Maintenance Olaparib for Germline BRCA -Mutated Metastatic Pancreatic Cancer
Open accessAbstract
BACKGROUND: mutation make up a small subgroup of those with metastatic pancreatic cancer. The poly(adenosine diphosphate-ribose) polymerase (PARP) inhibitor olaparib has had antitumor activity in this population. METHODS: mutation and metastatic pancreatic cancer and disease that had not progressed during first-line platinum-based chemotherapy. Patients were randomly assigned, in a 3:2 ratio, to receive maintenance olaparib tablets (300 mg twice daily) or placebo. The primary end point was progression-free survival, which was assessed by blinded independent central review. RESULTS: Of the 3315 patients who underwent screening, 154 underwent randomization and were assigned to a trial intervention (92 to receive olaparib and 62 to receive placebo). The median progression-free survival was significantly longer in the olaparib group than in the placebo group (7.4 months vs. 3.8 months; hazard ratio for disease progression or death, 0.53; 95% confidence interval [CI], 0.35 to 0.82; P = 0.004). An interim analysis of overall survival, at a data maturity of 46%, showed no difference between the olaparib and placebo groups (median, 18.9 months vs. 18.1 months; hazard ratio for death, 0.91; 95% CI, 0.56 to 1.46; P = 0.68). There was no significant between-group difference in health-related quality of life, as indicated by the overall change from baseline in the global quality-of-life score (on a 100-point scale, with higher scores indicating better quality of life) based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (between-group difference, -2.47 points; 95% CI, -7.27 to 2.33). The incidence of grade 3 or higher adverse events was 40% in the olaparib group and 23% in the placebo group (between-group difference, 16 percentage points; 95% CI, -0.02 to 31); 5% and 2% of the patients, respectively, discontinued the trial intervention because of an adverse event. CONCLUSIONS: mutation and metastatic pancreatic cancer, progression-free survival was longer with maintenance olaparib than with placebo. (Funded by AstraZeneca and others; POLO ClinicalTrials.gov number, NCT02184195.).
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Its use for treating pancreatic cancer was recently approved by the FDA.
“HRD targeted therapy with PARPi is mostly restricted to breast and ovarian cancer5, though its use for treating pancreatic cancer was recently approved by the FDA (US Food and Drug Administration)29.”
From Pan-cancer landscape of homologous recombination deficiency. (2020) · cites this paper as [29]
The paper’s introductory passage (labelled Abstract > Conclusions in our copy; page unavailable) says that no targeted therapies had been approved specifically for patients with a germline BRCA mutation and pancreatic cancer. It reports a trial of maintenance olaparib, not a recent FDA approval for pancreatic cancer. (LLM, conf=0.86)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredIn late-stage PDAC with germline BRCA1 or BRCA2 mutation (~7.5% of patients), PARP inhibitor olaparib can extend progression-free survival but not overall survival.
“Finally, in late-stage PDAC with germline mutation in BRCA1 or BRCA2 (~7.5% of the patients), the PARP inhibitor olaparib could extend progression free survival but not overall survival (8).”
From KRAS mutation in pancreatic cancer (2021) · cites this paper as [8]
A pivotal clinical trial in PDAC patients with germline BRCA1/2 mutations established that an oral PARP inhibitor improved progression-free survival, leading to approval in this setting.
“a pivotal clinical trial in patients with PDAC and germline BRCA1/2 mutations established the benefit of administering an orally bioavailable PARP inhibitor on improved progression free survival (PFS). This led to the approval of targeted therapy in this setting87.”
From Pancreatic cancer: Advances and challenges (2023) · cites this paper as [87]
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- Authors
- Golan, T., Hammel, P., Reni, M., Van Cutsem, E., Macarulla, T., Hall, M. J., Park, J.-O., Hochhauser, D., Arnold, D., Oh, D.-Y., Reinacher-Schick, A., Tortora, G., Algül, H., O’Reilly, E. M., McGuinness, D., Cui, K. Y., Schlienger, K., Locker, G. Y., & Kindler, H. L.
- Affiliations
- Tel Aviv University (IL)
- From the Oncology Institute, Sheba Medical Center, Tel Aviv University, Tel Aviv, Israel (T.G.); Hôpital Beaujon (Assistance Publique–Hôpitaux de Paris), Clichy, and University Paris VII, Paris (P.H.); IRCCS Ospedale San Raffaele Scientific Institute, Milan (M.R.), Azienda Ospedaliera Universitaria Integrata Verona, Verona (G.T.), and Fondazione Policlinico Universitario Gemelli IRCCS, Rome (G.T.) — all in Italy; University Hospitals Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); Vall...
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2019-07-25
- Volume
- 381
- Issue
- 4
- Pages
- 317-327
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC6810605
- OpenAlex
- W2947826965
- Cited by
- 2,302
- References
- 24
- Citations by year
- 2026: 195 · 2025: 268 · 2024: 292 · 2023: 312 · 2022: 412 · 2021: 452 · 2020: 299 · 2019: 66 · 2014: 1 · 2012: 1
- FWCI
- 129.05
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Lirias (submittedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- RECERCAT (Consorci de Serveis Universitaris de Catalunya) (submittedVersion, cc-by-nc-nd)
- Seoul National University Open Repository (Seoul National University) (submittedVersion)
- Funders
- AstraZeneca (NA)
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc (NA)
- NIH/NCI Cancer Center Support Grant (P30-17 CA008748)
- Topics
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › BRCA gene mutations in cancer
- Keywords
- olaparib, PARP inhibitors, germline BRCA mutation, metastatic pancreatic cancer, maintenance therapy, progression-free survival, overall survival, quality of life, adverse events, platinum-based chemotherapy, PARP inhibitor resistance, DNA repair deficiency, targeted therapy, interim analysis, predictive biomarkers, treatment discontinuation, health-related quality of life
- MeSH terms
- Progression-Free Survival, Adenocarcinoma, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Double-Blind Method, Female, Humans, Male, Middle Aged, Neoplasm Metastasis, Pancreatic Neoplasms, Phthalazines, Piperazines, Germ-Line Mutation, Genes, BRCA1, Genes, BRCA2, Kaplan-Meier Estimate, Maintenance Chemotherapy
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