Difference between revisions of "Low-grade serous ovarian cancer"
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)] |
|2014-2018 (C) | |2014-2018 (C) | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
| Line 31: | Line 31: | ||
===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] [ | + | #'''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 |
==Paclitaxel monotherapy {{#subobject:57d35e|Regimen=1}}== | ==Paclitaxel monotherapy {{#subobject:57d35e|Regimen=1}}== | ||
| Line 43: | Line 43: | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ Monk et al. 2020 (MILO)] |
|2013-2016 (F) | |2013-2016 (F) | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
| Line 49: | Line 49: | ||
| 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) | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)] |
|2014-2018 (C) | |2014-2018 (C) | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
| Line 61: | Line 61: | ||
'''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''' [ | + | # '''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 |
| − | #'''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] [ | + | #'''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 |
==Pegylated liposomal doxorubicin monotherapy {{#subobject:cd6479|Regimen=1}}== | ==Pegylated liposomal doxorubicin monotherapy {{#subobject:cd6479|Regimen=1}}== | ||
| Line 74: | Line 74: | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ Monk et al. 2020 (MILO)] |
|2013-2016 (F) | |2013-2016 (F) | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
| Line 80: | Line 80: | ||
| 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) | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)] |
|2014-2018 (C) | |2014-2018 (C) | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
| Line 101: | Line 101: | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)] |
|2014-2018 (C) | |2014-2018 (C) | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
| Line 114: | Line 114: | ||
'''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''' [ | + | # '''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 |
| − | #'''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] [ | + | #'''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 |
==Selumetinib monotherapy {{#subobject:5uh32e|Regimen=1}}== | ==Selumetinib monotherapy {{#subobject:5uh32e|Regimen=1}}== | ||
| Line 147: | Line 147: | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)] |
|2014-2018 (C) | |2014-2018 (C) | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
| 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] [ | + | #'''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 |
==Topotecan monotherapy {{#subobject:7dbd5a|Regimen=1}}== | ==Topotecan monotherapy {{#subobject:7dbd5a|Regimen=1}}== | ||
| Line 172: | Line 172: | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ Monk et al. 2020 (MILO)] |
|2013-2016 (F) | |2013-2016 (F) | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
| Line 192: | Line 192: | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)] |
|2014-2018 (C) | |2014-2018 (C) | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
| 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''' [ | + | # '''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 |
| − | #'''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] [ | + | #'''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 |
==Trametinib monotherapy {{#subobject:y1432e|Regimen=1}}== | ==Trametinib monotherapy {{#subobject:y1432e|Regimen=1}}== | ||
| Line 218: | Line 218: | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
| − | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)] |
|2014-2018 (C) | |2014-2018 (C) | ||
|style="background-color:#1a9851"|Phase 3 (E-switch-ooc) | |style="background-color:#1a9851"|Phase 3 (E-switch-ooc) | ||
| Line 230: | Line 230: | ||
'''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] [ | + | #'''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 |
[[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 12:50, 29 July 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
- 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. link to original article link to PMC article contains verified protocol 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
- Paclitaxel (Taxol) 80 mg/m2 IV over 60 minutes once per day on days 1, 8, 15
28-day cycles
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. link to original article contains verified protocol link to PMC article 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. link to original article link to PMC article contains verified protocol 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
- Pegylated liposomal doxorubicin (Doxil) 40 mg/m2 IV over 60 minutes once on day 1
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
- Pegylated liposomal doxorubicin (Doxil) 50 mg/m2 IV over 60 minutes once on day 1
28-day cycles
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. link to original article contains verified protocol link to PMC article 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. link to original article link to PMC article contains verified protocol PubMed NCT02101788
Selumetinib monotherapy
Regimen
| Study | Years of enrollment | Evidence |
|---|---|---|
| Farley et al. 2013 (GOG-0239) | 2007-2009 | Phase 2 |
Targeted therapy
- Selumetinib (Koselugo) 50 mg PO twice per day
28-day cycles
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. link to original article link to PMC article contains verified protocol 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
- 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. link to original article link to PMC article contains verified protocol 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
- Topotecan (Hycamtin) 1.25 mg/m2 IV over 30 minutes once per day on days 1 to 5
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
- Topotecan (Hycamtin) 4 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
28-day cycles
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. link to original article contains verified protocol link to PMC article 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. link to original article link to PMC article contains verified protocol 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
- 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. link to original article link to PMC article contains verified protocol PubMed NCT02101788