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

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m (Text replacement - "http://www.ncbi.nlm.nih.gov" to "https://www.ncbi.nlm.nih.gov")
m (Text replacement - "'''contains verified protocol'''" to "'''contains dosing details in manuscript'''")
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===References===
 
===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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
+
#'''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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
  
 
==Paclitaxel monotherapy {{#subobject:57d35e|Regimen=1}}==
 
==Paclitaxel monotherapy {{#subobject:57d35e|Regimen=1}}==
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'''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''' [https://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 dosing details in manuscript''' [https://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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
+
#'''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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
  
 
==Pegylated liposomal doxorubicin monotherapy {{#subobject:cd6479|Regimen=1}}==
 
==Pegylated liposomal doxorubicin monotherapy {{#subobject:cd6479|Regimen=1}}==
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'''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''' [https://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 dosing details in manuscript''' [https://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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
+
#'''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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
  
 
==Selumetinib monotherapy {{#subobject:5uh32e|Regimen=1}}==
 
==Selumetinib monotherapy {{#subobject:5uh32e|Regimen=1}}==
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'''28-day cycles'''
 
'''28-day cycles'''
 
===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 dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23261356 PubMed] NCT00551070
  
 
==Tamoxifen monotherapy {{#subobject:ugh7gz|Regimen=1}}==
 
==Tamoxifen monotherapy {{#subobject:ugh7gz|Regimen=1}}==
Line 160: Line 160:
  
 
===References===
 
===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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
+
#'''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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
  
 
==Topotecan monotherapy {{#subobject:7dbd5a|Regimen=1}}==
 
==Topotecan monotherapy {{#subobject:7dbd5a|Regimen=1}}==
Line 205: Line 205:
  
 
===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''' [https://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 dosing details in manuscript''' [https://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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
+
#'''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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
  
 
==Trametinib monotherapy {{#subobject:y1432e|Regimen=1}}==
 
==Trametinib monotherapy {{#subobject:y1432e|Regimen=1}}==
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'''Continued indefinitely'''
 
'''Continued indefinitely'''
 
===References===
 
===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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] NCT02101788
+
#'''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] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ link to PMC article] '''contains dosing details in manuscript''' [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 12:54, 29 August 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

Letrozole monotherapy

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 dosing details in manuscript PubMed NCT02101788

Paclitaxel monotherapy

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 dosing details in manuscript 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 dosing details in manuscript PubMed NCT02101788

Pegylated liposomal doxorubicin monotherapy

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 dosing details in manuscript 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 dosing details in manuscript PubMed NCT02101788

Selumetinib monotherapy

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 dosing details in manuscript PubMed NCT00551070

Tamoxifen monotherapy

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 dosing details in manuscript PubMed NCT02101788

Topotecan monotherapy

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 dosing details in manuscript 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 dosing details in manuscript PubMed NCT02101788

Trametinib monotherapy

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 dosing details in manuscript PubMed NCT02101788