Difference between revisions of "Staging page"

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<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">
 
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[[#top|Back to Top]]
 
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</div>
 
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{{#lst:Section editor transclusions|breast}}
 
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{| class="wikitable" style="float:right; margin-right: 5px;"
 
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|-
 
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|<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div>
 
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<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
 
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|}
 
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<big>'''Note: this page has regimens which are specific to breast cancer that is BRCA-mutated. Please see the [[Breast cancer|main breast cancer]] page for other chemotherapy regimens.'''</big>
 
−
{{TOC limit|limit=3}}
 
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=Guidelines=
 
−
==[http://www.asc.org/ ASCO]==
 
−
*'''2021:''' Tung et al. [https://doi.org/10.1200/jco.21.01532 Adjuvant PARP Inhibitors in Patients With High-Risk Early-Stage HER2-Negative Breast Cancer and Germline BRCA Mutations: ASCO Hereditary Breast Cancer Guideline Rapid Recommendation Update]
 
−
==[http://www.esmo.org/ ESMO]==
 
−
*'''2011:''' Balmaña et al. [https://doi.org/10.1093/annonc/mdr373 BRCA in breast cancer: ESMO Clinical Practice Guidelines]
 
−
=Adjuvant therapy=
 
−
==Olaparib monotherapy {{#subobject:56hxcd|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:3b0yga|Variant=1}}===
 
−
{| class="wikitable" style="color:white; background-color:#404040"
 
−
|<small>'''FDA-recommended dose'''</small>
 
−
|-
 
−
|}
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1056/nejmoa2105215 Tutt et al. 2021 (OlympiA)]
 
−
|2014-2019
 
−
| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
 
−
|[[Breast_cancer_-_null_regimens#Placebo|Placebo]]
 
−
|style="background-color:#1a9850"|Superior invasive DFS<br>IDFS36: 86% vs 77%<br>(HR 0.58, 99.5% CI 0.41-0.82)
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#cbd5e8">
 
−
====Preceding treatment====
 
−
*[[Surgery#Breast_cancer_surgery|Primary local treatment]] +/- (neo-)adjuvant therapy
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Targeted therapy====
 
−
*[[Olaparib (Lynparza)]] 300 mg PO twice per day
 
−
'''28-day cycle for 13 cycles (1 year)'''
 
−
</div></div>
 
−
===References===
 
−
# '''OlympiA:''' Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber RD, de Azambuja E, Fielding A, Balmaña J, Domchek SM, Gelmon KA, Hollingsworth SJ, Korde LA, Linderholm B, Bandos H, Senkus E, Suga JM, Shao Z, Pippas AW, Nowecki Z, Huzarski T, Ganz PA, Lucas PC, Baker N, Loibl S, McConnell R, Piccart M, Schmutzler R, Steger GG, Costantino JP, Arahmani A, Wolmark N, McFadden E, Karantza V, Lakhani SR, Yothers G, Campbell C, Geyer CE Jr; OlympiA Clinical Trial Steering Committee and Investigators. Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer. N Engl J Med. 2021 Jun 24;384(25):2394-2405. Epub 2021 Jun 3. [https://doi.org/10.1056/nejmoa2105215 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/34081848/ PubMed] NCT02032823
 
−
=Advanced or metastatic disease, subsequent lines of therapy=
 
−
==Capecitabine monotherapy {{#subobject:842c42|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:fb2810|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1056/NEJMoa1802905 Litton et al. 2018 (EMBRACA)]
 
−
|2013-2017
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Talazoparib_monotherapy|Talazoparib]]
 
−
| style="background-color:#d73027" |Inferior PFS
 
−
|-
 
−
|[https://doi.org/10.1056/NEJMoa1706450 Robson et al. 2017 (OlympiAD)]
 
−
|2014-2015
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Olaparib_monotherapy_2|Olaparib]]
 
−
| style="background-color:#d73027" |Inferior PFS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*EMBRACA: Germline BRCA1 or BRCA2 mutation
 
−
*OlympiAD: Confirmed deleterious or suspected deleterious germline BRCA mutation
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Capecitabine (Xeloda)]] 1250 mg/m<sup>2</sup> PO twice per day on days 1 to 14
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
# '''OlympiAD:''' Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. Epub 2017 Jun 4. [https://doi.org/10.1056/NEJMoa1706450 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28578601 PubMed] NCT02000622
 
