Evidence map›Paper›PMID 37634231›Full record

ArticleClinical and experimental medicine2023

Non-pegylated liposomal doxorubicin in older adjuvant early breast cancer patients: cardiac safety analysis and final results of the COLTONE study.

Luigi Coltelli, Chiara Finale, Gianna Musettini, Andrea Fontana, Maria Teresa Barletta, Alessandra Renata Lucarini, Iacopo Fabiani, Marco Scalese, Guido Bocci, Luna Chiara Masini and 13 more

Open access · hybridAbstract read
In one paragraph

Article in Clinical and experimental medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 42% 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

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. 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

23 authors at 6 institutions in 1 country.

Luigi ColtelliDivision of Medical Oncology, Leghorn Hospital, Viale Alfieri 36, Leghorn, Italy. luigi.coltelli@uslnordovest.toscana.it.
Chiara FinaleDivision of Medical Oncology, Leghorn Hospital, Viale Alfieri 36, Leghorn, Italy.
Gianna MusettiniDivision of Medical Oncology, Leghorn Hospital, Viale Alfieri 36, Leghorn, Italy.
Andrea FontanaDivision of Medical Oncology II, Azienda Ospedaliero-Universitaria Pisana, S. Chiara Hospital Via Roma, 67, Pisa, Italy.
Maria Teresa BarlettaDivision of Medical Oncology, Pontedera Hospital, Via Roma, 151, Pontedera, Italy.
Alessandra Renata LucariniDepartment of Cardiology, Azienda Usl Toscana Nord Ovest, Pisa, Italy.
Iacopo FabianiCardiology and Cardiovascular Medicine Division, Cardio-Thoracic Department, Fondazione Toscana Gabriele Monasterio, Pisa, Italy.
Marco ScaleseInstitute of Clinical Physiology, Italian National Research Council - CNR, Pisa, Italy.
Guido BocciDepartment of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
Luna Chiara MasiniDivision of Medical Oncology, Leghorn Hospital, Viale Alfieri 36, Leghorn, Italy.
Giulia SoriaDivision of Medical Oncology, Leghorn Hospital, Viale Alfieri 36, Leghorn, Italy.
Samanta CupiniDivision of Medical Oncology, Leghorn Hospital, Viale Alfieri 36, Leghorn, Italy.
Giada ArrighiDivision of Medical Oncology, Pontedera Hospital, Via Roma, 151, Pontedera, Italy.
Cecilia BarbaraDivision of Medical Oncology, Leghorn Hospital, Viale Alfieri 36, Leghorn, Italy.
Ermelinda De MaioDivision of Medical Oncology, Leghorn Hospital, Viale Alfieri 36, Leghorn, Italy.
Barbara SalvadoriDivision of Medical Oncology II, Azienda Ospedaliero-Universitaria Pisana, S. Chiara Hospital Via Roma, 67, Pisa, Italy.
Andrea MariniDivision of Medical Oncology, Leghorn Hospital, Viale Alfieri 36, Leghorn, Italy.
Antonio PellinoDivision of Medical Oncology, Leghorn Hospital, Viale Alfieri 36, Leghorn, Italy.
Irene StasiDivision of Medical Oncology, Leghorn Hospital, Viale Alfieri 36, Leghorn, Italy.
Michele EmdinCardiology and Cardiovascular Medicine Division, Cardio-Thoracic Department, Fondazione Toscana Gabriele Monasterio, Pisa, Italy.
Stefano GiaconiDepartment of Cardiology, Azienda Usl Toscana Nord Ovest, Pisa, Italy.
Lorenzo MarcucciDivision of Medical Oncology, Pontedera Hospital, Via Roma, 151, Pontedera, Italy.
Giacomo AllegriniDivision of Medical Oncology, Leghorn Hospital, Viale Alfieri 36, Leghorn, Italy.
Azienda Usl Toscana Centro · ITAzienda Ospedaliera Universitaria Pisana · ITFondazione Toscana Gabriele Monasterio · ITIstituto di Fisiologia Clinica · ITScuola Superiore Sant'Anna · ITUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo explore the cardiac safety of adjuvant Non-Pegylated Liposomal Doxorubicin (NPL-DOX) plus Cyclophosphamide (CTX) followed by weekly Paclitaxel, in elderly women (≥ 65 years) with high-risk breast cancer. Previously, we described no symptomatic cardiac events within the first 12 months from starting treatment. We now reported the updated results after a median follow-up 76 months.

methodsThe cardiac activity was evaluated with left ventricular ejection fraction (LVEF) echocardiograms assessments, before starting chemotherapy and every 6 months, until 30 months from baseline, then yearly for at least 5 years.

resultsForty-seven women were recruited by two Units of Medical Oncology (Ethics Committee authorization CESM-AOUP, 3203/2011; EudraCT identification number: 2010-024067-41, for Pisa and Pontedera Hospitals). An episode of grade 3 CHF (NCI-CTCAE, version 3.0) occurred after 18 months the beginning of chemotherapy. The echocardiograms assessments were performed comparing the LVEF values of each patient evaluated at fixed period of time, compared to baseline. We observed a slight changed in terms of mean values at 48, 60, 72 and 84 months. At these time points, a statistically significant reduction of - 3.2%, - 4.6%, - 6.4% and - 7.1%, respectively, was observed. However, LVEF remained above 50% without translation in any relevant clinical signs. No other cardiac significant episodes were reported. To this analysis, in 13 patients (28%) occurred disease relapse and,  of them, 11 (23%) died due to metastatic disease. Eight patients died of cancer-unrelated causes.

conclusionsThe combination including NPL-DOX in elderly patients revealed low rate of cardiac toxic effects. Comparative trials are encouraged.

Indexed as

Breast NeoplasmsAgedAntineoplastic Combined Chemotherapy ProtocolsCyclophosphamideDoxorubicinFemaleHumansNeoplasm Recurrence, LocalPolyethylene GlycolsStroke VolumeTreatment OutcomeVentricular Function, LeftCyclophosphamideDoxorubicinliposomal doxorubicinPolyethylene GlycolsAdjuvant chemotherapyCardiac safetyEarly breast cancer patientsHigh riskNon-pegylated liposomal doxorubicin

Identifiers

PMID37634231
PMCPMC10725369
OpenAlexW4386204076

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.