Evidence map›Paper›PMID 37183245›Full record

ArticleThrombosis journal2023

Clinical trial assessing the safety of edoxaban with concomitant chemotherapy in patients with gynecological cancer-associated thrombosis (EGCAT study).

Tadashi Oride, Kenjiro Sawada, Aasa Shimizu, Yasuto Kinose, Tsuyoshi Takiuchi, Michiko Kodama, Kae Hashimoto, Eiji Kobayashi, Eiji Nakatani, Tadashi Kimura

Open access · goldAbstract read
In one paragraph

Article in Thrombosis journal, 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
1.1field-weighted citation impact, top 23% 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, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. 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 1 institution in 1 country.

Tadashi OrideDepartment of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-15, Yamada-Oka, Suita City, Osaka, Japan.
Kenjiro SawadaDepartment of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-15, Yamada-Oka, Suita City, Osaka, Japan. daasawada@gyne.med.osaka-u.ac.jp.
Aasa ShimizuDepartment of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-15, Yamada-Oka, Suita City, Osaka, Japan.
Yasuto KinoseDepartment of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-15, Yamada-Oka, Suita City, Osaka, Japan.
Tsuyoshi TakiuchiDepartment of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-15, Yamada-Oka, Suita City, Osaka, Japan.
Michiko KodamaDepartment of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-15, Yamada-Oka, Suita City, Osaka, Japan.
Kae HashimotoDepartment of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-15, Yamada-Oka, Suita City, Osaka, Japan.
Eiji KobayashiDepartment of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-15, Yamada-Oka, Suita City, Osaka, Japan.
Eiji NakataniGraduate School of Public Health, Shizuoka Graduate University of Public Health, Shizuoka, Japan.
Tadashi KimuraDepartment of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-15, Yamada-Oka, Suita City, Osaka, Japan.
Osaka University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGynecological cancer is one of the highest risk factors for cancer-associated thrombosis (CAT). Although low-molecular-weight heparin (LMWH) is recommended as an anticoagulant for treating CAT, recent studies have shown that direct oral anticoagulants (DOACs) are an acceptable alternative. Patients with cancer require a series of chemotherapies concomitantly with DOAC administration; however, the extent to which these drugs influence DOAC blood concentrations is unknown. In this study, we measured the plasma concentration of edoxaban during chemotherapy for gynecological cancers to determine its safety.

methodsPatients histologically diagnosed with ovarian or uterine corpus cancer and CAT were recruited after primary surgery and before the initiation of postoperative adjuvant chemotherapy, including paclitaxel. Patients were administered edoxaban (30 or 60 mg) orally for CAT. The plasma concentrations of edoxaban and active factor Xa were determined and their percentage change before and after chemotherapy was calculated. Additionally, blood coagulation tests were analyzed.

resultsSixteen patients with gynecological cancer (12 with ovarian cancer and 4 with uterine corpus cancer) were enrolled. Among these, 15 samples were collected one day after chemotherapy initiation. During chemotherapy, the trough concentration of edoxaban changed from 17.6 ± 10.6 to 20.0 ± 15.6 ng/ml, and the mean percentage change in edoxaban concentration was 14.5%. Therefore, the trough concentrations of edoxaban, which represent excretion capacity, were not significantly increased by chemotherapy with paclitaxel. The area under the plasma edoxaban concentration-time curve and the active factor Xa concentration were also unaffected.

conclusionPatients with CAT and ovarian or uterine corpus cancer administered edoxaban orally showed no significant increase in the trough concentration of edoxaban while undergoing chemotherapy. This suggests the safety of edoxaban use during the treatment of gynecological cancers.

trial registrationEGCAT study; Japan Registry of Clinical Trials, jRCTs051190024.

Indexed as

Cancer associated thrombosisDOACEdoxabanGynecological cancerTrough concentration

Identifiers

PMID37183245
PMCPMC10184411
OpenAlexW4376610762

What OpenQuestion holds

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LicenceCC BY
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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.