Evidence map›Paper›PMID 34940072›Full record

Trial reportCurrent oncology (Toronto, Ont.)2021

Pegylated Liposomal Doxorubicin (Caelyx

Silvia Dellapasqua, Pamela Trillo Aliaga, Elisabetta Munzone, Vincenzo Bagnardi, Eleonora Pagan, Emilia Montagna, Giuseppe Cancello, Raffaella Ghisini, Claudia Sangalli, Mara Negri and 15 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Current oncology (Toronto, Ont.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.7field-weighted citation impact, top 36% 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

7 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Article
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  7. 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

25 authors at 4 institutions in 1 country.

Silvia DellapasquaDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Pamela Trillo AliagaDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Elisabetta MunzoneDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.ORCID 0000-0003-3371-3878
Vincenzo BagnardiDepartment of Statistics and Quantitative Methods, University of Milan-Bicocca, 20126 Milan, Italy.
Eleonora PaganDepartment of Statistics and Quantitative Methods, University of Milan-Bicocca, 20126 Milan, Italy.
Emilia MontagnaDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Giuseppe CancelloDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Raffaella GhisiniDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Claudia SangalliDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Mara NegriDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Manuelita MazzaDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Monica IorfidaDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Anna CardilloDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Angela SciandivasciDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Nadia BiancoDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.ORCID 0000-0001-5765-7765
Ana Paula De MaioDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Monica MilanoDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Giuseppe Maria CampennìDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Loredana SansonnoDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Giuseppe VialeDepartment of Pathology, European Institute of Oncology IRCCS and University of Milan, 20141 Milan, Italy.
Anna MorraDivision of Radiotherapy, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Maria Cristina LeonardiDivision of Radiotherapy, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Viviana GalimbertiDivision of Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Paolo VeronesiDivision of Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Marco ColleoniDivision of Medical Senology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Istituti di Ricovero e Cura a Carattere Scientifico · ITEuropean Institute of Oncology · ITUniversity of Milano-Bicocca · ITUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdjuvant chemotherapy for Luminal B-like breast cancers usually includes anthracycline-based regimens. However, some patients are reluctant to receive chemotherapy because of side-effects, especially alopecia, and ask for a "less intensive" or personalized approach. PATIENTS AND

methodsWe conducted a phase II feasibility trial to evaluate pegylated liposomal doxorubicin (PLD, Caelyx

resultsFrom March 2016 to July 2018, 63 patients were included in the trial. Median age was 49 years (range: 33-76), with mostly pre- and peri-menopausal (65%) and stage I-II (94%). Only 5% of patients had HER2-positive EBC. Median RDI was 100% (range: 12.5-100%; interquartile range, IQR: 87.5-100%). The proportion of patients meeting the primary endpoint was 84% (95% confidence interval, CI: 73-92%). Overall, 55 out of 63 enrolled patients completed treatment (87%, 95% CI: 77-94%). Most common AEs were palmar-plantar erythrodysesthesia (12.2%), fatigue (10.4%), and mucositis (8.5%). Only 13% of patients had G3 AEs. None had alopecia. After a median follow-up of 3.9 years (range: 0.3-4.7) two distant events were observed, and all patients were alive at the date of last visit.

conclusionsThe trial successfully met its primary endpoint: the regimen was feasible and well tolerated and could be considered for further evaluation as a treatment option for patients with contraindications to standard anthracyclines or requiring a personalized, less intensive approach.

Indexed as

Breast NeoplasmsDoxorubicinFeasibility StudiesFemaleHumansMiddle AgedPolyethylene GlycolsDoxorubicinliposomal doxorubicinPolyethylene Glycolsadjuvant chemotherapyCaelyx®early breast cancerluminal B-like subtypespegylated liposomal doxorubicin (PLD)

Identifiers

PMID34940072
PMCPMC8700739
OpenAlexW4200443951

What OpenQuestion holds

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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.