Evidence map›Paper›PMID 36228963›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2022

Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer.

C E Geyer, J E Garber, R D Gelber, G Yothers, M Taboada, L Ross, P Rastogi, K Cui, A Arahmani, G Aktan and 67 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07151911 (Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients), which is not on this map. Cited by 255 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
255citing papers in PubMed, 7 pooled it
40.3field-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.

NCT07151911 recruitingnot on this mapstarted 2024, after this paper: background citation

Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients

TypeobservationalSponsorAzienda Ospedaliero-Universitaria di ModenaRan2024 to 2031Enrolled100ConditionsBreast CancerArmsabemaciclib, olaparib and endocrine therapy
3 · Its place in the literature

Who cites it

255 citing papers in PubMed, 7 syntheses or guidelines pooled it, 415 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. SEOM-GEICAM-SOLTI clinical guidelines for early-stage breast cancer (UPDATE 2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Guideline
  5. Guideline
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Patient-Reported Outcomes in OlympiA: A Phase III, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib in gJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Trial
  14. Review
  15. Review
  16. Article
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  20. Review

195 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

77 authors at 20 institutions in 24 countries.

C E GeyerNRG Oncology/NSABP Foundation, Pittsburgh; Department of Medicine, UPMC Hillman Cancer Center, Pittsburgh.
J E GarberDana-Farber Cancer Institute, Harvard Medical School, Boston.
R D GelberDana-Farber Cancer Institute, Harvard Medical School, Boston; Harvard T.H. Chan School of Public Health, Boston; Frontier Science Foundation, Boston.
G YothersNRG Oncology/NSABP Foundation, Pittsburgh; Department of Biostatistics, University of Pittsburgh, Pittsburgh, USA.
M TaboadaOncology Biometrics Department, AstraZeneca, Macclesfield.
L RossDepartment of Data Management, Frontier Science (Scotland), Kincraig, Scotland, UK.
P RastogiNRG Oncology/NSABP Foundation, Pittsburgh; Department of Medicine, UPMC Hillman Cancer Center, Pittsburgh.
K CuiDepartment of Oncology R&D, AstraZeneca, Gaithersburg, USA.
A ArahmaniResearch Operations Department, Breast International Group, Brussels, Belgium.
G AktanGlobal Oncology Clinical Development, Merck and Co. Inc., Rahway, USA.
A C ArmstrongDepartment of Medical Oncology, The Christie Hospital NHS Foundation Trust Manchester, UK.
M ArnedosEuropean Organisation for Research and Treatment (EORTC), Brussels, Belgium; The Department of Medical Oncology, Institut Bergonie, Bordeaux, France.
J BalmañaMedical Oncology Department, Vall d'Hebron Institute of Oncology and Vall d'Hebron University Hospital, Barcelona, Spain.
J BerghDepartment of Oncology-Pathology, Swedish Breast Cancer Group, Karolinska Institute and Breast Cancer Center, Karolinska University Hospital and Karolinska Comprehensive Cancer Center, Stockholm, Sweden.
J BlissDepartment of Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK.
S DelalogeDepartment of Cancer Medicine, Institute Gustave Roussy and Unicancer Breast Group, Paris, France.
S M DomchekDepartment of Medicine, Basser Center for BRCA at the Abramson Cancer Center, University of Pennsylvania, Philadelphia, USA.
A EisenOdette Cancer Centre, Department of Medicine, University of Toronto, Toronto, Canada.
F ElsafyOncology Biometrics Department, AstraZeneca, Macclesfield.
L E FeinDepartment of Clinical Research, Instituto de Oncologia De Rosario, Santa Fe, Argentina.
A FieldingDepartment of Oncology R&D, AstraZeneca, Gaithersburg, USA.
J M FordDepartment of Medicine/Oncology, Stanford University School of Medicine, Stanford.
S FriedmanFacing Our Risk of Cancer Empowered, Tampa, USA.
K A GelmonDepartment of Medical Oncology, BC Cancer, Vancouver, Canada.
L GianniDepartment of Oncology, International Breast Cancer Study Group, Bern, Switzerland; Department of Medical Oncology, Ospedale Infermi AUSL della Romagna, Rimini, Italy.
M GnantComprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
S J HollingsworthDepartment of Late Development Oncology, AstraZeneca, Cambridge, UK.
S-A ImDepartment of Internal Medicine, Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
A JagerDepartment of Medical Oncology, Dutch Breast Cancer Research Group, Utrecht, the Netherlands.
Ó Þ JóhannssonDepartment of Medical Oncology, Landspítali University Hospital of Iceland, Icelandic Breast Cancer Group, Reykjavik, Iceland.
S R LakhaniDepartment of Anatomical Pathology, The University of Queensland Centre for Clinical Research and Pathology Queensland, Brisbane, Australia.
W JanniDepartment for Obstetrics and Gynecology, Universitaetsklinikum, University of Ulm, Ulm, Germany.
B LinderholmDepartment of Oncology, Sahlgrenska University Hospital, Gothenburg; Department of Oncology, The Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.
T-W LiuDivision of Cancer Research, National Health Research Institutes, Taiwan Cooperative Oncology Group, Taipei City, Taiwan.
