Evidence map›Paper›PMID 38301187›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024

Patient-Reported Outcomes in OlympiA: A Phase III, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib in g

Patricia A Ganz, Hanna Bandos, Tanja Španić, Sue Friedman, Volkmar Müller, Sherko Kuemmel, Suzette Delaloge, Etienne Brain, Masakazu Toi, Hideko Yamauchi and 36 more

Open access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Guideline
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

46 authors at 20 institutions in 13 countries.

Patricia A GanzUniversity of California, Los Angeles, Los Angeles, CA.ORCID 0000-0002-1841-4143
Hanna BandosNRG Oncology SDMC, The University of Pittsburgh, Pittsburgh, PA.
Tanja ŠpanićEuropa Donna-The European Breast Cancer Coalition, Milan, Italy.
Sue FriedmanFacing Our Risk of Cancer Empowered, Tampa, FL.
Volkmar MüllerDepatment of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID 0000-0003-4231-7906
Sherko KuemmelBreast Unit, Kliniken Essen-Mitte, Essen, Germany.ORCID 0000-0001-9355-494X
Suzette DelalogeGustave Roussy, Villejuif, France.ORCID 0000-0003-2106-9165
Etienne BrainDepartment of Medical Oncology, Institut Curie, Saint-Cloud, France.ORCID 0000-0003-0881-9371
Masakazu ToiKyoto University Hospital, Kyoto, Japan.ORCID 0000-0003-1488-9958
Hideko YamauchiSt Luke's International Hospital, Tokyo, Japan.
Eduardo-M de DueñasConsorcio Hospitalario Provincial de Castellón, Castellón, Spain.ORCID 0000-0003-0110-4816
Anne ArmstrongDepartment of Medical Oncology, Division of Cancer Sciences, The University of Manchester, The Christie Hospital, Manchester, United Kingdom.
Seock-Ah ImCancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea.ORCID 0000-0002-5396-6533
Chuan-Gui SongDepartment of Breast Surgery, Fujian Medical University Union Hospital, Fuzhou, China.
Hong ZhengWest China Hospital, Sichuan University, Chengdu, China.
Tomasz SarosiekLuxmed Onkologia, Warsaw, Poland.
Priyanka SharmaUniversity of Kansas Medical Center, Westwood, KS.ORCID 0000-0001-8592-2239
Cuizhi GengThe Fourth Hospital of Hebei Medical University, Shiijazhuang, China.
Peifen FuBreast Surgery Department, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.ORCID 0000-0002-2988-0502
Kerstin RhiemCenter for Hereditary Breast and Ovarian Cancer, Center for Integrated Oncology (CIO), Cologne, Germany.
Heike Frauchiger-HeuerBreast Center Unit, UniversitätsSpital Zürich, Zürich, Switzerland.ORCID 0000-0002-2311-5412
Pauline WimbergerDepartment of Gynecology and Obstetrics, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.ORCID 0000-0002-7380-577X
Daphné t'Kint de RoodenbekeInstitut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
Ning LiaoGuangdong People's Hospital, Guangzhou, China.
Annabel GoodwinConcord Repatriation General Hospital, University of Sydney, Sydney, NSW, Australia.
Camille Chakiba-BrugèreDépartement d'oncologie médicale, Institut Bergonié, Bordeaux, France.
Michael FriedlanderPrince of Wales Clinical School, University of NSW and Nelune Comprehensive Cancer Centre, Prince of Wales Hospital, Sydney, NSW, Australia.ORCID 0000-0003-3090-795X
Keun Seok LeeCenter for Breast Cancer, National Cancer Center, Goyang, Republic of Korea.
Sylvie GiacchettiBreast Disease Unit (Sénopole), AP-HP, Hôpital Saint-Louis, Paris, France.ORCID 0000-0001-8079-2930
Toshimi TakanoBreast Medical Oncology Department, The Cancer Institute Hospital of JFCR, Tokyo, Japan.ORCID 0000-0002-8417-5291
Fernando Henao-CarrascoHospital Universitario Virgen Macarena GEICAM Spanish Breast Cancer Group, Sevilla, Spain.ORCID 0000-0003-3819-9572
Shamsuddin ViraniAdvocate Aurora Health, Milwaukee, WI.
Frances Valdes-AlbiniUniversity of Miami Sylvester Comprehensive Cancer Center, Miami, FL.
Susan M DomchekBasser Center for BRCA, University of Pennsylvania, Philadelphia, PA.ORCID 0000-0002-5914-7272
Charles BaneDayton Physicians Network, Dayton, OH.
Edward C McCarronMedStar Franklin Square Medical Center-Harry and Jeanette Weinberg Cancer Institute, Baltimore, MD.ORCID 0009-0007-3640-3214
Monica MitaCedars Sinai Medical Center, SOCCI, Los Angeles, CA.
Giovanna RossiBreast International Group (BIG), Brussels, Belgium.ORCID 0000-0002-4995-5161
Priya RastogiUPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA.ORCID 0000-0002-6179-6407
Anitra FieldingOncology R&D, AstraZeneca, Gaithersburg, MD.
Richard D GelberDana-Farber Cancer Institute, Harvard Medical School, Harvard TH Chan School of Public Health, Boston, MA.ORCID 0000-0001-8270-8712
Elsemieke D ScheepersFrontier Science (Scotland), Kincraig, United Kingdom.
David CameronUniversity of Edinburgh, Edinburgh, United Kingdom.ORCID 0000-0002-2717-7979
Judy GarberDana-Farber/Harvard Cancer Center, Boston, MA.ORCID 0000-0001-9449-3982
Charles E GeyerUPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA.ORCID 0000-0002-2379-5702
Andrew N J TuttThe Institute of Cancer Research London, London, United Kingdom.ORCID 0000-0001-8715-2901
Alma Mater Europaea · SIAssistance Publique – Hôpitaux de Paris · FRAstraZeneca (United States) · USAurora Health Care · USBreast Center · CHBreast International Group · BECedars-Sinai Medical Center · USConsorcio Hospitalario Provincial de Castellón · ESDana-Farber/Harvard Cancer Center · USDayton Physicians Network · USFacing Our Risk of Cancer Empowered · USFirst Affiliated Hospital Zhejiang University · CNFrontier Agriculture (United Kingdom) · GBFujian Medical University · CNGerman Cancer Research Center · DEGuangdong Provincial People's Hospital · CNHarvard University · USHebei Medical University · CNHospital Universitario Virgen Macarena · ESInstitut Bergonié · FR

