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Pancreatic cancer, BRCA-mutated

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C Schwartz.jpg
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
2 regimens on this page
2 variants on this page

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.


Contents

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

Chemotherapy

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 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

  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 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

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 contains verified protocol PubMed

Additional resources