−
## '''Update:''' Robson ME, Tung N, Conte P, Im SA, Senkus E, Xu B, Masuda N, Delaloge S, Li W, Armstrong A, Wu W, Goessl C, Runswick S, Domchek SM. OlympiAD final overall survival and tolerability results: Olaparib versus chemotherapy treatment of physician's choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer. Ann Oncol. 2019 Apr 1;30(4):558-566. [https://doi.org/10.1093/annonc/mdz012 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6503629/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30689707 PubMed]
 
−
# '''EMBRACA:''' Litton JK, Rugo HS, Ettl J, Hurvitz SA, Gonçalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018 Aug 23;379(8):753-763. Epub 2018 Aug 15. [https://doi.org/10.1056/NEJMoa1802905 link to original article] '''contains dosing details in supplement''' [https://pubmed.ncbi.nlm.nih.gov/30110579 PubMed] NCT01945775
 
−
## '''Update:''' Litton JK, Hurvitz SA, Mina LA, Rugo HS, Lee KH, Gonçalves A, Diab S, Woodward N, Goodwin A, Yerushalmi R, Roché H, Im YH, Eiermann W, Quek RGW, Usari T, Lanzalone S, Czibere A, Blum JL, Martin M, Ettl J. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. Ann Oncol. 2020 Nov;31(11):1526-1535. Epub 2020 Aug 20. [https://doi.org/10.1016/j.annonc.2020.08.2098 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32828825 PubMed]
 
−
==Carboplatin monotherapy {{#subobject:16h4a8|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:ujsx06|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6372067/ Tutt et al. 2018 (TNT)]
 
−
|2008-2014
 
−
|style="background-color:#1a9851"|Phase 3 (E-switch-ic)
 
−
|[[#Docetaxel_monotherapy|Docetaxel]]
 
−
| style="background-color:#1a9850" |Superior ORR<sup>1</sup>
 
−
|-
 
−
|}
 
−
''<sup>1</sup>Reported efficacy is based on subgroup analysis.''
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Carboplatin (Paraplatin)]] AUC 6 IV once on day 1
 
−
'''21-day cycle for 6 to 8 cycles'''
 
−
</div></div>
 
−
===References===
 
−
# '''TNT:''' Tutt A, Tovey H, Cheang MCU, Kernaghan S, Kilburn L, Gazinska P, Owen J, Abraham J, Barrett S, Barrett-Lee P, Brown R, Chan S, Dowsett M, Flanagan JM, Fox L, Grigoriadis A, Gutin A, Harper-Wynne C, Hatton MQ, Hoadley KA, Parikh J, Parker P, Perou CM, Roylance R, Shah V, Shaw A, Smith IE, Timms KM, Wardley AM, Wilson G, Gillett C, Lanchbury JS, Ashworth A, Rahman N, Harries M, Ellis P, Pinder SE, Bliss JM. Carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups: the TNT Trial. Nat Med. 2018 May;24(5):628-637. Epub 2018 Apr 30. [https://www.nature.com/articles/s41591-018-0009-7 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6372067/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29713086 PubMed] NCT00532727
 
−
==Carboplatin & Paclitaxel (CP) {{#subobject:842252|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:f16cn0|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1016/s1470-2045(20)30447-2 Diéras et al. 2020 (BROCADE3)]
 
−
|2014-2018
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Carboplatin_.26_Paclitaxel_.28CP.29_.26_Veliparib_88|CP & Veliparib]]
 
−
| style="background-color:#d73027" |Inferior PFS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*Confirmed deleterious germline BRCA1 or BRCA2 mutation
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Carboplatin (Paraplatin)]] AUC 6 IV once on day 1
 
