Cited by 2,302PARP inhibition in cancer therapyPancreatic and Hepatic Oncology ResearchBRCA gene mutations in cancer

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Maintenance Olaparib for Germline BRCA -Mutated Metastatic Pancreatic Cancer

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Golan, Talia, Hammel, Pascal, Reni, Michele, Van Cutsem, Eric, Macarulla, Teresa, Hall, Michael J., Park, Joon-Oh, Hochhauser, Daniel, Arnold, Dirk, Oh, Do-Youn, Reinacher-Schick, Anke, Tortora, Giampaolo, Algül, Hana, O’Reilly, Eileen M., McGuinness, David, Cui, Karen Y., Schlienger, Katia, Locker, Gershon Y., Kindler, Hedy L.·2019·New England Journal of Medicine

DOI 10.1056/nejmoa1903387PMC PMC6810605

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Abstract

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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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: Golan, Talia
Hammel, Pascal
Reni, Michele
Macarulla, Teresa
Hall, Michael J.
Hochhauser, Daniel
Arnold, Dirk
Oh, Do-Youn
Tortora, Giampaolo
Algül, Hana
McGuinness, David
Cui, Karen Y.
Locker, Gershon Y.
Kindler, Hedy L.
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
DOI: 10.1056/nejmoa1903387
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
FWCI: 129.05
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
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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Maintenance Olaparib for Germline BRCA -Mutated Metastatic Pancreatic Cancer

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