Difference between revisions of "Low-grade serous ovarian cancer"

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|[[#top|back to top]]
 
|[[#top|back to top]]
 
|}
 
|}
−
===Regimen {{#subobject:3cc773|Variant=1}}===
+
===Regimen variant #1, 40 mg/m<sup>2</sup> {{#subobject:3cc773|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
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|[[#Binimetinib_monotherapy_99|Binimetinib]]
 
|[[#Binimetinib_monotherapy_99|Binimetinib]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS<br>Median PFS: 10.6 vs 9.1 mo<br>(HR 0.83, 95% CI 0.54-1.27)
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS<br>Median PFS: 10.6 vs 9.1 mo<br>(HR 0.83, 95% CI 0.54-1.27)
 +
|-
 +
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)]
 +
|2014-2018 (C)
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Trametinib_monotherapy|Trametinib]]
 +
| style="background-color:#d73027" |Inferior PFS
 
|-
 
|-
 
|}
 
|}
 +
''Note: this is the lower bound of dosing in LOGS.''
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Pegylated liposomal doxorubicin (Doxil)]] 40 mg/m<sup>2</sup> IV over 60 minutes once on day 1
 
*[[Pegylated liposomal doxorubicin (Doxil)]] 40 mg/m<sup>2</sup> IV over 60 minutes once on day 1
 +
 +
'''28-day cycles'''
 +
 +
===Regimen variant #2, 50 mg/m<sup>2</sup> {{#subobject:3uu773|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)]
 +
|2014-2018 (C)
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Trametinib_monotherapy|Trametinib]]
 +
| style="background-color:#d73027" |Inferior PFS
 +
|-
 +
|}
 +
''Note: this is the upper bound of dosing in LOGS.''
 +
====Chemotherapy====
 +
*[[Pegylated liposomal doxorubicin (Doxil)]] 50 mg/m<sup>2</sup> IV over 60 minutes once on day 1
  
 
'''28-day cycles'''
 
'''28-day cycles'''
 
===References===
 
===References===
 
# '''MILO:''' Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01164 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32822286/ PubMed] NCT01849874
 
# '''MILO:''' Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01164 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32822286/ PubMed] NCT01849874
 +
#'''LOGS:''' Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. [https://doi.org/10.1016/s0140-6736(21)02175-9 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
 +
 +
==Letrozole monotherapy {{#subobject:jyghgz|Regimen=1}}==
 +
{| class="wikitable sortable" style="float:right; margin-left: 5px;"
 +
|-
 +
|[[#top|back to top]]
 +
|}
 +
===Regimen {{#subobject:ugzhgj|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)]
 +
|2014-2018 (C)
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Trametinib_monotherapy|Trametinib]]
 +
| style="background-color:#d73027" |Inferior PFS
 +
|-
 +
|}
 +
====Endocrine therapy====
 +
*[[Letrozole (Femara)]] 2.5 mg PO once per day
 +
 +
'''Continued indefinitely'''
 +
 +
===References===
 +
#'''LOGS:''' Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. [https://doi.org/10.1016/s0140-6736(21)02175-9 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
  
 
==Paclitaxel monotherapy {{#subobject:57d35e|Regimen=1}}==
 
==Paclitaxel monotherapy {{#subobject:57d35e|Regimen=1}}==
Line 48: Line 105:
 
|[[#Binimetinib_monotherapy_99|Binimetinib]]
 
|[[#Binimetinib_monotherapy_99|Binimetinib]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS<br>Median PFS: 10.6 vs 9.1 mo<br>(HR 0.83, 95% CI 0.54-1.27)
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS<br>Median PFS: 10.6 vs 9.1 mo<br>(HR 0.83, 95% CI 0.54-1.27)
 +
|-
 +
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)]
 +
|2014-2018 (C)
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Trametinib_monotherapy|Trametinib]]
 +
| style="background-color:#d73027" |Inferior PFS
 
|-
 
|-
 
|}
 
|}
−
''Note: this trial studied patients with low-grade serous ovarian cancer (LGSOC).''
 
 
====Chemotherapy====
 
====Chemotherapy====
−
*[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
+
*[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1, 8, 15
  
 
'''28-day cycles'''
 
'''28-day cycles'''
 
===References===
 
===References===
 
# '''MILO:''' Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01164 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32822286/ PubMed] NCT01849874
 
# '''MILO:''' Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01164 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32822286/ PubMed] NCT01849874
 +
#'''LOGS:''' Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. [https://doi.org/10.1016/s0140-6736(21)02175-9 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
  
 
==Selumetinib monotherapy {{#subobject:5uh32e|Regimen=1}}==
 
==Selumetinib monotherapy {{#subobject:5uh32e|Regimen=1}}==
Line 80: Line 143:
 
