Evidence map›Paper›PMID 35300061›Full record

ArticleCancer management and research2022

Thromboembolic Events in Patients with HER2-Negative, Hormone Receptor-Positive, Metastatic Breast Cancer Treated with Ribociclib Combined with Letrozole or Fulvestrant: A Real-World Data.

Hikmat Abdel-Razeq, Baha' Sharaf, Rama AlMasri, Rashid Abdel-Razeq, Faris Tamimi, Omar Khader, Osama Salama, Mahmoud Abunasser, Sarah Edaily, Hazem Abdulelah

Open access · goldAbstract read
In one paragraph

Article in Cancer management and research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 12% 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. 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 3 institutions in 1 country.

Hikmat Abdel-RazeqDepartment of Internal Medicine, King Hussein Cancer Center, Amman, Jordan.ORCID 0000-0003-2833-6051
Baha' SharafDepartment of Internal Medicine, King Hussein Cancer Center, Amman, Jordan.ORCID 0000-0003-4368-1224
Rama AlMasriDepartment of Internal Medicine, Istishari Hospital, Amman, Jordan.
Rashid Abdel-RazeqDepartment of Internal Medicine, King Hussein Cancer Center, Amman, Jordan.
Faris TamimiDepartment of Internal Medicine, King Hussein Cancer Center, Amman, Jordan.
Omar KhaderDepartment of Internal Medicine, King Hussein Cancer Center, Amman, Jordan.
Osama SalamaDepartment of Internal Medicine, King Hussein Cancer Center, Amman, Jordan.
Mahmoud AbunasserDepartment of Internal Medicine, King Hussein Cancer Center, Amman, Jordan.ORCID 0000-0002-8682-227X
Sarah EdailyDepartment of Internal Medicine, King Hussein Cancer Center, Amman, Jordan.
Hazem AbdulelahDepartment of Internal Medicine, King Hussein Cancer Center, Amman, Jordan.
King Hussein Cancer Center · JOJordan Hospital · JOUniversity of Jordan · JO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: Cyclin dependent kinase (CDK) 4/6 inhibitors (palbociclib, ribociclib and abemaciclib) modulate endocrine resistance and are integral treatment for patients with advanced hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Since their approval, CDK4/6 inhibitors are widely used in clinical practice. Thromboembolic events (TEE) were not a major issue in patients treated on clinical trials utilizing these agents. However, conflicting data started to emerge describing higher than expected rates of both arterial and venous thrombosis in patients treated with CDK4/6 inhibitors. In this study, we report our experience on TEE in patients treated with one of these agents (ribociclib) in real-world settings. Patients and Methods: All consecutive patients with metastatic breast cancer (mBC) treated with ribociclib combined with letrozole or fulvestrant were retrospectively reviewed. All episodes of radiologically confirmed arterial or venous thrombosis were recorded. TEE was considered ribociclib-related if diagnosed while patients are on the drug, or within 4 weeks after the last dose. Results: A total of 305 patients, median age (range), 49 (22-87) years were enrolled. All patients had metastatic disease, and most (n=241, 79.0%) were with visceral metastasis. Ribociclib was used for a median duration of 7 months (range: 1-45) and was used beyond the first-line setting in 110 (35.9%) patients. TEE were confirmed on 6 (1.97%) patients; 3 were pulmonary embolism, 2 cerebral venous sinus thrombosis (CVST), and one case of limb ischemia and all were symptomatic. Similar rates of TEE were noted prior to initiation, and after stopping ribociclib. Conclusion: In real-world settings, breast cancer patients treated with ribociclib, combined with aromatase inhibitors or fulvestrant, may not be at higher risk for thromboembolic events. However, unusual sites of thrombosis, like CVST, may raise some concerns.

Indexed as

CDK4/6 inhibitorsfulvestrantletrozolepatient stratificationpredictionthrombosis

Identifiers

PMID35300061
PMCPMC8921668
OpenAlexW4220810902

What OpenQuestion holds

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LicenceCC BY-NC
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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.