Evidence map›Paper›PMID 37818869›Full record

ArticleCancer medicine2023

Selinexor for the treatment of recurrent or metastatic salivary gland tumors: Results from the GEMS-001 clinical trial.

Alberto Hernando-Calvo, Eoghan Malone, Daphne Day, Amy Prawira, Ilan Weinreb, S Y Cindy Yang, Horace Wong, Angela Rodriguez, Sarah Jennings, Anneli Eliason and 4 more

Open access · goldAbstract read
In one paragraph

Article in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.9field-weighted citation impact, top 14% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
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

14 authors at 2 institutions in 1 country.

Alberto Hernando-CalvoDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre. Department of Medicine, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0002-1692-1125
Eoghan MaloneDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre. Department of Medicine, University of Toronto, Toronto, Ontario, Canada.ORCID 0000-0001-9012-7141
Daphne DayDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre. Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Amy PrawiraDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre. Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Ilan WeinrebPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.
S Y Cindy YangPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.
Horace WongPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.
Angela RodriguezPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.
Sarah JenningsPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.
Anneli EliasonPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.
Lisa WangPrincess Margaret Cancer Centre, Toronto, Ontario, Canada.
Anna SpreaficoDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre. Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Lillian L SiuDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre. Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Aaron R HansenDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre. Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Princess Margaret Cancer Centre · CAUniversity of Toronto · CA

Funding

This study received partial funding by Karyopharm Therapeutics.
6 · The paper itself

Abstract

objectivesWe aimed to evaluate the activity of selinexor, an oral selective inhibitor of nuclear export, in patients with recurrent or metastatic salivary gland tumors (SGT).

methodsGEMS-001 is an open-label Phase 2 study for patients with recurrent or metastatic SGT with two parts. In Part 1 of the protocol, patients had tumor samples profiled with targeted next generation sequencing as well as immunohistochemistry for androgen receptor, HER-2 and ALK. For Part 2, patients with no targeted therapies available were eligible to receive selinexor 60 mg given twice weekly every 28 days. The primary endpoint was objective response rate. Secondary endpoints included progression-free survival (PFS) and prevalence of druggable alterations across SGT.

resultsOne hundred patients were enrolled in GEMS-001 and underwent genomic and immunohistochemistry profiling. A total of 21 patients who lacked available matched therapies were treated with selinexor. SGT subtypes (WHO classification) included adenoid cystic carcinoma (n = 10), salivary duct carcinoma (n = 3), acinic cell carcinoma (n = 2), myoepithelial carcinoma (n = 2), carcinoma ex pleomorphic adenoma (n = 2) and other (n = 2). Of 18 evaluable patients, stable disease (SD) was observed in 17 patients (94%) (SD ≥6 months in 7 patients (39%)). However, no objective responses were observed. The median PFS was 4.9 months (95% confidence interval, 3.4-10). The most common treatment-related Grade 1-2 adverse events were nausea [17 patients (81%)], fatigue [16 patients (76%)], and dysgeusia [12 patients (57%)]. Most common treatment-related Grade 3-4 adverse events were hyponatremia [3 patients (14%)], neutrophil count decrease [3 patients (14%)] and cataracts [2 patients (10%)]. No treatment-related deaths were observed.

conclusionsAlthough tumor reduction was observed across participants, single agent selinexor anti-tumor activity was limited.

Indexed as

Carcinoma, Acinar CellSalivary Gland NeoplasmsHumansHydrazinesTriazolesHydrazinesselinexorTriazolesbiomarkersdrug designexperimental therapeuticshead and neck cancernext generation sequencingsalivary gland tumors

Identifiers

PMID37818869
PMCPMC10652322
OpenAlexW4387562887

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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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.