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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
V. Makker, JA. Perez-Fidalgo, G. Valabrega, E. Hamilton, T. Van Gorp, J. Sehouli, K. Regináčová, DL. Richardson, T. Perri, AM. Oza, DS. Miller, EMG. Alía, U. De Giorgi, S. Henry, DL. Spitz, P. Wimberger, M. Bednaříková, HS. Chon, J....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, klinické zkoušky, fáze III, randomizované kontrolované studie, multicentrická studie
- MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- hydraziny * škodlivé účinky aplikace a dávkování terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- lokální recidiva nádoru * farmakoterapie MeSH
- nádorový supresorový protein p53 * genetika MeSH
- nádory endometria * farmakoterapie genetika patologie MeSH
- následné studie MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- staging nádorů MeSH
- triazoly * aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- udržovací chemoterapie metody MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
OBJECTIVE: To 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. METHODS: Analysis 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. RESULTS: Of 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. CONCLUSION: In 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).
Arizona Oncology Tucson AZ USA
Belgium and Luxembourg Gynaecological Oncology Group Namur Belgium
Charles University 3rd Faculty of Medicine Prague Czech Republic
Department of Oncology University Hospital Kralovske Vinohrady Prague Czech Republic
Florida Cancer Specialists and Research Institute Wellington FL USA
Fondazione Policlinico Universitario A Gemelli IRCCS Rome 00168 Italy
Hadassah Medical Center Hebrew University of Jerusalem Jerusalem Israel
Hospital Clínico Universitario Virgen de la Arrixaca IMIB ARRIXACA Murcia Spain
Hospital Universitario Ramón y Cajal Madrid Spain
INCLIVA CIBERONC GEICO Hospital Clinico Universitario de Valencia Valencia Spain
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola Italy
Istituto Nazionale Tumori di Napoli Naples Italy
Karyopharm Therapeutics Inc Newton MA USA
Memorial Sloan Kettering Cancer Center New York NY USA
Moffitt Cancer Center Tampa FL USA
Princess Margaret Cancer Centre University Health Network University of Toronto Toronto ON Canada
Sarah Cannon Research Institute Nashville TN USA
Stephenson Cancer Center University of Oklahoma Health Sciences Center Oklahoma City OK USA
Università Cattolica del Sacro Cuore Rome 00168 Italy
University Hospital and Masaryk University Brno Prague Czech Republic
University Hospital Carl Gustav Carus NOGGO and Technische Universität Dresden Dresden Germany
University Hospital Ulm Ulm Germany
University of Turin A O Ordine Mauriziano Turin Italy
Vall d'Hebron Universitiy Hospital Vall d'Hebron Institute of Oncology Barcelona Spain
Citace poskytuje Crossref.org
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