−
*[[Paclitaxel (Taxol)]] 80 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
#'''BROCADE3:''' Diéras V, Han HS, Kaufman B, Wildiers H, Friedlander M, Ayoub JP, Puhalla SL, Bondarenko I, Campone M, Jakobsen EH, Jalving M, Oprean C, Palácová M, Park YH, Shparyk Y, Yañez E, Khandelwal N, Kundu MG, Dudley M, Ratajczak CK, Maag D, Arun BK. Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Oct;21(10):1269-1282. Epub 2020 Aug 27. [https://doi.org/10.1016/s1470-2045(20)30447-2 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32861273 PubMed] NCT02163694
 
−
==Docetaxel monotherapy {{#subobject:3e34a8|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:71bf06|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6372067/ Tutt et al. 2018 (TNT)]
 
−
|2008-2014
 
−
|style="background-color:#1a9851"|Phase 3 (C)
 
−
|[[#Carboplatin_monotherapy|Carboplatin]]
 
−
| style="background-color:#d73027" |Inferior ORR<sup>1</sup>
 
−
|-
 
−
|}
 
−
''<sup>1</sup>Reported efficacy is based on subgroup analysis.''
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Docetaxel (Taxotere)]] 100 mg/m<sup>2</sup> IV once on day 1
 
−
'''21-day cycle for 6 to 8 cycles'''
 
−
</div></div>
 
−
===References===
 
−
# '''TNT:''' Tutt A, Tovey H, Cheang MCU, Kernaghan S, Kilburn L, Gazinska P, Owen J, Abraham J, Barrett S, Barrett-Lee P, Brown R, Chan S, Dowsett M, Flanagan JM, Fox L, Grigoriadis A, Gutin A, Harper-Wynne C, Hatton MQ, Hoadley KA, Parikh J, Parker P, Perou CM, Roylance R, Shah V, Shaw A, Smith IE, Timms KM, Wardley AM, Wilson G, Gillett C, Lanchbury JS, Ashworth A, Rahman N, Harries M, Ellis P, Pinder SE, Bliss JM. Carboplatin in BRCA1/2-mutated and triple-negative breast cancer BRCAness subgroups: the TNT Trial. Nat Med. 2018 May;24(5):628-637. Epub 2018 Apr 30. [https://www.nature.com/articles/s41591-018-0009-7 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6372067/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29713086 PubMed] NCT00532727
 
−
==Eribulin monotherapy {{#subobject:ef2415|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:25ef0|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1056/NEJMoa1802905 Litton et al. 2018 (EMBRACA)]
 
−
|2013-2017
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Talazoparib_monotherapy|Talazoparib]]
 
−
| style="background-color:#d73027" |Inferior PFS
 
−
|-
 
−
|[https://doi.org/10.1056/NEJMoa1706450 Robson et al. 2017 (OlympiAD)]
 
−
|2014-2015
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Olaparib_monotherapy_2|Olaparib]]
 
−
| style="background-color:#d73027" |Inferior PFS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*EMBRACA: Germline BRCA1 or BRCA2 mutation
 
−
*OlympiAD: Confirmed deleterious or suspected deleterious germline BRCA mutation
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Eribulin (Halaven)]] 1.4 mg/m<sup>2</sup> IV over 2 to 5 minutes once per day on days 1 & 8
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
# '''OlympiAD:''' Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. Epub 2017 Jun 4. [https://doi.org/10.1056/NEJMoa1706450 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28578601 PubMed] NCT02000622
 
−
## '''Update:''' Robson ME, Tung N, Conte P, Im SA, Senkus E, Xu B, Masuda N, Delaloge S, Li W, Armstrong A, Wu W, Goessl C, Runswick S, Domchek SM. OlympiAD final overall survival and tolerability results: Olaparib versus chemotherapy treatment of physician's choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer. Ann Oncol. 2019 Apr 1;30(4):558-566. [https://doi.org/10.1093/annonc/mdz012 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6503629/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30689707 PubMed]
 
−
# '''EMBRACA:''' Litton JK, Rugo HS, Ettl J, Hurvitz SA, Gonçalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018 Aug 23;379(8):753-763. Epub 2018 Aug 15. [https://doi.org/10.1056/NEJMoa1802905 link to original article] '''contains dosing details in supplement''' [https://pubmed.ncbi.nlm.nih.gov/30110579 PubMed] NCT01945775
 
