Evidence map›Paper›PMID 35658487›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

A Randomized, Phase III Trial to Evaluate Rucaparib Monotherapy as Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (ATHENA-MONO/GOG-3020/ENGOT-ov45).

Bradley J Monk, Christine Parkinson, Myong Cheol Lim, David M O'Malley, Ana Oaknin, Michelle K Wilson, Robert L Coleman, Domenica Lorusso, Paul Bessette, Sharad Ghamande and 29 more

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

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical 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 NCT03522246 (ATHENA), which is not on this map. Cited by 234 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
234citing papers in PubMed, 11 pooled it
34.5field-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.

NCT03522246 phase3active not recruitingnot on this map

ATHENA (A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)

TypeinterventionalSponsorpharmaand GmbHRan2018 to 2030Enrolled1,097ConditionsEpithelial Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancer, Newly DiagnosedArmsRucaparib, Nivolumab, Placebo Oral Tablet, Placebo IV Infusion
3 · Its place in the literature

Who cites it

234 citing papers in PubMed, 11 syntheses or guidelines pooled it, 355 citations in OpenAlex.

  1. Morphological and molecular characterization of epithelial ovarian cancer: SEOM-SEAP consensus guidelines for biomarker integration in clinical practice.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Guideline
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  3. Guideline
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  5. Causal inference in the diagnosis and prognosis of ovarian cancer: current state and future directions.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. SEOM-GEICO clinical guideline on epithelial ovarian cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  10. Pooled it
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  19. Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2024
    Trial
  20. Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

39 authors at 20 institutions in 19 countries.

Bradley J MonkGOG Foundation, HonorHealth Research Institute, University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ.ORCID 0000-0001-6985-0159
Christine ParkinsonMedical Oncology, Addenbrooke's Hospital, Cambridge, United Kingdom.
Myong Cheol LimGynecologic Oncology, National Cancer Center Korea, Goyang-si, Gyeonggi-do, South Korea.ORCID 0000-0001-8964-7158
David M O'MalleyDivision of Gynecologic Oncology, The Ohio State University, James Cancer Center, Columbus, OH.ORCID 0000-0002-2828-0177
Ana OakninGynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.ORCID 0000-0002-3592-7194
Michelle K WilsonDepartment of Cancer and Blood, Auckland City Hospital, Auckland, New Zealand.
Robert L ColemanUS Oncology Research, The Woodlands, TX.ORCID 0000-0001-9343-8754
Domenica LorussoMITO and Gynecologic Oncology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of Sacred Heart, Rome, Italy.ORCID 0000-0003-0981-0598
Paul BessetteDepartment of Obstetrics and Gynecology, University of Sherbrooke, Sherbrooke, Quebec, Canada.
Sharad GhamandeDepartment of Obstetrics and Gynecology, Augusta University, Augusta, GA.
Athina ChristopoulouMedical Oncology, St Andrews General Hospital, Patras, Greece.
Diane ProvencherPrincess Margaret Consortium and Department of Obstetrics-Gynaecology, Centre Hospitalier de l'Université de Montréal (CHUM), Institut du Cancer de Montréal, Montréal, Canada.ORCID 0000-0003-1902-3256
Emily PrendergastGynecologic Oncology, Minnesota Oncology and Metro-Minnesota Community Oncology Research Consortium, Minneapolis, MN.ORCID 0000-0001-7797-5146
Fuat DemirkiranGynecologic Oncology Department, Medical Faculty, Istanbul University, Cerrahpaşa, Istanbul, Turkey.ORCID 0000-0002-0439-2502
Olga MikheevaLimited Liability Company MedPomosch, Saint Petersburg, Russia.
Oladapo YekuGynecologic Cancers Program, Massachusetts General Hospital, Harvard Medical School, Boston, MA.ORCID 0000-0002-6319-1647
Anita Chudecka-GlazDepartment of Gynecological Surgery and Gynecological Oncology of Adults and Adolescents, Pomeranian Medical University, Szczecin, Poland.
Michael SchenkerDepartment of Medical Oncology, Sfantul Nectarie Oncology Center, Dolj, Romania.ORCID 0000-0003-2645-6391
Ramey D LittellKaiser Permanente Northern California Gynecologic Cancer Program, San Francisco, CA.ORCID 0000-0001-6096-6075
Tamar SafraOncology Department, Tel Aviv Medical Center, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.ORCID 0000-0001-6910-6426
Hung-Hsueh ChouDepartment of Obstetrics and Gynecology, Chang Gung Memorial Hospital (Linkou), Tao-Yuan, Taiwan.
Mark A MorganDivision of Gynecologic Oncology, University of Pennsylvania Health System, Philadelphia, PA.ORCID 0000-0001-5245-1709
Vít DrochýtekDepartment of Obstetrics and Gynaecology, Faculty Hospital Kralovske Vinohrady, 3rd Medical Faculty, Charles University, Prague, Czech Republic.ORCID 0000-0002-3391-1412
Joyce N BarlinWomen's Cancer Care Associates, Division of Gynecologic Oncology, Albany Medical College, Albany, NY.
Toon Van GorpDivision of Gynaecological Oncology, Department of Obstetrics and Gynecology, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0002-2564-721X
Fred UelandDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, College of Medicine, University of Kentucky, Lexington, KY.ORCID 0000-0003-1213-7509
Gabriel LindahlNordic Society of Gynaecological Oncology, Copenhagen, Denmark.
Charles AndersonDepartment of Gynecologic Oncology, Willamette Valley Cancer Institute and Research Center, Eugene, OR.
Dearbhaile C CollinsCancer Trials Ireland and Department of Medical Oncology, Cork University Hospital, Cork, Ireland.
Kathleen MooreStevenson Cancer Center at the University of Oklahoma Health Sciences Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK.ORCID 0000-0002-5803-0718
Frederik MarmeAGO and Department Obstetrics and Gynecology, University Hospital Mannheim, Mannheim, Germany.ORCID 0000-0002-6591-3367
Shannon N WestinDepartment of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-1922-0156
Iain A McNeishDepartment of Surgery and Cancer, Imperial College London, London, United Kingdom.ORCID 0000-0002-9387-7586
Danny ShihClinical Operations, Clovis Oncology Inc, Boulder, CO.
Kevin K LinMolecular Diagnostics, Clovis Oncology Inc, Boulder, CO.ORCID 0000-0003-4305-8352
Sandra GobleBiostatistics, Clovis Oncology Inc, Boulder, CO.
Stephanie HumeClinical Development, Clovis Oncology Inc, Boulder, CO.ORCID 0000-0002-8448-8917
Keiichi FujiwaraDepartment of Gynecologic Oncology, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan.ORCID 0000-0002-7388-0243
Rebecca S KristeleitDepartment of Oncology, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.ORCID 0000-0003-3825-1326
Clovis Oncology (United States) · USAddenbrooke's Hospital · GBAgostino Gemelli University Polyclinic · ITAuckland City Hospital · NZAugusta University · USCancerCare · USCentre Hospitalier de l’Université de Montréal · CACharles University · CZCork University Hospital · IECreighton University · USGeneral University Hospital of Patras · GRGuy's and St Thomas' NHS Foundation Trust · GBHarvard University · USHeidelberg University · DEImperial College London · GBIstanbul University-Cerrahpaşa · TRKaiser Permanente · USKU Leuven · BELinköping University · SEMetro-Minnesota Community Oncology Research Consortium · US

