Evidence map›Paper›PMID 40286474›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2025

Prognostic relation of body mass index on extended aromatase inhibition treatment in postmenopausal patients with estrogen receptor positive breast cancer: A retrospective analysis of the SOLE trial.

Giacomo Biganzoli, Edoardo Isnaldi, François Richard, Giuseppe Marano, Patrizia Boracchi, Marion Maetens, Giuseppe Floris, Patrick Neven, Guy Jerusalem, Elisabetta Munzone and 11 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00553410 (SOLE, Study of Letrozole Extension, A Phase III Trial Evaluating the Role of Continuous Letrozole Versus Intermittent Letrozole Following 4 to 6 Years of Prior Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone-Receptor Positive, Node Positive Early Stage Breast Cancer), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT00553410 phase3completednot on this map

SOLE, Study of Letrozole Extension, A Phase III Trial Evaluating the Role of Continuous Letrozole Versus Intermittent Letrozole Following 4 to 6 Years of Prior Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone-Receptor Positive, Node Positive Early Stage Breast Cancer

TypeinterventionalSponsorETOP IBCSG Partners FoundationRan2007 to 2019Enrolled4,884ConditionsBreast CancerArmsLetrozole
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

21 authors.

Giacomo BiganzoliUnit of Medical Statistics, Biometry and Epidemiology, Department of Biomedical and Clinical Sciences (DIBIC) "L. Sacco" & DSRC, LITA Vialba campus, University of Milan, Milan, Italy.
Edoardo IsnaldiKU Leuven, Department of Oncology, Laboratory for Translational Breast Cancer Research, Leuven, Belgium.
François RichardKU Leuven, Department of Oncology, Laboratory for Translational Breast Cancer Research, Leuven, Belgium.
Giuseppe MaranoUnit of Medical Statistics, Biometry and Epidemiology, Department of Biomedical and Clinical Sciences (DIBIC) "L. Sacco" & DSRC, LITA Vialba campus, University of Milan, Milan, Italy.
Patrizia BoracchiUnit of Medical Statistics, Biometry and Epidemiology, Department of Biomedical and Clinical Sciences (DIBIC) "L. Sacco" & DSRC, LITA Vialba campus, University of Milan, Milan, Italy.
Marion MaetensKU Leuven, Department of Oncology, Laboratory for Translational Breast Cancer Research, Leuven, Belgium.
Giuseppe FlorisKU Leuven, Translational Cell and Tissue Research Unit, Department of Imaging and Pathology, Leuven, Belgium; University Hospitals Leuven, Department of Pathology, Leuven, Belgium.
Patrick NevenGynecologic Oncology and Multidisciplinary Breast Center, University Hospitals UZ-Leuven, KU Leuven, Leuven, Belgium.
Guy JerusalemMedical Oncology Department, CHU Liège, Liège University, Liège, Belgium.
Elisabetta MunzoneDivision of Medical Senology, IEO European Institute of Oncology IRCCS, Milan, Italy.
Erika HitreDepartment of Medical Oncology and Clinical Pharmacology "B", National Institute of Oncology, Budapest, Hungary.
Andrea GombosMedical Oncology Department, Institut Jules Bordet and Université Libre de Bruxelles (ULB), Brussels, Belgium.
Alastair ThompsonDivision of Surgical Oncology, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, USA.
Stefan AebiDivision of Medical Oncology, Cancer Center, Lucerne Cantonal, Hospital, Lucerne, Switzerland; Faculty of Medicine, University of Bern, Bern, Switzerland.
Roswitha KammlerTranslational Research Coordination, ETOP IBCSG Partners Foundation, Bern, Switzerland.
Patrizia Dell'OrtoIBCSG Central Pathology Office, Milan, Italy.
Giuseppe VialeIBCSG Central Pathology Office, Milan, Italy; Department of Pathology and Laboratory Medicine, IEO European Institute of Oncology IRCCS, Milan, Italy.
Meredith M ReganIBCSG Statistical Center, Division of Biostatistics, Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA.
Marco ColleoniDivision of Medical Senology, IEO European Institute of Oncology IRCCS, Milan, Italy.
Elia BiganzoliUnit of Medical Statistics, Biometry and Epidemiology, Department of Biomedical and Clinical Sciences (DIBIC) "L. Sacco" & DSRC, LITA Vialba campus, University of Milan, Milan, Italy; KU Leuven, Department of Oncology, Laboratory for Translational Breast Cancer Research, Leuven, Belgium.
Christine DesmedtKU Leuven, Department of Oncology, Laboratory for Translational Breast Cancer Research, Leuven, Belgium. Electronic address: christine.desmedt@kuleuven.be.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundObesity is associated with a greater risk of developing distant recurrences in patients with estrogen receptor-positive (ER+) breast cancer. This association is however poorly investigated in patients treated with extended endocrine treatment (ET). We therefore evaluated the prognostic role of BMI in the SOLE trial, where postmenopausal patients, after having completed 4-6 years of adjuvant ET, were treated with 5 additional years of continuous or intermittent letrozole. PATIENTS &

methodsWe considered the 3606 patients with ER+ /HER2- lymph node-positive BC with available BMI from the SOLE trial (NCT00553410). Distant-recurrence free interval (DRFI) was the main endpoint, and breast cancer-free interval (BCFI), disease-free survival (DFS) and overall survival (OS) secondary endpoints. Adjusted risk ratios (RR) for distant metastases were estimated with crude cumulative incidence models.

results38.6 % of the patients were underweight or normal weight, 36.5 % overweight and 24.9 % obese. BMI was associated with age, tumor size, number of positive lymph nodes, menopausal status and type of prior ET. In the adjusted analyses, the prognostic value of BMI was dependent on prior ET and extended ET arm (second-order interaction p-value<0.001 for DRFI, BCFI and DFS, but not for OS). For instance, in patients treated with both a selective estrogen receptor modulator and an aromatase inhibitor in the first five years, obesity, as compared to normal-weight, was associated with better (RR

conclusionWe observed that the prognostic relation of BMI changes according to the type of adjuvant ET and mode of administration of extended AI. This warrants further investigation.

Indexed as

Antineoplastic Agents, HormonalAromatase InhibitorsBody Mass IndexBreast NeoplasmsObesityReceptors, EstrogenAgedDisease-Free SurvivalFemaleHumansLetrozoleMiddle AgedPostmenopausePrognosisRetrospective StudiesAntineoplastic Agents, HormonalAromatase InhibitorsLetrozoleReceptors, EstrogenBody mass indexBreast cancerExtended endocrine therapyObesity

Identifiers

PMID40286474
PMCPMC12118534

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Registered trials

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.