Funding

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 · 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 U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

purposeThe OlympiA randomized phase III trial compared 1 year of olaparib (OL) or placebo (PL) as adjuvant therapy in patients with germline

methodsData were collected before random assignment, and at 6, 12, 18, and 24 months. The primary end point was fatigue, measured with the Functional Assessment of Chronic Illness Therapy-Fatigue scale. Secondary end points, assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 item, included nausea and vomiting (NV), diarrhea, and multiple functional domains. Scores were compared between treatment groups using mixed model for repeated measures. Two-sided

resultsOne thousand five hundred and thirty-eight patients (NACT: 746, ACT: 792) contributed to the analysis. Fatigue severity was statistically significantly greater for OL versus PL, but not clinically meaningfully different by prespecified criteria (≥3 points) at 6 months (diff OL

conclusionTreatment-emergent symptoms from OL were limited, generally resolving after treatment ended. OL- and PL-treated patients had similar functional scores, slowly improving during the 24 months after (N)ACT and there was no clinically meaningful persistence of fatigue severity in OL-treated patients.

Indexed as

Breast NeoplasmsErb-b2 Receptor Tyrosine KinasesPhthalazinesPiperazinesQuality of LifeBRCA1 ProteinBRCA2 ProteinFatigueFemaleHumansMutationNauseaPatient Reported Outcome MeasuresVomitingBRCA1 ProteinBRCA1 protein, humanBRCA2 ProteinBRCA2 protein, humanERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesolaparibPhthalazinesPiperazines

Identifiers

PMID38301187
PMCPMC11095886
OpenAlexW4391451754

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.