Evidence map›Paper›PMID 31157963›Full record

Trial reportThe New England journal of medicine2019

Maintenance Olaparib for Germline

Talia Golan, Pascal Hammel, Michele Reni, Eric Van Cutsem, Teresa Macarulla, Michael J Hall, Joon-Oh Park, Daniel Hochhauser, Dirk Arnold, Do-Youn Oh and 9 more

10 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 10 registered trials, which are not on this map. Cited by 1,360 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,360citing papers in PubMed, 2 pooled it
123.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02184195 phase3completednot on this map

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

TypeinterventionalSponsorAstraZenecaRan2014 to 2023Enrolled154ConditionsGermline BRCA1/2 Mutations and, Metastatic Adenocarcinoma of the PancreasArmsOlaparib, Placebo
NCT02869802 recruitingnot on this map

Prospectively Defining Metastatic Pancreatic Ductal Adenocarcinoma Subtypes by Comprehensive Genomic Analysis

TypeobservationalSponsorBritish Columbia Cancer AgencyRan2016 to 2027Enrolled190ConditionsCancer, Pancreatic CancerArmsTumour Biopsy, Serial Collection of Plasma and Serum Samples
NCT04692740 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

A Pilot Study of Chlorambucil in Pre-treated Metastatic Pancreatic Adenocarcinoma Patients Bearing a Germ Line BRCA or Other DNA Defects Repair (DDR) Mutations.

TypeinterventionalSponsorMichele ReniRan2020 to 2023Enrolled20ConditionsPancreatic Ductal AdenocarcinomaArmsChlorambucil, Oral, 2 Mg
NCT04787991 phase1completednot on this mapstarted 2021, after this paper: background citation

A Multicenter, Open-label, ExploRatory Platform Trial to EValuate ImmunOtherapy Combinations With Chemotherapy for the Treatment of Patients With PreviousLy UnTreated MetastatIc Pancreatic AdenOcarciNoma (REVOLUTION)

TypeinterventionalSponsorCancer Insight, LLCRan2021 to 2025Enrolled45ConditionsMetastatic Pancreatic AdenocarcinomaArmsNivolumab (Cohort A), Ipilimumab (Cohort A, B and C), Hydroxychloroquine (HCQ) (Cohort B), Nab-paclitaxel (nP) (Cohort A, B and C), Gemcitabine (gem) (Cohort A, B and C)
NCT05222971 phase2recruitingnot on this mapstarted 2022, after this paper: background citation

Randomized Open-labeled Phase 2 Study of Maintenance Olaparib With or Without Durvalumab for DDR Gene Mutated Advanced Biliary Tract Cancer Following Platinum-based Chemotherapy

TypeinterventionalSponsorAsan Medical CenterRan2022 to 2026Enrolled62ConditionsBiliary Tract Cancer, DNA Damage Repair DeficiencyArmsDurvalumab, Olaparib
NCT05305001 completednot on this mapstarted 2020, after this paper: background citation

Prevalence Estimation of BRCA1, BRCA2 and Other Germline Mutations Associated With Hereditary Pancreatic Cancer Using a Comprehensive Gene Panel in an Unselected Cohort of Patients With Pancreatic Adenocarcinoma in Mexico

TypeobservationalSponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranRan2020 to 2022Enrolled107ConditionsPancreatic Cancer, Pancreatic AdenocarcinomaArmsInvitae Multi-Cancer Panel ®
NCT05351983 nacompletednot on this mapstarted 2022, after this paper: background citation

Patient-derived Organoid Generation in Pancreatic Cancer: a Single Centre, Open-label, Single Arm Feasibility Study

TypeinterventionalSponsorProf. Dr. med. Dres. h.c. Jan Schmidt, MMERan2022 to 2023Enrolled60ConditionsPancreas Cancer, Pancreas Neoplasm, Pancreas Adenocarcinoma, Pancreatic CancerArmsSurgical biopsy of tumoral tissue for organoid generation
NCT06095141 phase2 / phase3recruitingnot on this mapstarted 2023, after this paper: background citation

