Difference between revisions of "Low-grade serous ovarian cancer"
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Warner-admin (talk | contribs) m (Text replacement - "==[https://www.nccn.org/ NCCN]==" to "==NCCN==") |
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[[#top|Back to Top]] | [[#top|Back to Top]] | ||
</div> | </div> | ||
− | {{#lst: | + | {{#lst:Editorial board transclusions|gyn}} |
<big>'''Note: this page has regimens which are specific to low-grade serous ovarian cancer (LGSOC). Please see the [[Ovarian cancer|main ovarian cancer]] page for other chemotherapy regimens.'''</big> | <big>'''Note: this page has regimens which are specific to low-grade serous ovarian cancer (LGSOC). Please see the [[Ovarian cancer|main ovarian cancer]] page for other chemotherapy regimens.'''</big> | ||
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
+ | =Guidelines= | ||
+ | '''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.''' | ||
+ | ==NCCN== | ||
+ | *''NCCN does not currently have guidelines at this granular level; please see [https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1453 NCCN Guidelines - Ovarian Cancer, Including Fallopian Tube Cancer and Primary Peritoneal Cancer].'' | ||
=Relapsed or recurrent disease= | =Relapsed or recurrent disease= | ||
− | |||
==Letrozole monotherapy {{#subobject:jyghgz|Regimen=1}}== | ==Letrozole monotherapy {{#subobject:jyghgz|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:ugzhgj|Variant=1}}=== | ===Regimen {{#subobject:ugzhgj|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 | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!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 | + | |2014-2018 |
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
|[[#Trametinib_monotherapy|Trametinib]] | |[[#Trametinib_monotherapy|Trametinib]] | ||
Line 25: | Line 28: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Endocrine therapy==== | ====Endocrine therapy==== | ||
− | *[[Letrozole (Femara)]] 2.5 mg PO once per day | + | *[[Letrozole (Femara)]] 2.5 mg PO once per day on days 1 to 28 |
− | + | '''28-day cycles''' | |
− | ''' | + | </div></div> |
− | |||
===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 dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] [https://clinicaltrials.gov/study/NCT02101788 NCT02101788] |
− | |||
==Paclitaxel monotherapy {{#subobject:57d35e|Regimen=1}}== | ==Paclitaxel monotherapy {{#subobject:57d35e|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:3fyt10|Variant=1}}=== | ===Regimen {{#subobject:3fyt10|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 | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!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 | + | |2013-2016 |
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
− | |[[# | + | |[[#Binimetinib_monotherapy_999|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) | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)] |
− | |2014-2018 | + | |2014-2018 |
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
|[[#Trametinib_monotherapy|Trametinib]] | |[[#Trametinib_monotherapy|Trametinib]] | ||
Line 56: | Line 58: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV over 60 minutes 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''' | ||
+ | </div></div> | ||
===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 | + | # '''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] [https://clinicaltrials.gov/study/NCT01849874 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 dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] [https://clinicaltrials.gov/study/NCT02101788 NCT02101788] |
− | |||
==Pegylated liposomal doxorubicin monotherapy {{#subobject:cd6479|Regimen=1}}== | ==Pegylated liposomal doxorubicin monotherapy {{#subobject:cd6479|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen variant #1, 40 mg/m<sup>2</sup> {{#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 | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!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 | + | |2013-2016 |
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
− | |[[# | + | |[[#Binimetinib_monotherapy_999|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) | ||
|- | |- | ||
− | |[ | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)] |
− | |2014-2018 | + | |2014-2018 |
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
|[[#Trametinib_monotherapy|Trametinib]] | |[[#Trametinib_monotherapy|Trametinib]] | ||
Line 88: | Line 90: | ||
|} | |} | ||
''Note: this is the lower bound of dosing in LOGS.'' | ''Note: this is the lower bound of dosing in LOGS.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====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''' | '''28-day cycles''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, 50 mg/m<sup>2</sup> {{#subobject:3uu773|Variant=1}}=== | ===Regimen variant #2, 50 mg/m<sup>2</sup> {{#subobject:3uu773|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 | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!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 | + | |2014-2018 |
