Difference between revisions of "Pancreatic cancer, BRCA-mutated"

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! colspan="2" align="center" style="color:white; font-size:125%; background-color:#08519c" |'''Page editor'''
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| style="background-color:#F0F0F0; width:15%" |[[File:C Schwartz.jpg|frameless|upright=0.3|center]]
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{{#lst:Editorial board transclusions|giei}}
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| style="width:35%" |<big>[[User:Candiceschwartz|Candice Schwartz, MD]]<br>University of Illinois at Chicago<br>Chicago, IL</big>
 
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| style="background-color:#F0F0F0; width:15%" |[[File:nkv.jpg|frameless|upright=0.3|center]]
 
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| style="width:35%" |<big>[[User:Neetavenepalli|Neeta K. Venepalli, MD, MBA]]<br>University of Illinois at Chicago<br>Chicago, IL</big>
 
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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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<big>'''Note: this page has regimens which are specific to pancreatic cancer that is BRCA-mutated. Please see the [[Pancreatic cancer|main pancreatic cancer]] page for other chemotherapy regimens.'''</big>
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''Are you looking for a regimen, but can't find it here? For placebo or observational studies in this condition, please visit [[Pancreatic cancer, BRCA-mutated - null regimens|this page]]. If you still can't find it, please let us know so we can add it!'' <br>
 +
'''Note: this page has regimens which are specific to pancreatic cancer that is BRCA-mutated. Please see the [[Pancreatic cancer|main pancreatic cancer]] page for other chemotherapy regimens.'''
 
{{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=1455 NCCN Guidelines - Pancreatic Adenocarcinoma].''
 
=Advanced or metastatic disease, first-line=
 
=Advanced or metastatic disease, first-line=
−
 
+
==Cisplatin & Gemcitabine (GC) {{#subobject:344hc7|Regimen=1}}==
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==Cisplatin & Gemcitabine {{#subobject:344hc7|Regimen=1}}==
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===Regimen {{#subobject:3ab23a|Variant=1}}===
 
===Regimen {{#subobject:3ab23a|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/pmc7193749/ O'Reilly et al. 2020]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7193749/ O'Reilly et al. 2020 (MSKCC 12-045)]
 
|2014-2018
 
|2014-2018
−
| style="background-color:#1a9851" |Randomized Phase II (C)
+
| style="background-color:#1a9851" |Randomized Phase 2 (C)
−
|GC & Veliparib
+
|[[#Cisplatin_.26_Gemcitabine_.28GC.29_.26_Veliparib_999|GC & Veliparib]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of RR
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of RR
 
|-
 
|-
 
|}
 
|}
 
''Selected inclusion criteria: germline BRCA1/2 or PALB2 mutation and previously untreated stage III-IV pancreatic adenocarcinoma''. The addition of veliparib did not improve RR.
 
''Selected inclusion criteria: germline BRCA1/2 or PALB2 mutation and previously untreated stage III-IV pancreatic adenocarcinoma''. The addition of veliparib did not improve RR.
 +
<div class="toccolours" style="background-color:#fdcdac">
 
====Biomarker eligibility criteria====
 
====Biomarker eligibility criteria====
−
 
 
*Germline BRCA1/2 or PALB2+ mutation
 
*Germline BRCA1/2 or PALB2+ mutation
−
 
+
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV once per day on days 3 & 10
 
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV once per day on days 3 & 10
−
*[[Gemcitabine (Gemzar)]] 600 mg/m<sup>2</sup> IV once per day on days 3 & 10
+
*[[Gemcitabine (Gemzar)]] 600 mg/m<sup>2</sup> IV over 30 minutes once per day on days 3 & 10
−
 
 
 
'''21-day cycles'''
 