N LomanDepartment of Hematology, Oncology, and Radiation Physics, Swedish Association of Breast Oncologists, Skåne University Hospital, Lund, Sweden.
L KordeClinical Investigations Branch, Division of Cancer Treatment and Diagnosis, The National Cancer Institute, Rockville, USA.
S LoiblMedicine and Research, German Breast Group, Neu-Isenburg; Medicine and Research, The Center for Hematology and Oncology Bethanien and Goethe University, Frankfurt, Germany.
P C LucasNRG Oncology/NSABP Foundation, Pittsburgh; Department of Pathology, UPMC Hillman Cancer Center, Pittsburgh, USA.
F MarméMedical Faculty Mannheim, Heidelberg University, Mannheim Germany and the German Breast Group, Neu-Isenburg, Germany.
E Martinez de DueñasMédica Consorcio Hospitalario Provincial de Castellón, Servicio de Oncología, Castellón, Spain.
R McConnellDepartment of Data Management, Frontier Science (Scotland), Kincraig, Scotland, UK.
K-A PhillipsDepartment of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne; Breast Cancer Trials, Australia and New Zealand, Newcastle, Australia.
M PiccartDepartment of Scientific Direction, Institut Jules Bordet, l'Université Libre de Bruxelles, Brussels.
G RossiDepartment of Research and Development, Breast International Group, Brussels, Belgium.
R SchmutzlerThe Center for Familial Breast and Ovarian Cancer and the Center for Integrated Oncology, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.
E SenkusDepartment of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland.
Z ShaoFudan University Shanghai Cancer Center, Shanghai, China.
P SharmaDepartment of Internal Medicine, Division of Medical Oncology, University of Kansas Medical Center, Westwood, USA.
C F SingerDepartment of OB/GYN and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
T ŠpanićDepartment of Patient Advocacy, Europa Donna-The European Breast Cancer Coalition, Milan, Italy; Europa Donna Slovenia, Ljubljana, Slovenia.
E StickelerDepartment of Obstetrics and Gynecology, University Hospital Aachen, Aachen, Germany.
M ToiDepartment of Breast Surgery Kyoto University Hospital, Kyoto, Japan.
T A TrainaDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA.
G VialeDepartment of Pathology, University of Milan, European Institute of Oncology IRCCS, Milan.
G ZoppoliInternal Medicine Oncology Unit, Gruppo Oncologico Italiano di Ricerca Clinica, Parma; Università degli Studi di Genova and IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Y H ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
R YerushalmiDepartment of Oncology, Institute of Oncology, Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital, Petach Tikva; Faculty of Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
H YangDepartment of Breast Surgery, The Cancer Hospital of the University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Institute of Basic Medicine and Cancer (IBMC), Chinese Academy of Sciences, Hangzhou.
D PangDepartment of Breast Surgery, Harbin Medical University Cancer Hospital, Harbin, China.
K H JungDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
A MailliezDepartment of Medical Oncology, Breast Cancer Unit, Oscar Lambret Center, Lillie, France.
Z FanDepartment of Breast Surgery, First Hospital of Jilin University, Jilin, China.
I TennevetDepartment of Medical Oncology, Centre Henri Becquerel, Rouen, France.
J ZhangBreast Cancer Center, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.
T NagyChemotherapy Department B, Országos Onkológiai Intézet, National Institute of Oncology, Budapest, Hungary.
G S SonkeDepartment of Medical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Q SunDepartment of Breast Surgery, Peking Union Medical College Hospital, Peking, China.
M PartonBreast Unit, Royal Marsden Hospital, London, UK.
M A ColleoniDivision of Medical Senology, European Institute of Oncology (IEO), IRCCS, Milan.
M SchmidtDepartment of Obstetrics and Gynecology, University Medical Center Mainz, Mainz, Germany.
A M BrufskyNRG Oncology/NSABP Foundation, Pittsburgh; Department of Medicine, UPMC Hillman Cancer Center, Pittsburgh.
W RazaqDepartment of Internal Medicine, Section of Hematology/Oncology, Oklahoma University Health, Oklahoma City, USA.
B KaufmanThe Breast Oncology Institute, Chaim Sheba Medical Center, Tel Aviv University, Tel Aviv, Israel.
D CameronEdinburgh Cancer Research Centre, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh.
C CampbellDepartment of Statistics and Programming, Frontier Science (Scotland), Kincraig, Scotland.
A N J TuttThe Breast Cancer Now Toby Robins Research Centre, The Institute of Cancer Research, London; The Breast Cancer Now Unit, Guy's Hospital Cancer Centre, King's College London, London, UK. Electronic address: andrew.tutt@icr.ac.uk.
OlympiA Clinical Trial Steering Committee and Investigators
Harvard University · USUPMC Hillman Cancer Center · USTel Aviv University · ILThe Christie Hospital · GBAstraZeneca (Brazil) · BRCentre Oscar Lambret · FRCentre Virchow-Villermé · FRComprehensive Cancer Center Vienna · ATHarbin Medical University · CNInstitut Gustave Roussy · FRJilin University · CNNRG Oncology · USPeking Union Medical College Hospital · CNUlsan College · KRAstraZeneca (United States) · USBreast International Group · BEConsorcio Hospitalario Provincial de Castellón · ESEdinburgh Cancer Research · GBFrontier Agriculture (United Kingdom) · GBFudan University Shanghai Cancer Center · CN

