Difference between revisions of "Endometrial cancer - 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 [[Endometrial cancer|main endometrial cancer page]] for current regimens.
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[[#top|Back to Top]]
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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 [[Endometrial cancer|main endometrial cancer page]] for regimens that include active anticancer treatment.
  
 
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==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://clincancerres.aacrjournals.org/content/25/8/2424 Kitson et al. 2018 (PREMIUM)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6586555/ Kitson et al. 2018 (PREMIUM)]
 
|2015-2017
 
|2015-2017
−
|style="background-color:#1a9851"|Phase III (C)
+
|style="background-color:#1a9851"|Phase 3 (C)
−
|Metformin
+
|[[#Metformin_monotherapy_999|Metformin]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of posttreatment IHC expression of Ki-67
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of posttreatment IHC expression of Ki-67
 
|-
 
|-
 
|}
 
|}
 
''No active antineoplastic treatment prior to surgery.''
 
''No active antineoplastic treatment prior to surgery.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Subsequent treatment====
 
====Subsequent treatment====
 
*[[Surgery#Endometrial_cancer_surgery|Surgery]]
 
*[[Surgery#Endometrial_cancer_surgery|Surgery]]
−
 
+
</div></div>
 
===References===
 
===References===
−
# '''PREMIUM:''' Kitson SJ, Maskell Z, Sivalingam VN, Allen JL, Ali S, Burns S, Gilmour K, Latheef R, Slade RJ, Pemberton PW, Shaw J, Ryder WD, Kitchener HC, Crosbie EJ. PRE-surgical Metformin In Uterine Malignancy (PREMIUM): a Multi-Center, Randomized Double-Blind, Placebo-Controlled Phase III Trial. Clin Cancer Res. 2019 Apr 15;25(8):2424-2432. Epub 2018 Dec 18. [http://clincancerres.aacrjournals.org/content/25/8/2424 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30563932 PubMed] ISRCTN88589234
+
# '''PREMIUM:''' Kitson SJ, Maskell Z, Sivalingam VN, Allen JL, Ali S, Burns S, Gilmour K, Latheef R, Slade RJ, Pemberton PW, Shaw J, Ryder WD, Kitchener HC, Crosbie EJ. PRE-surgical Metformin In Uterine Malignancy (PREMIUM): a Multi-Center, Randomized Double-Blind, Placebo-Controlled Phase III Trial. Clin Cancer Res. 2019 Apr 15;25(8):2424-2432. Epub 2018 Dec 18. [http://clincancerres.aacrjournals.org/content/25/8/2424 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6586555/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30563932/ PubMed] ISRCTN88589234
  
 
=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 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
Line 49: Line 48:
 
|[https://doi.org/10.1200/JCO.1985.3.9.1240 Omura et al. 1985 (GOG 20)]
 
|[https://doi.org/10.1200/JCO.1985.3.9.1240 Omura et al. 1985 (GOG 20)]
 
|1973-1982
 
|1973-1982
−
|style="background-color:#1a9851"|Phase III (C)
+
|style="background-color:#1a9851"|Phase 3 (C)
−
|Doxorubicin
+
|[[#Doxorubicin_monotherapy_999|Doxorubicin]]
 
| style="background-color:#ffffbf" |Did not meet efficacy endpoints
 
| style="background-color:#ffffbf" |Did not meet efficacy endpoints
 
|-
 
|-
−
|[https://www.gynecologiconcology-online.net/article/S0090-8258(03)00863-1/fulltext Keys et al. 2004 (GOG 99)]
+
|[https://doi.org/10.1016/j.ygyno.2003.11.048 Keys et al. 2004 (GOG 99)]
 
|1987-1995
 
|1987-1995
−
|style="background-color:#1a9851"|Phase III (C)
+
|style="background-color:#1a9851"|Phase 3 (C)
 
|[[Endometrial_cancer#Radiation_therapy|RT]]
 
|[[Endometrial_cancer#Radiation_therapy|RT]]
 
| style="background-color:#d73027" |Inferior RFS
 
| style="background-color:#d73027" |Inferior RFS
Line 61: Line 60:
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3552301/ Hogberg et al. 2010 (EORTC 55991)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3552301/ Hogberg et al. 2010 (EORTC 55991)]
 
