Endometrial cancer

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 Summer B. Dewdney, MD
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35 regimens on this page
55 variants on this page


Guidelines

ESMO

NCCN

Adjuvant therapy

Carboplatin & Paclitaxel (CP)

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Regimen variant #1, 5/175 x 4

Study Years of enrollment Evidence Comparator Comparative Efficacy
de Boer et al. 2018 (PORTEC-3) 2006-2013 Phase III (E-esc) See link See link

Preceding treatment

Chemotherapy

21-day cycle for 4 cycles

Regimen variant #2, 6/175 x 6

Study Years of enrollment Evidence Comparator Comparative Efficacy
Matei et al. 2019 (GOG 258) 2009-2014 Phase III (C) Cisplatin & RT, then Carboplatin & Paclitaxel x 4 Did not meet primary endpoint of RFS

Preceding treatment

Chemotherapy

21-day cycle for 6 cycles

References

  1. PORTEC-3: de Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger PB, Ledermann JA, Khaw P, Colombo A, Fyles A, Baron MH, Jürgenliemk-Schulz IM, Kitchener HC, Nijman HW, Wilson G, Brooks S, Carinelli S, Provencher D, Hanzen C, Lutgens LCHW, Smit VTHBM, Singh N, Do V, D'Amico R, Nout RA, Feeney A, Verhoeven-Adema KW, Putter H, Creutzberg CL; PORTEC study group. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Mar;19(3):295-309. Epub 2018 Feb 12. link to original article link to PMC article PubMed NCT00411138
    1. Update: de Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger PB, Ledermann JA, Khaw P, D'Amico R, Fyles A, Baron MH, Jürgenliemk-Schulz IM, Kitchener HC, Nijman HW, Wilson G, Brooks S, Gribaudo S, Provencher D, Hanzen C, Kruitwagen RF, Smit VTHBM, Singh N, Do V, Lissoni A, Nout RA, Feeney A, Verhoeven-Adema KW, Putter H, Creutzberg CL; PORTEC Study Group. Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): patterns of recurrence and post-hoc survival analysis of a randomised phase 3 trial. Lancet Oncol. 2019 Sep;20(9):1273-1285. Epub 2019 Jul 22. Erratum in: Lancet Oncol. 2019 Sep;20(9):e468. link to original article contains verified protocol PubMed
  2. GOG 258: Matei D, Filiaci V, Randall ME, Mutch D, Steinhoff MM, DiSilvestro PA, Moxley KM, Kim YM, Powell MA, O'Malley DM, Spirtos NM, Small W Jr, Tewari KS, Richards WE, Nakayama J, Matulonis UA, Huang HQ, Miller DS. Adjuvant chemotherapy plus radiation for locally advanced endometrial cancer. N Engl J Med. 2019 Jun 13;380(24):2317-2326. link to original article contains verified protocol PubMed NCT00942357
  3. JGOG2043: Nomura H, Aoki D, Michimae H, Mizuno M, Nakai H, Arai M, Sasagawa M, Ushijima K, Sugiyama T, Saito M, Tokunaga H, Matoda M, Nakanishi T, Watanabe Y, Takahashi F, Saito T, Yaegashi N; Japanese Gynecologic Oncology Group. Effect of Taxane Plus Platinum Regimens vs Doxorubicin Plus Cisplatin as Adjuvant Chemotherapy for Endometrial Cancer at a High Risk of Progression: A Randomized Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):833-840. Epub 2019 Mar 21. link to original article contains verified protocol link to PMC article PubMed UMIN000000522
  4. KEYNOTE-B21: NCT04634877

CIM

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CIM: Cisplatin, Ifosfamide, Mesna

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Wolfson et al. 2007 (GOG 150) 1993-2005 Phase III (E-switch-ooc) Whole abdominal irradiation Might have superior OS

Preceding treatment

Chemotherapy

Supportive medications

  • Mesna (Mesnex) 120 mg/m2 IV over 15 minutes once on day 1, then 1500 mg/m2/day IV continuous infusion over 96 hours, given second, with Ifosfamide (Ifex)
  • Suggested hydration: 1 liter of NS or 1/2 NS over several hours once per day on days 1 to 4, prior to chemotherapy

21-day cycle for 3 cycles

References

  1. GOG 150: Wolfson AH, Brady MF, Rocereto T, Mannel RS, Lee YC, Futoran RJ, Cohn DE, Ioffe OB. A Gynecologic Oncology Group randomized phase III trial of whole abdominal irradiation (WAI) vs cisplatin-ifosfamide and mesna (CIM) as post-surgical therapy in stage I-IV carcinosarcoma (CS) of the uterus. Gynecol Oncol. 2007 Nov;107(2):177-85. Epub 2007 Sep 5. link to original article contains verified protocol link to PMC article PubMed NCT00002546

Cisplatin & Doxorubicin

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CD: Cisplatin & Doxorubicin
AP: Adriamycin (Doxorubicin) & Platinol (Cisplatin)

Regimen variant #1, 50/45, capped BSA

Study Years of enrollment Evidence Comparator Comparative Efficacy
Homesley et al. 2008 (GOG 184) 2000-2004 Phase III (C) CDP Did not meet primary endpoint of RFS

Note: Treatment was to start within 8 weeks of completion of RT.

Preceding treatment

Chemotherapy

Supportive medications

21-day cycle for 6 cycles

Regimen variant #2, 50/60 x 6

Study Years of enrollment Evidence Comparator Comparative Efficacy
Nomura et al. 2019 (JGOG2043) 2006-2011 Phase III (C) 1. Carboplatin & Paclitaxel
2. Cisplatin & Docetaxel 		Did not meet primary endpoint of PFS

Preceding treatment

Chemotherapy

21-day cycle for 6 cycles

Regimen variant #3, 50/60 x 8

Study Years of enrollment Evidence Comparator Comparative Efficacy
Randall et al. 2006 (GOG 122) 1992-2000 Phase III (E-switch-ooc) Whole abdominal irradiation Superior OS