'''21-day cycles'''
−
 
+
</div></div>
 
===References===
 
===References===
−
 
+
#'''MSKCC 12-045:''' O'Reilly EM, Lee JW, Zalupski M, Capanu M, Park J, Golan T, Tahover E, Lowery MA, Chou JF, Sahai V, Brenner R, Kindler HL, Yu KH, Zervoudakis A, Vemuri S, Stadler ZK, Do RKG, Dhani N, Chen AP, Kelsen D. Randomized, Multicenter, Phase II Trial of Gemcitabine and Cisplatin With or Without Veliparib in Patients With Pancreas Adenocarcinoma and a Germline ''BRCA/PALB2'' Mutation. J Clin Oncol. 2020 May 01;38:1378-1388. Epub 2020 Jan 24. [https://doi.org/10.1200/jco.19.02931 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7193749/ link to PMC article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/31976786/ PubMed] [https://clinicaltrials.gov/study/NCT01585805 NCT01585805]
−
#O'Reilly EM, Lee JW, Zalupski M, Capanu M, Park J, Golan T, Tahover E, Lowery MA, Chou JF, Sahai V, Brenner R, Kindler HL, Yu KH, Zervoudakis A, Vemuri S, Stadler ZK, Do RKG, Dhani N, Chen AP, Kelsen D. Randomized, Multicenter, Phase II Trial of Gemcitabine and Cisplatin With or Without Veliparib in Patients With Pancreas Adenocarcinoma and a Germline ''BRCA/PALB2'' Mutation. J Clin Oncol. 2020 May 01;38:1378-1388. [https://doi.org/10.1200/jco.19.02931 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7193749/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31976786/ PubMed]
 
  
 
=Maintenance after first-line therapy=
 
=Maintenance after first-line therapy=
−
 
 
==Olaparib monotherapy {{#subobject:388hc7|Regimen=1}}==
 
==Olaparib monotherapy {{#subobject:388hc7|Regimen=1}}==
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===Regimen {{#subobject:3ab86a|Variant=1}}===
 
===Regimen {{#subobject:3ab86a|Variant=1}}===
 
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! style="width: 20%" |Dates of enrollment
 
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
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|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6810605/ Golan et al. 2019 (POLO)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6810605/ Golan et al. 2019 (POLO)]
 +
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|2015-2019
 
|2015-2019
−
| style="background-color:#1a9851" |Phase III (E-RT-esc)
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| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
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|[[#Placebo|Placebo]]
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|[[Pancreatic_cancer,_BRCA-mutated_-_null_regimens#Placebo|Placebo]]
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| style="background-color:#1a9850" |Superior PFS
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| style="background-color:#1a9850" |Superior PFS (primary endpoint)<br>Median PFS: 7.4 vs 3.8 mo<br>(HR 0.53, 95% CI 0.35-0.82)
 
|-
 
|-
 
|}
 
|}
 
''Selected inclusion criteria: germline BRCA1 or BRCA2 mutation and metastatic pancreatic cancer and disease that had not progressed during first-line platinum-based chemotherapy.''
 
''Selected inclusion criteria: germline BRCA1 or BRCA2 mutation and metastatic pancreatic cancer and disease that had not progressed during first-line platinum-based chemotherapy.''
 +
<div class="toccolours" style="background-color:#fdcdac">
 
====Biomarker eligibility criteria====
 
====Biomarker eligibility criteria====
−
 
+
*Germline BRCA1 or BRCA2  mutation
−
*Germline BRCA1, BRCA2  mutation
+
</div>
−
 
+
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
−
 
+
*First-line [[Regimen_classes#Platinum-based_regimen|platinum-based chemotherapy]] for at least 16 weeks
−
*[[Regimen_classes#Platinum-based_regimen|Platinum-based chemotherapy]] for at least 16 weeks
+
</div>
−
 
+
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
−
 
 
*[[Olaparib (Lynparza)]] 300 mg PO twice per day
 
*[[Olaparib (Lynparza)]] 300 mg PO twice per day
−
 
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
−
 
+
</div></div>
−
===References===
 
−
 
 
−
#'''POLO:''' Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algül H, O'Reilly EM, McGuinness D, Cui KY, Schlienger K, Locker GY, Kindler HL. Maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer. N Engl J Med. 2019 Jul 25;381(4):317-327. Epub 2019 Jun 2. [https://www.nejm.org/doi/full/10.1056/NEJMoa1903387 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6810605/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/31157963 PubMed] NCT02184195
 
−
 
 
−
==Placebo==
 
−
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−
 
 
−
===Regimen===
 
−
{| 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/PMC6810605/ Golan et al. 2019 (POLO)]
 
−
|2015-2019
 
−
| style="background-color:#1a9851" |Phase III (C)
 
−
|[[#Olaparib_monotherapy|Olaparib]]
 
−
| style="background-color:#d73027" |Inferior PFS
 
−
|-
 
−
|}
 
−
====Preceding treatment====
 
−
 
 
−
*Platinum-based chemotherapy for at least 16 weeks
 
−
 
 
 
