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 main endometrial cancer page for current regimens.
Neoadjuvant therapy
Placebo
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Kitson et al. 2018 (PREMIUM) | 2015-2017 | Phase III (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 PubMed ISRCTN 88589234
Adjuvant therapy
Observation
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Omura et al. 1985 (GOG 20) | 1973-1982 | Phase III (C) | Doxorubicin | Did not meet efficacy endpoints |
| Keys et al. 2004 (GOG 99) | 1987-1995 | Phase III (C) | RT | Inferior RFS |
| Hogberg et al. 2010 (EORTC 55991) | 1996-2007 | Phase III (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 III (C) | Cisplatin & Doxorubicin | Did not meet primary endpoint of PFS |
No further treatment.
Preceding treatment
Subsequent treatment
- MaNGO ILIADE-III: RT
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/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. link to original article link to PMC article PubMed