Preceding treatment

Chemotherapy

Supportive hydration

21-day cycle for 8 cycles

References

  1. GOG 122: Randall ME, Filiaci VL, Muss H, Spirtos NM, Mannel RS, Fowler J, Thigpen JT, Benda JA; Gynecologic Oncology Group. Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2006 Jan 1;24(1):36-44. Epub 2005 Dec 5. link to original article contains verified protocol PubMed
  2. GOG 184: Homesley HD, Filiaci V, Gibbons SK, Long HJ, Cella D, Spirtos NM, Morris RT, DeGeest K, Lee R, Montag A. A randomized phase III trial in advanced endometrial carcinoma of surgery and volume directed radiation followed by cisplatin and doxorubicin with or without paclitaxel: A Gynecologic Oncology Group study. Gynecol Oncol. 2009 Mar;112(3):543-52. Epub 2008 Dec 23. link to original article contains verified protocol link to PMC article PubMed NCT00006011
    1. Update: Spirtos NM, Enserro D, Homesley HD, Gibbons SK, Cella D, Morris RT, DeGeest K, Lee RB, Miller DS. The addition of paclitaxel to doxorubicin and cisplatin and volume-directed radiation does not improve overall survival (OS) or long-term recurrence-free survival (RFS) in advanced endometrial cancer (EC): a randomized phase III NRG/Gynecologic Oncology Group (GOG) study. Gynecol Oncol. 2019 Jul;154(1):13-21. Epub 2019 Apr 30. link to original article link to PMC article PubMed
  3. JGOG2043: Nomura H, Aoki D, Michimae H, Mizuno M, Nakai H, Arai M, Sasagawa M, Ushijima K, Sugiyama T, Saito M, Tokunaga H, Matoda M, Nakanishi T, Watanabe Y, Takahashi F, Saito T, Yaegashi N; Japanese Gynecologic Oncology Group. Effect of Taxane Plus Platinum Regimens vs Doxorubicin Plus Cisplatin as Adjuvant Chemotherapy for Endometrial Cancer at a High Risk of Progression: A Randomized Clinical Trial. JAMA Oncol. 2019 Jun 1;5(6):833-840. Epub 2019 Mar 21. link to original article contains verified protocol link to PMC article PubMed UMIN000000522

Cisplatin & RT

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Cisplatin & RT: Cisplatin & Radiation Therapy

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
de Boer et al. 2018 (PORTEC-3) 2006-2013 Phase III (E-esc) See link See link

Note: in PORTEC-3, radiation is to start within 4 to 6 weeks after surgery, and no later than 8 weeks; reported efficacy is based on the 2019 update.

Preceding treatment

Chemotherapy

21-day cycle for 2 cycles

Radiotherapy

5.5-week course

Subsequent treatment

References

  1. PORTEC-3: de Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger PB, Ledermann JA, Khaw P, Colombo A, Fyles A, Baron MH, Jürgenliemk-Schulz IM, Kitchener HC, Nijman HW, Wilson G, Brooks S, Carinelli S, Provencher D, Hanzen C, Lutgens LCHW, Smit VTHBM, Singh N, Do V, D'Amico R, Nout RA, Feeney A, Verhoeven-Adema KW, Putter H, Creutzberg CL; PORTEC study group. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Mar;19(3):295-309. Epub 2018 Feb 12. link to original article link to PMC article PubMed NCT00411138
    1. Update: de Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger PB, Ledermann JA, Khaw P, D'Amico R, Fyles A, Baron MH, Jürgenliemk-Schulz IM, Kitchener HC, Nijman HW, Wilson G, Brooks S, Gribaudo S, Provencher D, Hanzen C, Kruitwagen RF, Smit VTHBM, Singh N, Do V, Lissoni A, Nout RA, Feeney A, Verhoeven-Adema KW, Putter H, Creutzberg CL; PORTEC Study Group. Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): patterns of recurrence and post-hoc survival analysis of a randomised phase 3 trial. Lancet Oncol. 2019 Sep;20(9):1273-1285. Epub 2019 Jul 22. Erratum in: Lancet Oncol. 2019 Sep;20(9):e468. link to original article contains verified protocol PubMed

Radiation therapy

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RT: Radiation Therapy

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Keys et al. 2004 (GOG 99) 1987-1995 Phase III (E-esc) Observation Superior RFS
Maggi et al. 2006 1990-1997 Phase III (C) CAP Did not meet primary endpoints of PFS/OS
Susumu et al. 2007 (JGOG 2033) 1994-2000 Phase III (C) CAP Did not meet primary endpoint of OS60
Homesley et al. 2008 (GOG 184) 2000-2004 Non-randomized portion of RCT
de Boer et al. 2018 (PORTEC-3) 2006-2013 Phase III (C) Cisplatin & RT, then Carboplatin & Paclitaxel Seems to have inferior OS1

1Reported efficacy for PORTEC-3 is based on the 2019 update.
Note: in PORTEC-3, radiation is to start within 4 to 6 weeks after surgery, and no later than 8 weeks.

