Evidence map›Paper›PMID 33109233›Full record

Trial reportBreast cancer research : BCR2020

Effect of body mass index on response to neo-adjuvant therapy in HER2-positive breast cancer: an exploratory analysis of the NeoALTTO trial.

Serena Di Cosimo, Luca Porcu, Dominique Agbor-Tarh, Saverio Cinieri, Maria Alice Franzoi, Maria Carmen De Santis, Cristina Saura, Jens Huober, Debora Fumagalli, Miguel Izquierdo and 3 more

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research : BCR, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 14% 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

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 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

13 authors at 10 institutions in 5 countries.

Serena Di CosimoBiomarkers Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, via G.A. Amadeo 42, 20133, Milano, Italy. serena.dicosimo@istitutotumori.mi.it.
Luca PorcuLaboratory of Methodology for Clinical Research, Department of Oncology, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milano, Italy.
Dominique Agbor-TarhFrontier Science (Scotland) Ltd, Kincraig, UK.
Saverio CinieriSan Antonio Perrino Hospital, Brindisi, Italy.
Maria Alice FranzoiInstitut Jules Bordet and l'Universitè Libre de Bruxelles (U.LB), Brussels, Belgium.
Maria Carmen De SantisRadiation Oncology, Fondazione IRSCCS Istituto Nazionale dei Tumori, Milano, Italy.
Cristina SauraVall d'Hebron Institute of Oncology, Barcelona, Spain.
Jens HuoberUniversity of Ulm, Ulm, Germany.
Debora FumagalliBreast International Group (BIG), Boulevard de Waterloo 76, 1000, Bruxelles, Belgium.
Miguel IzquierdoOncology Clinical Development, Oncology Business Unit, Novartis Pharma AG, Basel, Switzerland.
Martine PiccartInstitut Jules Bordet and l'Universitè Libre de Bruxelles (U.LB), Brussels, Belgium.
Maria Grazia DaidoneBiomarkers Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, via G.A. Amadeo 42, 20133, Milano, Italy.
Evandro de AzambujaInstitut Jules Bordet and l'Universitè Libre de Bruxelles (U.LB), Brussels, Belgium.
Fondazione IRCCS Istituto Nazionale dei Tumori · ITInstitut Jules Bordet · BEBreast International Group · BEFrontier Agriculture (United Kingdom) · GBMario Negri Institute for Pharmacological Research · ITNovartis (Switzerland) · CHOspedale A. Perrino · ITUniversität Ulm · DEUniversité Libre de Bruxelles · BEVall d'Hebron Institute of Oncology

Funding

GlaxoSmithKline The NeoALTTO study was sponsored by GlaxoSmithKline from its inception until November 30, 2015, and by Novartis since then. Lapatinib is an asset of Novartis AG as of March 2, 2015. Funding sources had no involvement in study design, data collection, analysis and interpretation, writing of the report, and decision to submit the article for publication.
6 · The paper itself

Abstract

backgroundObesity is a risk factor for breast cancer (BC) development, recurrence, and death. In view of this, we aimed to investigate the clinical value of obesity in BC patients treated with anti-HER2 therapies in the NeoALTTO trial, which randomized 455 patients to neo-adjuvant lapatinib, trastuzumab, or their combination plus paclitaxel.

methodsPatients were classified according to their basal body mass index (BMI) into underweight (< 18.5 kg/m

resultsAmong 454 patients analyzed, 14 (3%), 220 (48%), 137 (30%), and 83 (18%) were classified as underweight, normal weight, overweight, and obese, respectively; 231 (51%) and 223 (49%) had hormone receptor (HR)-positive and HR-negative primary tumors; 160 (35%) achieved pCR. In the overall patient population, no association was found between BMI groups and pCR, as we reported pCR rates of 57.1%, 35%, 30.7%, and 39.8% in underweight, normal weight, overweight, and obese cases, respectively. In contrast, in HR-positive tumors, overweight or obesity was generally associated with decreased likelihood of achieving a pCR independently of other clinical variables, including planned surgery, nodal status, and tumor size (odds ratio [OR] = 0.55, 95%CI 0.30-1.01, as compared to normal or underweight; p = 0.053); notably, no differential effect of BMI with respect to pCR was observed in HR-negative cases (odds ratio [OR] = 1.30, 95%CI 0.76-2.23, as compared to normal or underweight; p = 0.331), resulting in a statistically significant interaction between BMI and HR status (p = 0.036). There was no association between BMI and EFS neither in the overall nor in the HR-positive population, but this analysis was under-powered.

conclusionsNeoALTTO patients overweight or obese at baseline and with HR-positive primary BC appeared less likely to achieve pCR after neo-adjuvant anti-HER2 therapies. This finding paves the way to future research in targeting the interplay between HER2/HR signaling and metabolism.

Indexed as

Body Mass IndexAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesEstrogen Receptor alphaFemaleHumansLapatinibMiddle AgedNeoadjuvant TherapyObesityOverweightPaclitaxelRisk FactorsSurvival RateTrastuzumabERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesESR1 protein, humanEstrogen Receptor alphaLapatinibPaclitaxelTrastuzumabBody mass indexHER2-positive breast cancerNeo-adjuvant treatmentPathological complete response

Identifiers

PMID33109233
PMCPMC7590445
OpenAlexW3095427670

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.