Evidence map›Paper›PMID 35394800›Full record

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

Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial.

Mrinal M Gounder, Albiruni Abdul Razak, Neeta Somaiah, Sant Chawla, Javier Martin-Broto, Giovanni Grignani, Scott M Schuetze, Bruno Vincenzi, Andrew J Wagner, Bartosz Chmielowski and 61 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
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 2 registered trials, which are not on this map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
5.8field-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.

NCT02606461 phase2 / phase3completednot on this map

A Phase 2-3, Multicenter, Randomized, Double-blind Study of Selinexor (KPT-330) Versus Placebo in Patients With Advanced Unresectable Dedifferentiated Liposarcoma (DDLS)

TypeinterventionalSponsorKaryopharm Therapeutics IncRan2016 to 2021Enrolled342ConditionsDedifferentiated LiposarcomaArmsSelinexor, Placebo
NCT06114004 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

Phase I/II Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcomas

TypeinterventionalSponsorAsociación Europea y Latinoamericana SELNET para la Investigación en SarcomasRan2023 to 2026Enrolled88ConditionsSarcoma,Soft TissueArmsSelinexor 20 MG, Gemcitabine
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 40 citations in OpenAlex.

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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

71 authors at 20 institutions in 10 countries.

Mrinal M GounderMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.ORCID 0000-0001-8468-0119
Albiruni Abdul RazakPrincess Margaret Cancer Center, Toronto, Ontario, Canada.ORCID 0000-0001-7657-9950
Neeta SomaiahThe University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-0146-7732
Sant ChawlaSarcoma Oncology Center, Santa Monica, CA.
Javier Martin-BrotoFundacion Jimenez Diaz University Hospital, Madrid, Madrid, Spain.ORCID 0000-0001-7350-6916
Giovanni GrignaniDivision of Medical Oncology, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Torino, Italy.
Scott M SchuetzeUniversity of Michigan, Ann Arbor, MI.ORCID 0000-0002-7167-4163
Bruno VincenziPoliclinico Universitario Campus Bio-Medico, Roma, Italy.ORCID 0000-0001-8222-9025
Andrew J WagnerDana-Farber Cancer Institute, Boston, MA.ORCID 0000-0002-4384-9448
Bartosz ChmielowskiJonsson Comprehensive Cancer Center at UCLA, Los Angeles, CA.ORCID 0000-0002-2374-3320
Robin L JonesThe Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, Sutton, United Kingdom.ORCID 0000-0003-4173-3844
Richard F RiedelDuke Cancer Institute, Durham, NC.ORCID 0000-0001-5412-8710
Silvia StacchiottiFondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy.
Elizabeth T LoggersFred Hutchinson Cancer Research Center, Seattle, WA.ORCID 0000-0003-3432-0443
Kristen N GanjooStanford Cancer Institute, Stanford, CA.
Axel Le CesneInstitut Gustave Roussy, Villejuif, France.ORCID 0000-0002-8006-8659
Antoine ItalianoInstitut Bergonié, Bordeaux, France.ORCID 0000-0002-8540-5351
Xavier Garcia Del MuroCatalan Institute of Oncology, IDIBELL, University of Barcelona, Barcelona, Spain.ORCID 0000-0001-5571-2847
Melissa BurgessUniversity of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA.
Sophie Piperno-NeumannInstitut Curie, Paris, France.
Christopher RyanOregon Health & Science University, Portland, OR.
Mary F MulcahyThe Robert H Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL.ORCID 0000-0002-6103-0989
Charles ForscherCedars-Sinai Medical Center, West Hollywood, CA.
Nicolas PenelCentre Oscar Lambret and Lille University, Lille, France.ORCID 0000-0001-5243-1548
Scott OkunoMayo Clinic Rochester, Rochester, MN.ORCID 0000-0002-1297-6946
Anthony EliasUniversity of Colorado-Denver, Aurora, CO.ORCID 0000-0002-6509-9211
Lee HartnerUniversity of Pennsylvania, Philadelphia, PA.ORCID 0000-0002-9326-4755
Tony PhilipNorthwell Health Physician Partners, New Hyde Park, NY.ORCID 0000-0001-6014-1292
Thierry AlcindorMcGill University Health Centre, Montreal, Quebec, Canada.ORCID 0000-0002-6004-0405
Bernd KasperMannheim University Medical Center, Mannheim, Germany.
Peter ReichardtHelios Hospital Berlin-Buch, Berlin, Germany.
Lore LapeireUniversity Hospital Gent, Gent, Belgium.ORCID 0000-0002-5028-6305
Jean-Yves BlayCentre Leon Berard, Lyon, France.ORCID 0000-0001-7190-120X
Christine ChevreauInstitut Claudius Regaud-IUCT-O, Toulouse, France.
Claudia Maria Valverde MoralesVall d'Hebron University Hospital, Barcelona, Spain.
Gary K SchwartzColumbia University Irving Medical Center, New York, NY.
James L ChenThe Ohio State James Cancer Center, Columbus, OH.ORCID 0000-0002-4095-5202
Hari DeshpandeYale Cancer Center, New Haven, CT.
Elizabeth J DavisThe Vanderbilt Clinic, Nashville, TN.ORCID 0000-0001-7626-2435
Garth NicholasOttawa Hospital Cancer Center, Ottawa, Ontario, Canada.
Stefan GröschelNational Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg, Heidelberg, Germany.
Helen HatcherCambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom.ORCID 0000-0002-1348-832X
Florence DuffaudLa Timone University Hospital Center and Aix-Marseille University, Marseille, France.
Antonio Casado HerráezHospital Universitario Clínico San Carlos, Madrid, Spain.
Roberto Diaz BeveridgeHospital La Fe Valencia, Valencia, Spain.
Giuseppe BadalamentiDepartment of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, Palermo, Italy.
Mikael ErikssonSkane University Hospital, Lund, Sweden.
Christian MeyerJohns Hopkins, Baltimore, MD.ORCID 0000-0003-3329-7106
Margaret von MehrenFox Chase Cancer Center, Philadelphia, PA.ORCID 0000-0001-6158-890X
Brian A Van TineWashington University School of Medicine, St Louis, MO.ORCID 0000-0003-4572-6668
Katharina GötzeKlinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie Klinikum rechts der Isar der TU Muenchen, Marburg, Germany.ORCID 0000-0002-6276-8002
Filomena MazzeoUCL Saint-Luc, Brussels, Belgium.ORCID 0000-0003-1772-4681
Alexander YakobsonSoroka University Medical Center, Be'er Sheva, Israel.
Aviad ZickFaculty of Medicine, Hebrew University of Jerusalem, Israel; The Oncology Department, Hadassah Medical Center, Jerusalem, Israel.ORCID 0000-0002-5077-9249
Alexander LeeThe Christie NHS Foundation, Manchester, United Kingdom.ORCID 0000-0003-2976-6811
Anna Estival GonzalezCatalan Institute of Oncology (ICO) Germans Trias I Pujol University Hospital, B-ARGO, Barcelona, Spain.ORCID 0000-0002-2788-9159
Andrea NapolitanoPoliclinico Universitario Campus Bio-Medico, Roma, Italy.ORCID 0000-0002-7509-1555
Mark A DicksonMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY.
Dayana MichelKaryopharm Therapeutics Inc, Newton, MA.ORCID 0000-0001-6479-8566
Changting MengKaryopharm Therapeutics Inc, Newton, MA.ORCID 0000-0002-9438-5719
Lingling LiKaryopharm Therapeutics Inc, Newton, MA.
Jianjun LiuKaryopharm Therapeutics Inc, Newton, MA.
Osnat Ben-ShaharKaryopharm Therapeutics Inc, Newton, MA.ORCID 0000-0001-7064-0474
Dane R Van DomelenKaryopharm Therapeutics Inc, Newton, MA.ORCID 0000-0003-0051-7790
Christopher J WalkerKaryopharm Therapeutics Inc, Newton, MA.
Hua ChangKaryopharm Therapeutics Inc, Newton, MA.
Yosef LandesmanKaryopharm Therapeutics Inc, Newton, MA.
Jatin J ShahKaryopharm Therapeutics Inc, Newton, MA.
Sharon ShachamKaryopharm Therapeutics Inc, Newton, MA.
Michael G KauffmanKaryopharm Therapeutics Inc, Newton, MA.
Steven AttiaMayo Clinic, Jacksonville, FL.
Karyopharm Therapeutics (United States) · USCampus Bio Medico University Hospital · ITHeidelberg University · DEMemorial Sloan Kettering Cancer Center · USAix-Marseille Université · FRCambridge University Hospitals NHS Foundation Trust · GBCancer Prevention Institute of California · USCandiolo Cancer Institute · ITCedars-Sinai Medical Center · USCentre Léon Bérard · FRCentre Oscar Lambret · FRColumbia University Irving Medical Center · USDana-Farber Cancer Institute · USDuke Medical Center · USFondazione IRCCS Istituto Nazionale dei Tumori · ITFox Chase Cancer Center · USFred Hutch Cancer Center · USGhent University Hospital · BEHebrew University of Jerusalem · ILHelios Hospital Berlin-Buch · DE

