.1093/annonc/mds545 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23139262 PubMed]
+
# '''SARCGYN:''' Pautier P, Floquet A, Gladieff L, Bompas E, Ray-Coquard I, Piperno-Neumann S, Selle F, Guillemet C, Weber B, Largillier R, Bertucci F, Opinel P, Duffaud F, Reynaud-Bougnoux A, Delcambre C, Isambert N, Kerbrat P, Netter-Pinon G, Pinto N, Duvillard P, Haie-Meder C, Lhommé C, Rey A; French Sarcoma Group. A randomized clinical trial of adjuvant chemotherapy with doxorubicin, ifosfamide, and cisplatin followed by radiotherapy versus radiotherapy alone in patients with localized uterine sarcomas (SARCGYN study). Ann Oncol. 2013 Apr;24(4):1099-104. Epub 2012 Nov 8. [https://doi.org/10.1093/annonc/mds545 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23139262/ PubMed] [https://clinicaltrials.gov/study/NCT00162721 NCT00162721]
# '''GOG-0277:''' Hensley ML, Enserro D, Hatcher H, Ottevanger PB, Krarup-Hansen A, Blay JY, Fisher C, Moxley KM, Lele SB, Lea JS, Tewari KS, Thaker PH, Zivanovic O, O'Malley DM, Robison K, Miller DS. Adjuvant gemcitabine plus docetaxel followed by doxorubicin versus observation for high-grade uterine leiomyosarcoma: a phase III NRG Oncology/Gynecologic Oncology Group study. J Clin Oncol. 2018 Nov 20;36(33):3324-30. Epub 2018 Oct 5. [https://doi.org/10.1200/JCO.18.00454 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30289732 PubMed]
+
# '''GOG-0277:''' Hensley ML, Enserro D, Hatcher H, Ottevanger PB, Krarup-Hansen A, Blay JY, Fisher C, Moxley KM, Lele SB, Lea JS, Tewari KS, Thaker PH, Zivanovic O, O'Malley DM, Robison K, Miller DS. Adjuvant gemcitabine plus docetaxel followed by doxorubicin versus observation for high-grade uterine leiomyosarcoma: a phase III NRG Oncology/Gynecologic Oncology Group study. J Clin Oncol. 2018 Nov 20;36(33):3324-30. Epub 2018 Oct 5. [https://doi.org/10.1200/JCO.18.00454 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6241678/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30289732/ PubMed] [https://clinicaltrials.gov/study/NCT01533207 NCT01533207]
  
 
[[Category:Leiomyosarcoma regimens]]
 
[[Category:Leiomyosarcoma regimens]]

Latest revision as of 12:51, 14 October 2023

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 LMS page for regimens that include active anticancer treatment.


Adjuvant therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Pautier et al. 2012 (SARCGYN) 2001-2009 Phase 3 (C) API Seems to have inferior DFS
Hensley et al. 2018 (GOG-0277) 2012-2016 Phase 3 (C) GD, then Doxorubicin Did not meet primary endpoint of OS

No further treatment.

Preceding treatment

References

  1. SARCGYN: Pautier P, Floquet A, Gladieff L, Bompas E, Ray-Coquard I, Piperno-Neumann S, Selle F, Guillemet C, Weber B, Largillier R, Bertucci F, Opinel P, Duffaud F, Reynaud-Bougnoux A, Delcambre C, Isambert N, Kerbrat P, Netter-Pinon G, Pinto N, Duvillard P, Haie-Meder C, Lhommé C, Rey A; French Sarcoma Group. A randomized clinical trial of adjuvant chemotherapy with doxorubicin, ifosfamide, and cisplatin followed by radiotherapy versus radiotherapy alone in patients with localized uterine sarcomas (SARCGYN study). Ann Oncol. 2013 Apr;24(4):1099-104. Epub 2012 Nov 8. link to original article PubMed NCT00162721
  2. GOG-0277: Hensley ML, Enserro D, Hatcher H, Ottevanger PB, Krarup-Hansen A, Blay JY, Fisher C, Moxley KM, Lele SB, Lea JS, Tewari KS, Thaker PH, Zivanovic O, O'Malley DM, Robison K, Miller DS. Adjuvant gemcitabine plus docetaxel followed by doxorubicin versus observation for high-grade uterine leiomyosarcoma: a phase III NRG Oncology/Gynecologic Oncology Group study. J Clin Oncol. 2018 Nov 20;36(33):3324-30. Epub 2018 Oct 5. link to original article link to PMC article PubMed NCT01533207