Difference between revisions of "Pancreatic cancer, BRCA-mutated"
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{| class="wikitable" style="width: 100%; text-align:center;" | {| class="wikitable" style="width: 100%; text-align:center;" | ||
| − | ! style="width: | + | !style="width: 20%"|Study |
| − | ! style="width: | + | !style="width: 20%"|Years of enrollment |
| − | ! style="width: | + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] |
| − | ! style="width: | + | !style="width: 20%"|Comparator |
| + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
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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)] | ||
| + | |2015-2019 | ||
| style="background-color:#1a9851" |Phase III (E-RT-esc) | | style="background-color:#1a9851" |Phase III (E-RT-esc) | ||
|[[#Placebo|Placebo]] | |[[#Placebo|Placebo]] | ||
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| − | '''Biomarker eligibility criteria | + | ''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, BRCA2 mutation | ||
| − | |||
| − | |||
| − | |||
====Preceding treatment==== | ====Preceding treatment==== | ||
| − | *Platinum-based chemotherapy for at least 16 weeks | + | *[[Regimen_classes#Platinum-based_regimen|Platinum-based chemotherapy]] for at least 16 weeks |
====Chemotherapy==== | ====Chemotherapy==== | ||
Revision as of 20:54, 17 February 2020
| Page editor | Section editor | ||
|---|---|---|---|
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Candice Schwartz, MD University of Illinois at Chicago Chicago, IL |
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Neeta K. Venepalli, MD, MBA University of Illinois at Chicago Chicago, IL |
3 regimens on this page
3 variants on this page
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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.
Maintenance after first-line therapy
Olaparib monotherapy
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Regimen
| FDA-recommended dose |
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Golan et al. 2019 (POLO) | 2015-2019 | Phase III (E-RT-esc) | Placebo | Superior PFS |
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, BRCA2 mutation
Preceding treatment
- Platinum-based chemotherapy for at least 16 weeks
Chemotherapy
- Olaparib (Lynparza) 300 mg PO twice per day
Continued indefinitely
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. link to original article contains protocol link to PMC article PubMed
Placebo
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Regimen
| Study | Evidence | Comparator | Efficacy |
|---|---|---|---|
| Golan et al. 2019 (POLO) | Phase III (C) | Olaparib | Inferior PFS |
Preceding treatment
- Platinum-based chemotherapy for at least 16 weeks
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. link to original article link to PMC article PubMed
Metastatic disease, refractory
Olaparib monotherapy
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Regimen
| Study | Evidence |
|---|---|
| Kaufman et al. 2014 (Study 42) | Phase II |
Patients had germline BRCA1/2 mutations.
Preceding treatment
- Gemcitabine, with progression
Chemotherapy
- Olaparib (Lynparza) 400 mg PO twice per day
Continued indefinitely
References
- 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 contains verified protocol PubMed
Additional resources
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