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
|[[#Trametinib_monotherapy|Trametinib]] | |[[#Trametinib_monotherapy|Trametinib]] | ||
Line 109: | Line 112: | ||
|} | |} | ||
''Note: this is the upper bound of dosing in LOGS.'' | ''Note: this is the upper bound of dosing in LOGS.'' | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Pegylated liposomal doxorubicin (Doxil)]] 50 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | *[[Pegylated liposomal doxorubicin (Doxil)]] 50 mg/m<sup>2</sup> IV over 60 minutes once on day 1 | ||
− | |||
'''28-day cycles''' | '''28-day cycles''' | ||
+ | </div></div> | ||
===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 | + | # '''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] [https://clinicaltrials.gov/study/NCT01849874 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 dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] [https://clinicaltrials.gov/study/NCT02101788 NCT02101788] |
− | |||
==Selumetinib monotherapy {{#subobject:5uh32e|Regimen=1}}== | ==Selumetinib monotherapy {{#subobject:5uh32e|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:3q1cb0|Variant=1}}=== | ===Regimen {{#subobject:3q1cb0|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 60%; text-align:center;" | {| class="wikitable sortable" style="width: 60%; text-align:center;" | ||
!style="width: 33%"|Study | !style="width: 33%"|Study | ||
− | !style="width: 33%"| | + | !style="width: 33%"|Dates of enrollment |
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
|- | |- | ||
Line 130: | Line 133: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
− | *[[Selumetinib (Koselugo)]] 50 mg PO twice per day | + | *[[Selumetinib (Koselugo)]] 50 mg PO twice per day on days 1 to 28 |
− | |||
'''28-day cycles''' | '''28-day cycles''' | ||
+ | </div></div> | ||
===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 | + | # '''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] [https://clinicaltrials.gov/study/NCT00551070 NCT00551070] |
− | |||
==Tamoxifen monotherapy {{#subobject:ugh7gz|Regimen=1}}== | ==Tamoxifen monotherapy {{#subobject:ugh7gz|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:ug17gj|Variant=1}}=== | ===Regimen {{#subobject:ug17gj|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 | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!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 | + | |2014-2018 |
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
|[[#Trametinib_monotherapy|Trametinib]] | |[[#Trametinib_monotherapy|Trametinib]] | ||
Line 154: | Line 157: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Endocrine therapy==== | ====Endocrine therapy==== | ||
*[[Tamoxifen (Nolvadex)]] 20 mg PO twice per day | *[[Tamoxifen (Nolvadex)]] 20 mg PO twice per day | ||
− | |||
'''Continued indefinitely''' | '''Continued indefinitely''' | ||
− | + | </div></div> | |
===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 dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] [https://clinicaltrials.gov/study/NCT02101788 NCT02101788] |
− | |||
==Topotecan monotherapy {{#subobject:7dbd5a|Regimen=1}}== | ==Topotecan monotherapy {{#subobject:7dbd5a|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen variant #1, 5 days per cycle {{#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 | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!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 | + | |2013-2016 |
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
− | |[[# | + | |[[#Binimetinib_monotherapy_999|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) | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Topotecan (Hycamtin)]] 1.25 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 5 | *[[Topotecan (Hycamtin)]] 1.25 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 5 | ||
− | |||
'''21-day cycles''' | '''21-day cycles''' | ||
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#eeeeee"> | ||
===Regimen variant #2, 3 weeks out of 4 {{#subobject:b7c7gj|Variant=1}}=== | ===Regimen variant #2, 3 weeks out of 4 {{#subobject:b7c7gj|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 | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!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 | + | |2014-2018 |
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
|[[#Trametinib_monotherapy|Trametinib]] | |[[#Trametinib_monotherapy|Trametinib]] | ||
Line 199: | Line 202: | ||
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Topotecan (Hycamtin)]] 4 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 | *[[Topotecan (Hycamtin)]] 4 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15 | ||
− | |||
'''28-day cycles''' | '''28-day cycles''' | ||
− | + | </div></div> | |