Preceding treatment

Radiotherapy

One course

Subsequent treatment

  • GOG 184: CD x 6 versus CDP x 6

References

  1. 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
  2. Maggi R, Lissoni A, Spina F, Melpignano M, Zola P, Favalli G, Colombo A, Fossati R. Adjuvant chemotherapy vs radiotherapy in high-risk endometrial carcinoma: results of a randomised trial. Br J Cancer. 2006 Aug 7;95(3):266-71. Epub 2006 Jul 25. link to original article link to PMC article PubMed
  3. JGOG 2033: Susumu N, Sagae S, Udagawa Y, Niwa K, Kuramoto H, Satoh S, Kudo R; Japanese Gynecologic Oncology Group. Randomized phase III trial of pelvic radiotherapy versus cisplatin-based combined chemotherapy in patients with intermediate- and high-risk endometrial cancer: a Japanese Gynecologic Oncology Group study. Gynecol Oncol. 2008 Jan;108(1):226-33. Epub 2007 Nov 9. link to original article PubMed
  4. GOG 184: Homesley HD, Filiaci V, Gibbons SK, Long HJ, Cella D, Spirtos NM, Morris RT, DeGeest K, Lee R, Montag A. A randomized phase III trial in advanced endometrial carcinoma of surgery and volume directed radiation followed by cisplatin and doxorubicin with or without paclitaxel: A Gynecologic Oncology Group study. Gynecol Oncol. 2009 Mar;112(3):543-52. Epub 2008 Dec 23. link to original article contains verified protocol link to PMC article PubMed NCT00006011
    1. Update: Spirtos NM, Enserro D, Homesley HD, Gibbons SK, Cella D, Morris RT, DeGeest K, Lee RB, Miller DS. The addition of paclitaxel to doxorubicin and cisplatin and volume-directed radiation does not improve overall survival (OS) or long-term recurrence-free survival (RFS) in advanced endometrial cancer (EC): a randomized phase III NRG/Gynecologic Oncology Group (GOG) study. Gynecol Oncol. 2019 Jul;154(1):13-21. Epub 2019 Apr 30. link to original article link to PMC article PubMed
  5. PORTEC-3: de Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger PB, Ledermann JA, Khaw P, Colombo A, Fyles A, Baron MH, Jürgenliemk-Schulz IM, Kitchener HC, Nijman HW, Wilson G, Brooks S, Carinelli S, Provencher D, Hanzen C, Lutgens LCHW, Smit VTHBM, Singh N, Do V, D'Amico R, Nout RA, Feeney A, Verhoeven-Adema KW, Putter H, Creutzberg CL; PORTEC study group. Adjuvant chemoradiotherapy versus radiotherapy alone for women with high-risk endometrial cancer (PORTEC-3): final results of an international, open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Mar;19(3):295-309. Epub 2018 Feb 12. link to original article link to PMC article PubMed NCT00411138
    1. Update: de Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger PB, Ledermann JA, Khaw P, D'Amico R, Fyles A, Baron MH, Jürgenliemk-Schulz IM, Kitchener HC, Nijman HW, Wilson G, Brooks S, Gribaudo S, Provencher D, Hanzen C, Kruitwagen RF, Smit VTHBM, Singh N, Do V, Lissoni A, Nout RA, Feeney A, Verhoeven-Adema KW, Putter H, Creutzberg CL; PORTEC Study Group. Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): patterns of recurrence and post-hoc survival analysis of a randomised phase 3 trial. Lancet Oncol. 2019 Sep;20(9):1273-1285. Epub 2019 Jul 22. Erratum in: Lancet Oncol. 2019 Sep;20(9):e468. link to original article PubMed

Whole abdominal radiation (WAI)

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Randall et al. 2006 (GOG 122) 1992-2000 Phase III (E-switch-ooc) Cisplatin & Doxorubicin Inferior OS
Wolfson et al. 2007 (GOG 150) 1993-2005 Phase III (C) CIM Might have inferior OS

Not commonly used but was a comparator arm; here for reference purposes only.

Radiotherapy

References

  1. GOG 122: Randall ME, Filiaci VL, Muss H, Spirtos NM, Mannel RS, Fowler J, Thigpen JT, Benda JA; Gynecologic Oncology Group. Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2006 Jan 1;24(1):36-44. Epub 2005 Dec 5. link to original article contains verified protocol PubMed
  2. GOG 150: Wolfson AH, Brady MF, Rocereto T, Mannel RS, Lee YC, Futoran RJ, Cohn DE, Ioffe OB. A Gynecologic Oncology Group randomized phase III trial of whole abdominal irradiation (WAI) vs cisplatin-ifosfamide and mesna (CIM) as post-surgical therapy in stage I-IV carcinosarcoma (CS) of the uterus. Gynecol Oncol. 2007 Nov;107(2):177-85. Epub 2007 Sep 5. link to original article contains verified protocol link to PMC article PubMed NCT00002546

Non-endocrine therapy for advanced, recurrent, or metastatic disease

Bevacizumab monotherapy

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Regimen

Study Evidence
Aghajanian et al. 2011 (GOG-0229E) Phase II

Targeted therapy

21-day cycles

References

  1. GOG-0229E: Aghajanian C, Sill MW, Darcy KM, Greer B, McMeekin DS, Rose PG, Rotmensch J, Barnes MN, Hanjani P, Leslie KK; Gynecologic Oncology Group. Phase II trial of bevacizumab in recurrent or persistent endometrial cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2011 Jun 1;29(16):2259-65. Epub 2011 May 2. link to original article contains verified protocol link to PMC article PubMed NCT00301964

Carboplatin monotherapy

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Regimen variant #1, 300 mg/m2

Study Evidence Efficacy
van Wijk et al. 2003 Phase II ORR: 13% (95% CI 6-25%)

This dosing is intended for patients previously treated with chemotherapy.

Chemotherapy

28-day cycles

Regimen variant #2, 400 mg/m2

Study Evidence Efficacy
van Wijk et al. 2003 Phase II ORR: 13% (95% CI 6-25%)

Chemotherapy

28-day cycles

References

  1. van Wijk FH, Lhommé C, Bolis G, Scotto di Palumbo V, Tumolo S, Nooij M, de Oliveira CF, Vermorken JB; EORTC Gynaecological Cancer Group. Phase II study of carboplatin in patients with advanced or recurrent endometrial carcinoma: a trial of the EORTC Gynaecological Cancer Group. Eur J Cancer. 2003 Jan;39(1):78-85. link to original article contains verified protocol PubMed

Carboplatin & Doxorubicin liposomal

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Regimen

Study Evidence
Pignata et al. 2007 (END-1) Phase II

Note: All patients received 3 cycles of therapy. If there was no unacceptable toxicity, patients with stable or responsive disease received an additional 3 cycles.

Chemotherapy

Supportive medications

  • G-CSF as follows:
    • Prophylaxis: not recommended
    • Grade 4 neutropenia: therapeutic and prophylactic use was allowed

28-day cycle for 3 to 6 cycles

References

  1. END-1: Pignata S, Scambia G, Pisano C, Breda E, Di Maio M, Greggi S, Ferrandina G, Lorusso D, Zagonel V, Febbraro A, Riva N, De Rosa V, Gallo C, Perrone F; Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies Group. A multicentre phase II study of carboplatin plus pegylated liposomal doxorubicin as first-line chemotherapy for patients with advanced or recurrent endometrial carcinoma: the END-1 study of the MITO (Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies) group. Br J Cancer. 2007 Jun 4;96(11):1639-43. Epub 2007 May 8. link to original article contains verified protocol link to PMC article PubMed

Carboplatin & Paclitaxel (CP)

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Regimen variant #1, 5/175, finite duration

Study Evidence
Pectasides et al. 2008 Phase II

Chemotherapy

21-day cycle for 6 to 9 cycles

Regimen variant #2, 5/175, indefinite

Study Evidence
Hoskins et al. 2001 Phase II
Sorbe et al. 2007 Phase II

Note: this is the lower limit of carboplatin dosing allowed in Hoskins et al. 2001.

