Evidence map›Paper›PMID 34549539›Full record

Trial reportCancer medicine2021

Maintenance treatment with rucaparib for recurrent ovarian carcinoma in ARIEL3, a randomized phase 3 trial: The effects of best response to last platinum-based regimen and disease at baseline on efficacy and safety.

Ana Oaknin, Amit M Oza, Domenica Lorusso, Carol Aghajanian, Andrew Dean, Nicoletta Colombo, Johanne I Weberpals, Andrew R Clamp, Giovanni Scambia, Alexandra Leary and 14 more

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 37% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
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

24 authors at 20 institutions in 8 countries.

Ana OakninGynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Amit M OzaDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, Canada.
Domenica LorussoMulticentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies and Gynecologic Oncology Unit, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy.
Carol AghajanianDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Andrew DeanOncology, St 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 WeberpalsDivision of Gynecologic Oncology, Ottawa Hospital Research Institute, Ottawa, Canada.ORCID 0000-0002-0355-547X
Andrew R ClampDepartment of Medical Oncology, The Christie NHS Foundation Trust and University of Manchester, Manchester, United Kingdom.
Giovanni ScambiaGynecologic Oncology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS and Scientific Directorate, Rome, Italy.ORCID 0000-0002-9503-9041
Alexandra LearyGynecological Unit, Gustave Roussy Cancer Center, INSERM U981, and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens, Villejuif, France.
Robert W HollowayGynecologic Oncology, AdventHealth Cancer Institute, Orlando, Florida, USA.
Margarita Amenedo GancedoMedical Oncology Department, Oncology Center of Galicia, Doctor Camilo Veiras, La Coruña, Spain.
Peter C FongMedical Oncology Department, Auckland City Hospital, and University of Auckland, Auckland, New Zealand.
Jeffrey C GohDepartment of Oncology, Cancer Care Services, Royal Brisbane and Women's Hospital, and University of Queensland, Herston, Queensland, Australia.
David M O'MalleyDivision of Gynecologic Oncology, The Ohio State University, James Cancer Center, Columbus, Ohio, USA.
Deborah K ArmstrongOncology, Gynecology and Obstetrics, Johns Hopkins Kimmel Cancer Center, Baltimore, Maryland, USA.
Susana BanerjeeGynaecology Unit, The Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, United Kingdom.
Jesus García-DonasDivision of Medical Oncology, HM Hospitales-Centro Integral Oncológico Hospital de Madrid Clara Campal, Madrid, Spain.
Elizabeth M SwisherDivision of Gynecologic Oncology, University of Washington, Seattle, Washington, USA.
Terri CameronClinical Science, Clovis Oncology UK Ltd, Cambridge, United Kingdom.
Lara MaloneyClinical Development, Clovis Oncology, Inc, Boulder, Colorado, USA.
Sandra GobleBiostatistics, Clovis Oncology, Inc, Boulder, Colorado, USA.
Jonathan A LedermannDepartment of Oncology, University College London (UCL) Cancer Institute and UCL Hospitals, London, United Kingdom.
Robert L ColemanDepartment of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID 0000-0001-9343-8754
Clovis Oncology (United States) · USAgostino Gemelli University Polyclinic · ITCentro Oncológico de Galicia · ESClovis Oncology (United Kingdom) · GBFlorida Hospital Cancer Institute · USFondazione IRCCS Istituto Nazionale dei Tumori · ITHM Hospitales · ESInserm · FRJohns Hopkins University · USMemorial Sloan Kettering Cancer Center · USOttawa Hospital · CARoyal Marsden NHS Foundation Trust · GBSt John of God Subiaco Hospital · AUThe Christie NHS Foundation Trust · GBThe Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute · USThe University of Queensland · AUThe University of Texas MD Anderson Cancer Center · USUniversity College Hospital · GBUniversity Health Network · CAUniversity of Auckland · NZ

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Ann Rife Cox Chair in Gynecology and the Judy Reis/Albert Pisani, MD, Ovarian Cancer Research Fund (to R.L.C)Clovis Oncology, IncMemorial Sloan Kettering Cancer Center P30 CA008748 (to C.A)NCI NIH HHS P30 CA008748NIHR Biomedical Research Centre at UCL (to J.A.L)Stand Up To Cancer-Ovarian Cancer Research Fund Alliance-National Ovarian Cancer Coalition Dream Team Translational Research Grant SU2C-AACR-DT16-15 (to E.M.S)US Department of Defense Ovarian Cancer Research Program OC120506 (to E.M.S)
6 · The paper itself

Abstract

backgroundThe efficacy and safety of rucaparib maintenance treatment in ARIEL3 were evaluated in subgroups based on best response to most recent platinum-based chemotherapy and baseline disease.

methodsPatients were randomized 2:1 to receive either oral rucaparib at a dosage of 600 mg twice daily or placebo. Investigator-assessed PFS was assessed in prespecified, nested cohorts: BRCA-mutated, homologous recombination deficient (HRD; BRCA mutated or wild-type BRCA/high loss of heterozygosity), and the intent-to-treat (ITT) population.

resultsMedian PFS for patients in the ITT population with a complete response to most recent platinum-based chemotherapy was 11.1 months in the rucaparib arm (126 patients) versus 5.6 months in the placebo arm (64 patients) (HR, 0.33 [95% CI, 0.23-0.48]), and in patients with a partial response (249 vs. 125), it was 9.0 versus 5.3 months (HR, 0.38 [0.30-0.49]). In subgroups of the ITT population based on baseline disease, median PFS was 8.2 versus 5.3 months (HR, 0.40 [0.28-0.57]) in patients with measurable disease (141 rucaparib vs. 66 placebo), 10.4 versus 4.5 months (HR, 0.31 [0.20-0.48]) in those with nonmeasurable but evaluable disease (104 vs. 56), and 14.1 versus 7.3 months (HR, 0.35 [0.24-0.51]) in those with no residual disease (130 vs. 67). Across subgroups, significantly longer median PFS was observed with rucaparib versus placebo in the BRCA-mutated and HRD cohorts. Objective responses were reported in patients with measurable disease and in patients with nonmeasurable but evaluable baseline disease. Safety was consistent across subgroups.

conclusionRucaparib maintenance treatment provided clinically meaningful efficacy benefits across subgroups based on response to last platinum-based chemotherapy or baseline disease.

Indexed as

Carcinoma, Ovarian EpithelialDouble-Blind MethodFemaleHumansIndolesNeoplasm Recurrence, LocalPoly(ADP-ribose) Polymerase InhibitorsIndolesPoly(ADP-ribose) Polymerase Inhibitorsrucaparibclinical trialsgynecological oncologymedical oncologytarget therapywomen's cancer

Identifiers

PMID34549539
PMCPMC8525125
OpenAlexW3199611447

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.