===References===
 
===References===
−
 
+
#'''POLO:''' Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algül H, O'Reilly EM, McGuinness D, Cui KY, Schlienger K, Locker GY, Kindler HL. Maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer. N Engl J Med. 2019 Jul 25;381(4):317-327. Epub 2019 Jun 2. [https://doi.org/10.1056/NEJMoa1903387 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6810605/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31157963/ PubMed] [https://clinicaltrials.gov/study/NCT02184195 NCT02184195]
−
#'''POLO:''' Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algül H, O'Reilly EM, McGuinness D, Cui KY, Schlienger K, Locker GY, Kindler HL. Maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer. N Engl J Med. 2019 Jul 25;381(4):317-327. Epub 2019 Jun 2. [https://www.nejm.org/doi/full/10.1056/NEJMoa1903387 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6810605/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/31157963 PubMed] NCT02184195
+
##'''HRQoL analysis:''' Hammel P, Kindler HL, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algül H, O'Reilly EM, McGuinness D, Cui KY, Joo S, Yoo HK, Patel N, Golan T; POLO Investigators. Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib. Ann Oncol. 2019 Dec 1;30(12):1959-1968. [https://doi.org/10.1093/annonc/mdz406 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6938600/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31562758/ PubMed]
 +
##'''Update:''' Kindler HL, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algül H, O'Reilly EM, Bordia S, McGuinness D, Cui K, Locker GY, Golan T. Overall Survival Results From the POLO Trial: A Phase III Study of Active Maintenance Olaparib Versus Placebo for Germline BRCA-Mutated Metastatic Pancreatic Cancer. J Clin Oncol. 2022 Dec 1;40(34):3929-3939. Epub 2022 Jul 14. [https://doi.org/10.1200/jco.21.01604 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10476841/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/35834777/ PubMed]
  
 
=Metastatic disease, refractory=
 
=Metastatic disease, refractory=
 
==Olaparib monotherapy {{#subobject:0c2eb3|Regimen=1}}==
 
==Olaparib monotherapy {{#subobject:0c2eb3|Regimen=1}}==
−
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|[[#top|back to top]]
 
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===Regimen {{#subobject:21eb78|Variant=1}}===
 
===Regimen {{#subobject:21eb78|Variant=1}}===
−
{| class="wikitable" style="width: 50%; text-align:center;"  
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{| class="wikitable sortable" style="width: 60%; text-align:center;"  
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! style="width: 50%" |Study
+
!style="width: 33%"|Study
−
! style="width: 50%" |[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
−
|[http://jco.ascopubs.org/content/33/3/244.long Kaufman et al. 2014 (Study 42)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6057749/ Kaufman et al. 2014 (Study 42)]
−
| style="background-color:#91cf61" |Phase II
+
|2010-02-21 to 2012-07-31
 +
| style="background-color:#91cf61" |Phase 2
 
|-
 
|-
 
|}
 
|}
−
''Patients had germline BRCA1/2 mutations.''
+
<div class="toccolours" style="background-color:#fdcdac">
−
====Preceding treatment====
+
====Biomarker eligibility criteria====
−
 
+
*Germline BRCA1/2 mutations
 +
====Prior treatment criteria====
 
*Gemcitabine, with progression
 
*Gemcitabine, with progression
−
 
+
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
−
 
 
*[[Olaparib (Lynparza)]] 400 mg PO twice per day
 
*[[Olaparib (Lynparza)]] 400 mg PO twice per day
−
 
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
−
 
+
</div></div>
 
===References===
 
===References===
 
<!-- Presented at the 49th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 4, 2013. -->
 
<!-- 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] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6057749/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/25366685/ PubMed] [https://clinicaltrials.gov/study/NCT01078662 NCT01078662]
−
#'''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. [http://jco.ascopubs.org/content/33/3/244.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/25366685 PubMed]
 
  
 
=Additional resources=
 
=Additional resources=
−
{| class="wikitable" style="float:right; margin-left: 5px;"
 
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
−
 
 
*[https://oncomx.org/searchview/?gene=BRCA1 OncoMX -- BRCA1]
 
*[https://oncomx.org/searchview/?gene=BRCA1 OncoMX -- BRCA1]
 
*[https://oncomx.org/searchview/?gene=BRCA2 OncoMX -- BRCA2]
 
*[https://oncomx.org/searchview/?gene=BRCA2 OncoMX -- BRCA2]
−
 
 
[[Category:Pancreatic cancer regimens]]
 
