Evidence map›Paper›PMID 29660836›Full record

Trial reportCancer2018

Final results of a phase 2, open-label study of indisulam, idarubicin, and cytarabine in patients with relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.

Rita Assi, Hagop M Kantarjian, Tapan M Kadia, Naveen Pemmaraju, Elias Jabbour, Nitin Jain, Naval Daver, Zeev Estrov, Taisuke Uehara, Takashi Owa and 2 more

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

Trial report in Cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed
6.2field-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.

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

67 citing papers in PubMed, 138 citations in OpenAlex.

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  17. Targeting RNA splicing modulation: new perspectives for anticancer strategy?Journal of experimental & clinical cancer research : CR · 2025
    Review
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  20. Aberrant pre-mRNA processing in cancer.The Journal of experimental medicine · 2024
    Review

7 more citing papers are in PubMed but not listed here.

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

12 authors at 2 institutions in 2 countries.

Rita AssiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-1159-883X
Hagop M KantarjianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1908-3307
Tapan M KadiaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-9892-9832
Naveen PemmarajuDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Elias JabbourDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-4465-6119
Nitin JainDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Naval DaverDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-7103-373X
Zeev EstrovDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Taisuke UeharaTsukuba Research Laboratories, Eisai Company, Ltd, Tsukuba, Ibaraki, Japan.
Takashi OwaTsukuba Research Laboratories, Eisai Company, Ltd, Tsukuba, Ibaraki, Japan.
Jorge E CortesDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Gautam BorthakurDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
The University of Texas MD Anderson Cancer Center · USEisai (Japan) · JP

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
University of Texas M.D. Anderson Cancer SPORE-LeukemiaP50CA100632 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI SHPALL, ELIZABETH J · 2003 to 2023
$43.7M
NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA100632
6 · The paper itself

Abstract

backgroundIndisulam possesses anticancer properties through down-regulation of various cell-cycle checkpoint molecules, thereby blocking the phosphorylation of retinoblastoma protein and inducing p53 and p21. Indisulam exhibits synergy with nucleoside analogs and topoisomerase inhibitors.

methodsThe authors designed a phase 2 study of indisulam in combination with idarubicin and cytarabine in patients who had relapsed/refractory acute myeloid leukemia AML and high-risk myelodysplastic syndrome. In stage 1, patients received intravenous indisulam at 400 mg/m

resultsForty patients were enrolled. Of the 37 evaluable patients, 31 received indisulam with chemotherapy. Of these, 11 (35%) responded for a median duration of 5.3 months. The estimated 1-year overall survival rate was 51% for responders compared with 8 % for nonresponders (P < .001). The most common grade ≥3 nonhematologic toxicities were electrolyte abnormalities (50%) and febrile neutropenia (28%).

conclusionsThe combination of indisulam with idarubicin and cytarabine yielded a 35% response rate in heavily pretreated patients with AML. With emerging data identifying the expression of DCAF15 (DDB1 and CUL4-associated factor 15) as a potential biomarker for activity, the combination of indisulam with idarubicin and cytarabine should be studied in a biomarker-driven trial or in patients who have splicing factor mutations. Cancer 2018;124:2758-65. © 2018 American Cancer Society. Cancer 2018;124:2758-2765. © 2018 American Cancer Society.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCytarabineDrug Resistance, NeoplasmDrug SynergismFebrile NeutropeniaFemaleHumansIdarubicinKaplan-Meier EstimateLeukemia, Myeloid, AcuteMaleMiddle AgedMutationMyelodysplastic SyndromesCytarabineIdarubicinN-(3-chloro-7-indolyl)-1,4-benzenedisulphonamideRNA Splicing FactorsSulfonamidesacute myeloid leukemia (AML)biomarkercytarabineidarubicinindisulamrelapsed/refractory

Identifiers

PMID29660836
PMCPMC6800041
OpenAlexW2802288784

What OpenQuestion holds

Textmetadata
LicenceTDM
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.