===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 | + | # '''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] [https://clinicaltrials.gov/study/NCT01849874 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 dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] [https://clinicaltrials.gov/study/NCT02101788 NCT02101788] |
− | |||
==Trametinib monotherapy {{#subobject:y1432e|Regimen=1}}== | ==Trametinib monotherapy {{#subobject:y1432e|Regimen=1}}== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen {{#subobject:asghb0|Variant=1}}=== | ===Regimen {{#subobject:asghb0|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 | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!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 | + | |2014-2018 |
|style="background-color:#1a9851"|Phase 3 (E-switch-ooc) | |style="background-color:#1a9851"|Phase 3 (E-switch-ooc) | ||
− | | | + | |Investigator's choice of:<br>1a. [[#Paclitaxel_monotherapy|Paclitaxel]]<br>1b. [[#Topotecan_monotherapy|Topotecan]]<br>1c. [[#Pegylated_liposomal_doxorubicin_monotherapy|PLD]]<br>1d. [[#Letrozole_monotherapy|Letrozole]]<br>1e. [[#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) | + | | style="background-color:#1a9850" |Superior PFS (primary endpoint)<br>Median PFS: 13 vs 7.2 mo<br>(HR 0.48, 95% CI 0.36-0.64) |
|- | |- | ||
|} | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Trametinib (Mekinist)]] 2 mg PO once per day | *[[Trametinib (Mekinist)]] 2 mg PO once per day | ||
− | |||
'''Continued indefinitely''' | '''Continued indefinitely''' | ||
+ | </div></div> | ||
===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 dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] [https://clinicaltrials.gov/study/NCT02101788 NCT02101788] |
− | |||
[[Category:Low-grade serous ovarian cancer regimens]] | [[Category:Low-grade serous ovarian cancer regimens]] | ||
− | [[Category: | + | [[Category:Histology-specific pages]] |
[[Category:Gynecologic cancers]] | [[Category:Gynecologic cancers]] |
Latest revision as of 11:37, 13 May 2024
Section editor | |
---|---|
Alaina J. Brown, MD, MPH Vanderbilt University Nashville, TN, USA |
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.
Guidelines
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
NCCN
- NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Ovarian Cancer, Including Fallopian Tube Cancer and Primary Peritoneal Cancer.
Relapsed or recurrent disease
Letrozole monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Gershenson et al. 2022 (LOGS) | 2014-2018 | Phase 3 (C) | Trametinib | Inferior PFS |
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 dosing details in manuscript PubMed NCT02101788
Paclitaxel monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Monk et al. 2020 (MILO) | 2013-2016 | 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 | 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 dosing details in manuscript 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 dosing details in manuscript PubMed NCT02101788
Pegylated liposomal doxorubicin monotherapy
Regimen variant #1, 40 mg/m2
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Monk et al. 2020 (MILO) | 2013-2016 | 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 | 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 | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Gershenson et al. 2022 (LOGS) | 2014-2018 | 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 dosing details in manuscript 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 dosing details in manuscript PubMed NCT02101788
Selumetinib monotherapy
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Farley et al. 2013 (GOG-0239) | 2007-2009 | Phase 2 |
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 dosing details in manuscript PubMed NCT00551070
Tamoxifen monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Gershenson et al. 2022 (LOGS) | 2014-2018 | Phase 3 (C) | Trametinib | Inferior PFS |
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 dosing details in manuscript PubMed NCT02101788
Topotecan monotherapy
Regimen variant #1, 5 days per cycle
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Monk et al. 2020 (MILO) | 2013-2016 | 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 | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Gershenson et al. 2022 (LOGS) | 2014-2018 | 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 dosing details in manuscript 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 dosing details in manuscript PubMed NCT02101788
Trametinib monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Gershenson et al. 2022 (LOGS) | 2014-2018 | Phase 3 (E-switch-ooc) | Investigator's choice of: 1a. Paclitaxel 1b. Topotecan 1c. PLD 1d. Letrozole 1e. Tamoxifen |
Superior PFS (primary endpoint) Median PFS: 13 vs 7.2 mo (HR 0.48, 95% CI 0.36-0.64) |
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 dosing details in manuscript PubMed NCT02101788