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Women's CancersP30CA016042 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Samuel Wheeler French · 1985 to 2026
$134.5M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA016042
6 · The paper itself

Abstract

purposeAntitumor activity in preclinical models and a phase I study of patients with dedifferentiated liposarcoma (DD-LPS) was observed with selinexor. We evaluated the clinical benefit of selinexor in patients with previously treated DD-LPS whose sarcoma progressed on approved agents.

methodsSEAL was a phase II-III, multicenter, randomized, double-blind, placebo-controlled study. Patients age 12 years or older with advanced DD-LPS who had received two-five lines of therapy were randomly assigned (2:1) to selinexor (60 mg) or placebo twice weekly in 6-week cycles (crossover permitted). The primary end point was progression-free survival (PFS). Patients who received at least one dose of study treatment were included for safety analysis (ClinicalTrials.gov identifier: NCT02606461).

resultsTwo hundred eighty-five patients were enrolled (selinexor, n = 188; placebo, n = 97). PFS was significantly longer with selinexor versus placebo: hazard ratio (HR) 0.70 (95% CI, 0.52 to 0.95; one-sided

conclusionPatients with advanced, refractory DD-LPS showed improved PFS and time to next treatment with selinexor compared with placebo. Supportive care and dose reductions mitigated side effects of selinexor. Prospective validation of

Indexed as

HydrazinesLiposarcomaTriazolesChildDouble-Blind MethodHumansHydrazinesselinexorTriazoles

Identifiers

PMID35394800
PMCPMC9467680
OpenAlexW4223496858

What OpenQuestion holds

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LicenceCC BY-NC-ND
Read underepoch 390

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.