Evidence map›Paper›PMID 38778365›Full record

SynthesisBreast cancer research : BCR2024

Reporting on patient's body mass index (BMI) in recent clinical trials for patients with breast cancer: a systematic review.

Josephine Van Cauwenberge, Karen Van Baelen, Marion Maetens, Tatjana Geukens, Ha Linh Nguyen, Ines Nevelsteen, Ann Smeets, Anne Deblander, Patrick Neven, Stijn Koolen and 3 more

Abstract readSystematic Review
In one paragraph

Synthesis in Breast cancer research : BCR, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Black Cumin Seed (Food science & nutrition · 2025
    Article
  5. The evolving tumor-associated adipose tissue microenvironment in breast cancer: from cancer initiation to metastatic outgrowth.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Review
  6. Article
  7. Article
  8. Article
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.

Josephine Van Cauwenberge *Laboratory for Translational Breast Cancer Research, Department of Oncology, KU Leuven, Herestraat 49, Box 808, 3000, Louvain, Belgium.
Karen Van Baelen *Laboratory for Translational Breast Cancer Research, Department of Oncology, KU Leuven, Herestraat 49, Box 808, 3000, Louvain, Belgium.
Marion MaetensLaboratory for Translational Breast Cancer Research, Department of Oncology, KU Leuven, Herestraat 49, Box 808, 3000, Louvain, Belgium.
Tatjana GeukensLaboratory for Translational Breast Cancer Research, Department of Oncology, KU Leuven, Herestraat 49, Box 808, 3000, Louvain, Belgium.
Ha Linh NguyenLaboratory for Translational Breast Cancer Research, Department of Oncology, KU Leuven, Herestraat 49, Box 808, 3000, Louvain, Belgium.
Ines NevelsteenDepartment of Surgical Oncology, University Hospitals Leuven, Leuven, Belgium.
Ann SmeetsDepartment of Surgical Oncology, University Hospitals Leuven, Leuven, Belgium.
Anne DeblanderDepartment of Gynecological Oncology, University Hospitals Leuven, Leuven, Belgium.
Patrick NevenDepartment of Gynecological Oncology, University Hospitals Leuven, Leuven, Belgium.
Stijn KoolenDepartment of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Hans WildiersDepartment of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.
Kevin PunieDepartment of Medical Oncology, GZA Hospitals Sint-Augustinus, Wilrijk, Belgium.
Christine DesmedtLaboratory for Translational Breast Cancer Research, Department of Oncology, KU Leuven, Herestraat 49, Box 808, 3000, Louvain, Belgium. christine.desmedt@kuleuven.be.ORCID 0000-0002-5223-5579

Funding

European Research Council (ERC) FAT-BC 101003153
6 · The paper itself

Abstract

backgroundThe proportion of patients with breast cancer and obesity is increasing. While the therapeutic landscape of breast cancer has been expanding, we lack knowledge about the potential differential efficacy of most drugs according to the body mass index (BMI). Here, we conducted a systematic review on recent clinical drug trials to document the dosing regimen of recent drugs, the reporting of BMI and the possible exclusion of patients according to BMI, other adiposity measurements and/or diabetes (leading comorbidity of obesity). We further explored whether treatment efficacy was evaluated according to BMI.

methodsA search of Pubmed and ClinicalTrials.gov was performed to identify phase I-IV trials investigating novel systemic breast cancer treatments. Dosing regimens and exclusion based on BMI, adiposity measurements or diabetes, documentation of BMI and subgroup analyses according to BMI were assessed.

results495 trials evaluating 26 different drugs were included. Most of the drugs (21/26, 81%) were given in a fixed dose independent of patient weight. BMI was an exclusion criterion in 3 out of 495 trials. Patients with diabetes, the leading comorbidity of obesity, were excluded in 67/495 trials (13.5%). Distribution of patients according to BMI was mentioned in 8% of the manuscripts, subgroup analysis was performed in 2 trials. No other measures of adiposity/body composition were mentioned in any of the trials. Retrospective analyses on the impact of BMI were performed in 6 trials.

conclusionsPatient adiposity is hardly considered as most novel drug treatments are given in a fixed dose. BMI is generally not reported in recent trials and few secondary analyses are performed. Given the prevalence of patients with obesity and the impact obesity can have on pharmacokinetics and cancer biology, more attention should be given by investigators and study sponsors to reporting patient's BMI and evaluating its impact on treatment efficacy and toxicity.

Indexed as

Body Mass IndexBreast NeoplasmsClinical Trials as TopicObesityAntineoplastic AgentsFemaleHumansTreatment OutcomeAntineoplastic AgentsBody mass index (BMI)Breast cancerClinical drug trialsDosingObesityTreatment efficacy

Identifiers

PMID38778365
PMCPMC11112918

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.