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. 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
- 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.
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. link to original article 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. link to original article 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. link to original article link to PMC article PubMed 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. 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
- 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
- First-line platinum-based chemotherapy
References
- 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