Evidence map›Paper›PMID 32750143›Full record

Trial reportJournal of the National Cancer Institute2021

Clinical Implications of Body Mass Index in Metastatic Breast Cancer Patients Treated With Abemaciclib and Endocrine Therapy.

Maria Alice Franzoi, Daniel Eiger, Lieveke Ameye, Noam Ponde, Rafael Caparica, Claudia De Angelis, Mariana Brandão, Christine Desmedt, Serena Di Cosimo, Nuria Kotecki and 4 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the National Cancer Institute, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
2.7field-weighted citation impact, top 8% 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

31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 45 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

14 authors at 6 institutions in 3 countries.

Maria Alice FranzoiClinical Trials Support Unit, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.
Daniel EigerClinical Trials Support Unit, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.
Lieveke AmeyeClinical Trials Support Unit, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.
Noam PondeOncology Department, AC Camargo Cancer Center, São Paulo, Brazil.
Rafael CaparicaClinical Trials Support Unit, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.
Claudia De AngelisClinical Trials Support Unit, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.
Mariana BrandãoClinical Trials Support Unit, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.
Christine DesmedtLaboratory for Translational Breast Cancer Research, Department of Oncology, KU Leuven, Leuven, Belgium.
Serena Di CosimoFondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.
Nuria KoteckiOncology Department, Institut Jules Bordet, Brussels, Belgium.
Matteo LambertiniUniversity of Genova and IRCCS Ospedale Policlinico San Martino, Genova, Italy.
Ahmad AwadaOncology Department, Institut Jules Bordet, Brussels, Belgium.
Martine PiccartOncology Department, Institut Jules Bordet, Brussels, Belgium.
Evandro de AzambujaClinical Trials Support Unit, Institut Jules Bordet, and l'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.
Université Libre de Bruxelles · BEInstitut Jules Bordet · BEAC Camargo Hospital · BRFondazione IRCCS Istituto Nazionale dei Tumori · ITKU Leuven · BEOspedale Policlinico San Martino · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are limited data regarding the impact of body mass index (BMI) on outcomes in advanced breast cancer, especially in patients treated with endocrine therapy (ET) + cyclin-dependent kinase 4/6 inhibitors.

methodsA pooled analysis of individual patient-level data from MONARCH 2 and 3 trials was performed. Patients were classified according to baseline BMI into underweight (<18.5 kg/m2), normal (18.5-24.9 kg/m2), overweight (25-29.9 kg/m2), and obese (≥30 kg/m2) and divided into 2 treatment groups: abemaciclib + ET vs placebo + ET. The primary endpoint was progression-free survival (PFS) according to BMI in each treatment group. Secondary endpoints were response rate, adverse events according to BMI, and loss of weight (≥5% from baseline) during treatment.

resultsThis analysis included 1138 patients (757 received abemaciclib + ET and 381 placebo + ET). There was no difference in PFS between BMI categories in either group, although normal-weight patients presented a numerically higher benefit with abemaciclib + ET (Pinteraction = .07). Normal and/or underweight patients presented higher overall response rate in the abemaciclib + ET group compared with overweight and/or obese patients (49.4% vs 41.6%, odds ratio = 0.73, 95% confidence interval = 0.54 to 0.99) as well as higher neutropenia frequency (51.0% vs 40.4%, P = .004). Weight loss was more frequent in the abemaciclib + ET group (odds ratio = 3.23, 95% confidence interval = 2.09 to 5.01).

conclusionsAdding abemaciclib to ET prolongs PFS regardless of BMI, showing that overweight or obese patients also benefit from this regimen. Our results elicit the possibility of a better effect of abemaciclib in normal and/or underweight patients compared with overweight and/or obese patients. More studies analyzing body composition parameters in patients under treatment with cyclin-dependent kinase 4/6 inhibitors may further clarify this hypothesis.

Indexed as

Body Mass IndexAdultAgedAged, 80 and overAminopyridinesAntineoplastic Agents, HormonalAromatase InhibitorsBenzimidazolesBreast NeoplasmsConfidence IntervalsCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6FemaleFulvestrantHumansMiddle AgedabemaciclibAminopyridinesAntineoplastic Agents, HormonalAromatase InhibitorsBenzimidazolesCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6FulvestrantPlacebos

Identifiers

PMID32750143
PMCPMC8023855
OpenAlexW3048214562

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.