{
  "abstract": "BACKGROUND: The randomised phase III OlympiA trial (NCT02032823) compared 1 year of adjuvant olaparib [oral poly (ADP-ribose) polymerase inhibitor] with placebo in 1836 patients with pathogenic/likely pathogenic BRCA1 or BRCA2 [germline BRCA pathogenic variants (gBRCApvs)] germline variants and high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (BC). Previous interim analyses (IAs) demonstrated statistically significant improvements in invasive disease-free survival (IDFS), distant disease-free survival (DDFS) and overall survival (OS), irrespective of hormone receptor status, prior platinum administration, timing of prior chemotherapy or type of gBRCApv. Herein are the results of the third prespecified IA with a median follow-up (MFU) of 6.1 years. PATIENTS AND METHODS: Descriptive analyses are presented for the primary endpoint IDFS and key secondary endpoints of DDFS and OS. Estimates of the hazard ratio (HR) based on the stratified Cox's proportional hazards model and 95% confidence intervals (CIs) are presented with yearly event rates at an MFU of ≤6.1 years. Safety analyses included adverse events of special interest (AESIs). RESULTS: Olaparib benefits were maintained in IDFS (HR 0.65, 95% CI 0.53-0.78), DDFS (HR 0.65, 95% CI 0.53-0.81) and OS (HR 0.72, 95% CI 0.56-0.93). The 6-year OS for olaparib versus placebo was 87.5% versus 83.2% (difference 4.4%, 95% CI 0.9% to 6.7%). Olaparib benefit was consistent across all key subgroups, including patients with high-risk hormone receptor-positive disease. There were fewer BRCA-associated new BC and ovarian/fallopian tube cancer cases and there was no increase in AESI risks (6.3% versus 9.3%), including myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) (0.4% versus 0.7%), with olaparib versus placebo. CONCLUSIONS: At an MFU of 6.1 years, 1 year of adjuvant olaparib after (neo)adjuvant chemotherapy demonstrated ongoing clinically meaningful improvements in IDFS, DDFS and OS in patients with gBRCApvs and high-risk, HER2-negative early BC, with acceptable toxicity and without increased risk of MDS/AML. These data continue to provide support for adjuvant olaparib in the treatment of gBRCApv-associated high-risk, HER2-negative early BC.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA",
    "Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK",
    "Department of Biostatistics, Frontier Science (Scotland), Kincraig, Scotland, UK",
    "NRG Oncology/NSABP Foundation, Pittsburgh, USA",
    "Department of Biostatistics, University of Pittsburgh, Pittsburgh, USA",
    "Oncology Biometrics Department, AstraZeneca, Macclesfield, UK",
    "R&D Department, Breast International Group (BIG), Brussels, Belgium",
    "Department of Medicine, UPMC Hillman Cancer Center, Pittsburgh, USA",
    "Department of Data Management, Frontier Science (Scotland), Kincraig, Scotland, UK",
    "Late Development, Oncology Research and Development, AstraZeneca, Cambridge, UK",
    "Department of Cancer Medicine, Institute Gustave Roussy and Unicancer Breast Group, Paris, France",
    "Taiwan Cooperative Oncology Group, Division of Cancer Research, National Institute of Cancer Research, National Health Research Institutes, Taipei City, Taiwan",
    "Department of Internal Medicine, Division of Medical Oncology, University of Kansas Medical Center, Westwood, USA",
    "Department of Oncology-Pathology, Swedish Breast Cancer Group, Cancer Research KI, Karolinska Institute Breast Center, Cancer Theme Karolinska University Hospital, Karolinska Comprehensive Cancer Center, Stockholm, Sweden",
    "Department for Obstetrics and Gynecology, Universitaetsklinikum, University of Ulm, Ulm, Germany",
    "Medical Oncology Department, Vall d’Hebron Institute of Oncology and Vall d’Hebron University Hospital, Barcelona, Spain",