Chemotherapy

21-day cycles

Regimen variant #3, 6/175 x 7

ESMO-preferred (I-A, 2016)
Study Years of enrollment Evidence Comparator Comparative Efficacy
Miller et al. 2020 (GOG0209 2003-2009 Phase III (E-de-esc) TAP Non-inferior OS

Note: ESMO recommends 6 cycles, whereas the cited RCT uses 7 cycles.

Chemotherapy

21-day cycle for 7 cycles

Regimen variant #4, 7/175

Study Evidence
Hoskins et al. 2001 Phase II

Note: this is the upper limit of carboplatin dosing allowed in Hoskins et al. 2001.

Chemotherapy

21-day cycles

References

  1. Hoskins PJ, Swenerton KD, Pike JA, Wong F, Lim P, Acquino-Parsons C, Lee N. Paclitaxel and carboplatin, alone or with irradiation, in advanced or recurrent endometrial cancer: a phase II study. J Clin Oncol. 2001 Oct 15;19(20):4048-53. link to original article contains verified protocol PubMed
  2. Sorbe B, Andersson H, Boman K, Rosenberg P, Kalling M. Treatment of primary advanced and recurrent endometrial carcinoma with a combination of carboplatin and paclitaxel-long-term follow-up. Int J Gynecol Cancer. 2008 Jul-Aug;18(4):803-8. Epub 2007 Oct 18. link to original article contains verified protocol PubMed
  3. Pectasides D, Xiros N, Papaxoinis G, Pectasides E, Sykiotis C, Koumarianou A, Psyrri A, Gaglia A, Kassanos D, Gouveris P, Panayiotidis J, Fountzilas G, Economopoulos T. Carboplatin and paclitaxel in advanced or metastatic endometrial cancer. Gynecol Oncol. 2008 May;109(2):250-4. Epub 2008 Mar 4. link to original article contains verified protocol PubMed content property of HemOnc.org
  4. Retrospective: Shechter-Maor G, Bruchim I, Ben-Harim Z, Altaras M, Fishman A. Combined chemotherapy regimen of carboplatin and paclitaxel as adjuvant treatment for papillary serous and clear cell endometrial cancer. Int J Gynecol Cancer. 2009 May;19(4):662-4. link to original article PubMed
  5. GOG0209: Miller DS, Filiaci VL, Mannel RS, Cohn DE, Matsumoto T, Tewari KS, DiSilvestro P, Pearl ML, Argenta PA, Powell MA, Zweizig SL, Warshal DP, Hanjani P, Carney ME, Huang H, Cella D, Zaino R, Fleming GF. Carboplatin and Paclitaxel for Advanced Endometrial Cancer: Final Overall Survival and Adverse Event Analysis of a Phase III Trial (NRG Oncology/GOG0209). J Clin Oncol. 2020 Nov 20;38(33):3841-3850. Epub 2020 Sep 29. link to original article contains verified protocol link to PMC article PubMed NCT00063999
  6. RUBY: NCT03981796

CIM

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CIM: Cisplatin, Ifosfamide, Mesna

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Sutton et al. 2000 (GOG 108) 1989-1996 Phase III (E-esc) Ifosfamide Seems to have superior PFS

Chemotherapy

Supportive medications

References

  1. GOG 108: Sutton G, Brunetto VL, Kilgore L, Soper JT, McGehee R, Olt G, Lentz SS, Sorosky J, Hsiu JG. A phase III trial of ifosfamide with or without cisplatin in carcinosarcoma of the uterus: A Gynecologic Oncology Group study. Gynecol Oncol. 2000 Nov;79(2):147-53. link to original article PubMed

Cisplatin & Doxorubicin

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AP: Adriamycin (Doxorubicin) & Platinol (Cisplatin)

Regimen variant #1, 50/45

Study Years of enrollment Evidence Comparator Comparative Efficacy
Fleming et al. 2004a (GOG 177) 1998-2000 Phase III (C) Cisplatin, Doxorubicin, Paclitaxel Seems to have inferior OS

Note: body surface area was capped at 2 m2. This dosage was for patients with previous pelvic radiation or who were greater than 65 years old.

Chemotherapy

21-day cycle for 7 cycles

Regimen variant #2, 50/60, capped BSA

Study Years of enrollment Evidence Comparator Comparative Efficacy
Fleming et al. 2004a (GOG 177) 1998-2000 Phase III (C) Cisplatin, Doxorubicin, Paclitaxel Seems to have inferior OS

Note: body surface area was capped at 2 m2.

Chemotherapy

21-day cycle for 7 cycles

Regimen variant #3, 50/60, no cap on BSA

Study Years of enrollment Evidence Comparator Comparative Efficacy
Fleming et al. 2004 (GOG 163) 1996-1998 Phase III (C) Doxorubicin & Paclitaxel Did not meet primary endpoint of ORR
Thigpen et al. 2004 (GOG 107) NR Phase III (E-esc) Doxorubicin Seems to have superior PFS

Chemotherapy

Supportive hydration

21-day cycle for up to 8 cycles

Regimen variant #4, 60/60

Study Years of enrollment Evidence Comparator Comparative Efficacy
Gallion et al. 2003 (GOG 139) 1993-1996 Phase III (C) Chronomodulated Cisplatin & Doxorubicin Did not meet primary endpoint of ORR

Chemotherapy

21-day cycle for up to 8 cycles

References

  1. GOG 139: Gallion HH, Brunetto VL, Cibull M, Lentz SS, Reid G, Soper JT, Burger RA, Andersen W; Gynecologic Oncology Group. Randomized phase III trial of standard timed doxorubicin plus cisplatin versus circadian timed doxorubicin plus cisplatin in stage III and IV or recurrent endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2003 Oct 15;21(20):3808-13. link to original article contains protocol PubMed
  2. GOG 177: Fleming GF, Brunetto VL, Cella D, Look KY, Reid GC, Munkarah AR, Kline R, Burger RA, Goodman A, Burks RT. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2004 Jun 1;22(11):2159-66. link to original article contains verified protocol PubMed NCT00003691
  3. GOG 163: Fleming GF, Filiaci VL, Bentley RC, Herzog T, Sorosky J, Vaccarello L, Gallion H. Phase III randomized trial of doxorubicin + cisplatin versus doxorubicin + 24-h paclitaxel + filgrastim in endometrial carcinoma: a Gynecologic Oncology Group study. Ann Oncol. 2004 Aug;15(8):1173-8. link to original article contains protocol PubMed
  4. GOG 107: Thigpen JT, Brady MF, Homesley HD, Malfetano J, DuBeshter B, Burger RA, Liao S. Phase III trial of doxorubicin with or without cisplatin in advanced endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2004 Oct 1;22(19):3902-8. link to original article contains protocol PubMed

