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

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m (Text replacement - "==[https://www.nccn.org/ NCCN]==" to "==NCCN==")
 
(29 intermediate revisions by 2 users not shown)
Line 1: Line 1:
−
{{#lst:Section editor transclusions|gyn}}
+
<span id="BackToTop"></span>
 +
<div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px">
 +
[[#top|Back to Top]]
 +
</div>
 +
{{#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=
−
==Doxorubicin pegylated liposomal monotherapy {{#subobject:cd6479|Regimen=1}}==
+
==Letrozole monotherapy {{#subobject:jyghgz|Regimen=1}}==
−
{| class="wikitable sortable" style="float:right; margin-left: 5px;"
+
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:ugzhgj|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!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
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Trametinib_monotherapy|Trametinib]]
 +
| style="background-color:#d73027" |Inferior PFS
 
|-
 
|-
−
|[[#top|back to top]]
 
 
|}
 
|}
−
===Regimen {{#subobject:3cc773|Variant=1}}===
+
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Endocrine therapy====
 +
*[[Letrozole (Femara)]] 2.5 mg PO once per day on days 1 to 28
 +
'''28-day cycles'''
 +
</div></div>
 +
===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 dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] [https://clinicaltrials.gov/study/NCT02101788 NCT02101788]
 +
==Paclitaxel monotherapy {{#subobject:57d35e|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===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%"|Years of enrollment
+
!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]]
 
|-
 
|-
−
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ Monk et al. 2020 (MILO)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ Monk et al. 2020 (MILO)]
 
|2013-2016
 
|2013-2016
−
|style="background-color:#1a9851"|Phase III (C)
+
|style="background-color:#1a9851"|Phase 3 (C)
−
|Binimetinib
+
|[[#Binimetinib_monotherapy_999|Binimetinib]]
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
+
| 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
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Trametinib_monotherapy|Trametinib]]
 +
| style="background-color:#d73027" |Inferior PFS
 
|-
 
|-
 
|}
 
|}
 +
<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
+
*[[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 verified protocol''' [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32822286/ PubMed] NCT01849874
+
# '''MILO:''' Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01164 link to original article] '''contains 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] [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}}==
+
==Pegylated liposomal doxorubicin monotherapy {{#subobject:cd6479|Regimen=1}}==
−
{| class="wikitable sortable" style="float:right; margin-left: 5px;"
+
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #1, 40 mg/m<sup>2</sup> {{#subobject:3cc773|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!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
 +
|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)
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)]
 +
|2014-2018
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Trametinib_monotherapy|Trametinib]]
 +
| style="background-color:#d73027" |Inferior PFS
 
|-
 
|-
−
|[[#top|back to top]]
 
 
|}
 
|}
−
===Regimen {{#subobject:3fyt10|Variant=1}}===
+
''Note: this is the lower bound of dosing in LOGS.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Pegylated liposomal doxorubicin (Doxil)]] 40 mg/m<sup>2</sup> IV over 60 minutes once on day 1
 +
'''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}}===
 
{| 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%"|Years of enrollment
+
!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]]
 
|-
 
|-
−
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ Monk et al. 2020 (MILO)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8819271/ Gershenson et al. 2022 (LOGS)]
−
|2013-2016
+
|2014-2018
−
|style="background-color:#1a9851"|Phase III (C)
+
|style="background-color:#1a9851"|Phase 3 (C)
−
|Binimetinib
+
|[[#Trametinib_monotherapy|Trametinib]]
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
+
| style="background-color:#d73027" |Inferior PFS
 
|-
 
|-
 
|}
 
|}
−
''Note: this trial studied patients with low-grade serous ovarian cancer (LGSOC).''
+
''Note: this is the upper bound of dosing in LOGS.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
−
*[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
+
*[[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 verified protocol''' [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32822286/ PubMed] NCT01849874
+
# '''MILO:''' Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. Epub 2020 Aug 21. [https://doi.org/10.1200/jco.20.01164 link to original article] '''contains 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] [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}}==
−
{| class="wikitable sortable" style="float:right; margin-left: 5px;"
+
<div class="toccolours" style="background-color:#eeeeee">
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
 