===References===
 
===References===
 
# '''GOG-0239:''' Farley J, Brady WE, Vathipadiekal V, Lankes HA, Coleman R, Morgan MA, Mannel R, Yamada SD, Mutch D, Rodgers WH, Birrer M, Gershenson DM. Selumetinib in women with recurrent low-grade serous carcinoma of the ovary or peritoneum: an open-label, single-arm, phase 2 study. Lancet Oncol. 2013 Feb;14(2):134-40. Epub 2012 Dec 21. [https://doi.org/10.1016/s1470-2045(12)70572-7 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3627419/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/23261356 PubMed] NCT00551070
 
# '''GOG-0239:''' Farley J, Brady WE, Vathipadiekal V, Lankes HA, Coleman R, Morgan MA, Mannel R, Yamada SD, Mutch D, Rodgers WH, Birrer M, Gershenson DM. Selumetinib in women with recurrent low-grade serous carcinoma of the ovary or peritoneum: an open-label, single-arm, phase 2 study. Lancet Oncol. 2013 Feb;14(2):134-40. Epub 2012 Dec 21. [https://doi.org/10.1016/s1470-2045(12)70572-7 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3627419/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/23261356 PubMed] NCT00551070
 +
 +
==Tamoxifen monotherapy {{#subobject:ugh7gz|Regimen=1}}==
 +
{| class="wikitable sortable" style="float:right; margin-left: 5px;"
 +
|-
 +
|[[#top|back to top]]
 +
|}
 +
===Regimen {{#subobject:ug17gj|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)]
 +
|2014-2018 (C)
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Trametinib_monotherapy|Trametinib]]
 +
| style="background-color:#d73027" |Inferior PFS
 +
|-
 +
|}
 +
====Endocrine therapy====
 +
*[[Tamoxifen (Nolvadex)]] 20 mg PO twice per day
 +
 +
'''Continued indefinitely'''
 +
 +
===References===
 +
#'''LOGS:''' Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. [https://doi.org/10.1016/s0140-6736(21)02175-9 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
  
 
==Topotecan monotherapy {{#subobject:7dbd5a|Regimen=1}}==
 
==Topotecan monotherapy {{#subobject:7dbd5a|Regimen=1}}==
Line 86: Line 177:
 
|[[#top|back to top]]
 
|[[#top|back to top]]
 
|}
 
|}
−
===Regimen {{#subobject:b7c302|Variant=1}}===
+
===Regimen variant #1, 5 days per cycle {{#subobject:b7c302|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
Line 105: Line 196:
  
 
'''21-day cycles'''
 
'''21-day cycles'''
 +
 +
===Regimen variant #2, 3 weeks out of 4 {{#subobject:b7c7gj|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)]
 +
|2014-2018 (C)
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Trametinib_monotherapy|Trametinib]]
 +
| style="background-color:#d73027" |Inferior PFS
 +
|-
 +
|}
 +
====Chemotherapy====
 +
*[[Topotecan (Hycamtin)]] 4 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15
 +
 +
'''28-day cycles'''
 +
 
===References===
 
===References===
 
# '''MILO:''' Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01164 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32822286/ PubMed] NCT01849874
 
# '''MILO:''' Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01164 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32822286/ PubMed] NCT01849874
 +
#'''LOGS:''' Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. [https://doi.org/10.1016/s0140-6736(21)02175-9 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
 +
 +
==Trametinib monotherapy {{#subobject:y1432e|Regimen=1}}==
 +
{| class="wikitable sortable" style="float:right; margin-left: 5px;"
 +
|-
 +
|[[#top|back to top]]
 +
|}
 +
===Regimen {{#subobject:asghb0|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)]
 +
|2014-2018 (C)
 +
|style="background-color:#1a9851"|Phase 3 (E-switch-ooc)
 +
|Physician's choice of:<br>1. [[#Paclitaxel_monotherapy|Paclitaxel]]<br>2. [[#Topotecan_monotherapy|Topotecan]]<br>3. [[#Doxorubicin_pegylated_liposomal_monotherapy|PLD]]<br>4. [[#Letrozole_monotherapy|Letrozole]]<br>5. [[#Tamoxifen_monotherapy|Tamoxifen]]
 +
| style="background-color:#1a9850" |Superior PFS<br>Median PFS: 13 vs 7.2 mo<br>(HR 0.48, 95% CI 0.36-0.64)
 +
|-
 +
|}
 +
====Targeted therapy====
 +
*[[Trametinib (Mekinist)]] 2 mg PO once per day
 +
 +
'''Continued indefinitely'''
 +
===References===
 +
#'''LOGS:''' Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. [https://doi.org/10.1016/s0140-6736(21)02175-9 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
  
 
[[Category:Low-grade serous ovarian cancer regimens]]
 
[[Category:Low-grade serous ovarian cancer regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Gynecologic cancers]]
 
[[Category:Gynecologic cancers]]

Revision as of 14:30, 3 March 2022

Section editor transclusions Note: this page has regimens which are specific to low-grade serous ovarian cancer (LGSOC). Please see the main ovarian cancer page for other chemotherapy regimens.


