Evidence map›Paper›PMID 33752918›Full record

ArticleGynecologic oncology2021

Population exposure-efficacy and exposure-safety analyses for rucaparib in patients with recurrent ovarian carcinoma from Study 10 and ARIEL2.

Gottfried E Konecny, Amit M Oza, Anna V Tinker, Ana Oaknin, Ronnie Shapira-Frommer, Isabelle Ray-Coquard, Carol Aghajanian, Robert L Coleman, David M O'Malley, Alexandra Leary and 16 more

Open access · bronzeAbstract read
In one paragraph

Article in Gynecologic oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
0.8field-weighted citation impact, top 25% 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

8 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
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  4. Review
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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

26 authors at 20 institutions in 6 countries.

Gottfried E KonecnyDepartment of Medicine, University of California Los Angeles, Los Angeles, CA, USA. Electronic address: GKonecny@mednet.ucla.edu.
Amit M OzaDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
Anna V TinkerMedical Oncology, BC Cancer Agency, Vancouver, BC, Canada.
Ana OakninMedical Oncology Department, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Ronnie Shapira-FrommerDepartment of Oncology, Chaim Sheba Medical Center, Tel HaShomer, Israel.
Isabelle Ray-CoquardMedical Oncology Department, Centre Léon Bérard and University Claude Bernard and Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Lyon, France.
Carol AghajanianDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Robert L ColemanDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
David M O'MalleyDivision of Gynecologic Oncology, The Ohio State University, James Cancer Center, Columbus, OH, USA.
Alexandra LearyGynecological Unit, Gustave Roussy Cancer Center, INSERM U981, GINECO, Villejuif, France.
Lee-May ChenGynecologic Oncology Division, University of California San Francisco, San Francisco, CA, USA.
Diane ProvencherInstitut du Cancer de Montréal, Centre Hospitalier de l'Université de Montréal, Université de Montréal, Montreal, QC, Canada.
Ling MaMedical Oncology, Rocky Mountain Cancer Centers, Lakewood, CO, USA.
James D BrentonCancer Research UK Cambridge Institute, University of Cambridge, Cambridge, UK.
Cesar CastroCancer Center, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.
Michelle GreenIntegrated Drug Development, Certara Strategic Consulting, Menlo Park, CA, USA.
Andrew D SimmonsMolecular Diagnostics, Clovis Oncology, Inc., Boulder, CO, USA.
Jeri BeltmanRegulatory Affairs, Clovis Oncology, Inc., Boulder, CO, USA.
Thomas HardingMolecular Diagnostics, Clovis Oncology, Inc., Boulder, CO, USA.
Kevin K LinMolecular Diagnostics, Clovis Oncology, Inc., Boulder, CO, USA.
Sandra GobleBiostatistics, Clovis Oncology, Inc., Boulder, CO, USA.
Lara MaloneyClinical Development, Clovis Oncology, Inc., Boulder, CO, USA.
Rebecca S KristeleitDepartment of Oncology, University College London (UCL) Cancer Institute, UCL Hospitals, London, UK.
Iain A McNeishInstitute of Cancer Sciences, University of Glasgow, Glasgow, UK.
Elizabeth M SwisherDivision of Gynecologic Oncology, University of Washington, Seattle, WA, USA.
Jim J XiaoClinical Pharmacology, Clovis Oncology, Inc., Boulder, CO, USA.
Clovis Oncology (United States) · USBC Cancer Agency · CACancer Research UK · GBCentre Hospitalier de l’Université de Montréal · CACentre Léon Bérard · FRCertara (United States) · USHarvard University · USInserm · FRMemorial Sloan Kettering Cancer Center · USRocky Mountain Cancer Centers · USSheba Medical Center · ILThe Ohio State University · USThe University of Texas MD Anderson Cancer Center · USUniversity College London · GBUniversity Health Network · CAUniversity of California, Los Angeles · USUniversity of California, San Francisco · USUniversity of Glasgow · GBUniversity of Washington · USVall d'Hebron Hospital Universitari · ES

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Cancer Research UK 22905NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

objectiveTo evaluate correlations between rucaparib exposure and selected efficacy and safety endpoints in patients with recurrent ovarian carcinoma using pooled data from Study 10 and ARIEL2.

methodsEfficacy analyses were limited to patients with carcinomas harboring a deleterious BRCA1 or BRCA2 mutation who had received ≥2 prior lines of chemotherapy. Safety was evaluated in all patients who received ≥1 rucaparib dose. Steady-state daily area under the concentration-time curve (AUC

resultsRucaparib exposure was dose-proportional and not associated with baseline patient weight. In the exposure-efficacy analyses (n = 121), AUC

conclusionThe exposure-response analyses provide support for the approved starting dose of rucaparib 600 mg BID for maximum clinical benefit with subsequent dose modification only following the occurrence of a treatment-emergent adverse event in patients with BRCA-mutated recurrent ovarian carcinoma.

Indexed as

Administration, OralAgedArea Under CurveBRCA1 ProteinCarcinoma, Ovarian EpithelialDose-Response Relationship, DrugFemaleHumansIndolesMiddle AgedNeoplasm Recurrence, LocalOvarian NeoplasmsPlatinumBRCA1 ProteinBRCA1 protein, humanIndolesPlatinumrucaparibEfficacyExposureOvarian carcinomaPharmacokineticsRucaparibSafety

Identifiers

PMID33752918
PMCPMC9535637
OpenAlexW3137926322

What OpenQuestion holds

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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.