−
## '''Update:''' Litton JK, Hurvitz SA, Mina LA, Rugo HS, Lee KH, Gonçalves A, Diab S, Woodward N, Goodwin A, Yerushalmi R, Roché H, Im YH, Eiermann W, Quek RGW, Usari T, Lanzalone S, Czibere A, Blum JL, Martin M, Ettl J. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. Ann Oncol. 2020 Nov;31(11):1526-1535. Epub 2020 Aug 20. [https://doi.org/10.1016/j.annonc.2020.08.2098 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32828825 PubMed]
 
−
==Gemcitabine monotherapy {{#subobject:af0915|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:11b425|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1056/NEJMoa1802905 Litton et al. 2018 (EMBRACA)]
 
−
|2013-2017
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Talazoparib_monotherapy|Talazoparib]]
 
−
| style="background-color:#d73027" |Inferior PFS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*Germline BRCA1 or BRCA2 mutation
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Gemcitabine (Gemzar)]] 1250 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
# '''EMBRACA:''' Litton JK, Rugo HS, Ettl J, Hurvitz SA, Gonçalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018 Aug 23;379(8):753-763. Epub 2018 Aug 15. [https://doi.org/10.1056/NEJMoa1802905 link to original article] '''contains dosing details in supplement''' [https://pubmed.ncbi.nlm.nih.gov/30110579 PubMed] NCT01945775
 
−
## '''Update:''' Litton JK, Hurvitz SA, Mina LA, Rugo HS, Lee KH, Gonçalves A, Diab S, Woodward N, Goodwin A, Yerushalmi R, Roché H, Im YH, Eiermann W, Quek RGW, Usari T, Lanzalone S, Czibere A, Blum JL, Martin M, Ettl J. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. Ann Oncol. 2020 Nov;31(11):1526-1535. Epub 2020 Aug 20. [https://doi.org/10.1016/j.annonc.2020.08.2098 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32828825 PubMed]
 
−
==Olaparib monotherapy {{#subobject:a019cd|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #1, 100 mg twice per day {{#subobject:31ed8c|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://doi.org/10.1016/S0140-6736(10)60892-6 Tutt et al. 2010 (KU36-44)]
 
−
|2007-2008
 
−
|style="background-color:#91cf61"|Phase 2
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Targeted therapy====
 
−
*[[Olaparib (Lynparza)]] 100 mg PO twice per day
 
−
'''Continued indefinitely'''
 
−
</div></div><br>
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #2, 300 mg twice per day {{#subobject:3b0774|Variant=1}}===
 
−
{| class="wikitable sortable" style="color:white; background-color:#404040"
 
−
|<small>'''FDA-recommended dose'''</small>
 
−
|-
 
−
|}
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1056/NEJMoa1706450 Robson et al. 2017 (OlympiAD)]
 
−
|2014-2015
 
−
|style="background-color:#1a9851"|Phase 3 (E-RT-switch-ooc)
 
−
|1a. [[#Capecitabine_monotherapy|Capecitabine]]<br>1b. [[#Eribulin_monotherapy|Eribulin]]<br>1c. [[#Vinorelbine_monotherapy|Vinorelbine]]
 
−
|style="background-color:#1a9850"|Superior PFS <br>Median PFS: 7.0 mo vs 4.2 mo <br>(HR 0.58, 95% CI 0.43-0.80)
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*Confirmed deleterious or suspected deleterious germline BRCA mutation
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Targeted therapy====
 
−
*[[Olaparib (Lynparza)]] 300 mg PO twice per day
 
−
'''Continued indefinitely'''
 
−
</div></div><br>
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #3, 400 mg twice per day {{#subobject:31cf8c|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 
−
!style="width: 33%"|Study
 
−
!style="width: 33%"|Years of enrollment
 
−
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
|-
 
−
|[https://doi.org/10.1016/S0140-6736(10)60892-6 Tutt et al. 2010 (KU36-44)]
 
−
|2007-2008
 
−
|style="background-color:#91cf61"|Phase 2
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6057749/ Kaufman et al. 2014 (Study 42)]
 
−
|2010-NR
 
−
|style="background-color:#91cf61"|Phase 2
 
−
|-
 
−
|}
 
−
''Note: Patients in Study 42 had germline BRCA1/2 mutations and had progressed after at least three lines of treatment for metastatic disease.''
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Targeted therapy====
 
