Endometrial cancer

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Hormone therapy for endometrioid histologies

Anastrozole (Arimidex)

Level of Evidence: Phase II

given until progression of disease or unacceptable toxicity

References

  1. Rose PG, Brunetto VL, VanLe L, Bell J, Walker JL, Lee RB. 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 acetate (MPA)

Regimen

Level of Evidence: Phase III

given until progression of disease or unacceptable toxicity

References

  1. Thigpen JT, Brady MF, Alvarez RD, Adelson MD, Homesley HD, Manetta A, Soper JT, Given FT. 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 acetate & Tamoxifen

Regimen

Level of Evidence: Phase II

given until progression of disease or unacceptable toxicity

References

  1. Whitney CW, Brunetto VL, Zaino RJ, Lentz SS, Sorosky J, Armstrong DK, Lee RB; Gynecologic Oncology Group study. 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 acetate (Megace)

Regimen

Level of Evidence: Randomized Phase II, >20 per arm

given until progression of disease or unacceptable toxicity

References

  1. 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 acetate & Tamoxifen

Regimen

Level of Evidence: Randomized Phase II, >20 per arm

3-week courses of Megestrol acetate (Megace), alternating back and forth with 3-week courses of Tamoxifen (Nolvadex); given until progression of disease or unacceptable toxicity

References

  1. 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 study. 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 (Nolvadex)

Regimen

Level of Evidence: Phase II

given until progression of disease or unacceptable toxicity

References

  1. Quinn MA, Campbell JJ. Tamoxifen therapy in advanced/recurrent endometrial carcinoma. Gynecol Oncol. 1989 Jan;32(1):1-3. PubMed
  2. 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

Adjuvant radiation & chemotherapy

Cisplatin, Doxorubicin, RT

Regimen

Level of Evidence: Phase III

Adjuvant radiation

  • Radiation therapy to the pelvis, 1.8 Gy x 28 fractions (total dose: 50.4 Gy)
    • Patients with positive para-aortic lymph nodes received 1.5 to 1.8 Gy x 24 to 29 fractions (total dose: 43.5 Gy)

6-week course, begins within 8 weeks after surgery

Chemotherapy

21-day cycles x 6 cycles, to start within 8 weeks after adjuvant radiation is complete

Supportive medications:

References

  1. 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 PubMed

Cisplatin, Doxorubicin, Paclitaxel, RT

Regimen

Level of Evidence: Phase III

Adjuvant radiation

  • Radiation therapy to the pelvis, 1.8 Gy x 28 fractions (total dose: 50.4 Gy)
    • Patients with positive para-aortic lymph nodes received 1.5 to 1.8 Gy x 24 to 29 fractions (total dose: 43.5 Gy)

6-week course, begins within 8 weeks after surgery

Chemotherapy

21-day cycles x 6 cycles, to start within 8 weeks after adjuvant radiation is complete

Supportive medications:

References

  1. 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 PubMed

Advanced, recurrent, or metastatic disease

Bevacizumab (Avastin)

Regimen, Aghajanian, et al. 2011

Level of Evidence: Phase II

21-day cycles, given until progression of disease or unacceptable toxicity

References

  1. Aghajanian C, Sill MW, Darcy KM, Greer B, McMeekin DS, Rose PG, Rotmensch J, Barnes MN, Hanjani P, Leslie KK. 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. doi: 10.1200/JCO.2010.32.6397. Epub 2011 May 2. link to original article contains verified protocol PubMed

Carboplatin (Paraplatin)

Regimen

Level of Evidence: Phase II

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; European Organization for Research and Treatment of Cancer. 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

Regimen, Pignata, et al. 2007 (END-1)

Level of Evidence: Phase II

28-day cycles x 3 to 6 cycles; all patients received 3 cycles of therapy. If there was no unacceptable toxicity, patients with stable or responsive disease received an additional 3 cycles.

Supportive medications:

  • "No prophylactic use of G-CSF was recommended. In case of grade 4 neutropaenia, even without fever, therapeutic and prophylactic use of G-CSF was allowed."

