Evidence map›Paper›PMID 35767226›Full record

Observational studyCancer2022

Venous and arterial thrombosis associated with abemaciclib therapy for metastatic breast cancer.

Nathan W Watson, Seth A Wander, Joseph J Shatzel, Hanny Al-Samkari

Open access · greenAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
4.0field-weighted citation impact, top 5% 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

13 citing papers in PubMed, 26 citations in OpenAlex.

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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

4 authors at 2 institutions in 1 country.

Nathan W WatsonHarvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0001-5322-8058
Seth A WanderHarvard Medical School, Boston, Massachusetts, USA.
Joseph J ShatzelKnight Cancer Institute, Oregon Health and Sciences University, Portland, Oregon, USA.
Hanny Al-SamkariHarvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0001-6175-1383
Harvard University · USOregon Health & Science University · US

Funding

Evaluating the Safety and Efficacy of Targeting the Contact Pathway to Prevent Device Associated Thrombosis.R01HL151367 · NHLBI · OREGON HEALTH & SCIENCE UNIVERSITY · PI SHATZEL, JOSEPH JAMES · 2020 to 2024
$1.5M
Antiangiogenic Therapy to Reduce Bleeding and Improve Health-Related Quality of Life in Hereditary Hemorrhagic TelangiectasiaK23HL159313 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI Hanny T Al-Samkari · 2022 to 2026
$999k
NHLBI NIH HHS K23 HL159313NHLBI NIH HHS R01 HL151367
6 · The paper itself

Abstract

backgroundThe CDK4/6 inhibitor abemaciclib is a mainstay of treatment for hormone receptor-positive breast cancer. However, increased venous thromboembolism (VTE) rates in multiple clinical trials resulted in a black-box warning for this agent. Thrombosis rates in unselected real-world populations receiving abemaciclib remain ill defined.

methodsA multicenter observational cohort study was conducted of patients with metastatic breast cancer receiving abemaciclib. The primary end point was thrombosis during treatment or within 30 days of discontinuation. Multivariable logistic models assessed predictors of VTE, and a multivariable Cox proportional hazards model assessed mortality.

resultsA total of 364 patients were included, with a median treatment duration of 5.5 months. Twenty-six patients developed 27 (7.4%) thrombotic events (17 VTE, nine arterial thrombosis, and one with both events). No baseline characteristics were associated with increased VTE risk in multivariable modeling. Patients developing VTE during therapy had a higher risk of death than those who did not (hazard ratio, 2.09; 95% CI, 1.07-4.13). Median survival in patients who developed VTE compared with those who did not was 9.6 vs 25.8 months, respectively. The rate of VTE and any thrombosis during abemaciclib therapy was 9.1 and 13.7 events per 100 person-years, respectively, which is notably higher than rates observed in clinical trials.

conclusionsIn a real-world setting, abemaciclib was associated with a VTE rate approximately two-fold greater than the already elevated rates reported in the MONARCH trials. Patients developing thrombosis on abemaciclib had a significantly higher risk of death. Given these findings, studies evaluating the role of thromboprophylaxis in patients receiving abemaciclib are needed.

Indexed as

Breast NeoplasmsThrombosisVenous ThromboembolismAminopyridinesAnticoagulantsBenzimidazolesFemaleHumansabemaciclibAminopyridinesAnticoagulantsBenzimidazolesabemaciclibarterial thrombosisbreast cancerCDK 4/6 inhibitorsvenous thromboembolism

Identifiers

PMID35767226
PMCPMC10042227
OpenAlexW4283688352

What OpenQuestion holds

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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.