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

  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 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

  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/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