===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%"|Years of enrollment
+
!style="width: 33%"|Dates of enrollment
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3627419/ Farley et al. 2013 (GOG-0239)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3627419/ Farley et al. 2013 (GOG-0239)]
 
|2007-2009
 
|2007-2009
−
| style="background-color:#91cf61" |Phase II
+
| style="background-color:#91cf61" |Phase 2
 
|-
 
|-
 
|}
 
|}
 +
<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 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] [https://clinicaltrials.gov/study/NCT00551070 NCT00551070]
−
 
+
==Tamoxifen monotherapy {{#subobject:ugh7gz|Regimen=1}}==
−
==Topotecan monotherapy {{#subobject:7dbd5a|Regimen=1}}==
+
<div class="toccolours" style="background-color:#eeeeee">
−
{| class="wikitable sortable" style="float:right; margin-left: 5px;"
+
===Regimen {{#subobject:ug17gj|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!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
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Trametinib_monotherapy|Trametinib]]
 +
| style="background-color:#d73027" |Inferior PFS
 
|-
 
|-
−
|[[#top|back to top]]
 
 
|}
 
|}
−
===Regimen {{#subobject:b7c302|Variant=1}}===
+
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Endocrine therapy====
 +
*[[Tamoxifen (Nolvadex)]] 20 mg PO twice per day
 +
'''Continued indefinitely'''
 +
</div></div>
 +
===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 dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35123694/ PubMed] [https://clinicaltrials.gov/study/NCT02101788 NCT02101788]
 +
==Topotecan monotherapy {{#subobject:7dbd5a|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===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%"|Years of enrollment
+
!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]]
 
|-
 
|-
−
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ Monk et al. 2020 (MILO)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ Monk et al. 2020 (MILO)]
 
|2013-2016
 
|2013-2016
−
|style="background-color:#1a9851"|Phase III (C)
+
|style="background-color:#1a9851"|Phase 3 (C)
−
|Binimetinib
+
|[[#Binimetinib_monotherapy_999|Binimetinib]]
−
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
+
| 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}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!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
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Trametinib_monotherapy|Trametinib]]
 +
| style="background-color:#d73027" |Inferior PFS
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Topotecan (Hycamtin)]] 4 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15
 +
'''28-day cycles'''
 +
</div></div>
 +
===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 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] [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}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:asghb0|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!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
 +
|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 (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====
 +
*[[Trametinib (Mekinist)]] 2 mg PO once per day
 +
'''Continued indefinitely'''
 +
</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 verified protocol''' [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7655017/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32822286/ PubMed] NCT01849874
+
#'''LOGS:''' Gershenson DM, Miller A, Brady WE, Paul J, Carty K, Rodgers W, Millan D, Coleman RL, Moore KN, Banerjee S, Connolly K, Secord AA, O'Malley DM, Dorigo O, Gaillard S, Gabra H, Slomovitz B, Hanjani P, Farley J, Churchman M, Ewing A, Hollis RL, Herrington CS, Huang HQ, Wenzel L, Gourley C. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet. 2022 Feb 5;399(10324):541-553. [https://doi.org/10.1016/s0140-6736(21)02175-9 link to original article] [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:Disease-specific pages]]
+
[[Category:Histology-specific pages]]
 
[[Category:Gynecologic cancers]]
 
[[Category:Gynecologic cancers]]

Latest revision as of 11:37, 13 May 2024

Back to Top

Section editor
Brown-alaina.jpeg
 Alaina J. Brown, MD, MPH
Vanderbilt University
Nashville, TN, USA
LinkedIn

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

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

Endocrine therapy

28-day cycles

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 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

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 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

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

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 Dates 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 Dates of enrollment Evidence Comparator Comparative Efficacy
Gershenson et al. 2022 (LOGS) 2014-2018 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 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

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

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 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)

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
Retrieved from "https://hemonc.org/w/index.php?title=Low-grade_serous_ovarian_cancer&oldid=85612"