Relapsed or recurrent disease

Doxorubicin pegylated liposomal monotherapy

back to top

Regimen variant #1, 40 mg/m2

Study Years of enrollment Evidence Comparator Comparative Efficacy
Monk et al. 2020 (MILO) 2013-2016 (F) Phase 3 (C) Binimetinib Did not meet primary endpoint of PFS
Median PFS: 10.6 vs 9.1 mo
(HR 0.83, 95% CI 0.54-1.27)
Gershenson et al. 2022 (LOGS) 2014-2018 (C) Phase 3 (C) Trametinib Inferior PFS

Note: this is the lower bound of dosing in LOGS.

Chemotherapy

28-day cycles

Regimen variant #2, 50 mg/m2

Study Years of enrollment Evidence Comparator Comparative Efficacy
Gershenson et al. 2022 (LOGS) 2014-2018 (C) Phase 3 (C) Trametinib Inferior PFS

Note: this is the upper bound of dosing in LOGS.

Chemotherapy

28-day cycles

References

  1. MILO: Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. Epub 2020 Aug 21. link to original article contains verified protocol link to PMC article PubMed NCT01849874
  2. LOGS: Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. link to original article link to PMC article contains verified protocol PubMed NCT02101788

Letrozole monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Gershenson et al. 2022 (LOGS) 2014-2018 (C) Phase 3 (C) Trametinib Inferior PFS

Endocrine therapy

Continued indefinitely

References

  1. LOGS: Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. link to original article link to PMC article contains verified protocol PubMed NCT02101788

Paclitaxel monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Monk et al. 2020 (MILO) 2013-2016 (F) Phase 3 (C) Binimetinib Did not meet primary endpoint of PFS
Median PFS: 10.6 vs 9.1 mo
(HR 0.83, 95% CI 0.54-1.27)
Gershenson et al. 2022 (LOGS) 2014-2018 (C) Phase 3 (C) Trametinib Inferior PFS

Chemotherapy

28-day cycles

References

  1. MILO: Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. Epub 2020 Aug 21. link to original article contains verified protocol link to PMC article PubMed NCT01849874
  2. LOGS: Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. link to original article link to PMC article contains verified protocol PubMed NCT02101788

Selumetinib monotherapy

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Regimen

Study Years of enrollment Evidence
Farley et al. 2013 (GOG-0239) 2007-2009 Phase 2

Targeted therapy

28-day cycles

References

  1. GOG-0239: Farley J, Brady WE, Vathipadiekal V, Lankes HA, Coleman R, Morgan MA, Mannel R, Yamada SD, Mutch D, Rodgers WH, Birrer M, Gershenson DM. Selumetinib in women with recurrent low-grade serous carcinoma of the ovary or peritoneum: an open-label, single-arm, phase 2 study. Lancet Oncol. 2013 Feb;14(2):134-40. Epub 2012 Dec 21. link to original article link to PMC article contains verified protocol PubMed NCT00551070

Tamoxifen monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Gershenson et al. 2022 (LOGS) 2014-2018 (C) Phase 3 (C) Trametinib Inferior PFS

Endocrine therapy

Continued indefinitely

References

  1. LOGS: Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. link to original article link to PMC article contains verified protocol PubMed NCT02101788

Topotecan monotherapy

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Regimen variant #1, 5 days per cycle

Study Years of enrollment Evidence Comparator Comparative Efficacy
Monk et al. 2020 (MILO) 2013-2016 (F) Phase 3 (C) Binimetinib Did not meet primary endpoint of PFS
Median PFS: 10.6 vs 9.1 mo
(HR 0.83, 95% CI 0.54-1.27)

Chemotherapy

21-day cycles

Regimen variant #2, 3 weeks out of 4

Study Years of enrollment Evidence Comparator Comparative Efficacy
Gershenson et al. 2022 (LOGS) 2014-2018 (C) Phase 3 (C) Trametinib Inferior PFS

Chemotherapy

28-day cycles

References

  1. MILO: Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. Epub 2020 Aug 21. link to original article contains verified protocol link to PMC article PubMed NCT01849874
  2. LOGS: Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. link to original article link to PMC article contains verified protocol PubMed NCT02101788

Trametinib monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Gershenson et al. 2022 (LOGS) 2014-2018 (C) Phase 3 (E-switch-ooc) Physician's choice of:
1. Paclitaxel
2. Topotecan
3. PLD
4. Letrozole
5. Tamoxifen 		Superior PFS
Median PFS: 13 vs 7.2 mo
(HR 0.48, 95% CI 0.36-0.64)

Targeted therapy

Continued indefinitely

References

  1. LOGS: Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. link to original article link to PMC article contains verified protocol PubMed NCT02101788
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