−
*[[Olaparib (Lynparza)]] 400 mg PO twice per day
 
−
'''Continued indefinitely'''
 
−
</div></div>
 
−
===References===
 
−
# '''KU36-44:''' Tutt A, Robson M, Garber JE, Domchek SM, Audeh MW, Weitzel JN, Friedlander M, Arun B, Loman N, Schmutzler RK, Wardley A, Mitchell G, Earl H, Wickens M, Carmichael J. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial. Lancet. 2010 Jul 24;376(9737):235-44. Epub 2010 Jul 6. [https://doi.org/10.1016/S0140-6736(10)60892-6 link to original article] [https://pubmed.ncbi.nlm.nih.gov/20609467 PubMed] NCT00494234
 
−
<!-- Presented at the 49th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 4, 2013. -->
 
−
# '''Study 42:''' Kaufman B, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña J, Mitchell G, Fried G, Stemmer SM, Hubert A, Rosengarten O, Steiner M, Loman N, Bowen K, Fielding A, Domchek SM. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol. 2015 Jan 20;33(3):244-50. Epub 2014 Nov 3. [https://doi.org/10.1200/jco.2014.56.2728 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6057749/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/25366685 PubMed] NCT01078662
 
−
# '''OlympiAD:''' Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. Epub 2017 Jun 4. [https://doi.org/10.1056/NEJMoa1706450 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28578601 PubMed] NCT02000622
 
−
## '''Update:''' Robson ME, Tung N, Conte P, Im SA, Senkus E, Xu B, Masuda N, Delaloge S, Li W, Armstrong A, Wu W, Goessl C, Runswick S, Domchek SM. OlympiAD final overall survival and tolerability results: Olaparib versus chemotherapy treatment of physician's choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer. Ann Oncol. 2019 Apr 1;30(4):558-566. [https://doi.org/10.1093/annonc/mdz012 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6503629/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30689707 PubMed]
 
  
−
==Talazoparib monotherapy {{#subobject:bb55eb|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen {{#subobject:06a5b4|Variant=1}}===
 
−
{| class="wikitable" style="color:white; background-color:#404040"
 
−
|<small>'''FDA-recommended dose'''</small>
 
−
|-
 
−
|}
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1056/NEJMoa1802905 Litton et al. 2018 (EMBRACA)]
 
−
|2013-2017
 
−
| style="background-color:#1a9851" |Phase 3 (E-RT-switch-ooc)
 
−
|Physician's choice of:<br>1a. [[#Capecitabine_monotherapy|Capecitabine]]<br>1b. [[#Eribulin_monotherapy|Eribulin]]<br>1c. [[#Gemcitabine_monotherapy|Gemcitabine]]<br>1d. [[#Vinorelbine_monotherapy|Vinorelbine]]
 
−
| style="background-color:#1a9850" |Superior PFS<br>Median PFS: 8.6 vs 5.6 mo<br>(HR 0.54, 95% CI 0.41-0.71)
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*Germline BRCA1 or BRCA2 mutation
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Targeted therapy====
 
−
*[[Talazoparib (Talzenna)]] 1 mg PO once per day
 
−
'''Continued indefinitely'''
 
−
</div></div>
 
−
===References===
 
−
# '''EMBRACA:''' Litton JK, Rugo HS, Ettl J, Hurvitz SA, Gonçalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018 Aug 23;379(8):753-763. Epub 2018 Aug 15. [https://doi.org/10.1056/NEJMoa1802905 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/30110579 PubMed] NCT01945775
 
−
## '''Update:''' Litton JK, Hurvitz SA, Mina LA, Rugo HS, Lee KH, Gonçalves A, Diab S, Woodward N, Goodwin A, Yerushalmi R, Roché H, Im YH, Eiermann W, Quek RGW, Usari T, Lanzalone S, Czibere A, Blum JL, Martin M, Ettl J. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. Ann Oncol. 2020 Nov;31(11):1526-1535. Epub 2020 Aug 20. [https://doi.org/10.1016/j.annonc.2020.08.2098 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32828825 PubMed]
 