Cisplatin, Doxorubicin, Paclitaxel

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TAP: Taxol (Paclitaxel), Adriamycin (Doxorubicin), Platinol (Cisplatin)

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Fleming et al. 2004 (GOG 177) 1998-2000 Phase III (E-esc) Cisplatin & Doxorubicin Seems to have superior OS
Miller et al. 2020 (GOG0209 2003-2009 Phase III (C) TC Non-inferior OS

Note: in GOG 177, body surface area was capped at 2 m2.

Chemotherapy

Supportive medications

21-day cycle for 7 cycles

References

  1. GOG 177: Fleming GF, Brunetto VL, Cella D, Look KY, Reid GC, Munkarah AR, Kline R, Burger RA, Goodman A, Burks RT. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2004 Jun 1;22(11):2159-66. link to original article contains verified protocol PubMed NCT00003691
  2. GOG0209: Miller DS, Filiaci VL, Mannel RS, Cohn DE, Matsumoto T, Tewari KS, DiSilvestro P, Pearl ML, Argenta PA, Powell MA, Zweizig SL, Warshal DP, Hanjani P, Carney ME, Huang H, Cella D, Zaino R, Fleming GF. Carboplatin and Paclitaxel for Advanced Endometrial Cancer: Final Overall Survival and Adverse Event Analysis of a Phase III Trial (NRG Oncology/GOG0209). J Clin Oncol. 2020 Nov 20;38(33):3841-3850. Epub 2020 Sep 29. link to original article contains verified protocol link to PMC article PubMed NCT00063999

Cisplatin & Paclitaxel

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Regimen

Study Evidence
Dimopoulos et al. 2000 Phase II

Chemotherapy

Supportive medications

21-day cycle for up to 6 cycles

References

  1. Dimopoulos MA, Papadimitriou CA, Georgoulias V, Moulopoulos LA, Aravantinos G, Gika D, Karpathios S, Stamatelopoulos S. Paclitaxel and cisplatin in advanced or recurrent carcinoma of the endometrium: long-term results of a phase II multicenter study. Gynecol Oncol. 2000 Jul;78(1):52-7. link to original article contains verified protocol PubMed

Dactinomycin monotherapy

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Regimen

Study Evidence
Moore et al. 1999 Phase II

Chemotherapy

28-day cycles

References

  1. Moore DH, Blessing JA, Dunton C, Buller RE, Reid GC; Gynecologic Oncology Group. Dactinomycin in the treatment of recurrent or persistent endometrial carcinoma: A Phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 1999 Dec;75(3):473-5. link to original article contains verified protocol PubMed

Dostarlimab monotherapy

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Regimen

FDA-recommended dose
Study Years of enrollment Evidence
Oaknin et al. 2020 (GARNET) 2017-2019 Phase 1, >20 pts in this cohort (RT)

Immunotherapy

  • Dostarlimab (Jemperli) as follows:
    • Cycles 1 to 4: 500 mg IV over 30 minutes once on day 1
    • Cycle 5 onwards: 1000 mg IV over 30 minutes once on day 1

21-day cycle for 4 cycles, then 42-day cycles

References

  1. GARNET: Oaknin A, Tinker AV, Gilbert L, Samouëlian V, Mathews C, Brown J, Barretina-Ginesta MP, Moreno V, Gravina A, Abdeddaim C, Banerjee S, Guo W, Danaee H, Im E, Sabatier R. Clinical Activity and Safety of the Anti-Programmed Death 1 Monoclonal Antibody Dostarlimab for Patients With Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer: A Nonrandomized Phase 1 Clinical Trial. JAMA Oncol. 2020 Oct 1;6(11):1–7. Epub ahead of print. link to original article link to PMC article contains verified protocol PubMed NCT02715284

Doxorubicin monotherapy

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Regimen variant #1, 7 cycles

Study Years of enrollment Evidence Comparator Comparative Efficacy
van Wijk et al. 2003 (EORTC 55872) 1988-1994 Phase III (C) Cisplatin & Doxorubicin Might have inferior OS

Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.

Chemotherapy

28-day cycle for up to 7 cycles

Regimen variant #2, 8 cycles

Study Years of enrollment Evidence Comparator Comparative Efficacy
Thigpen et al. 1979 NR Phase II
Omura et al. 1983 (GOG 21) 1973-1979 Randomized (C) Dacarbazine & Doxorubicin Did not meet primary endpoint of ORR
Muss et al. 1985 (GOG 42) 1979-1982 Phase III (C) Cyclophosphamide & Doxorubicin (AC) Did not meet efficacy endpoints
Thigpen et al. 1994 (GOG 48) 1979-1985 Randomized (C) Cyclophosphamide & Doxorubicin (AC) Did not meet efficacy endpoints
Thigpen et al. 2004 (GOG 107) NR Phase III (C) Cisplatin & Doxorubicin Seems to have inferior PFS

Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.

