Evidence map›Paper›PMID 36273926›Full record

Trial reportGynecologic oncology2022

Clinical and molecular characteristics of ARIEL3 patients who derived exceptional benefit from rucaparib maintenance treatment for high-grade ovarian carcinoma.

David M O'Malley, Amit M Oza, Domenica Lorusso, Carol Aghajanian, Ana Oaknin, Andrew Dean, Nicoletta Colombo, Johanne I Weberpals, Andrew R Clamp, Giovanni Scambia and 12 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Gynecologic 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 NCT01968213 (A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
5.4field-weighted citation impact, top 3% 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.

NCT01968213 phase3completednot on this map

A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer ( ARIEL3 )

TypeinterventionalSponsorpharmaand GmbHRan2014 to 2022Enrolled564ConditionsOvarian Cancer, Fallopian Tube Cancer, Peritoneal CancerArmsRucaparib, Placebo
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Clinical and molecular determinants of response to maintenance olaparib for primary and recurrent epithelial ovarian carcinoma.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Article
  8. Article
  9. Article
  10. Observational
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 16 institutions in 7 countries.

David M O'MalleyDivision of Gynecologic Oncology, The Ohio State University, James Cancer Center, Columbus, OH, USA. Electronic address: David.O'Malley@osumc.edu.
Amit M OzaDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Domenica LorussoFondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy.
Carol AghajanianDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Ana OakninGynecologic Cancer Program, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Andrew DeanDepartment of Medical Oncology, St John of God Subiaco Hospital, Subaico, WA, Australia.
Nicoletta ColomboDepartment of Gynecologic Oncology, University of Milan-Bicocca and European Institute of Oncology (IEO) IRCCS, Milan, Italy.
Johanne I WeberpalsDepartment of Obstetrics and Gynecology, Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Andrew R ClampMedical Oncology, The Christie NHS Foundation Trust and University of Manchester, Manchester, UK.
Giovanni ScambiaDepartment of Cancer Gynecology, Fondazione Policlinico Universitario A. Gemelli IRCCS and Scientific Directorate, Rome, Italy.
Alexandra LearyGynecological Unit, Gustave Roussy Cancer Center, INSERM U981, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Villejuif, France.
Robert W HollowayGynecologic Oncology, Florida Hospital Cancer Institute, Orlando, FL, USA.
Margarita Amenedo GancedoMedical Oncology Department, Oncology Center of Galicia, La Coruña, Spain.
Peter C FongMedical Oncology, Auckland City Hospital and University of Auckland, New Zealand.
Jeffrey C GohCancer Care Services, Royal Brisbane and Women's Hospital, Herston, Australia; Faculty of Medicine, University of Queensland, St Lucia, Australia.
Elizabeth M SwisherDivision of Gynecologic Oncology, University of Washington, Seattle, WA, USA.
Lara MaloneyClinical Development, Clovis Oncology, Inc., Boulder, CO, USA.
Sandra GobleBiostatistics, Clovis Oncology, Inc., Boulder, CO, USA.
Kevin K LinMolecular Diagnostics, Clovis Oncology, Inc., Boulder, CO, USA.
Tanya KwanMolecular Diagnostics, Clovis Oncology, Inc., Boulder, CO, USA.
Jonathan A LedermannDepartment of Oncology, UCL Cancer Institute, University College London and UCL Hospitals, London, UK.
Robert L ColemanDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Clovis Oncology (United States) · USAgostino Gemelli University Polyclinic · ITAuckland City Hospital · NZCentro Oncológico de Galicia · ESEuropean Institute of Oncology · ITFlorida Hospital Cancer Institute · USFondazione IRCCS Istituto Nazionale dei Tumori · ITMemorial Sloan Kettering Cancer Center · USOttawa Hospital · CASt John of God Subiaco Hospital · AUThe Christie NHS Foundation Trust · GBThe University of Texas MD Anderson Cancer Center · USUniversity College London · GBUniversity Health Network · CAUniversity of Washington · USVall d'Hebron Hospital Universitari · ES

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Combined Methylation and Mutation to Predict Response to PARP InhibitorsR01CA237600 · NCI · UNIVERSITY OF WASHINGTON · PI SWISHER, ELIZABETH MARY · 2020 to 2024
$2.9M
NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA237600
6 · The paper itself

Abstract

objectiveARIEL3 (NCT01968213) is a placebo-controlled randomized trial of the poly(ADP-ribose) polymerase inhibitor rucaparib as maintenance treatment in patients with recurrent high-grade ovarian carcinoma who responded to their latest line of platinum therapy. Rucaparib improved progression-free survival across all predefined subgroups. Here, we present an exploratory analysis of clinical and molecular characteristics associated with exceptional benefit from rucaparib.

methodsPatients were randomized 2:1 to receive rucaparib 600 mg twice daily or placebo. Molecular features (genomic alterations, BRCA1 promoter methylation) and baseline clinical characteristics were evaluated for association with exceptional benefit (progression-free survival ≥2 years) versus progression on first scan (short-term subgroup) and other efficacy outcomes.

resultsRucaparib treatment was significantly associated with exceptional benefit compared with placebo: 79/375 (21.1%) vs 4/189 (2.1%), respectively (p < 0.0001). Exceptional benefit was more frequent among patients with favorable baseline clinical characteristics and with carcinomas harboring molecular evidence of homologous recombination deficiency (HRD). A comparison between patients who derived exceptional benefit from rucaparib and those in the short-term subgroup revealed both clinical markers (no measurable disease at baseline, complete response to latest platinum, longer penultimate platinum-free interval) and molecular markers (BRCA1, BRCA2, RAD51C, and RAD51D alterations and genome-wide loss of heterozygosity) significantly associated with exceptional benefit.

conclusionsExceptional benefit in ARIEL3 was more common in, but not exclusive to, patients with favorable clinical characteristics or molecular features associated with HRD. Our results suggest that rucaparib can deliver exceptional benefit to a diverse set of patients with recurrent high-grade ovarian carcinoma.

Indexed as

Antineoplastic AgentsCarcinomaOvarian NeoplasmsCarcinoma, Ovarian EpithelialFemaleHumansNeoplasm Recurrence, LocalPlatinumPoly(ADP-ribose) Polymerase InhibitorsAntineoplastic AgentsPlatinumPoly(ADP-ribose) Polymerase InhibitorsGenomicsOvarian carcinomaRucaparibSafety

Identifiers

PMID36273926
PMCPMC10339359
OpenAlexW4306926620

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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.