Evidence map›Paper›PMID 40580808›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2025

Rucaparib for maintenance treatment of platinum-sensitive, recurrent ovarian carcinoma: Final results of the phase 3, randomized, placebo-controlled ARIEL3 trial.

Jonathan A Ledermann, Amit M Oza, Domenica Lorusso, Carol Aghajanian, Ana Oaknin, Andrew Dean, Nicoletta Colombo, Johanne I Weberpals, Andrew R Clamp, Giovanni Scambia and 18 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–field-weighted citation impact
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

14 citing papers in PubMed.

  1. Trial
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  9. Observational
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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

28 authors.

Jonathan A LedermannUCL Cancer Institute, University College London and UCL Hospitals, London, UK. Electronic address: j.ledermann@ucl.ac.uk.
Amit M OzaPrincess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.
Domenica LorussoMITO and Gynecologic Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Carol AghajanianMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Ana OakninMedical Oncology Service, Vall d'Hebron Institute of Oncology, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Andrew DeanSt John of God Subiaco Hospital, Subiaco, Western Australia, Australia.
Nicoletta ColomboGynecologic Cancer Program, University of Milan-Bicocca and European Institute of Oncology IRCCS, Milan, Italy.
Johanne I WeberpalsOttawa Hospital Research Institute, Ottawa, Ontario, Canada.
Andrew R ClampThe Christie NHS Foundation Trust and University of Manchester, Manchester, UK.
Giovanni ScambiaFondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica del Sacro Cuore and Scientific Directorate, Rome, Italy.
Alexandra LearyGustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Villejuif, France.
Robert W HollowayAdventHealth Cancer Institute, Orlando, FL, USA.
Margarita Amenedo GancedoOncology Center of Galicia, La Coruña, Spain.
Peter C FongAuckland City Hospital and the University of Auckland, Grafton, Auckland, New Zealand.
Jeffrey C GohCancer Care Services, Royal Brisbane and Women's Hospital, Herston, Queensland, Australia; Queensland University of Technology, Brisbane, Queensland, Australia.
David M O'MalleyThe Ohio State University, James Cancer Center Hospital, Columbus, OH, USA.
Deborah K ArmstrongSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
Susana BanerjeeThe Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, UK.
Jesús García-DonasCentro Integral Oncológico Clara Campal, Madrid, Spain.
Elizabeth M SwisherUniversity of Washington, Seattle, WA, USA.
Coriolan LebretonInstitut Bergonié, Comprehensive Cancer Centre, Bordeaux, France; Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Paris, France.
Gottfried E KonecnyUniversity of California, Los Angeles, Los Angeles, CA, USA.
Iain A McNeishImperial College London, London, UK.
Clare L ScottRoyal Melbourne Hospital, Parkville, and Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
Lara MaloneyClovis Oncology, Inc., Boulder, CO, USA.
Sandra GobleClovis Oncology, Inc., Boulder, CO, USA.
Kevin K LinClovis Oncology, Inc., Boulder, CO, USA.
Robert L ColemanThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundIn ARIEL3, rucaparib maintenance significantly improved progression-free survival (PFS; primary endpoint) and long-term follow-up (LTFU) outcomes (including PFS2: time to disease progression on subsequent therapy or death) versus placebo in patients with recurrent, platinum-sensitive ovarian cancer. Here we report the final analysis of overall survival (OS; key secondary endpoint), LTFU outcomes, and safety.

methodsOS and updated LTFU efficacy outcomes were analyzed (data cutoff date: April 4, 2022) across three nested populations (BRCA-mutated, homologous recombination deficient [HRD], and intention to treat [ITT]).

resultsPatients were randomized 2:1 to rucaparib (600 mg BID; n = 375) or placebo (n = 189). Median follow-up was 77.0 months. 168 patients in the placebo arm received subsequent treatment; of these, 77 (46 %) received a poly(ADP-ribose) polymerase inhibitor-containing treatment. Median OS from randomization post chemotherapy for rucaparib vs placebo was 45.9 vs 47.8 months (HR 0.83, 95 % CI 0.58-1.19) for the BRCA-mutated population; no OS benefit was found with rucaparib in the HRD and ITT populations. Median PFS2 for rucaparib vs placebo was 26.1 vs 18.4 months (HR 0.67, 95 % CI 0.48-0.94) for the BRCA-mutated population. Rucaparib numerically improved PFS2 and other LTFU outcomes versus placebo in the HRD and ITT populations. Safety was consistent with prior reports; myelodysplastic syndrome and/or acute myeloid leukemia occurred in 4 % and 3 % of patients in the rucaparib and placebo arms, respectively.

conclusionsOS was similar between treatment arms. PFS benefit with rucaparib was maintained through the subsequent therapy line. These data support rucaparib as maintenance treatment for recurrent ovarian carcinoma.

Indexed as

Carcinoma, Ovarian EpithelialIndolesNeoplasm Recurrence, LocalOvarian NeoplasmsPoly(ADP-ribose) Polymerase InhibitorsAdultAgedAged, 80 and overDouble-Blind MethodFemaleHumansMaintenance ChemotherapyMiddle AgedProgression-Free SurvivalIndolesPoly(ADP-ribose) Polymerase InhibitorsrucaparibBRCAHomologous recombination deficientLong-term follow-upOverall survivalPFS2Poly(ADP-ribose) polymerase inhibitorProgression-free intervalRecurrent ovarian cancer

Identifiers

PMID40580808
PMCPMC12687737

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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.