Funding

University of Kentucky Markey Cancer Center Support Grant ECIA SupplementP30CA177558 · NCI · UNIVERSITY OF KENTUCKY · PI Bernard Mark Evers · 2013 to 2026
$38.3M
Department of Health BRC-1215-20,014NCI NIH HHS P30 CA177558
6 · The paper itself

Abstract

purposeATHENA (ClinicalTrials.gov identifier: NCT03522246) was designed to evaluate rucaparib first-line maintenance treatment in a broad patient population, including those without

methodsPatients with stage III-IV high-grade ovarian cancer undergoing surgical cytoreduction (R0/complete resection permitted) and responding to first-line platinum-doublet chemotherapy were randomly assigned 4:1 to oral rucaparib 600 mg twice a day or placebo. Stratification factors were HRD test status, residual disease after chemotherapy, and timing of surgery. The primary end point of investigator-assessed progression-free survival was assessed in a step-down procedure, first in the HRD population (BRCA-mutant or BRCA wild-type/loss of heterozygosity high tumor), and then in the intent-to-treat population.

resultsAs of March 23, 2022 (data cutoff), 427 and 111 patients were randomly assigned to rucaparib or placebo, respectively (HRD population: 185

conclusionRucaparib monotherapy is effective as first-line maintenance, conferring significant benefit versus placebo in patients with advanced ovarian cancer with and without HRD.

Indexed as

Ovarian NeoplasmsPoly(ADP-ribose) Polymerase InhibitorsCarcinoma, Ovarian EpithelialFemaleHumansIndolesMaintenance ChemotherapyIndolesPoly(ADP-ribose) Polymerase Inhibitorsrucaparib

Identifiers

PMID35658487
PMCPMC9746782
OpenAlexW4281666355

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.