[[Category:Pancreatic cancer regimens]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Gastrointestinal cancers]]
 
[[Category:Gastrointestinal cancers]]

Latest revision as of 23:34, 15 July 2024

Back to Top

Section editor
Eric Marks Headshot.jpg
 Eric I. Marks, MD
Boston University
Boston, MA, USA
3 regimens on this page
3 variants on this page

Are you looking for a regimen, but can't find it here? For placebo or observational studies in this condition, please visit this page. If you still can't find it, please let us know so we can add it!
Note: this page has regimens which are specific to pancreatic cancer that is BRCA-mutated. Please see the main pancreatic 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

Advanced or metastatic disease, first-line

Cisplatin & Gemcitabine (GC)

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
O'Reilly et al. 2020 (MSKCC 12-045) 2014-2018 Randomized Phase 2 (C) GC & Veliparib Did not meet primary endpoint of RR

Selected inclusion criteria: germline BRCA1/2 or PALB2 mutation and previously untreated stage III-IV pancreatic adenocarcinoma. The addition of veliparib did not improve RR.

Biomarker eligibility criteria

  • Germline BRCA1/2 or PALB2+ mutation

Chemotherapy

21-day cycles

References

  1. MSKCC 12-045: O'Reilly EM, Lee JW, Zalupski M, Capanu M, Park J, Golan T, Tahover E, Lowery MA, Chou JF, Sahai V, Brenner R, Kindler HL, Yu KH, Zervoudakis A, Vemuri S, Stadler ZK, Do RKG, Dhani N, Chen AP, Kelsen D. Randomized, Multicenter, Phase II Trial of Gemcitabine and Cisplatin With or Without Veliparib in Patients With Pancreas Adenocarcinoma and a Germline BRCA/PALB2 Mutation. J Clin Oncol. 2020 May 01;38:1378-1388. Epub 2020 Jan 24. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT01585805

Maintenance after first-line therapy

Olaparib monotherapy

Regimen

FDA-recommended dose
Study Dates of enrollment Evidence Comparator Comparative Efficacy
Golan et al. 2019 (POLO) 2015-2019 Phase 3 (E-RT-esc) Placebo Superior PFS (primary endpoint)
Median PFS: 7.4 vs 3.8 mo
(HR 0.53, 95% CI 0.35-0.82)

Selected inclusion criteria: germline BRCA1 or BRCA2 mutation and metastatic pancreatic cancer and disease that had not progressed during first-line platinum-based chemotherapy.

Biomarker eligibility criteria

  • Germline BRCA1 or BRCA2 mutation

Preceding treatment

Targeted therapy

Continued indefinitely

References

  1. POLO: Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algül H, O'Reilly EM, McGuinness D, Cui KY, Schlienger K, Locker GY, Kindler HL. Maintenance olaparib for germline BRCA-mutated metastatic pancreatic cancer. N Engl J Med. 2019 Jul 25;381(4):317-327. Epub 2019 Jun 2. link to original article dosing details in abstract have been reviewed by our editors link to PMC article PubMed NCT02184195
    1. HRQoL analysis: Hammel P, Kindler HL, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algül H, O'Reilly EM, McGuinness D, Cui KY, Joo S, Yoo HK, Patel N, Golan T; POLO Investigators. Health-related quality of life in patients with a germline BRCA mutation and metastatic pancreatic cancer receiving maintenance olaparib. Ann Oncol. 2019 Dec 1;30(12):1959-1968. link to original article link to PMC article PubMed
    2. Update: Kindler HL, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algül H, O'Reilly EM, Bordia S, McGuinness D, Cui K, Locker GY, Golan T. Overall Survival Results From the POLO Trial: A Phase III Study of Active Maintenance Olaparib Versus Placebo for Germline BRCA-Mutated Metastatic Pancreatic Cancer. J Clin Oncol. 2022 Dec 1;40(34):3929-3939. Epub 2022 Jul 14. link to original article link to PMC article PubMed

Metastatic disease, refractory

Olaparib monotherapy

Regimen

Study Dates of enrollment Evidence
Kaufman et al. 2014 (Study 42) 2010-02-21 to 2012-07-31 Phase 2

Biomarker eligibility criteria

  • Germline BRCA1/2 mutations

Prior treatment criteria

  • Gemcitabine, with progression

Targeted therapy

Continued indefinitely

References

  1. 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. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT01078662

Additional resources

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