    "Department of Hematology, Oncology, and Radiation Physics, Swedish Association of Breast Oncologists, Skåne University Hospital, Lund, Sweden",
    "Department of Patient Advocacy, Europa Donna - The European Breast Cancer Coalition, Milan, Italy",
    "Europa Donna Slovenia, Ljubljana, Slovenia",
    "Facing Our Risk of Cancer Empowered, Tampa, USA",
    "Department of Pathology, University of Pittsburgh, Pittsburgh, USA",
    "Department of Medical Oncology, The Christie Hospital NHS Foundation Trust, Manchester, UK",
    "Clinical Investigations Branch, Division of Cancer Treatment and Diagnosis, The National Cancer Institute, Rockville, USA",
    "Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine Cancer Research Institute, Seoul National University, Seoul, Republic of Korea",
    "Department of Breast and Thyroid Surgical Oncology, Hakuaikai Sagara Hospital, Kagoshima, Japan",
    "Department of Pathology and Laboratory Medicine, IEO European Institute of Oncology IRCCS, Milan, Italy",
    "Departement of Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK",
    "Department of Oncology, International Breast Cancer Study Group, Bern, Switzerland",
    "Department of Medical Oncology, Ospedale Infermi AUSL della Romagna, Rimini, Italy",
    "Department of Medical Oncology, Landspítali University Hospital of Iceland, Icelandic Breast Cancer Group, Reykjavik, Iceland",
    "Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC), Parma, Italy",
    "Department of Internal Medicine and Medical Specialties (DiMI), Università degli Studi di Genova and IRCCS Ospedale Policlinico San Martino, Genoa, Italy",
    "Consorcio Hospitalario Provincial de Castellón, Servicio de Oncología Médica, Castellón, Spain",
    "GEICAM Spanish Breast Cancer Group, Madrid, Spain",
    "Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany",
    "German Breast Group, Neu-Isenburg, Germany",
    "Department of Clinical Research, Instituto de Oncologia De Rosario, Santa Fe, Argentina",
    "European Organisation for Research and Treatment (EORTC), Brussels, Belgium",
    "Department of Medical Oncology, Institut Bergonie, Bordeaux, France",
    "Department of Medicine/Oncology, Stanford University School of Medicine, Stanford, USA"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 67,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "J. E. Garber"
    },
    {
      "affs": [
        1
      ],
      "name": "D. Cameron"
    },
    {
      "affs": [
        2
      ],
      "name": "C. Campbell"
    },
    {
      "affs": [
        3,
        4
      ],
      "name": "G. Yothers"
    },
    {
      "affs": [
        5
      ],
      "name": "M. Taboada"
    },
    {
      "affs": [
        6
      ],
      "name": "S. El-abed"
    },
    {
      "affs": [
        3,
        7
      ],
      "name": "P. Rastogi"
    },
    {
      "affs": [
        8
      ],
      "name": "R. McConnell"
    },
    {
      "affs": [
        9
      ],
      "name": "A. Correa"
    },
    {
      "affs": [
        10
      ],
      "name": "S. Delaloge"
    },
    {
      "affs": [
        11
      ],
      "name": "W. T. Liu"
    },
    {
      "affs": [
        12
      ],
      "name": "P. Sharma"
    },
    {
      "affs": [
        13
      ],
      "name": "J. Bergh"
    },
    {
      "affs": [
        14
      ],
      "name": "W. Janni"
    },
    {
      "affs": [
        15
      ],
      "name": "J. Balmaña"
    },
    {
      "affs": [
        16
      ],
      "name": "N. Loman"
    },
    {
      "affs": [
        17,
        18
      ],
      "name": "T. Španić"
    },
    {
      "affs": [
        19
      ],
      "name": "S. Friedman"
    },
    {
      "affs": [
        3,
        20
      ],
      "name": "T. Freeman"
    },
    {
      "affs": [
        21
      ],
      "name": "A. Armstrong"
