Evidence map›Paper›PMID 39436588›Full record

Trial reportLa Radiologia medica2024

Subclinical cardiac damage monitoring in breast cancer patients treated with an anthracycline-based chemotherapy receiving left-sided breast radiation therapy: subgroup analysis from a phase 3 trial.

Livia Marrazzo, Icro Meattini, Carlotta Becherini, Viola Salvestrini, Luca Visani, Giuseppe Barletta, Calogero Saieva, Maria Riccarda Del Bene, Giuseppe Pilato, Isacco Desideri and 11 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in La Radiologia medica, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
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

21 authors.

Livia Marrazzo *Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Icro Meattini *Department of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy. icro.meattini@unifi.it.ORCID http://orcid.org/0000-0002-1861-2895
Carlotta BecheriniRadiation Oncology and Breast Unit, Oncology Department, Azienda Ospedaliero-Universitaria Careggi, Viale Morgagni 50, 50134, Florence, Italy.
Viola SalvestriniRadiation Oncology and Breast Unit, Oncology Department, Azienda Ospedaliero-Universitaria Careggi, Viale Morgagni 50, 50134, Florence, Italy.
Luca VisaniRadiation Oncology and Breast Unit, Oncology Department, Azienda Ospedaliero-Universitaria Careggi, Viale Morgagni 50, 50134, Florence, Italy.
Giuseppe BarlettaCardioThoracic and Vascular Department, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
Calogero SaievaCancer Risk Factors and Lifestyle Epidemiology Unit, Institute for Cancer Research Prevention and Clinical Network (ISPRO), Florence, Italy.
Maria Riccarda Del BeneCardioThoracic and Vascular Department, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
Giuseppe PilatoCardioThoracic and Vascular Department, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
Isacco DesideriDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Chiara ArilliMedical Physics Unit, Oncology Department, Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
Lisa PaolettiBreast Unit, Oncology Department, Azienda USL Toscana Centro, Florence, Italy.
Serenella RussoBreast Unit, Oncology Department, Azienda USL Toscana Centro, Florence, Italy.
Silvia ScocciantiBreast Unit, Oncology Department, Azienda USL Toscana Centro, Florence, Italy.
Francesca MartellaBreast Unit, Oncology Department, Azienda USL Toscana Centro, Florence, Italy.
Giulio FrancoliniRadiation Oncology and Breast Unit, Oncology Department, Azienda Ospedaliero-Universitaria Careggi, Viale Morgagni 50, 50134, Florence, Italy.
Gabriele SimontacchiRadiation Oncology and Breast Unit, Oncology Department, Azienda Ospedaliero-Universitaria Careggi, Viale Morgagni 50, 50134, Florence, Italy.
Jacopo Nori CucchiariRadiation Oncology and Breast Unit, Oncology Department, Azienda Ospedaliero-Universitaria Careggi, Viale Morgagni 50, 50134, Florence, Italy.
Roberto PellegriniElekta AB, Stockholm, Sweden.
Lorenzo LiviDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.
Stefania PallottaDepartment of Experimental and Clinical Biomedical Sciences "M. Serio", University of Florence, Florence, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study, derived from the phase 3 SAFE trial (ClinicalTrials.gov identifier: NCT2236806), explores subclinical cardiac damage in breast cancer patients receiving anthracycline-based chemotherapy and left-sided breast radiation therapy (RT). MATERIALS AND

methodsEligible patients were randomized to a cardioprotective pharmacological therapy (bisoprolol, ramipril, or both) or placebo, with cardiac surveillance at multiple time-point using standard and 3-dimensional echocardiography. Dosimetric parameters were analysed, including mean heart dose (MHD) and various metrics for heart substructures, employing advanced contouring techniques and auto-contouring software.

resultsIn the analysis of left-sided breast RT patients, the study encompassed 39 out of 46 irradiated individuals, focusing on GLS and 3D-LVEF outcomes with ≥ 10% worsening, defined as subclinical heart damage. Distinct RT schedules were used, with placebo exhibiting the highest ≥ 10% worsening (36.4%). In terms of treatment arms, bisoprolol exhibited 11.1% worsening, while ramipril 16.7% and bisoprolol + ramipril 25%. For patients with no subclinical damage, the mean MHD was 1.5 Gy; for patients with subclinical heart damage, the mean MHD was 1.6 Gy (p = 0.94). Dosimetric parameters related to heart and heart substructures (left anterior descending artery, right and left atrium, right and left ventricle) showed no statistically significant differences between patients with and without subclinical damage.

conclusionOur results emphasize the crucial role of cardioprotective measures in mitigating adverse effects, highlighting RT as having negligible influence on cardiac performance. An extended follow-up assessment of the whole series is warranted to determine whether a subclinical effect could significantly influence clinical outcomes and cardiac events.

Indexed as

AnthracyclinesBisoprololRamiprilAdultAgedBreast NeoplasmsCardiotonic AgentsCardiotoxicityEchocardiography, Three-DimensionalFemaleHeartHumansMiddle AgedUnilateral Breast NeoplasmsAnthracyclinesBisoprololCardiotonic AgentsRamiprilAnthracycline-based chemotherapyBreast cancerCardioprotective therapyLeft-sided breast radiotherapySubclinical cardiac damage

Identifiers

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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.