Cisplatin Based Regimen to Patients With Advanced Pancreatic Cancer and Homologous Recombination Deficiency

TypeinterventionalSponsorFudan UniversityRan2023 to 2026Enrolled30ConditionsPancreatic Adenocarcinoma, Homologous Recombination DeficiencyArmsCisplatin
NCT06388967 recruitingnot on this mapstarted 2023, after this paper: background citation

Early Detection of Pancreatic Cancer: Prospective Study

TypeobservationalSponsorCity of Hope Medical CenterRan2023 to 2030Enrolled2,000ConditionsPancreatic Cancer, Pancreatic Carcinoma, Pancreatic Adenocarcinoma, Pancreatic Ductal AdenocarcinomaArmsPANcreatic cancer Exosome Early detectiON (PANXEON)
NCT06574620 narecruitingnot on this mapstarted 2025, after this paper: background citation

Accelerating the Actionability of Treatment in Resected and Locally Advanced Pancreatic Cancer

TypeinterventionalSponsorBritish Columbia Cancer AgencyRan2025 to 2031Enrolled200ConditionsPancreatic Ductal Adenocarcinoma, Resectable Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Ductal Adenocarcinoma, Locally Advanced Pancreatic Ductal AdenocarcinomaArmsGenetic testing, Optional biopsy, Tissue collection
3 · Its place in the literature

Who cites it

1,360 citing papers in PubMed, 2 syntheses or guidelines pooled it, 2,145 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. A Phase II Trial of Niraparib in Patients with Advanced Pancreatic Cancer Harboring Pathogenic Variants in ATM, BRCA1, BRCA2, PALB2, and CHEK2.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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1,300 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 1 institution in 2 countries.

Talia GolanFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Pascal HammelFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Michele ReniFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Eric Van CutsemFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Teresa MacarullaFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Michael J HallFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Joon-Oh ParkFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Daniel HochhauserFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Dirk ArnoldFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Do-Youn OhFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Anke Reinacher-SchickFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Giampaolo TortoraFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Hana AlgülFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Eileen M O'ReillyFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
David McGuinnessFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Karen Y CuiFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Katia SchliengerFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Gershon Y LockerFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Hedy L KindlerFrom 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 d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona (T.M.); Fox Chase Cancer Center, Philadelphia (M.J.H.); Samsung Medical Center, Sungkyunkwan University School of Medicine (J.-O.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (D.-Y.O.) - both in Seoul, South Korea; University College London Cancer Institute, London (D.H.), and AstraZeneca, Cambridge (D.M.) - both in the United Kingdom; Asklepios Tumorzentrum Hamburg Asklepios Klinik Altona, Hamburg (D.A.), St. Josef-Hospital, Ruhr University Bochum, Bochum (A.R.-S.), and Klinikum rechts der Isar, Department of Internal Medicine II, Technische Universität München, Munich (H.A.) - all in Germany; Memorial Sloan Kettering Cancer Center, New York (E.M.O.); AstraZeneca, Gaithersburg, MD (K.Y.C., G.Y.L.); Merck, Kenilworth, NJ (K.S.); and the University of Chicago, Chicago (H.L.K.).
Université Paris Cité · FR

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
AstraZeneca NAMerck Sharp and Dohme NANCI NIH HHS P30-17 CA008748NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundPatients with a germline

methodsWe conducted a randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy of olaparib as maintenance therapy in patients who had a germline

resultsOf 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.

conclusionsAmong patients with a germline

Indexed as

Genes, BRCA1Genes, BRCA2Germ-Line MutationMaintenance ChemotherapyAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic AgentsDouble-Blind MethodFemaleHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm MetastasisAntineoplastic AgentsolaparibPhthalazinesPiperazines

Identifiers

PMID31157963
PMCPMC6810605
OpenAlexW2947826965

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and 4 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.