References

  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 PubMed

Carboplatin & Paclitaxel

Regimen #1, Pectasides, et al. 2008

Level of Evidence: Phase II

21-day cycles x 6 to 9 cycles

Regimen #2, Hoskins, et al. 2001 & Shechter-Maor, et al. 2008

Level of Evidence: Phase II

21-day cycles

Regimen #3, Sorbe, et al. 2008

Level of Evidence: Phase II

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. 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
  3. 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. PubMed
  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

Cisplatin & Doxorubicin

Regimen #1, Fleming et al. 2004

Level of Evidence: Phase III

21-day cycles x 7 cycles

Regimen #2, Randall et al. 2006

Level of Evidence: Phase III

21-day cycles x 8 cycles

Supportive hydration:

  • Normal saline at 500 mL/H for 2 hours prior to and after cisplatin

References

  1. 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
  2. Randall ME, Filiaci VL, Muss H, Spirtos NM, Mannel RS, Fowler J, Thigpen JT, Benda JA; Gynecologic Oncology Group Study. 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

Cisplatin, Doxorubicin, Paclitaxel

Regimen

Level of Evidence: Phase III

21-day cycles x 7 cycles

Supportive medications:

References

  1. 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

Cisplatin, Ifosfamide, Mesna (CIM)

CIM: Cisplatin, Ifosfamide, Mesna

Regimen, Wolfson, et al. 2007 (GOG 150)

Level of Evidence: Phase III

  • Cisplatin (Platinol) 20 mg/m2 IV at an infusion rate of approximately 1 mg/min once per day on days 1 to 4, given first
  • Ifosfamide (Ifex) 1500 mg/m2 IV over 1 hour once per day on days 1 to 4, given second together with mesna
  • Mesna (Mesnex) 120 mg/m2 IV bolus over 15 minutes once on day 1;, then Mesna (Mesnex) 1500 mg/m2/day IV continuous infusion over 96 hours on days 1 to 4, given second together with ifosfamide

21-day cycles x 3 cycles

Supportive medications:

  • Suggested hydration: 1 liter of NS or 1/2 NS given over several hours prior to chemotherapy

References

  1. 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 PubMed

Cisplatin & Paclitaxel

Regimen

Level of Evidence: Phase II

21-day cycles x up to 6 cycles

Supportive medications:

  • Dexamethasone (Decadron) 20 mg PO/IV given twice, 12 and 6 hours prior to paclitaxel
  • Diphenhydramine (Benadryl) 25 mg IV once 30 minutes prior to paclitaxel
  • Ranitidine (Zantac) 50 mg IV once 30 minutes prior to paclitaxel
  • 900 mL normal saline mixed with 100 mL mannitol given over 1 hour prior to cisplatin
  • 2 liters NS with potassium & magnesium after cisplatin
  • "Appropriate antiemetics"
  • Filgrastim (Neupogen) 5 mcg/kg SC once per day, starting on day 5 and continuing until WBC >10,000

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 (Cosmegen)

Regimen

Level of Evidence: Phase II

28-day cycles

References

  1. Moore DH, Blessing JA, Dunton C, Buller RE, Reid GC. 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

Ifosfamide

Regimen

Level of Evidence: Phase III

Note: Homesley, et al. 2007 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.

  • Ifosfamide (Ifex) 1600 mg/m2 IV once per day on days 1 to 3
    • Dosage for patients with previous radiation is Ifosfamide (Ifex) 1200 mg/m2 IV once per day on days 1 to 3
  • Mesna (Mesnex) 2000 mg IV over 12 hours once per day on days 1 to 3, starting 15 minutes before ifosfamide
    • Alternate PO dosing: Mesna (Mesnex) 1330 mg PO taken three times per day, 1 hour before, 4 hours after, and 8 hours after ifosfamide (4000 mg total dose per day), on days 1 to 3

21-day cycles x 8 cycles

Supportive medications:

  • Filgrastim (Neupogen) 5 mcg/kg SC once per day starting on day 4, to continue until ANC is greater than or equal to 2000

References

  1. 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

Ifosfamide & Paclitaxel

Regimen

Level of Evidence: Phase III

Note: Homesley, et al. 2007 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.