−
==Vinorelbine monotherapy {{#subobject:5c104c|Regimen=1}}==
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #1, 2 out of 3 weeks {{#subobject:7321fd|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1056/NEJMoa1706450 Robson et al. 2017 (OlympiAD)]
 
−
|2014-2015
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Olaparib_monotherapy_2|Olaparib]]
 
−
| style="background-color:#d73027" |Inferior PFS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*Confirmed deleterious or suspected deleterious germline BRCA mutation
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Vinorelbine (Navelbine)]] 30 mg/m<sup>2</sup> IV once per day on days 1 & 8
 
−
'''21-day cycles'''
 
−
</div></div><br>
 
−
<div class="toccolours" style="background-color:#eeeeee">
 
−
===Regimen variant #2, weekly {{#subobject:bjab1fd|Variant=1}}===
 
−
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
−
!style="width: 20%"|Study
 
−
!style="width: 20%"|Years of enrollment
 
−
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 20%"|Comparator
 
−
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://doi.org/10.1056/NEJMoa1802905 Litton et al. 2018 (EMBRACA)]
 
−
|2013-2017
 
−
| style="background-color:#1a9851" |Phase 3 (C)
 
−
|[[#Talazoparib_monotherapy|Talazoparib]]
 
−
| style="background-color:#d73027" |Inferior PFS
 
−
|-
 
−
|}
 
−
<div class="toccolours" style="background-color:#fdcdac">
 
−
====Biomarker eligibility criteria====
 
−
*Germline BRCA1 or BRCA2 mutation
 
−
</div>
 
−
<div class="toccolours" style="background-color:#b3e2cd">
 
−
====Chemotherapy====
 
−
*[[Vinorelbine (Navelbine)]] 30 mg/m<sup>2</sup> IV over 6 to 10 minutes once per day on days 1, 8, 15
 
−
'''21-day cycles'''
 
−
</div></div>
 
−
===References===
 
−
# '''OlympiAD:''' Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. Epub 2017 Jun 4. [https://doi.org/10.1056/NEJMoa1706450 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28578601 PubMed] NCT02000622
 
−
## '''Update:''' Robson ME, Tung N, Conte P, Im SA, Senkus E, Xu B, Masuda N, Delaloge S, Li W, Armstrong A, Wu W, Goessl C, Runswick S, Domchek SM. OlympiAD final overall survival and tolerability results: Olaparib versus chemotherapy treatment of physician's choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer. Ann Oncol. 2019 Apr 1;30(4):558-566. [https://doi.org/10.1093/annonc/mdz012 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6503629/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30689707 PubMed]
 
−
# '''EMBRACA:''' Litton JK, Rugo HS, Ettl J, Hurvitz SA, Gonçalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roché H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in patients with advanced breast cancer and a germline BRCA mutation. N Engl J Med. 2018 Aug 23;379(8):753-763. Epub 2018 Aug 15. [https://doi.org/10.1056/NEJMoa1802905 link to original article] '''contains dosing details in supplement''' [https://pubmed.ncbi.nlm.nih.gov/30110579 PubMed] NCT01945775
 
−
## '''Update:''' Litton JK, Hurvitz SA, Mina LA, Rugo HS, Lee KH, Gonçalves A, Diab S, Woodward N, Goodwin A, Yerushalmi R, Roché H, Im YH, Eiermann W, Quek RGW, Usari T, Lanzalone S, Czibere A, Blum JL, Martin M, Ettl J. Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial. Ann Oncol. 2020 Nov;31(11):1526-1535. Epub 2020 Aug 20. [https://doi.org/10.1016/j.annonc.2020.08.2098 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32828825 PubMed]
 
−
=Additional resources=
 
−
*[[Breast cancer BRCA1 & BRCA2 genetic testing]]
 
−
*[https://oncomx.org/searchview/?gene=BRCA1 OncoMX -- BRCA1]
 
−
*[https://oncomx.org/searchview/?gene=BRCA2 OncoMX -- BRCA2]
 
−
[[Category:Breast cancer regimens]]
 
−
[[Category:Biomarker-specific pages]]
 
−
[[Category:Malignant breast neoplasm]]
 

Latest revision as of 00:13, 18 June 2023

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