    },
    {
      "affs": [
        22
      ],
      "name": "L. Korde"
    },
    {
      "affs": [
        23
      ],
      "name": "S. Im"
    },
    {
      "affs": [
        24
      ],
      "name": "Y. Sagara"
    },
    {
      "affs": [
        25
      ],
      "name": "G. Viale"
    },
    {
      "affs": [
        26
      ],
      "name": "J. Bliss"
    },
    {
      "affs": [
        27,
        28
      ],
      "name": "L. Gianni"
    },
    {
      "affs": [
        29
      ],
      "name": "Ó. Jóhannsson"
    },
    {
      "affs": [
        30,
        31
      ],
      "name": "G. Zoppoli"
    },
    {
      "affs": [
        32,
        33
      ],
      "name": "E. Martinez De Dueñas"
    },
    {
      "affs": [
        34,
        35
      ],
      "name": "F. Marmé"
    },
    {
      "affs": [
        36
      ],
      "name": "L. Fein"
    },
    {
      "affs": [
        37,
        38
      ],
      "name": "M. Arnedos"
    },
    {
      "affs": [
        39
      ],
      "name": "J. Ford"
    },
    {
      "name": "R. Schmutzler"
    },
    {
      "name": "S. Loibl"
    },
    {
      "name": "B. Linderholm"
    },
    {
      "name": "S. R. Lakhani"
    },
    {
      "name": "M. Gnant"
    },
    {
      "name": "K. Gelmon"
    },
    {
      "name": "S. M. Domchek"
    },
    {
      "name": "E. Senkus"
    },
    {
      "name": "A. Eisen"
    },
    {
      "name": "A. Jager"
    },
    {
      "name": "M. Piccart"
    },
    {
      "name": "KA. Phillips"
    },
    {
      "name": "T. Traina"
    },
    {
      "name": "E. Stickeler"
    },
    {
      "name": "C.F. Singer"
    },
    {
      "name": "Z. Shao"
    },
    {
      "name": "X. Liu"
    },
    {
      "affs": [
        9
      ],
      "name": "H. Tipping"
    },
    {
      "name": "G. Aktan"
    },
    {
      "name": "M. Martinez"
    },
    {
      "name": "J. L. Canon"
    },
    {
      "name": "M. Takahashi"
    },
    {
      "name": "H. Yasojima"
    },
    {
      "name": "K. Middleton"
    },
    {
      "name": "G. Pristauz-Telsnigg"
    },
    {
      "name": "G. Pfeiler"
    },
    {
      "name": "S. Virani"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/a6y35bvrd8ha9.bib",
  "cited_by": 1,
  "doi": "10.1016/j.annonc.2026.08.002",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13729705/",
  "id": "a6y35bvrd8ha9",
  "issns": [
    "0923-7534",
    "1569-8041"
  ],
  "landing_url": "https://doi.org/10.1016/j.annonc.2026.08.002",
  "language": "en",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Article"
    ],
    [
      "openalex",
      "2730|PARP inhibition in cancer therapy"
    ]
  ],
  "openalex": "W7204088122",
  "pdf_url": null,
  "pmcid": "PMC13729705",
  "pmid": "42636977",
  "published": "2026-08-24",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/a6y35bvrd8ha9.ris",
  "sources": [
    {
      "first_seen": "2026-11-07T12:22:27Z",
      "native_id": "PMC13729705",
      "source": "pmc",
      "url": "https://doi.org/10.1016/j.annonc.2026.08.002"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2730|PARP inhibition in cancer therapy",
      "subfield": "oncology"
    }
  ],
  "title": "Sustained benefit of adjuvant olaparib in women with germline BRCA1- and BRCA2- -associated high-risk HER2-negative early breast cancer: Updated results from the OlympiA phase III trial",
  "title_text": "Sustained benefit of adjuvant olaparib in women with germline BRCA1- and BRCA2- -associated high-risk HER2-negative early breast cancer: Updated results from the OlympiA phase III trial",
  "type": "peer-reviewed",
  "updated_at": "2026-11-07T12:22:27Z",
  "url": "https://research.draconitic.com/paper/a6y35bvrd8ha9",
  "venue": "Annals of oncology : official journal of the European Society for Medical Oncology",
  "versions": []
}