Chemotherapy

21-day cycle for up to 8 cycles

References

  1. Thigpen JT, Buchsbaum HJ, Mangan C, Blessing JA; Gynecologic Oncology Group. Phase II trial of adriamycin in the treatment of advanced or recurrent endometrial carcinoma: a Gynecologic Oncology Group study. Cancer Treat Rep. 1979 Jan;63(1):21-7. PubMed
  2. GOG 21: Omura GA, Major FJ, Blessing JA, Sedlacek TV, Thigpen JT, Creasman WT, Zaino RJ. A randomized study of adriamycin with and without dimethyl triazenoimidazole carboxamide in advanced uterine sarcomas. Cancer. 1983 Aug 15;52(4):626-32. link to original article PubMed
  3. GOG 42: Muss HB, Bundy B, DiSaia PJ, Homesley HD, Fowler WC Jr, Creasman W, Yordan E. Treatment of recurrent or advanced uterine sarcoma: a randomized trial of doxorubicin versus doxorubicin and cyclophosphamide (a phase III trial of the Gynecologic Oncology Group). Cancer. 1985 Apr 15;55(8):1648-53. link to original article PubMed
  4. GOG 48: Thigpen JT, Blessing JA, DiSaia PJ, Yordan E, Carson LF, Evers C. A randomized comparison of doxorubicin alone versus doxorubicin plus cyclophosphamide in the management of advanced or recurrent endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 1994 Jul;12(7):1408-14. link to original article contains protocol PubMed
  5. EORTC 55872: van Wijk FH, Aapro MS, Bolis G, Chevallier B, van der Burg ME, Poveda A, de Oliveira CF, Tumolo S, Scotto di Palumbo V, Piccart M, Franchi M, Zanaboni F, Lacave AJ, Fontanelli R, Favalli G, Zola P, Guastalla JP, Rosso R, Marth C, Nooij M, Presti M, Scarabelli C, Splinter TA, Ploch E, Beex LV, ten Bokkel Huinink W, Forni M, Melpignano M, Blake P, Kerbrat P, Mendiola C, Cervantes A, Goupil A, Harper PG, Madronal C, Namer M, Scarfone G, Stoot JE, Teodorovic I, Coens C, Vergote I, Vermorken JB; EORTC Gynaecological Cancer Group. Doxorubicin versus doxorubicin and cisplatin in endometrial carcinoma: definitive results of a randomised study (55872) by the EORTC Gynaecological Cancer Group. Ann Oncol. 2003 Mar;14(3):441-8. Erratum in: Ann Oncol. 2003 May;14(5):811. link to original article contains verified protocol PubMed
  6. GOG 107: Thigpen JT, Brady MF, Homesley HD, Malfetano J, DuBeshter B, Burger RA, Liao S. Phase III trial of doxorubicin with or without cisplatin in advanced endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2004 Oct 1;22(19):3902-8. link to original article contains protocol PubMed

Ifosfamide monotherapy

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Regimen variant #1, 1200 mg/m2 (3 days/cycle)

Study Years of enrollment Evidence Comparator Comparative Efficacy
Homesley et al. 2007 (GOG 161) 1997-2004 Phase III (C) Ifosfamide & Paclitaxel Seems to have inferior OS

Note: GOG 161 specifies that PO Mesna (Mesnex) is to be taken in 3 divided doses, but only lists 2 time points for its use. The timing of the middle dose is estimated based on other references. This dosage is intended for patients with previous radiation.

Chemotherapy

Supportive medications

  • Mesna (Mesnex) 2000 mg IV over 12 hours once per day on days 1 to 3, starting 15 minutes before Ifosfamide (Ifex) (total dose per cycle: 6000 mg/m2)
    • Alternate PO dosing: 1330 mg PO three times per day on days 1 to 3, taken 1 hour before, 4 hours after, and 8 hours after Ifosfamide (Ifex) (total dose per cycle: 11,970 mg)
  • Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 4, to continue until ANC is greater than or equal to 2000/uL

21-day cycle for 8 cycles

Regimen variant #2, 1500 mg/m2 (5 days/cycle)

Study Years of enrollment Evidence Comparator Comparative Efficacy
Sutton et al. 2000 (GOG 108) 1989-1996 Phase III (C) CIM Seems to have inferior PFS

Chemotherapy

Supportive medications

21-day cycle for 8 cycles

Regimen variant #3, 1600 mg/m2 (3 days/cycle)

Study Years of enrollment Evidence Comparator Comparative Efficacy
Homesley et al. 2007 (GOG 161) 1997-2004 Phase III (C) Ifosfamide & Paclitaxel Seems to have inferior OS

Note: GOG 161 specifies that PO Mesna (Mesnex) is to be taken in 3 divided doses, but only lists 2 time points for its use. The timing of the middle dose is estimated based on other references.

Chemotherapy

  • Ifosfamide (Ifex) 1600 mg/m2 IV once per day on days 1 to 3
    • Dosage for patients with previous radiation: 1200 mg/m2 IV once per day on days 1 to 3

Supportive medications

  • Mesna (Mesnex) 2000 mg IV over 12 hours once per day on days 1 to 3, starting 15 minutes before Ifosfamide (Ifex) (total dose per cycle: 6000 mg/m2)
    • Alternate PO dosing: 1330 mg PO three times per day on days 1 to 3, taken 1 hour before, 4 hours after, and 8 hours after Ifosfamide (Ifex) (total dose per cycle: 11,970 mg)
  • Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 4, to continue until ANC is greater than or equal to 2000/uL

21-day cycle for 8 cycles

References

  1. GOG 108: Sutton G, Brunetto VL, Kilgore L, Soper JT, McGehee R, Olt G, Lentz SS, Sorosky J, Hsiu JG. A phase III trial of ifosfamide with or without cisplatin in carcinosarcoma of the uterus: A Gynecologic Oncology Group study. Gynecol Oncol. 2000 Nov;79(2):147-53. link to original article contains verified protocol PubMed
  2. GOG 161: Homesley HD, Filiaci V, Markman M, Bitterman P, Eaton L, Kilgore LC, Monk BJ, Ueland FR; Gynecologic Oncology Group. Phase III trial of ifosfamide with or without paclitaxel in advanced uterine carcinosarcoma: a Gynecologic Oncology Group study. J Clin Oncol. 2007 Feb 10;25(5):526-31. link to original article contains verified protocol PubMed NCT00003128

Ifosfamide & Paclitaxel

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Homesley et al. 2007 (GOG 161) 1997-2004 Phase III (E-esc) Ifosfamide Seems to have superior OS

Note: GOG 161 specifies that PO Mesna (Mesnex) is to be taken in 3 divided doses, but only lists 2 time points for its use. The timing of the middle dose is estimated based on other references.