|1996-2007
 
|1996-2007
−
|style="background-color:#1a9851"|Phase III (C)
+
|style="background-color:#1a9851"|Phase 3 (C)
−
|1. [[Endometrial_cancer#Cisplatin_.26_Doxorubicin|Cisplatin & Doxorubicin]]<br> 2. Cisplatin & Epirubicin<br> 3. Epirubicin & Paclitaxel<br> 4. Carboplatin & Doxorubicin<br> 5. [[Endometrial_cancer#Carboplatin_.26_Paclitaxel_.28CP.29|Carboplatin & Paclitaxel]]
+
|1. [[Endometrial_cancer#Cisplatin_.26_Doxorubicin|Cisplatin & Doxorubicin]]<br>2. [[#Cisplatin_.26_Epirubicin_888|Cisplatin & Epirubicin]]<br> 3. [[#Epirubicin_.26_Paclitaxel_.28EP.29_888|Epirubicin & Paclitaxel]]<br> 4. [[#Carboplatin_.26_Doxorubicin_888|Carboplatin & Doxorubicin]]<br> 5. [[Endometrial_cancer#Carboplatin_.26_Paclitaxel_.28CP.29|Carboplatin & Paclitaxel]]
 
| style="background-color:#fc8d59" |Seems to have inferior PFS
 
| style="background-color:#fc8d59" |Seems to have inferior PFS
 
|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3552301/ Hogberg et al. 2010 (MaNGO ILIADE-III)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3552301/ Hogberg et al. 2010 (MaNGO ILIADE-III)]
 
|1998-2007
 
|1998-2007
−
|style="background-color:#1a9851"|Phase III (C)
+
|style="background-color:#1a9851"|Phase 3 (C)
 
|[[Endometrial_cancer#Cisplatin_.26_Doxorubicin|Cisplatin & Doxorubicin]]
 
|[[Endometrial_cancer#Cisplatin_.26_Doxorubicin|Cisplatin & Doxorubicin]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
Line 73: Line 72:
 
|}
 
|}
 
''No further treatment.''
 
''No further treatment.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
 
*GOG 20, GOG 99, MaNGO ILIADE-III: [[Surgery#Endometrial_cancer_surgery|Surgery]]
 
*GOG 20, GOG 99, MaNGO ILIADE-III: [[Surgery#Endometrial_cancer_surgery|Surgery]]
−
*EORTC 55991: [[Surgery#Endometrial_cancer_surgery|Surgery]], then [[Endometrial_cancer#Radiation_therapy|RT]]
+
*EORTC 55991: [[Surgery#Endometrial_cancer_surgery|Surgery]], then adjuvant [[Endometrial_cancer#Radiation_therapy|RT]]
 
====Subsequent treatment====
 
====Subsequent treatment====
−
*MaNGO ILIADE-III: [[Endometrial_cancer#Radiation_therapy|RT]]
+
*MaNGO ILIADE-III: Adjuvant [[Endometrial_cancer#Radiation_therapy|RT]]
 +
</div></div>
 
