Evidence map›Paper›PMID 35076812›Full record

Trial reportBreast cancer research and treatment2022

Implication of body mass index (BMI) on the biological and clinical effects of endocrine therapy plus abemaciclib as neoadjuvant therapy for early breast cancer patients.

Maria Alice Franzoi, Matteo Lambertini, Marcello Ceppi, Marco Bruzzone, Evandro de Azambuja

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02441946 (neoMONARCH), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT02441946 phase2completednot on this map

neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination With Anastrozole to Those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy With Abemaciclib in Combination With Anastrozole in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer

TypeinterventionalSponsorEli Lilly and CompanyRan2015 to 2018Enrolled224ConditionsBreast Cancer, Hormone Receptor Positive Tumor, Early-Stage Breast CarcinomaArmsAbemaciclib, Loperamide, Anastrozole
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. 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

5 authors.

Maria Alice FranzoiClinical Trials Support Unit and Academic Trials Promoting Team, Institut Jules Bordet and L'Université Libre de Bruxelles (U.L.B), Brussels, Belgium. franzoi.alice@gmail.com.ORCID http://orcid.org/0000-0002-2470-6054
Matteo LambertiniDepartment of Medical Oncology, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Marcello CeppiClinical Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Marco BruzzoneClinical Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
Evandro de AzambujaClinical Trials Support Unit and Academic Trials Promoting Team, Institut Jules Bordet and L'Université Libre de Bruxelles (U.L.B), Brussels, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeInferior overall response rate with abemaciclib plus endocrine therapy was observed in patients with hormone receptor-positive/HER2-negative advanced breast cancer (BC) and BMI ≥ 25. We assessed the impact of baseline BMI on KI67% changes, achievement of complete cell cycle arrest (CCCA), clinical, and radiological responses in patients included in the NEOMONARCH trial.

methodsExploratory post hoc analysis of the NEOMONARCH trial was performed. Patients were classified according to baseline BMI into underweight/normal weight (BMI < 25 kg/m

results222 patients (84.4%) had baseline BMI information available. In the overall cohort, mean Ki67% changes at 2 weeks were similar between the two BMI groups: - 19 (IQR - 27.8 to - 10.4) for patients with BMI < 25 and - 17.2 (IQR - 26.8 to - 11) for patients with BMI ≥ 25 (p = 0.760). There was no statistical difference in patients achieving CCCA after 2 weeks of treatment according to BMI (p = 0.096). Mean Ki67% reduction at 2 weeks was significantly higher for patients receiving abemaciclib plus anastrozole when compared to either anastrozole or abemaciclib alone, regardless of BMI. At the end of treatment, there was no significant difference regarding radiological (p = 0.366) or clinical response (p = 0.261).

conclusionBMI categorized by the threshold of 25 did not significantly impact KI67% changes or clinical and radiological response. Although limited by the small sample size, these results are reassuring that the combination of abemaciclib plus anastrazole appears to be active in the early setting regardless of baseline BMI.

trial registrationClinicalTrials.gov identifier: NCT02441946.

Indexed as

Breast NeoplasmsNeoadjuvant TherapyAminopyridinesAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesBody Mass IndexErb-b2 Receptor Tyrosine KinasesFemaleHumansabemaciclibAminopyridinesBenzimidazolesErb-b2 Receptor Tyrosine KinasesAbemaciclibAnastrazoleBody mass indexKi67 changesNeoadjuvant treatment

Identifiers

PMID35076812

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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.