Chemotherapy

  • Ifosfamide (Ifex) 1600 mg/m2 IV once per day on days 1 to 3
    • Dosage for patients with previous radiation: 1200 mg/m2 IV once per day on days 1 to 3
  • Paclitaxel (Taxol) 135 mg/m2 IV over 3 hours once on day 1

Supportive medications

21-day cycle for 8 cycles

References

  1. GOG 161: Homesley HD, Filiaci V, Markman M, Bitterman P, Eaton L, Kilgore LC, Monk BJ, Ueland FR; Gynecologic Oncology Group. Phase III trial of ifosfamide with or without paclitaxel in advanced uterine carcinosarcoma: a Gynecologic Oncology Group study. J Clin Oncol. 2007 Feb 10;25(5):526-31. link to original article contains verified protocol PubMed NCT00003128

Lenvatinib & Pembrolizumab

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Regimen

Study Years of enrollment Evidence
Makker et al. 2019 (KEYNOTE-146) 2015-2017 Phase II (RT)

Targeted therapy

Immunotherapy

21-day cycles

References

  1. KEYNOTE-146: Makker V, Rasco D, Vogelzang NJ, Brose MS, Cohn AL, Mier J, Di Simone C, Hyman DM, Stepan DE, Dutcus CE, Schmidt EV, Guo M, Sachdev P, Shumaker R, Aghajanian C, Taylor M. Lenvatinib plus pembrolizumab in patients with advanced endometrial cancer: an interim analysis of a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncol. 2019 May;20(5):711-718. Epub 2019 Mar 25. link to original article contains protocol PubMed NCT02501096
  2. KEYNOTE-775: NCT03517449

Paclitaxel monotherapy

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Regimen variant #1, 175 mg/m2

Study Years of enrollment Evidence Comparator Comparative Efficacy
Lissoni et al. 1996 1993-1995 Phase II
Lincoln et al. 2003 1994-1996 Phase II
McMeekin et al. 2015 (IXAMPLE2) 2009-2012 Phase III (C) Ixabepilone Seems to have superior OS

Note: in Lincoln et al. 2003, this was the dosage for patients with previous pelvic radiation.

Chemotherapy

Supportive medications

21-day cycles

Regimen variant #2, 200 mg/m2

Study Evidence
Ball et al. 1996 Phase II
Lincoln et al. 2003 Phase II

Note: in Ball et al. 1996, this was the dosage for patients with previous pelvic radiation.

Chemotherapy

  • Paclitaxel (Taxol) 200 mg/m2 IV over 3 hours once on day 1
    • Ball et al. 1996 gave as a 24 hour continuous infusion
    • Dose can be changed to 135 or 110 mg/m2 depending on toxicity

Supportive medications

21-day cycles

Regimen variant #3, 250 mg/m2

Study Evidence
Ball et al. 1996 Phase II

Chemotherapy

  • Paclitaxel (Taxol) 250 mg/m2 IV continuous infusion over 24 hours, started on day 1
    • Dosage for patients with previous pelvic radiation: 200 mg/m2 IV continuous infusion over 24 hours, started on day 1
    • Dose can be changed to 200, 170, 135, 110 mg/m2 depending on toxicity

Supportive medications

21-day cycles

References

  1. Ball HG, Blessing JA, Lentz SS, Mutch DG; Gynecologic Oncology Group. A phase II trial of paclitaxel in patients with advanced or recurrent adenocarcinoma of the endometrium: a Gynecologic Oncology Group study. Gynecol Oncol. 1996 Aug;62(2):278-81. link to original article contains verified protocol PubMed
  2. Lissoni A, Zanetta G, Losa G, Gabriele A, Parma G, Mangioni C. Phase II study of paclitaxel as salvage treatment in advanced endometrial cancer. Ann Oncol. 1996 Oct;7(8):861-3. link to original article contains verified protocol PubMed
  3. Lincoln S, Blessing JA, Lee RB, Rocereto TF; Gynecologic Oncology Group. Activity of paclitaxel as second-line chemotherapy in endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2003 Mar;88(3):277-81. link to original article contains verified protocol PubMed
  4. IXAMPLE2: McMeekin S, Dizon D, Barter J, Scambia G, Manzyuk L, Lisyanskaya A, Oaknin A, Ringuette S, Mukhopadhyay P, Rosenberg J, Vergote I. Phase III randomized trial of second-line ixabepilone versus paclitaxel or doxorubicin in women with advanced endometrial cancer. Gynecol Oncol. 2015 Jul;138(1):18-23. Epub 2015 Apr 26. link to original article contains protocol PubMed NCT00883116

Pembrolizumab monotherapy

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Regimen

Study Years of enrollment Evidence
Le et al. 2017 (KEYNOTE-016) 2013-2016 Phase II, <20 pts of this subtype
Ott et al. 2017b (KEYNOTE-028) NR Phase II

Note: KEYNOTE-016 was an expansion to a CRC-specific trial.

Immunotherapy

14-day cycle for up to 52 cycles (2 years)

References

  1. KEYNOTE-028: Ott PA, Bang YJ, Berton-Rigaud D, Elez E, Pishvaian MJ, Rugo HS, Puzanov I, Mehnert JM, Aung KL, Lopez J, Carrigan M, Saraf S, Chen M, Soria JC. Safety and antitumor activity of pembrolizumab in advanced programmed death ligand 1-positive endometrial cancer: results from the KEYNOTE-028 study. J Clin Oncol. 2017 Aug 1;35(22):2535-2541. Epub 2017 May 10. link to original article contains protocol PubMed NCT02054806
  2. KEYNOTE-016: Le DT, Durham JN, Smith KN, Wang H, Bartlett BR, Aulakh LK, Lu S, Kemberling H, Wilt C, Luber BS, Wong F, Azad NS, Rucki AA, Laheru D, Donehower R, Zaheer A, Fisher GA, Crocenzi TS, Lee JJ, Greten TF, Duffy AG, Ciombor KK, Eyring AD, Lam BH, Joe A, Kang SP, Holdhoff M, Danilova L, Cope L, Meyer C, Zhou S, Goldberg RM, Armstrong DK, Bever KM, Fader AN, Taube J, Housseau F, Spetzler D, Xiao N, Pardoll DM, Papadopoulos N, Kinzler KW, Eshleman JR, Vogelstein B, Anders RA, Diaz LA Jr. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade. Science. 2017 Jul 28;357(6349):409-413. Epub 2017 Jun 8. link to original article link to PMC article contains verified protocol in supplement PubMed NCT01876511