===References===
 
===References===
−
# '''GOG 20:''' Omura GA, Blessing JA, Major F, Lifshitz S, Ehrlich CE, Mangan C, Beecham J, Park R, Silverberg S. A randomized clinical trial of adjuvant adriamycin in uterine sarcomas: a Gynecologic Oncology Group study. J Clin Oncol. 1985 Sep;3(9):1240-5. [https://doi.org/10.1200/JCO.1985.3.9.1240 link to original article] [https://pubmed.ncbi.nlm.nih.gov/3897471 PubMed]
+
# '''GOG 20:''' Omura GA, Blessing JA, Major F, Lifshitz S, Ehrlich CE, Mangan C, Beecham J, Park R, Silverberg S. A randomized clinical trial of adjuvant adriamycin in uterine sarcomas: a Gynecologic Oncology Group study. J Clin Oncol. 1985 Sep;3(9):1240-5. [https://doi.org/10.1200/JCO.1985.3.9.1240 link to original article] [https://pubmed.ncbi.nlm.nih.gov/3897471/ PubMed]
−
# '''GOG 99:''' Keys HM, Roberts JA, Brunetto VL, Zaino RJ, Spirtos NM, Bloss JD, Pearlman A, Maiman MA, Bell JG; Gynecologic Oncology Group. A phase III trial of surgery with or without adjunctive external pelvic radiation therapy in intermediate risk endometrial adenocarcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2004 Mar;92(3):744-51. Erratum in: Gynecol Oncol. 2004 Jul;94(1):241-2. [https://www.gynecologiconcology-online.net/article/S0090-8258(03)00863-1/fulltext link to original article] [https://pubmed.ncbi.nlm.nih.gov/14984936 PubMed]
+
# '''GOG 99:''' Keys HM, Roberts JA, Brunetto VL, Zaino RJ, Spirtos NM, Bloss JD, Pearlman A, Maiman MA, Bell JG; Gynecologic Oncology Group. A phase III trial of surgery with or without adjunctive external pelvic radiation therapy in intermediate risk endometrial adenocarcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2004 Mar;92(3):744-51. Erratum in: Gynecol Oncol. 2004 Jul;94(1):241-2. [https://doi.org/10.1016/j.ygyno.2003.11.048 link to original article] [https://pubmed.ncbi.nlm.nih.gov/14984936/ PubMed]
−
# '''EORTC 55991/MaNGO ILIADE-III:''' Hogberg T, Signorelli M, de Oliveira CF, Fossati R, Lissoni AA, Sorbe B, Andersson H, Grenman S, Lundgren C, Rosenberg P, Boman K, Tholander B, Scambia G, Reed N, Cormio G, Tognon G, Clarke J, Sawicki T, Zola P, Kristensen G. Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer--results from two randomised studies. Eur J Cancer. 2010 Sep;46(13):2422-31. Epub 2010 Jul 7. [https://doi.org/10.1016/j.ejca.2010.06.002 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3552301/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/20619634 PubMed]
+
# '''EORTC 55991:''' Hogberg T, Signorelli M, Freire de Oliveira C, Fossati R, Lissoni AA, Sorbe B, Andersson H, Grenman S, Lundgren C, Rosenberg P, Boman K, Tholander B, Scambia G, Reed N, Cormio G, Tognon G, Clarke J, Sawicki T, Zola P, Kristensen G. Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer--results from two randomised studies. Eur J Cancer. 2010 Sep;46(13):2422-31. Epub 2010 Jul 7. [https://doi.org/10.1016/j.ejca.2010.06.002 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3552301/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/20619634/ PubMed] [https://clinicaltrials.gov/study/NCT00005583 NCT00005583]
 +
# '''MaNGO ILIADE-III:''' Hogberg T, Signorelli M, Freire de Oliveira C, Fossati R, Lissoni AA, Sorbe B, Andersson H, Grenman S, Lundgren C, Rosenberg P, Boman K, Tholander B, Scambia G, Reed N, Cormio G, Tognon G, Clarke J, Sawicki T, Zola P, Kristensen G. Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer--results from two randomised studies. Eur J Cancer. 2010 Sep;46(13):2422-31. Epub 2010 Jul 7. [https://doi.org/10.1016/j.ejca.2010.06.002 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3552301/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/20619634/ PubMed]
  
 
==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
Line 98: Line 97:
 
|[https://doi.org/10.1200/jco.2005.02.8464 Barakat et al. 2006 (GOG 137A)]
 
|[https://doi.org/10.1200/jco.2005.02.8464 Barakat et al. 2006 (GOG 137A)]
 
|1997-2003
 
|1997-2003
−
|style="background-color:#1a9851"|Phase III (C)
+
|style="background-color:#1a9851"|Phase 3 (C)
 
|Estrogen replacement therapy
 
|Estrogen replacement therapy
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of RFS
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of RFS
Line 104: Line 103:
 
|}
 
|}
 
''No active antineoplastic treatment. Note that this trial was stopped early due to the increased risk of ERT in the Women's Health Initiative trial, and should be considered inconclusive.''
 
''No active antineoplastic treatment. Note that this trial was stopped early due to the increased risk of ERT in the Women's Health Initiative trial, and should be considered inconclusive.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
 
*[[Surgery#Endometrial_cancer_surgery|Hysterectomy]]
 