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

backgroundThe randomized, double-blind OlympiA trial compared 1 year of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor, olaparib, to matching placebo as adjuvant therapy for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative, early breast cancer (EBC). The first pre-specified interim analysis (IA) previously demonstrated statistically significant improvement in invasive disease-free survival (IDFS) and distant disease-free survival (DDFS). The olaparib group had fewer deaths than the placebo group, but the difference did not reach statistical significance for overall survival (OS). We now report the pre-specified second IA of OS with updates of IDFS, DDFS, and safety. PATIENTS AND

methodsOne thousand eight hundred and thirty-six patients were randomly assigned to olaparib or placebo following (neo)adjuvant chemotherapy, surgery, and radiation therapy if indicated. Endocrine therapy was given concurrently with study medication for hormone receptor-positive cancers. Statistical significance for OS at this IA required P < 0.015.

resultsWith a median follow-up of 3.5 years, the second IA of OS demonstrated significant improvement in the olaparib group relative to the placebo group [hazard ratio 0.68; 98.5% confidence interval (CI) 0.47-0.97; P = 0.009]. Four-year OS was 89.8% in the olaparib group and 86.4% in the placebo group (Δ 3.4%, 95% CI -0.1% to 6.8%). Four-year IDFS for the olaparib group versus placebo group was 82.7% versus 75.4% (Δ 7.3%, 95% CI 3.0% to 11.5%) and 4-year DDFS was 86.5% versus 79.1% (Δ 7.4%, 95% CI 3.6% to 11.3%), respectively. Subset analyses for OS, IDFS, and DDFS demonstrated benefit across major subgroups. No new safety signals were identified including no new cases of acute myeloid leukemia or myelodysplastic syndrome.

conclusionWith 3.5 years of median follow-up, OlympiA demonstrates statistically significant improvement in OS with adjuvant olaparib compared with placebo for gBRCA1/2pv-associated EBC and maintained improvements in the previously reported, statistically significant endpoints of IDFS and DDFS with no new safety signals.

Indexed as

Breast NeoplasmsBRCA1 ProteinFemaleGerm CellsGold AlloysHumansPhthalazinesPiperazinesBRCA1 ProteinBRCA1 protein, humanGold AlloysolaparibolympiaPhthalazinesPiperazinesadjuvant therapyBRCA1/2breast cancerolaparibPARP inhibition

Identifiers

PMID36228963
PMCPMC10207856
OpenAlexW4304084160

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Registered trials

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.