  • Ifosfamide (Ifex) 1600 mg/m2 IV once per day on days 1 to 3
    • Dosage for patients with previous radiation is Ifosfamide (Ifex) 1200 mg/m2 IV once per day on days 1 to 3
  • Mesna (Mesnex) 2000 mg IV over 12 hours once per day on days 1 to 3, starting 15 minutes before ifosfamide
    • Alternate PO dosing: Mesna (Mesnex) 1330 mg PO taken three times per day, 1 hour before, 4 hours after, and 8 hours after ifosfamide (4000 mg total dose per day), on days 1 to 3
  • Paclitaxel (Taxol) 135 mg/m2 IV over 3 hours once on day 1

21-day cycles x 8 cycles

Supportive medications:

  • Filgrastim (Neupogen) 5 mcg/kg SC once per day starting on day 4, to continue until ANC is greater than or equal to 2000
  • Dexamethasone (Decadron) 20 mg PO/IV given twice, 12 and 6 hours prior to paclitaxel
  • Diphenhydramine (Benadryl) 50 mg IV once 30 minutes prior to paclitaxel
  • Cimetidine (Tagamet) 300 mg IV or Ranitidine (Zantac) 50 mg IV once 30 minutes prior to paclitaxel

References

  1. 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

Paclitaxel (Taxol)

Regimen #1, Lincoln, et al. 2003

Level of Evidence: Phase II

21-day cycles

Supportive medications:

  • Dexamethasone (Decadron) 20 mg PO/IV given twice, 12 and 6 hours prior to paclitaxel
  • Diphenhydramine (Benadryl) 50 mg PO/IV once 30 minutes prior to paclitaxel
  • Cimetidine (Tagamet) 300 mg IV once 30 minutes prior to paclitaxel

Regimen #2, Lissoni, et al. 1996

Level of Evidence: Phase II

21-day cycles

Supportive medications:

  • Hydrocortisone (Cortef) 250 mg IV once 1 hour prior to paclitaxel
  • Chlorphenamine/chlorpheniramine (H1 blocker) 10 mg IM once 1 hour prior to paclitaxel
  • Cimetidine (Tagamet) 300 mg IV once 1 hour prior to paclitaxel

Regimen #3, Ball, et al. 1996

Level of Evidence: Phase II

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

21-day cycles

Supportive medications:

  • Dexamethasone (Decadron) 20 mg PO/IV given twice, 12 and 6 hours prior to paclitaxel
  • Diphenhydramine (Benadryl) 50 mg PO/IV once 30 minutes prior to paclitaxel
  • Cimetidine (Tagamet) 300 mg IV once 30 minutes prior to paclitaxel
  • Filgrastim (Neupogen) 5 mcg/kg SC once per day starting on day 3, 24 hours after chemotherapy, continued for at least 12 days or until two successive total leukocyte counts are 10,000 or greater, whichever comes last

References

  1. Ball HG, Blessing JA, Lentz SS, Mutch DG. 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. 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

Temsirolimus (Torisel)

Regimen, Oza, et al. 2011

Level of Evidence: Phase II

28-day cycles, given until progression of disease, unacceptable toxicity, or patient decision

References

  1. 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. 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. doi: 10.1200/JCO.2010.34.1578. Epub 2011 Jul 25. link to original article contains verified protocol PubMed

Topotecan (Hycamtin)

Regimen

Level of Evidence: Phase II

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

21-day cycles

References

  1. 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

Whole abdominal radiation (WAI)

Regimen

Level of Evidence: Phase III

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

References

  1. Randall ME, Filiaci VL, Muss H, Spirtos NM, Mannel RS, Fowler J, Thigpen JT, Benda JA; Gynecologic Oncology Group Study. 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. 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 PubMed
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