Evidence map›Paper›PMID 29934062›Full record

Trial reportClinical lymphoma, myeloma & leukemia2018

An Open-label, Phase II Trial of Entospletinib (GS-9973), a Selective Spleen Tyrosine Kinase Inhibitor, in Diffuse Large B-cell Lymphoma.

John M Burke, Andrei Shustov, James Essell, Dipti Patel-Donnelly, Jay Yang, Robert Chen, Wei Ye, Wen Shi, Sarit Assouline, Jeff Sharman

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical lymphoma, myeloma & leukemia, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 9% 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Review
  6. New insights into SYK targeting in solid tumors.Trends in pharmacological sciences · 2024
    Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Platelet GPVI (Glycoprotein VI) and Thrombotic Complications in the Venous System.Arteriosclerosis, thrombosis, and vascular biology · 2021
    Review
  12. Article
  13. New agents and regimens for diffuse large B cell lymphoma.Journal of hematology & oncology · 2020
    Review
  14. Hyponatremia in Patients with Hematologic Diseases.Journal of clinical medicine · 2020
    Review
  15. Review
  16. Article
  17. Review
  18. Role of spleen tyrosine kinase in liver diseases.World journal of gastroenterology · 2020
    Review
  19. Genetic alterations and their clinical implications in DLBCL.Nature reviews. Clinical oncology · 2019
    Review
  20. 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

10 authors at 7 institutions in 2 countries.

John M BurkeRocky Mountain Cancer Centers, The US Oncology Network, Aurora, CO. Electronic address: John.Burke@USOncology.com.
Andrei ShustovUniversity of Washington School of Medicine, Seattle, WA.
James EssellOncology Hematology Care, Inc, Cincinnati, OH.
Dipti Patel-DonnellyVirginia Cancer Specialists, The US Oncology Network, Fairfax, VA.
Jay YangKarmanos Cancer Institute, Wayne State University, Detroit, MI.
Robert ChenCity of Hope, Duarte, CA.
Wei YeGilead Sciences, Inc, Foster City, CA.
Wen ShiGilead Sciences, Inc, Foster City, CA.
Sarit AssoulineGerald Bronfman Centre, McGill University, Montreal, QC, Canada.
Jeff SharmanWillamette Valley Cancer Institute and Research Center, The US Oncology Network, Eugene, OR.
Gilead Sciences (United States) · USCity of Hope · USMcGill University · CAOncology Hematology Care · USThe Barbara Ann Karmanos Cancer Institute · USUniversity of Washington · USVirginia Cancer Specialists · US

Funding

Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI Julie Lynn Boerner · 1985 to 2026
$68.4M
NCI NIH HHS P30 CA022453
6 · The paper itself

Abstract

backgroundEntospletinib (GS-9973) is an oral, selective inhibitor of spleen tyrosine kinase. Entospletinib monotherapy was evaluated in a multicenter, phase II study of subjects with relapsed or refractory B-cell malignancy. PATIENTS AND

methodsThe study included 43 patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The participants received 800 mg of the original, monomesylate formulation of entospletinib twice daily as a starting dose; the doses could be reduced because of toxicity throughout the study.

resultsNo patient achieved a complete or partial response, 5 patients (12%) had stable disease, and 26 patients (60%) had progressive disease. Progression-free survival (PFS) at 16 weeks was 3.6% (95% confidence interval [CI], 0.3%-15.3%), and the median PFS was 1.5 months (95% CI, 1-1.7 months). The independent review committee-assessed nodal response for 27 evaluable patients showed a reduced tumor burden in 6 patients (22%). The median duration of entospletinib treatment for these 6 patients was 9 weeks (range, 3-24 weeks). One patient (4%) had a decrease of ≥ 50% in the sum of the product of the nodal diameters. The treatment-emergent adverse events occurring in ≥ 20% of the cohort were fatigue, nausea, decreased appetite, constipation, dyspnea, diarrhea, dehydration, cough, insomnia, and peripheral edema. The common laboratory abnormalities occurring in ≥ 20% of the subjects were lymphocytopenia, anemia, creatinine (chronic kidney disease), increased aspartate aminotransferase, hypoalbuminemia, total bilirubin, hyponatremia, leukopenia, increased alanine aminotransferase, increased alkaline phosphatase, and hyperglycemia.

conclusionEntospletinib monotherapy at 800 mg twice daily demonstrated limited activity in patients with advanced, relapsed DLBCL.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsDisease ProgressionDrug Administration ScheduleFemaleHumansIndazolesLymphoma, Large B-Cell, DiffuseMaleMiddle AgedMorpholinesProgression-Free SurvivalProtein Kinase InhibitorsPyrazines6-(1H-indazol-6-yl)-N-(4-morpholinophenyl)imidazo(1,2-a)pyrazin-8-amineAntineoplastic AgentsIndazolesMorpholinesProtein Kinase InhibitorsPyrazinesSyk KinaseSYK protein, humanB-cell receptor signaling inhibitorsDLBCLHematologic malignanciesMonotherapySyk

Identifiers

PMID29934062
PMCPMC6857170
OpenAlexW2806039308

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.