Evidence map›Paper›PMID 38834399›Full record

Trial reportGynecologic oncology2024

Long-term follow-up of efficacy and safety of selinexor maintenance treatment in patients with TP53wt advanced or recurrent endometrial cancer: A subgroup analysis of the ENGOT-EN5/GOG-3055/SIENDO study.

Vicky Makker, Jose Alejandro Perez-Fidalgo, Giorgio Valabrega, Erika Hamilton, Toon Van Gorp, Jalid Sehouli, Klaudia Regináčová, Debra L Richardson, Tamar Perri, Amit M Oza and 20 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Gynecologic oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05611931 (A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

NCT05611931 phase3active not recruitingnot on this map

A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

TypeinterventionalSponsorKaryopharm Therapeutics IncRan2023 to 2028Enrolled257ConditionsEndometrial CancerArmsSelinexor, Matching Placebo for selinexor
3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

  1. Phase I/II Trial of Exportin 1 Inhibitor Selinexor plus Docetaxel in Previously Treated, Advanced KRAS-Mutant Non-Small Cell Lung Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  2. Review
  3. Review
  4. Review
  5. A new therapeutic approach toTranslational lung cancer research · 2026
    Article
  6. Review
  7. Translational lung cancer research · 2025
    Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
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

30 authors.

Vicky MakkerMemorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical Center, New York, NY, USA.
Jose Alejandro Perez-FidalgoINCLIVA, CIBERONC, GEICO, Hospital Clinico Universitario de Valencia, Valencia, Spain.
Giorgio ValabregaUniversity of Turin, A.O. Ordine Mauriziano, Turin, Italy.
Erika HamiltonSarah Cannon Research Institute, Nashville, TN, USA.
Toon Van GorpBelgium and Luxembourg Gynaecological Oncology Group (BGOG), Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium.
Jalid SehouliEuropean Competence Center for Ovarian Cancer, Charité Comprehensive Cancer Center, NOGGO, Charité-Berlin University of Medicine, Berlin, Germany.
Klaudia RegináčováDepartment of Oncology, University Hospital Kralovske Vinohrady, Prague, Czech Republic; Charles University, Third Faculty of Medicine, Prague, Czech Republic.
Debra L RichardsonStephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
Tamar PerriHadassah Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel.
Amit M OzaPrincess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
David S MillerHarold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Eva Maria Guerra AlíaHospital Universitario Ramón y Cajal, Madrid, Spain.
Ugo De GiorgiIRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori, Meldola, Italy.
Stephanie HenryBelgium and Luxembourg Gynaecological Oncology Group (BGOG) and Université Catholique de Louvain CHU UCL Site Ste Elisabeth, Service d'onco-hématologie (SORMIN), Namur, Belgium.
Daniel L SpitzSarah Cannon Research Institute, Nashville, TN, USA; Florida Cancer Specialists & Research Institute, Wellington, FL, USA.
Pauline WimbergerUniversity Hospital Carl Gustav Carus, NOGGO, and Technische Universität Dresden, Dresden, Germany.
Markéta BednaříkováUniversity Hospital and Masaryk University, Brno, Prague, Czech Republic; Charles University, Third Faculty of Medicine, Prague, Czech Republic.
Hye Sook ChonMoffitt Cancer Center, Tampa, FL, USA.
Jerónimo Martínez-GarciaHospital Clínico Universitario Virgen de la Arrixaca, IMIB-ARRIXACA, Murcia, Spain.
Carmela PisanoIstituto Nazionale Tumori di Napoli, Naples, Italy.
Jonathan S BerekStanford Women's Cancer Center, Stanford Cancer Institute, University School of Medicine, Stanford, CA, USA.
Ignacio RomeroINCLIVA, CIBERONC, GEICO, Hospital Clinico Universitario de Valencia, Valencia, Spain.
Giovanni ScambiaUniversità Cattolica del Sacro Cuore, Rome 00168, Italy; Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome 00168, Italy.
Lorena Fariñas-MadridVall d'Hebron Universitiy Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
Joseph BuscemaArizona Oncology, Tucson, AZ, USA.
Fabienne SchochterUniversity Hospital Ulm, Ulm, Germany.
Kai LiKaryopharm Therapeutics Inc., Newton, MA, USA.
Pratheek KalyanapuKaryopharm Therapeutics Inc., Newton, MA, USA.
Christopher J WalkerKaryopharm Therapeutics Inc., Newton, MA, USA.
Ignace VergoteBelgium and Luxembourg Gynaecological Oncology Group (BGOG), Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium. Electronic address: Ignace.vergote@uzleuven.be.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
UT Southwestern Medical Center Simmons Comprehensive Cancer CenterP30CA142543 · NCI · UT SOUTHWESTERN MEDICAL CENTER · PI MELANIE H. COBB · 2010 to 2026
$53.7M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

objectiveTo report long-term efficacy and safety of selinexor maintenance therapy in adults with TP53 wild-type (TP53wt) stage IV or recurrent endometrial cancer (EC) who achieved partial remission (PR) or complete remission (CR) following chemotherapy.

methodsAnalysis of the prespecified, exploratory subgroup of patients with TP53wt EC from the phase 3 SIENDO study was performed. Progression-free survival (PFS) benefit in patients with TP53wt EC and across other patient subgroups were exploratory endpoints. Safety and tolerability were also assessed.

resultsOf the 263 patients enrolled in the SIENDO trial, 113 patients had TP53wt EC; 70/113 (61.9%) had TP53wt/proficient mismatch repair (pMMR) EC, and 29/113 (25.7%) had TP53wt/deficient mismatch repair (dMMR) EC. As of April 1, 2024, the median PFS (mPFS) for TP53wt patients who received selinexor compared with placebo was 28.4 versus 5.2 months (36.8-month follow-up, HR 0.44; 95% CI 0.27-0.73). A benefit in mPFS was seen with selinexor versus placebo regardless of MMR status (patients with TP53wt/pMMR EC: 39.5 vs 4.9 months, HR 0.36; 95% CI 0.19-0.71; patients with TP53wt/dMMR EC: 13.1 vs 3.7 months, HR 0.49; 95% CI 0.18-1.34). Selinexor treatment was generally manageable, with no new safety signals identified.

conclusionIn the phase 3 SIENDO study, selinexor maintenance therapy showed a promising efficacy signal and a manageable safety profile in the prespecified subgroup of patients with TP53wt EC who achieved a PR or CR following chemotherapy. These results are being further evaluated in an ongoing randomized phase 3 trial (NCT05611931).

Indexed as

Endometrial NeoplasmsHydrazinesNeoplasm Recurrence, LocalTriazolesTumor Suppressor Protein p53AdultAgedAged, 80 and overFemaleFollow-Up StudiesHumansMaintenance ChemotherapyMiddle AgedNeoplasm StagingProgression-Free SurvivalHydrazinesselinexorTP53 protein, humanTriazolesTumor Suppressor Protein p53Cancer biomarkerEndometrial neoplasmExportin 1 proteinp53 tumor-suppressor protein

Identifiers

PMID38834399
PMCPMC12903923

What OpenQuestion holds

Textmetadata
LicenceTDM
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.