*[[Surgery#Endometrial_cancer_surgery|Hysterectomy]]
 +
</div></div>
 
===References===
 
===References===
−
# '''GOG 137A:''' Barakat RR, Bundy BN, Spirtos NM, Bell J, Mannel RS; Gynecologic Oncology Group. Randomized double-blind trial of estrogen replacement therapy versus placebo in stage I or II endometrial cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2006 Feb 1;24(4):587-92. [https://doi.org/10.1200/jco.2005.02.8464 link to original article] [https://doi.org/10.1200/jco.2005.02.8464 link to original article] NCT00002976
+
# '''GOG 137A:''' Barakat RR, Bundy BN, Spirtos NM, Bell J, Mannel RS; Gynecologic Oncology Group. Randomized double-blind trial of estrogen replacement therapy versus placebo in stage I or II endometrial cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2006 Feb 1;24(4):587-92. [https://doi.org/10.1200/jco.2005.02.8464 link to original article] [https://pubmed.ncbi.nlm.nih.gov/16446331/ PubMed] [https://clinicaltrials.gov/study/NCT00002976 NCT00002976]
−
# '''SIENDO:''' NCT03555422
 
  
 
=Maintenance after first-line therapy=
 
=Maintenance after first-line therapy=
  
 
==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]]
 
|-
 
|-
−
|(DUO-E)
+
|[https://doi.org/10.1200/jco.22.02906 Vergote et al. 2023 (SIENDO)]
−
|2020-ongoing
+
|2018-01 to 2021-12
−
|style="background-color:#1a9851"|Phase III (C)
+
|style="background-color:#1a9851"|Phase 3 (C)
−
|1. Durvalumab<br> 2. Durvalumab & Olaparib
+
|[[#Selinexor_monotherapy_999|Selinexor]]
−
| style="background-color:#d3d3d3" |In progress
+
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
−
*Platinum-based chemotherapy
+
*First-line [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]]
 +
</div></div>
  
 
===References===
 
===References===
−
# '''DUO-E:''' NCT04269200
+
#'''SIENDO:''' Vergote I, Pérez-Fidalgo JA, Hamilton EP, Valabrega G, Van Gorp T, Sehouli J, Cibula D, Levy T, Welch S, Richardson DL, Guerra EM, Scambia G, Henry S, Wimberger P, Miller DS, Klat J, Martínez-Garcia J, Raspagliesi F, Pothuri B, Romero I, Bergamini A, Slomovitz B, Schochter F, Høgdall E, Fariñas-Madrid L, Monk BJ, Michel D, Kauffman MG, Shacham S, Mirza MR, Makker V; ENGOT-EN5/GOG-3055/SIENDO Investigators. Oral Selinexor as Maintenance Therapy After First-Line Chemotherapy for Advanced or Recurrent Endometrial Cancer. J Clin Oncol. 2023 Dec 10;41(35):5400-5410. Epub 2023 Sep 5. [https://doi.org/10.1200/jco.22.02906 link to original article] [https://pubmed.ncbi.nlm.nih.gov/37669480/ PubMed] [https://clinicaltrials.gov/study/NCT03555422 NCT03555422]
  
 
[[Category:Endometrial cancer regimens]]
 
[[Category:Endometrial cancer regimens]]

Latest revision as of 23:15, 30 May 2024

Back to Top

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 endometrial cancer page for regimens that include active anticancer treatment.


Neoadjuvant therapy

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Kitson et al. 2018 (PREMIUM) 2015-2017 Phase 3 (C) Metformin Did not meet primary endpoint of posttreatment IHC expression of Ki-67

No active antineoplastic treatment prior to surgery.

Subsequent treatment

References

  1. PREMIUM: Kitson SJ, Maskell Z, Sivalingam VN, Allen JL, Ali S, Burns S, Gilmour K, Latheef R, Slade RJ, Pemberton PW, Shaw J, Ryder WD, Kitchener HC, Crosbie EJ. PRE-surgical Metformin In Uterine Malignancy (PREMIUM): a Multi-Center, Randomized Double-Blind, Placebo-Controlled Phase III Trial. Clin Cancer Res. 2019 Apr 15;25(8):2424-2432. Epub 2018 Dec 18. link to original article link to PMC article PubMed ISRCTN88589234

Adjuvant therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Omura et al. 1985 (GOG 20) 1973-1982 Phase 3 (C) Doxorubicin Did not meet efficacy endpoints
Keys et al. 2004 (GOG 99) 1987-1995 Phase 3 (C) RT Inferior RFS
Hogberg et al. 2010 (EORTC 55991) 1996-2007 Phase 3 (C) 1. Cisplatin & Doxorubicin
2. Cisplatin & Epirubicin
3. Epirubicin & Paclitaxel
4. Carboplatin & Doxorubicin
5. Carboplatin & Paclitaxel 		Seems to have inferior PFS
Hogberg et al. 2010 (MaNGO ILIADE-III) 1998-2007 Phase 3 (C) Cisplatin & Doxorubicin Did not meet primary endpoint of PFS

No further treatment.

