Evidence mapPaperPMID 33613693Full record

ArticleTherapeutic advances in medical oncology2021

Phase II study of liposomal doxorubicin, docetaxel and trastuzumab in combination with metformin as neoadjuvant therapy for HER2-positive breast cancer.

Andrea Rocca, Pietro Cortesi, Laura Cortesi, Lorenzo Gianni, Federica Matteucci, Lorenzo Fantini, Antonio Maestri, Donata Casadei Giunchi, Luigi Cavanna, Rosa Ciani and 11 more

Open access · goldAbstract read
In one paragraph

Article in Therapeutic advances in medical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
1.8field-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

14 citing papers in PubMed, 25 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

21 authors at 9 institutions in 1 country.

Andrea RoccaDepartment of Clinical and Experimental Oncology and Hematology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Via Maroncelli 40, Meldola 47014, Italy.
Pietro CortesiDepartment of Clinical and Experimental Oncology and Hematology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Laura CortesiDepartment of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, Modena, Italy.
Lorenzo GianniDepartment of Medical Oncology, Infermi Hospital, Rimini, Italy.
Federica MatteucciNuclear Medicine Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Lorenzo FantiniNuclear Medicine Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Antonio MaestriDepartment of Medical Oncology, Santa Maria della Scaletta Hospital, Imola, Italy.
Donata Casadei GiunchiDepartment of Clinical and Experimental Oncology and Hematology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Luigi CavannaDepartment of Onco-Hematology, Guglielmo da Saliceto Hospital, Piacenza, Italy.
Rosa CianiCancer Prevention Unit, Azienda Usl della Romagna, Forlì, Italy.
Fabio FalciniCancer Prevention Unit, Azienda Usl della Romagna, Forlì, Italy Romagna Cancer Registry, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Antonella BagniBreast Diagnostic Unit, Maurizio Bufalini Hospital, Cesena, Italy.
Elena MeldoliBreast Diagnostic Unit, Maurizio Bufalini Hospital, Cesena, Italy.
Monia Dall'AgataUnit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Roberta VolpiUnit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Daniele AndreisUnit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Oriana NanniUnit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Annalisa CurcioBreast Surgery Unit, Morgagni-Pierantoni Hospital, Forlì, Italy.
Leonardo LucchiBreast Surgery Unit, Maurizio Bufalini Hospital, Forlì, Italy.
Dino AmadoriDepartment of Clinical and Experimental Oncology and Hematology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Anna FedeliDepartment of Clinical and Experimental Oncology and Hematology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITOspedale “M. Bufalini” di Cesena · ITAzienda Unità Sanitaria Locale Della Romagna · ITGuglielmo da Saliceto Hospital · ITOspedale G.B. Morgagni - L.Pierantoni · ITOspedale Infermi di Rimini · ITPoliclinico di Modena · ITSanta Maria Nuova Hospital · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe aim of this study was to improve activity over single human epidermal growth factor receptor 2 (HER2)-blockade sequential neaodjuvant regimens for HER2-positive breast cancer, by exploiting the concomitant administration of trastuzumab, taxane and anthracycline, while restraining cardiac toxicity with use of liposomal doxorubicin, and by adding metformin, based on preliminary evidence of antitumor activity. PATIENTS AND

methodsThis multi-center, single-arm, two-stage phase II trial, assessed the safety and the activity of a new treatment regimen for HER2-positive, early or locally advanced breast cancer. Patients received six 21-day cycles of non-pegylated liposomal doxorubicin, 50 mg/m

resultsAmong 47 evaluable patients, there were 18 pCR [38.3%, 95% confidence interval (CI) 24.5-53.6%]. A negative estrogen-receptor status, high Ki67, and histological grade 3 were related with pCR, although only grade reached statistical significance. FLT-PET maximum standardized uptake value after one cycle was inversely related to pCR in the breast (odds ratio 0.29, 95% CI 0.06-1.30,

conclusionsThe concomitant administration of trastuzumab, liposomal doxorubicin, docetaxel, and metformin is safe and shows good activity, but does not appear to improve activity over conventional sequential regimens.

Indexed as

HER2+ breast cancermetforminneoadjuvant therapynon-pegylated liposomal doxorubicinprimary systemic therapytrastuzumab

Identifiers

PMID33613693
PMCPMC7876584
OpenAlexW3129776355

What Socratic 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 Socratic graph.