Temsirolimus monotherapy

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Regimen

Study Evidence
Oza et al. 2011 (NCIC IND.160) Phase II

Targeted therapy

28-day cycles

References

  1. NCIC IND.160: Oza AM, Elit L, Tsao MS, Kamel-Reid S, Biagi J, Provencher DM, Gotlieb WH, Hoskins PJ, Ghatage P, Tonkin KS, Mackay HJ, Mazurka J, Sederias J, Ivy P, Dancey JE, Eisenhauer EA; NCIC Clinical Trials Group. Phase II study of temsirolimus in women with recurrent or metastatic endometrial cancer: a trial of the NCIC Clinical Trials Group. J Clin Oncol. 2011 Aug 20;29(24):3278-85. Epub 2011 Jul 25. link to original article contains verified protocol link to PMC article PubMed NCT00072176

Topotecan monotherapy

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Regimen

Study Evidence
Wadler et al. 2003 (ECOG E3E93) Phase II

Chemotherapy

  • Topotecan (Hycamtin) 1.5 mg/m2 IV once per day on days 1 to 5
    • Dosage for patients with previous pelvic radiation: 1.2 mg/m2, which can be increased to the 1.5 mg/m2 dose in later cycles if there are no toxicities higher than grade 1

21-day cycles

References

  1. ECOG E3E93: Wadler S, Levy DE, Lincoln ST, Soori GS, Schink JC, Goldberg G. Topotecan is an active agent in the first-line treatment of metastatic or recurrent endometrial carcinoma: Eastern Cooperative Oncology Group Study E3E93. J Clin Oncol. 2003 Jun 1;21(11):2110-4. link to original article contains verified protocol PubMed

Endocrine therapy for advanced, recurrent, or metastatic disease

Anastrozole monotherapy

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Regimen

Study Evidence
Rose et al. 2000 Phase II

Endocrine therapy

Continued indefinitely

References

  1. Rose PG, Brunetto VL, VanLe L, Bell J, Walker JL, Lee RB; Gynecologic Oncology Group. A phase II trial of anastrozole in advanced recurrent or persistent endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2000 Aug;78(2):212-6. link to original article contains verified protocol PubMed

Medroxyprogesterone monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Kelley & Baker 1961 1950-1959 Non-randomized
Thigpen et al. 1999 1985-1989 Phase III (C) High-dose medroxyprogesterone Did not meet primary endpoint of ORR

Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm. Kelley & Baker 1961 examined a variety of progestins and is included for historic interest.

Endocrine therapy

Continued indefinitely

References

  1. Kelley RM, Baker WH. Progestational agents in the treatment of carcinoma of the endometrium. N Engl J Med. 1961 Feb 2;264:216-22. link to original article PubMed
  2. Thigpen JT, Brady MF, Alvarez RD, Adelson MD, Homesley HD, Manetta A, Soper JT, Given FT; Gynecologic Oncology Group. Oral medroxyprogesterone acetate in the treatment of advanced or recurrent endometrial carcinoma: a dose-response study by the Gynecologic Oncology Group. J Clin Oncol. 1999 Jun;17(6):1736-44. link to original article contains verified protocol PubMed

Medroxyprogesterone & Tamoxifen

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Regimen

Study Evidence
Whitney et al. 2004 Phase II

Endocrine therapy

Continued indefinitely

References

  1. Whitney CW, Brunetto VL, Zaino RJ, Lentz SS, Sorosky J, Armstrong DK, Lee RB; Gynecologic Oncology Group. Phase II study of medroxyprogesterone acetate plus tamoxifen in advanced endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2004 Jan;92(1):4-9. link to original article contains verified protocol PubMed

Megestrol monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Kelley & Baker 1961 1950-1959 Non-randomized
Pandya et al. 2001 (ECOG E4882) 1982-1984 Randomized Phase II (C) Megestrol & Tamoxifen Did not meet efficacy endpoints

Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm. Kelley & Baker 1961 examined a variety of progestins and is included for historic interest.

Endocrine therapy

Continued indefinitely

References

  1. Kelley RM, Baker WH. Progestational agents in the treatment of carcinoma of the endometrium. N Engl J Med. 1961 Feb 2;264:216-22. link to original article PubMed
  2. ECOG E4882: Pandya KJ, Yeap BY, Weiner LM, Krook JE, Erban JK, Schinella RA, Davis TE. Megestrol and tamoxifen in patients with advanced endometrial cancer: an Eastern Cooperative Oncology Group Study (E4882). Am J Clin Oncol. 2001 Feb;24(1):43-6. link to original article contains verified protocol PubMed

Megestrol & Tamoxifen

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Pandya et al. 2001 (ECOG E4882) 1982-1984 Randomized Phase II (E-switch-ic) Megestrol Did not meet primary efficacy endpoints
Fiorica et al. 2004 1994-1995 Phase II

Hormonotherapy, part 1

21-day cycles, alternating with tamoxifen

Hormonotherapy, part 2

21-day cycles, alternating with megestrol

References

  1. ECOG E4882: Pandya KJ, Yeap BY, Weiner LM, Krook JE, Erban JK, Schinella RA, Davis TE. Megestrol and tamoxifen in patients with advanced endometrial cancer: an Eastern Cooperative Oncology Group Study (E4882). Am J Clin Oncol. 2001 Feb;24(1):43-6. link to original article contains verified protocol PubMed
  2. Fiorica JV, Brunetto VL, Hanjani P, Lentz SS, Mannel R, Andersen W; Gynecologic Oncology Group. Phase II trial of alternating courses of megestrol acetate and tamoxifen in advanced endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2004 Jan;92(1):10-4. link to original article contains verified protocol PubMed

Tamoxifen monotherapy

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Regimen

Study Evidence
Quinn et al. 1989 Phase II
Thigpen et al. 2001 (GOG-81F) Phase II

Endocrine therapy

Continued indefinitely

References

  1. Quinn MA, Campbell JJ. Tamoxifen therapy in advanced/recurrent endometrial carcinoma. Gynecol Oncol. 1989 Jan;32(1):1-3. link to original article PubMed
  2. GOG-81F: Thigpen T, Brady MF, Homesley HD, Soper JT, Bell J. Tamoxifen in the treatment of advanced or recurrent endometrial carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2001 Jan 15;19(2):364-7. link to original article contains verified protocol PubMed
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