Preceding treatment

  • GOG 20, GOG 99, MaNGO ILIADE-III: Surgery
  • EORTC 55991: Surgery, then adjuvant RT

Subsequent treatment

  • MaNGO ILIADE-III: Adjuvant RT

References

  1. GOG 20: Omura GA, Blessing JA, Major F, Lifshitz S, Ehrlich CE, Mangan C, Beecham J, Park R, Silverberg S. A randomized clinical trial of adjuvant adriamycin in uterine sarcomas: a Gynecologic Oncology Group study. J Clin Oncol. 1985 Sep;3(9):1240-5. link to original article PubMed
  2. GOG 99: Keys HM, Roberts JA, Brunetto VL, Zaino RJ, Spirtos NM, Bloss JD, Pearlman A, Maiman MA, Bell JG; Gynecologic Oncology Group. A phase III trial of surgery with or without adjunctive external pelvic radiation therapy in intermediate risk endometrial adenocarcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2004 Mar;92(3):744-51. Erratum in: Gynecol Oncol. 2004 Jul;94(1):241-2. link to original article PubMed
  3. EORTC 55991: Hogberg T, Signorelli M, Freire de Oliveira C, Fossati R, Lissoni AA, Sorbe B, Andersson H, Grenman S, Lundgren C, Rosenberg P, Boman K, Tholander B, Scambia G, Reed N, Cormio G, Tognon G, Clarke J, Sawicki T, Zola P, Kristensen G. Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer--results from two randomised studies. Eur J Cancer. 2010 Sep;46(13):2422-31. Epub 2010 Jul 7. link to original article link to PMC article PubMed NCT00005583
  4. MaNGO ILIADE-III: Hogberg T, Signorelli M, Freire de Oliveira C, Fossati R, Lissoni AA, Sorbe B, Andersson H, Grenman S, Lundgren C, Rosenberg P, Boman K, Tholander B, Scambia G, Reed N, Cormio G, Tognon G, Clarke J, Sawicki T, Zola P, Kristensen G. Sequential adjuvant chemotherapy and radiotherapy in endometrial cancer--results from two randomised studies. Eur J Cancer. 2010 Sep;46(13):2422-31. Epub 2010 Jul 7. link to original article link to PMC article PubMed

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Barakat et al. 2006 (GOG 137A) 1997-2003 Phase 3 (C) Estrogen replacement therapy Did not meet primary endpoint of RFS

No active antineoplastic treatment. Note that this trial was stopped early due to the increased risk of ERT in the Women's Health Initiative trial, and should be considered inconclusive.

Preceding treatment

References

  1. GOG 137A: Barakat RR, Bundy BN, Spirtos NM, Bell J, Mannel RS; Gynecologic Oncology Group. Randomized double-blind trial of estrogen replacement therapy versus placebo in stage I or II endometrial cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2006 Feb 1;24(4):587-92. link to original article PubMed NCT00002976

Maintenance after first-line therapy

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Vergote et al. 2023 (SIENDO) 2018-01 to 2021-12 Phase 3 (C) Selinexor Did not meet primary endpoint of PFS

Preceding treatment

References

  1. SIENDO: Vergote I, Pérez-Fidalgo JA, Hamilton EP, Valabrega G, Van Gorp T, Sehouli J, Cibula D, Levy T, Welch S, Richardson DL, Guerra EM, Scambia G, Henry S, Wimberger P, Miller DS, Klat J, Martínez-Garcia J, Raspagliesi F, Pothuri B, Romero I, Bergamini A, Slomovitz B, Schochter F, Høgdall E, Fariñas-Madrid L, Monk BJ, Michel D, Kauffman MG, Shacham S, Mirza MR, Makker V; ENGOT-EN5/GOG-3055/SIENDO Investigators. Oral Selinexor as Maintenance Therapy After First-Line Chemotherapy for Advanced or Recurrent Endometrial Cancer. J Clin Oncol. 2023 Dec 10;41(35):5400-5410. Epub 2023 Sep 5. link to original article PubMed NCT03555422
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